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Therapeutic Goods Act 1989

  • - C2010C00430
  • In force - Superseded Version
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Act No. 21 of 1990 as amended, taking into account amendments up to Act No. 54 of 2010
An Act relating to therapeutic goods
Administered by: Health
Registered 01 Jul 2010
Start Date 01 Jul 2010
End Date 15 Dec 2010
Table of contents.
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Collapse Chapter 1—PreliminaryChapter 1—Preliminary
1 Short title [see Note 1]
2 Commencement [see Note 1]
3 Interpretation
3A Declaration—member of European Community
3B Declaration—country covered by non‑EC EFTA MRA
3C Exempting monographs in pharmacopoeias
4 Objects of Act
5 Act to bind Crown
5A Application of the Criminal Code—extended geographical jurisdiction
6 Operation of Act
6AAA Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws
6AAB When duty imposed
6AAC Imposing duty under State law
6AAD Conferral of jurisdiction on federal courts
6AAE Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority
6B Review of certain decisions under State laws
6C Fees payable to Commonwealth under State laws
7 Declaration that goods are are not therapeutic goods
7A Authorised persons
7B Kits
7C Secretary may arrange for use of computer programs to make decisions
8 Power to obtain information with respect to therapeutic goods
9 Arrangements with States etc.
Expand Chapter 2—Australian Register of Therapeutic GoodsChapter 2—Australian Register of Therapeutic Goods
Chapter 3—Medicines and other therapeutic goods that are not medical devices
Expand Part 3‑1—StandardsPart 3‑1—Standards
Expand Part 3‑2—Registration and listing of therapeutic goodsPart 3‑2—Registration and listing of therapeutic goods
Expand Part 3‑3—Manufacturing of therapeutic goodsPart 3‑3—Manufacturing of therapeutic goods
Chapter 4—Medical devices
Expand Part 4‑1—IntroductionPart 4‑1—Introduction
Expand Part 4‑2—Essential principles and medical device standardsPart 4‑2—Essential principles and medical device standards
Expand Part 4‑3—Conformity assessment proceduresPart 4‑3—Conformity assessment procedures
Expand Part 4‑4—Conformity assessment certificatesPart 4‑4—Conformity assessment certificates
Expand Part 4‑5—Including medical devices in the RegisterPart 4‑5—Including medical devices in the Register
Expand Part 4‑6—Suspension and cancellation from the RegisterPart 4‑6—Suspension and cancellation from the Register
Expand Part 4‑6A—Exempting medical devices to deal with emergenciesPart 4‑6A—Exempting medical devices to deal with emergencies
Expand Part 4‑7—Other exemptions from including medical devices in the RegisterPart 4‑7—Other exemptions from including medical devices in the Register
Expand Part 4‑8—Obtaining informationPart 4‑8—Obtaining information
Expand Part 4‑9—Public notification and recovery of medical devicesPart 4‑9—Public notification and recovery of medical devices
Expand Part 4‑10—Assessment feesPart 4‑10—Assessment fees
Expand Part 4‑11—Offences and civil penalty provisions relating to medical devicesPart 4‑11—Offences and civil penalty provisions relating to medical devices
Chapter 5—Advertising, counterfeit therapeutic goods and product tampering
Expand Part 5‑1—Advertising and generic informationPart 5‑1—Advertising and generic information
Expand Part 5‑2—Counterfeit therapeutic goodsPart 5‑2—Counterfeit therapeutic goods
Expand Part 5‑3—Product tamperingPart 5‑3—Product tampering
Chapter 5A—Enforcement
Expand Part 5A‑1—Civil penaltiesPart 5A‑1—Civil penalties
Expand Part 5A‑2—Infringement noticesPart 5A‑2—Infringement notices
Expand Part 5A‑3—Enforceable undertakingsPart 5A‑3—Enforceable undertakings
Chapter 6—Administration
Expand Part 6‑1—Payment of chargesPart 6‑1—Payment of charges
Expand Part 6‑2—Entry, searches and warrantsPart 6‑2—Entry, searches and warrants
Expand Part 6‑3—Scheduling of substancesPart 6‑3—Scheduling of substances
Expand Chapter 7—MiscellaneousChapter 7—Miscellaneous
Expand Chapter 8—Repeal and transitional provisionsChapter 8—Repeal and transitional provisions
Schedule—Consequential Amendments

Therapeutic Goods Act 1989

Act No. 21 of 1990 as amended

This compilation was prepared on 1 July 2010
taking into account amendments up to Act No. 54 of 2010

The text of any of those amendments not in force
on that date is appended in the Notes section

The operation of amendments that have been incorporated may be affected
by application provisions that are set out in the Notes section

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department,
Canberra

  

  

  


Contents

Chapter 1—Preliminary                                                                                                       1

1............ Short title [see Note 1]....................................................................... 1

2............ Commencement [see Note 1].............................................................. 1

3............ Interpretation...................................................................................... 1

3A......... Declaration—member of European Community.............................. 16

3B......... Declaration—country covered by non‑EC/EFTA MRA................. 16

3C......... Exempting monographs in pharmacopoeias..................................... 16

4............ Objects of Act.................................................................................. 17

5............ Act to bind Crown............................................................................ 17

5A......... Application of the Criminal Code—extended geographical jurisdiction  18

6............ Operation of Act.............................................................................. 18

6AAA... Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws.......................................................................................................... 18

6AAB... When duty imposed......................................................................... 19

6AAC... Imposing duty under State law......................................................... 20

6AAD... Conferral of jurisdiction on federal courts........................................ 21

6AAE.... Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority.......................................................................................................... 22

6B......... Review of certain decisions under State laws................................... 22

6C......... Fees payable to Commonwealth under State laws........................... 23

7............ Declaration that goods are/are not therapeutic goods....................... 23

7A......... Authorised persons.......................................................................... 24

7B......... Kits................................................................................................... 24

7C......... Secretary may arrange for use of computer programs to make decisions                25

8............ Power to obtain information with respect to therapeutic goods...... 25

9............ Arrangements with States etc........................................................... 26

Chapter 2—Australian Register of Therapeutic Goods                                 27

9A......... Australian Register of Therapeutic Goods....................................... 27

9B......... When registrations or listings of medical devices are taken to be cancelled             28

9C......... Inspection of entries in Register....................................................... 30

9D......... Variation of entries in Register......................................................... 30

9E.......... Publication of list of goods on Register............................................ 31

Chapter 3—Medicines and other therapeutic goods that are not medical devices               32

Part 3‑1—Standards                                                                                                            32

10.......... Determination of standards.............................................................. 32

10A....... Application of standards to medical devices.................................... 33

13.......... Special provisions relating to standards........................................... 33

14.......... Criminal offences for importing, supplying or exporting goods that do not comply with standards     35

14A....... Civil penalties for importing, supplying or exporting goods that do not comply with standards          39

14B....... Application of Customs Act 1901.................................................... 40

15.......... Criminal offences relating to breaching a condition of a consent...... 41

15AA.... Civil penalty relating to breaching a condition of a consent............. 41

Part 3‑2—Registration and listing of therapeutic goods                                 43

Division 1—Preliminary                                                                                            43

15A....... Application of this Part to medical devices...................................... 43

16.......... Therapeutic goods and gazetted groups........................................... 45

18.......... Exempt goods................................................................................... 46

18A....... Exemption because of emergency..................................................... 46

19.......... Exemptions for special and experimental uses................................. 50

19A....... Exemptions where unavailability etc. of therapeutic goods............. 52

19B....... Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods................................................................................................. 54

19C....... Notice required to adduce evidence in support of exception under subsection 19B(6)           57

19D....... Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods................................................................................................. 59

20.......... Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A              61

20A....... Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification........................................................................................ 63

21.......... Offence relating to wholesale supply............................................... 64

21A....... General criminal offences relating to this Part.................................. 64

21B....... General civil penalties relating to this Part....................................... 69

22.......... General offences relating to this Part................................................ 70

22AA.... Civil penalty for breaching a condition of an exemption.................. 72

22A....... Criminal offences for false statements in applications for registration 73

22B....... Civil penalty for false statements in applications for registration... 74

Division 2—Registration and listing                                                                   75

23.......... Applications generally...................................................................... 75

24.......... Applications for registration............................................................ 75

24A....... When evaluation fee due for payment.............................................. 76

24B....... Payment of evaluation fee by instalments........................................ 76

24C....... Recovery of evaluation fee............................................................... 77

24D....... Reduction of evaluation fee where evaluation not completed within prescribed period         77

24E........ Deemed refusal of application.......................................................... 78

25.......... Evaluation and registration of therapeutic goods.............................. 78

25A....... When the Secretary must not use protected information................. 82

25B....... Registration of therapeutic device to which EC/EFTA attestation of conformity applies     83

26.......... Listing of therapeutic goods............................................................. 83

26AA.... Listing of therapeutic device to which EC/EFTA attestation of conformity applies              87

26A....... Listing of certain medicines.............................................................. 88

26B....... Certificates required in relation to patents....................................... 91

26BA.... Approved form for notices............................................................... 93

26BB..... Permissible active ingredients........................................................... 93

26BC..... Variation of list of active ingredients—Minister’s initiative............ 94

26BD.... Variation of list of active ingredients—application by person......... 94

26BE..... Prohibited or limited components or ingredients.............................. 95

26C....... Certificates required in relation to patent infringement proceedings 96

26D....... Requirements for interlocutory injunction....................................... 98

27.......... Registration or listing number......................................................... 100

28.......... Conditions of registration or listing................................................ 100

28A....... Certification of manufacturing steps outside Australia following application for listing        104

29.......... Duration of registration or listing................................................... 104

29A....... Criminal offence for failing to notify adverse effects etc. of goods 104

29AA.... Civil penalty for failing to notify adverse effects etc. of goods..... 105

29B....... Notification of adverse effects etc. where application withdrawn or lapses           106

29C....... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses            106

29D....... Suspension of registration or listing............................................... 107

29E........ When suspension takes effect etc................................................... 108

29F........ Revocation of suspension............................................................... 109

29G....... Effect of suspension....................................................................... 109

30.......... Cancellation of registration or listing.............................................. 110

30A....... Revocation of cancellation of registration or listing upon request.. 113

30C....... Consultation with Gene Technology Regulator............................. 113

30D....... Secretary may seek advice about classes of GM products or genetically modified organisms               114

30E........ Secretary to take advice into account............................................. 114

Division 2A—Public notification and recovery of therapeutic goods 116

30EA..... Public notification and recovery of therapeutic goods................... 116

30EB..... Publication of requirements............................................................ 118

30EC..... Criminal offences for non‑compliance with requirements.............. 118

30ECA.. Civil penalty for non‑compliance with requirements..................... 119

30ED..... Powers of suspension and cancellation unaffected......................... 119

Division 3—General                                                                                                  120

30F........ Criminal offences for goods exempt under section 18A not conforming to standards etc.      120

30FA..... Civil penalty for goods exempt under section 18A not conforming to standards etc.             122

30G....... Disposal of unused goods exempt under section 18A.................... 122

30H....... Record for goods exempt under section 18A.................................. 123

31.......... Secretary may require information................................................. 123

31AAA. Civil penalty for providing false or misleading information in relation to medicines listed under section 26A      127

31A....... Secretary may require information etc. about goods exempt under section 18        127

31AA.... Secretary may require information etc. about goods exempt under section 18A     128

31B....... Secretary may require information relating to approvals and authorities under section 19     129

31C....... Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B               130

31D....... False or misleading information...................................................... 131

31E........ False or misleading documents....................................................... 131

31F........ Self‑incrimination............................................................................ 132

Part 3‑3—Manufacturing of therapeutic goods                                                 133

33A....... Application of this Part to medical devices.................................... 133

34.......... Exempt goods and exempt persons................................................ 133

35.......... Criminal offences relating to manufacturing therapeutic goods...... 133

35A....... Civil penalties relating to manufacturing therapeutic goods........... 136

35B....... Criminal offences relating to breaching a condition of a licence...... 137

35C....... Civil penalty relating to breaching a condition of a licence............. 138

36.......... Manufacturing principles............................................................... 138

37.......... Application for licence................................................................... 139

38.......... Grant of licence............................................................................... 140

38A....... Guidelines for multi‑site licences.................................................... 143

38B....... Splitting multi‑site licences............................................................. 143

39.......... Term of licence............................................................................... 145

40.......... Conditions of licences..................................................................... 145

40A....... Variation of manufacturing site authorisations—Secretary’s own initiative           148

40B....... Variation of licences—application by licence holder...................... 148

41.......... Revocation and suspension of licences........................................... 150

41AA.... Spent convictions scheme............................................................... 153

41AAA. Transfer of licences......................................................................... 153

41A....... Publication of list of manufacturers etc.......................................... 153

Chapter 4—Medical devices                                                                                        154

Part 4‑1—Introduction                                                                                                      154

Division 1—Overview of this Chapter                                                            154

41B....... General............................................................................................ 154

41BA.... Requirements for medical devices (Parts 4‑2 and 4‑3)................... 154

41BB..... Administrative processes (Parts 4‑4 to 4‑10)................................ 154

41BC..... Enforcement (Part 4‑11)................................................................. 155

Division 2—Interpretation                                                                                     156

41BD.... What is a medical device................................................................. 156

41BE..... Kinds of medical devices................................................................ 157

41BEA.. Excluded purposes.......................................................................... 158

41BF..... System or procedure packs............................................................ 158

41BG.... Manufacturers of medical devices.................................................. 158

41BH.... Meaning of compliance with essential principles........................... 159

41BI...... Meaning of non‑application of conformity assessment procedures 160

Division 3—Application provisions                                                                   161

41BJ...... Application of this Chapter to medical devices covered by Part 3‑2 161

41BK.... Application of the Criminal Code.................................................. 161

Part 4‑2—Essential principles and medical device standards                   162

41C....... What this Part is about................................................................... 162

Division 1—Essential principles                                                                         163

41CA.... Essential principles......................................................................... 163

Division 2—Medical device standards                                                            164

41CB..... Medical device standards................................................................ 164

41CC..... Content of medical device standards.............................................. 164

41CD.... Inconsistencies between medical device standards......................... 165

Part 4‑3—Conformity assessment procedures                                                   166

41D....... What this Part is about................................................................... 166

Division 1—Conformity assessment procedures                                      167

41DA.... Conformity assessment procedures............................................... 167

41DB.... Medical device classifications......................................................... 168

Division 2—Conformity assessment standards                                          169

41DC.... Conformity assessment standards.................................................. 169

41DD.... Content of conformity assessment standards................................ 169

41DE..... Inconsistencies between conformity assessment standards........... 170

Part 4‑4—Conformity assessment certificates                                                   171

41E........ What this Part is about................................................................... 171

Division 1—Issuing conformity assessment certificates                       172

41EA..... When conformity assessment certificates are required................... 172

41EB..... Applications................................................................................... 172

41EC..... Considering applications................................................................ 173

41ED..... Time for making decisions on applications.................................... 174

41EE..... Procedure following making a decision whether to issue certificate 175

41EF..... Duration of certificate..................................................................... 175

41EG..... Lapsing of applications.................................................................. 175

41EH..... Treating applications as having been refused................................. 176

41EI...... Criminal offences for making a false statement.............................. 177

41EIA... Civil penalty for making a false statement..................................... 178

Division 2—Conditions                                                                                            179

41EJ...... Automatic conditions on conformity assessment certificates........ 179

41EK..... Conditions imposed when conformity assessment certificates are issued              181

41EL..... Conditions imposed after issuing a conformity assessment certificate 181

Division 3—Suspension of conformity assessment certificates         182

41EM.... Suspension of conformity assessment certificates......................... 182

41EN..... Notice of proposed suspension...................................................... 182

41EO..... Duration of suspension.................................................................. 183

41EP..... Revocation of suspension............................................................... 183

41EQ..... Powers of revocation of conformity assessment certificates unaffected 184

Division 4—Revocation of conformity assessment certificates         185

41ER..... Automatic revocation of conformity assessment certificates......... 185

41ES...... Immediate revocation of conformity assessment certificates......... 185

41ET..... Revocation of conformity assessment certificates after notice of proposed revocation         185

41EU..... Limiting revocation of conformity assessment certificates to some medical devices of a particular kind               187

41EV..... Publication of revocation etc. of conformity assessment certificates 188

41EW.... Date of effect of revocation etc. of conformity assessment certificates  188

Part 4‑5—Including medical devices in the Register                                      189

41F........ What this Part is about................................................................... 189

Division 1—Including medical devices in the Register                         190

41FA..... What this Division is about............................................................ 190

41FB..... How this Division works............................................................... 191

Subdivision A—Applications                                                                                 191

41FC..... Applications................................................................................... 191

41FD..... Matters to be certified.................................................................... 192

41FE..... Criminal offences for making a false statement.............................. 193

41FEA.. Civil penalty for making a false statement..................................... 195

Subdivision B—Including kinds of medical devices in the Register             195

41FF..... Obligation to include kinds of medical devices in the Register....... 195

41FG..... Notification of unsuccessful applications...................................... 196

Subdivision C—Auditing of applications                                                            196

41FH..... Selecting applications for auditing.................................................. 196

41FI...... Auditing of applications................................................................. 196

41FJ...... Procedure following audits............................................................. 197

41FK..... Lapsing of applications.................................................................. 197

Subdivision D—Miscellaneous                                                                             198

41FL..... Device number................................................................................ 198

41FM.... Duration of inclusion in the Register.............................................. 198

Division 2—Conditions                                                                                            199

41FN..... Conditions applying automatically................................................ 199

41FO..... Conditions imposed when kinds of medical devices are included in the Register    201

41FP..... Conditions imposed after kinds of medical devices are included in the Register     202

Part 4‑6—Suspension and cancellation from the Register                          203

Division 1—Suspension from the Register                                                   203

Subdivision A—General power of suspension                                                   203

41G....... What this Part is about................................................................... 203

41GA.... Suspension of kinds of medical devices from the Register............. 203

41GB.... Notice of proposed suspension must be given in certain cases...... 204

41GC.... Duration of suspension.................................................................. 204

41GD.... Revocation of suspension............................................................... 205

41GE..... Treating applications for revocation as having been refused.......... 206

Subdivision B—Suspension as a result of suspension under Part 4‑4         206

41GF..... Suspension of kinds of medical devices from the Register............. 206

41GG.... Duration of suspension.................................................................. 207

41GH.... Revocation of suspension............................................................... 207

Subdivision C—Effect of suspension                                                                   207

41GI...... Effect of suspension....................................................................... 207

41GJ..... Powers of cancellation from Register unaffected............................ 208

Division 2—Cancellation of entries from the Register                          209

41GK.... Automatic cancellation of entries of kinds of medical devices from the Register    209

41GL..... Immediate cancellation of entries of kinds of medical devices from the Register    209

41GM... Cancellation of entries of kinds of medical devices from the Register after section 41JA notice            210

41GN.... Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation          211

41GO.... Limiting cancellation of entries from Register to some medical devices of a particular kind   212

41GP..... Publication of cancellation of entry from Register......................... 212

41GQ.... Date of effect of cancellation of entries from Register................... 213

Part 4‑6A—Exempting medical devices to deal with emergencies         214

41GR.... What this Part is about................................................................... 214

41GS..... Minister may make exemptions..................................................... 214

41GT.... Conditions of exemptions............................................................... 215

41GU.... Variation or revocation of exemption............................................. 216

41GV.... Informing persons of exemption etc............................................... 217

41GW... Notification and tabling.................................................................. 217

41GY.... Disposal of unused medical devices............................................... 218

Part 4‑7—Other exemptions from including medical devices in the Register          219

41H....... What this Part is about................................................................... 219

41HA.... Devices exempted from inclusion in the Register........................... 219

41HB.... Exemptions for special and experimental uses............................... 220

41HC.... Exemptions for medical practitioners............................................. 221

Part 4‑8—Obtaining information                                                                                223

41J........ What this Part is about................................................................... 223

Division 1—Information relating to compliance with requirements and other matters                224

41JA..... Secretary may require information................................................. 224

41JB...... Complying with the Secretary’s requirements............................... 226

41JBA... Civil penalty for giving false or misleading information in purported compliance with a notice            227

41JC...... Self‑incrimination............................................................................ 228

Division 2—Information relating to medical devices covered by exemptions   229

41JCA... Secretary may require information etc. about medical devices exempt under Part 4‑6A         229

41JD..... Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register........................................................................................................ 229

41JE...... Secretary may require information relating to approvals under section 41HB        230

41JF...... Secretary may require information relating to authorities under section 41HC       232

41JG..... Criminal offences for failing to give information or documents sought under this Division    232

41JH..... False or misleading information...................................................... 233

41JI....... False or misleading documents....................................................... 233

41JJ....... Self‑incrimination............................................................................ 234

Part 4‑9—Public notification and recovery of medical devices                 235

41K....... What this Part is about................................................................... 235

41KA.... Public notification and recovery of medical devices....................... 235

41KB.... Publication of requirements............................................................ 237

41KC.... Criminal offences for failing to comply with requirements relating to a kind of medical device             238

41KCA. Civil penalty for failing to comply with requirements relating to a kind of medical device    238

41KD.... Powers of suspension and cancellation unaffected......................... 239

Part 4‑10—Assessment fees                                                                                         240

41L........ What this Part is about................................................................... 240

41LA..... Assessment fees............................................................................. 240

41LB..... When assessment fee due for payment.......................................... 241

41LC..... Payment of assessment fee by instalments.................................... 241

41LD..... Recovery of assessment fee............................................................ 241

41LE..... Reduction of conformity assessment fee where decision not made within prescribed period                241

Part 4‑11—Offences and civil penalty provisions relating to medical devices         243

41M...... What this Part is about................................................................... 243

Division 1—Non‑compliance with essential principles                           244

41MA... Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles........................................................................................ 244

41MAA Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles........................................................................................................ 248

41MB... Exceptions...................................................................................... 249

41MC... Criminal offences relating to breaching a condition of a consent.... 249

41MCA Civil penalty relating to breaching a condition of a consent........... 250

41MD... Treating medical devices as prohibited imports or exports............ 251

Division 2—Failure to apply conformity assessment procedures     252

41ME.... Criminal offences for failing to apply conformity assessment procedures—manufacturers   252

41MEA. Civil penalties for failing to apply conformity assessment procedures—manufacturers        254

41MF.... Criminal offences for failing to apply conformity assessment procedures—sponsors           255

41MG... Exceptions...................................................................................... 257

41MH... Criminal offence for making false statements in declarations......... 257

41MHA Civil penalty for making false statements in declarations.............. 258

Division 3—Medical devices not included in the Register and related matters              259

41MI..... Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register........................................................................................................ 259

41MIA.. Notice required to adduce evidence in support of exception under subsection 41MI(7)        261

41MIB.. Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register........................................................................................................ 263

41MJ.... Treating medical devices as prohibited imports or exports............ 264

41MK... Wholesale supply of medical devices not included in the Register 264

41ML.... False advertising about medical devices.......................................... 265

41MLA. Civil penalty for making misrepresentations about medical devices 265

41MM.. Claims about arranging supplies of medical devices not included in the Register    266

41MN... Criminal offences relating to breaches of conditions...................... 266

41MNA Civil penalties for breaching conditions.......................................... 268

Division 3A—Offences and civil penalties related to exemptions under Part 4‑6A       270

41MNB Criminal offences for breaching a condition of an exemption......... 270

41MNC Civil penalty for breaching a condition of an exemption................ 271

41MND Civil penalty for making misrepresentations about medical devices 271

Division 4—Other offences and civil penalty provisions                       272

41MO... Criminal offences for misusing medical devices exempted for special or experimental uses   272

41MP.... Criminal offence for failing to notify adverse events etc................ 274

41MPA. Civil penalty for failing to notify adverse events etc..................... 276

41MPB. Relief from liability for contraventions for failing to notify adverse events etc.     277

41MQ... Notification of adverse events etc. where application withdrawn or lapses           278

41MR... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses            278

Chapter 5—Advertising, counterfeit therapeutic goods and product tampering     280

Part 5‑1—Advertising and generic information                                                 280

Division 1—Preliminary                                                                                          280

42AA.... This Part not to apply to advertisements directed at health professionals etc.      280

42AB.... This Part not to apply to advertisements for goods not for human use  281

42AC.... This Part not to apply to advertisements for exported goods....... 281

42B....... Definitions...................................................................................... 281

42BAA. Therapeutic Goods Advertising Code............................................ 283

Division 2—Therapeutic goods advertisements for which an approval is required        284

42BA.... Application of Division.................................................................. 284

42C....... Offences relating to publication of advertisements........................ 284

Division 3—General provisions about advertising therapeutic goods 287

42DA.... Simplified outline............................................................................ 287

42DB.... Definitions...................................................................................... 287

42DD.... Restricted representations.............................................................. 287

42DE..... Applications for approval of use of restricted representation....... 288

42DF..... Approval of use of restricted representation................................. 288

42DG.... Notice of approval or refusal.......................................................... 288

42DH.... Variation of conditions of approval................................................ 289

42DI...... Withdrawal of approval.................................................................. 289

42DJ..... Prohibited and required representations......................................... 290

42DK.... Use of restricted or prohibited representations.............................. 290

Division 3A—Therapeutic goods advertisements for which an approval is not required            291

42DKA. Application of Division.................................................................. 291

42DKB. Certain representations not to be published or broadcast.............. 291

42DL..... Advertising offences....................................................................... 291

42DM... Compliance with Code................................................................... 293

Division 4—Generic information about ingredients or components of therapeutic goods          294

42DN.... Application of Division.................................................................. 294

42DO.... Compliance with the Code............................................................. 294

42DP..... Offences—publication of generic information................................ 294

Part 5‑2—Counterfeit therapeutic goods                                                               295

42E........ Offence of dealing with counterfeit therapeutic goods................... 295

42EA..... Civil penalty relating to dealing with counterfeit therapeutic goods 296

42EB..... Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods   296

42F........ Customs treatment of counterfeit therapeutic goods..................... 297

Part 5‑3—Product tampering                                                                                        298

42T....... Notifying of actual or potential tampering..................................... 298

42U....... Meaning of actual or potential tampering etc................................. 299

42V....... Recovery of therapeutic goods because of actual or potential tampering                299

42VA.... Civil penalty relating to the recovery of therapeutic goods because of actual or potential tampering    301

42VB..... Relief from liability for contraventions relating to the recovery of therapeutic goods because of actual or potential tampering........................................................................................ 302

42W...... Supply etc. of therapeutic goods that are subject to recovery requirements           302

42X....... Saving of other laws........................................................................ 303

Chapter 5A—Enforcement                                                                                            304

Part 5A‑1—Civil penalties                                                                                             304

Division 1—Obtaining an order for a civil penalty                                    304

42Y....... Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision    304

42YA.... What is a civil penalty provision?................................................... 305

42YB..... Meaning of penalty unit................................................................. 305

42YC..... Persons involved in contravening civil penalty provision.............. 305

42YD.... Recovery of a pecuniary penalty................................................... 305

42YE..... Gathering information for application for pecuniary penalty........ 306

Division 2—Civil penalty proceedings and criminal proceedings    307

42YF..... Civil proceedings after criminal proceedings.................................. 307

42YG.... Criminal proceedings during civil proceedings................................ 307

42YH.... Criminal proceedings after civil proceedings.................................. 307

42YI...... Evidence given in proceedings for civil penalty not admissible in criminal proceedings         307

Part 5A‑2—Infringement notices                                                                               309

42YJ...... Infringement notices in respect of offences.................................... 309

42YK.... Infringement notices in respect of civil penalty provisions........... 309

Part 5A‑3—Enforceable undertakings                                                                    310

42YL..... Enforcement of undertakings.......................................................... 310

Chapter 6—Administration                                                                                            311

Part 6‑1—Payment of charges                                                                                     311

43.......... By whom charges payable.............................................................. 311

44.......... Time for payment of charges.......................................................... 311

44A....... Exemptions from liability to pay charges....................................... 312

44B....... Recovery of unpaid charges............................................................ 313

45.......... Therapeutic Goods Administration Account................................. 314

Part 6‑2—Entry, searches and warrants                                                                316

45A....... Definitions...................................................................................... 316

46.......... Searches to monitor compliance with Act...................................... 317

46A....... Searches of certain premises to monitor compliance with Act....... 317

46B....... Searches and seizures on public health grounds............................. 319

47.......... Searches and seizures related to offences and civil penalty provisions 319

48.......... General powers of authorised persons in relation to premises...... 320

48A....... Details of warrant to be given to occupier etc................................ 321

48B....... Announcement before entry........................................................... 322

48C....... Use of electronic equipment at premises........................................ 322

48D....... Compensation for damage to electronic equipment........................ 324

48E........ Copies of seized things to be provided.......................................... 324

48F........ Occupier entitled to be present during search................................ 325

48G....... Receipts for things seized under warrant....................................... 325

48H....... Retention of seized things.............................................................. 325

48J........ Magistrate may permit a thing to be retained................................. 326

49.......... Monitoring warrants....................................................................... 326

50.......... Offence and civil penalty provision related warrants..................... 327

51.......... Offence and civil penalty provision related warrants by telephone 328

51A....... Searches at request of manufacturer............................................... 330

51B....... Offences relating to warrants.......................................................... 330

52.......... Identity cards.................................................................................. 331

Part 6‑3—Scheduling of substances                                                                         332

52AA.... Overview........................................................................................ 332

52A....... Definitions...................................................................................... 332

52B....... Advisory Committee on Medicines Scheduling............................. 333

52C....... Advisory Committee on Chemicals Scheduling.............................. 334

52CA.... Joint meetings................................................................................. 334

52D....... Poisons Standard............................................................................ 335

52E........ Secretary to take certain matters into account in exercising powers 335

52EAA.. Application for amendment of the Poisons Standard..................... 336

52EA..... Poisons Standard—validation etc................................................... 337

52EB..... Compensation for acquisition of property..................................... 338

52EC..... Review of scheduling regime........................................................... 339

Chapter 7—Miscellaneous                                                                                            341

53.......... Retention of material on withdrawal of application....................... 341

53A....... Alternative verdicts for various offences........................................ 341

54.......... Offences and forfeiture................................................................... 342

54AA.... Offences for contravening conditions or requirements imposed under the regulations           343

54AB.... Criminal offence for damaging etc. documents............................... 344

54AC.... Civil penalty for damaging etc. documents..................................... 344

54A....... Time for bringing prosecutions....................................................... 344

54B....... Application of this Act to an executive officer of a body corporate 344

54C....... Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision...................................... 345

55.......... Conduct by directors, servants and agents..................................... 346

56.......... Judicial notice................................................................................. 347

56A....... Certificates to provide evidence of certain matters........................ 348

57.......... Delegation....................................................................................... 350

58.......... Export certifications....................................................................... 352

59.......... Fees................................................................................................. 352

60.......... Review of decisions........................................................................ 352

60A....... New information on review—discretion to remit........................... 355

61.......... Release of information.................................................................... 357

61A....... Immunity from civil actions........................................................... 362

62.......... Consequential amendments............................................................ 363

63.......... Regulations..................................................................................... 363

Chapter 8—Repeal and transitional provisions                                                 367

64.......... Interpretation.................................................................................. 367

65.......... Repeal............................................................................................. 367

66.......... Transitional arrangements for goods required to be registered or listed.. 367

67.......... Transitional provision for therapeutic goods for export only........ 369

68.......... Transitional arrangements for Part 3‑3........................................... 369

69.......... Continuation of standards and requirements.................................. 370

Schedule—Consequential Amendments                                                                371

Notes                                                                                                                                          373


An Act relating to therapeutic goods

Chapter 1Preliminary

  

  

1  Short title [see Note 1]

                   This Act may be cited as the Therapeutic Goods Act 1989.

2  Commencement [see Note 1]

                   This Act commences on the day after the day on which a House of the Parliament approves regulations made under this Act in the same form as approved by the other House, provided that:

                     (a)  not more than 90 days have elapsed; and

                     (b)  the places of Senators have not become vacant under section 13 of the Constitution; and

                     (c)  a dissolution or expiration of the House of Representatives has not occurred;

between the approval of one House and the approval of the other House.

3  Interpretation

             (1)  In this Act, unless the contrary intention appears:

accessory, in relation to a medical device covered by paragraph 41BD(1)(a), (aa) or (ab), means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable the device to be used as the manufacturer of the device intended.

actual or potential tampering has the meaning given by section 42U.

advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

application audit assessment fee means a fee payable under subsection 41LA(3).

assessment fee means:

                     (a)  a conformity assessment fee; or

                     (b)  an application audit assessment fee;

payable under Part 4‑10.

authorised person means:

                     (a)  in relation to any provision of this Act, a person authorised by the Secretary to exercise powers under that provision; or

                     (b)  in relation to a provision of Part 6‑2, a member of the Australian Federal Police, or a Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the Customs Act 1901).

batch means a quantity of a product that is:

                     (a)  uniform in composition, method of manufacture and probability of chemical or microbial contamination; and

                     (b)  made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle.

bioburden, in relation to therapeutic goods, means the quantity and characteristics of microorganisms present in the goods or to which the goods may be exposed in a manufacturing environment.

British Pharmacopoeia means the edition of the publication of that name, including any additions or amendments, that was in effect for the purposes of this Act immediately before the commencement of Schedule 4 to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the British Pharmacopoeia Commission or any replacement body.

civil penalty provision has the meaning given by section 42YA.

Commonwealth authority includes:

                     (a)  a body corporate, or an unincorporated body, established for a public purpose by or under an Act; and

                     (b)  a tribunal or authority established by or in accordance with an Act.

Commonwealth officer includes:

                     (a)  a Minister; and

                     (b)  a person holding:

                              (i)  an office established by or under an Act; or

                             (ii)  an appointment made under an Act; or

                            (iii)  an appointment made by the Governor‑General or a Minister but not under an Act; and

                     (c)  a person who is a member or officer of a Commonwealth authority; and

                     (d)  a person who is in the service or employment of the Commonwealth, or of a Commonwealth authority, or is employed or engaged under an Act or regulations made under an Act.

composite pack has the meaning given by subsection 7B(2).

conformity assessment certificate means a certificate issued under section 41EE.

conformity assessment fee means a fee payable under subsection 41LA(1).

conformity assessment procedures has the meaning given by section 41DA.

conformity assessment standard means a conformity assessment standard specified in an order under section 41DC.

container, in relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.

corporation means a body corporate that is:

                     (a)  a foreign corporation; or

                     (b)  a trading corporation formed within the limits of the Commonwealth or a financial corporation so formed.

corresponding State law means a State law declared by the regulations to correspond to this Act or the regulations, including such a law as amended from time to time.

counterfeit has the meaning given by section 42E.

current Poisons Standard has the meaning given by section 52A.

Customs officer means an officer of Customs within the meaning of the Customs Act 1901.

data processing device means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device.

default standard means any of the following:

                     (a)  a standard referred to in paragraph (b) of the definition of standard in this subsection;

                     (b)  a standard referred to in paragraph (c) of that definition;

                     (c)  a standard referred to in paragraph (d) of that definition.

device number, in relation to a medical device, means any combination of numbers, symbols and letters assigned to the device under section 41FL.

directions for use, in relation to therapeutic goods, includes information on:

                     (a)  appropriate doses of the goods; and

                     (b)  the method of administration or use of the goods; and

                     (c)  the frequency and duration of treatment for each indication of the goods; and

                     (d)  the use of the goods by persons of particular ages or by persons having particular medical conditions.

EC/EFTA attestation of conformity means an attestation of conformity (within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment body that is approved by the Secretary in writing.

EC/EFTA conformity assessment body means a Conformity Assessment Body designated in one of the following Sectoral Annexes to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement:

                     (a)  Sectoral Annex (Medical Devices);

                     (b)  Sectoral Annex (Medicinal Products GMP Inspection and Batch Certification).

EC Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time.

EFTA Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time.

essential principles has the meaning given by section 41CA.

ethics committee means a committee:

                     (a)  constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and

                     (b)  which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.

European Pharmacopoeia means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the Council of Europe or any replacement body.

exempt device means a medical device that is of a kind that is exempted from Division 3 of Part 4‑11 by the regulations.

exempt goods, in relation to a provision of Part 3‑2, means therapeutic goods that are exempted from the operation of that Part (except section 31A and sections 31C to 31F) by the regulations.

exempt goods, in relation to a provision of Part 3‑3, means therapeutic goods that are exempted from the operation of that Part by the regulations.

exempt person, in relation to therapeutic goods, means a person exempted from the operation of Part 3‑3 in relation to those goods by the regulations.

export only medicine means a medicine that:

                     (a)  is manufactured in Australia for export only, or imported into Australia for export only; and

                     (b)  is listable goods only because it is so manufactured or imported (and not for any other reason).

Federal Court means the Federal Court of Australia.

financial corporation means a financial corporation within the meaning of paragraph 51(xx) of the Constitution.

first Poisons Standard has the meaning given by section 52A.

foreign corporation means a foreign corporation within the meaning of paragraph 51(xx) of the Constitution.

gazetted kits group means a group of kits identified in an order in force under subsection 16(3A).

gazetted therapeutic devices group has the meaning given by subsection 16(3).

gazetted therapeutic goods group has the meaning given by subsection 16(2).

Gene Technology Regulator has the same meaning as in the Gene Technology Act 2000.

genetically modified organism has the same meaning as in the Gene Technology Act 2000.

GM product has the same meaning as in the Gene Technology Act 2000.

grouped therapeutic goods means therapeutic goods included in:

                     (a)  a gazetted therapeutic goods group; or

                     (b)  a gazetted therapeutic devices group; or

                     (c)  a gazetted kits group.

included in the Register, in relation to a medical device to which Chapter 4 applies, means included in the Register under Chapter 4.

Note:          For medical devices to which Chapter 4 applies, see section 41BJ.

indications, in relation to therapeutic goods, means the specific therapeutic uses of the goods.

international instrument means:

                     (a)  any treaty, convention, protocol, agreement or other instrument that is binding in international law; and

                     (b)  a part of such a treaty, convention, protocol, agreement or other instrument.

kind, in relation to a medical device, has the meaning given by section 41BE.

label, in relation to therapeutic goods, means a display of printed information:

                     (a)  on or attached to the goods; or

                     (b)  on or attached to a container or primary pack in which the goods are supplied; or

                     (c)  supplied with such a container or pack.

licence means a licence under Part 3‑3.

listable devices means therapeutic devices that are required to be included in the part of the Register for listed goods.

listable goods means therapeutic goods that are required:

                     (a)  under the regulations; or

                     (b)  by a notice published in the Gazette under subsection 9A(5);

to be included in the part of the Register relating to listed goods.

listed goods means therapeutic goods that are included in the Part of the Register for goods known as listed goods.

listing number, in relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 27.

major interest holder of a body corporate means a person who:

                     (a)  is in a position to cast, or control the casting of, more than one‑fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or

                     (b)  holds more than one‑fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital).

manufacture, in relation to therapeutic goods that are not medical devices, means:

                     (a)  to produce the goods; or

                     (b)  to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process.

manufacturer, of a medical device, has the meaning given by section 41BG.

manufacturing principles means the principles for the time being having effect under section 36.

manufacturing site means premises:

                     (a)  that are for use in the manufacture of a particular kind of therapeutic goods; and

                     (b)  at which the same persons have control of the management of the production of the goods and the procedures for quality control.

manufacturing site authorisation means an authorisation referred to in subsection 38(2B) or 40B(4).

medical device has the meaning given by section 41BD.

medical device classification means a classification specified in the regulations made for the purposes of section 41DB.

medical device standard, in relation to a kind of medical device, means a medical device standard, specified in an order under section 41CB, that is applicable to that kind of medical device.

medicine means:

                     (a)  therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human; and

                     (b)  any other therapeutic goods declared by the Secretary, for the purpose of the definition of therapeutic device, not to be therapeutic devices.

member of EFTA means a country declared by the Minister under section 3A to be a member of the European Free Trade Association.

member of the European Community means a country declared by the Minister under section 3A to be a member of the European Community.

Mutual Recognition Convention means the Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products done at Geneva on 8 October 1970.

National Manager of the Therapeutic Goods Administration means:

                     (a)  the person holding the position of National Manager of the Therapeutic Goods Administration; or

                     (b)  if the position of National Manager of the Therapeutic Goods Administration ceases to exist, or ceases to be referred to by that name—the person holding a position determined in writing by the Secretary.

non‑EC/EFTA attestation of conformity, for a non‑EC/EFTA MRA, means an attestation of conformity issued, after the non‑EC/EFTA MRA has come into force, by a conformity assessment body that is designated in the non‑EC/EFTA MRA and approved by the Secretary in writing for the non‑EC/EFTA MRA.

non‑EC/EFTA MRA means an international instrument that Australia is bound by, or is a party to, if:

                     (a)  a purpose of the instrument is the recognition of attestations of conformity; and

                     (b)  the instrument satisfies the requirements (if any) set out in regulations made for the purposes of this paragraph;

but does not include:

                     (c)  the EC Mutual Recognition Agreement; or

                     (d)  the EFTA Mutual Recognition Agreement.

oath includes affirmation.

penalty unit, in relation to a civil penalty provision, has the meaning given by section 42YB.

poison means an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury and includes any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard.

premises includes:

                     (a)  a structure, building, aircraft, vehicle or vessel; and

                     (b)  a place (whether enclosed or built upon or not); and

                     (c)  a part of a thing referred to in paragraph (a) or (b).

presentation, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.

primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.

protected information, in relation to therapeutic goods, has the meaning given by section 25A.

quality, in relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the goods.

refurbishment has the meaning given by the regulations.

Register means the Australian Register of Therapeutic Goods maintained under section 9A.

registered goods means therapeutic goods included in the part of the Register for goods known as registered goods.

registration number, in relation to registered goods, means any combination of numbers, symbols and letters assigned to the goods under section 27.

scheduling has the meaning given by section 52A.

Secretary means the Secretary to the Department.

sponsor, in relation to therapeutic goods, means:

                     (a)  a person who exports, or arranges the exportation of, the goods from Australia; or

                     (b)  a person who imports, or arranges the importation of, the goods into Australia; or

                     (c)  a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);

but does not include a person who:

                     (d)  exports, imports or manufactures the goods; or

                     (e)  arranges the exportation, importation or manufacture of the goods;

on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

standard, in relation to therapeutic goods, means any of the following:

                     (a)  a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods;

                     (b)  if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the British Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the British Pharmacopoeia;

                     (c)  if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the European Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the European Pharmacopoeia;

                     (d)  if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the United States Pharmacopeia‑National Formulary—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the United States Pharmacopeia‑National Formulary.

Note:          See also section 13.

State includes the Australian Capital Territory and the Northern Territory.

State law means a law of a State, of the Australian Capital Territory or of the Northern Territory.

supply includes:

                     (a)  supply by way of sale, exchange, gift, lease, loan, hire or hire‑purchase; and

                     (b)  supply, whether free of charge or otherwise, by way of sample or advertisement; and

                     (c)  supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons; and

                     (d)  supply by way of administration to, or application in the treatment of, a person.

system or procedure pack has the meaning given by section 41BF.

tamper: therapeutic goods are tampered with if:

                     (a)  they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and

                     (b)  the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.

therapeutic device means therapeutic goods consisting of an instrument, apparatus, appliance, material or other article (whether for use alone or in combination), together with any accessories or software required for its proper functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means though it may be assisted in its function by such means, but the expression does not include therapeutic goods declared by the Secretary, by order published in the Gazette, not to be therapeutic devices.

therapeutic goods means goods:

                     (a)  that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:

                              (i)  for therapeutic use; or

                             (ii)  for use as an ingredient or component in the manufacture of therapeutic goods; or

                            (iii)  for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or

                     (b)  included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);

and includes medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:

                     (c)  goods declared not to be therapeutic goods under an order in force under section 7; or

                     (d)  goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or

                     (e)  goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991); or

                      (f)  goods (other than goods declared to be therapeutic goods under an order in force under section 7) which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented.

Therapeutic Goods Advertising Code means the code in force under section 42BAA.

therapeutic use means use in or in connection with:

                     (a)  preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

                     (b)  influencing, inhibiting or modifying a physiological process in persons; or

                     (c)  testing the susceptibility of persons to a disease or ailment; or

                     (d)  influencing, controlling or preventing conception in persons; or

                     (e)  testing for pregnancy in persons; or

                      (f)  the replacement or modification of parts of the anatomy in persons.

trading corporation means a trading corporation within the meaning of paragraph 51(xx) of the Constitution.

United States Pharmacopeia‑National Formulary means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the United States Pharmacopeial Convention or any replacement body.

working day, for a person, means any day except:

                     (a)  Saturday or Sunday; or

                     (b)  a day that is a public holiday in the State or Territory in which the person is located.

             (2)  For the purposes of this Act, therapeutic goods are taken to be for use in humans if they are not solely for use in animals.

             (3)  The Secretary must, at least once in each year, cause to be published in the Gazette a list of the names of all persons, other than members of the Australian Federal Police, who are, at the time of publication, authorised persons.

             (4)  The provisions of this Act are in addition to, and not in substitution for, the provisions of any other Act that relate to therapeutic goods.

             (5)  For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:

                     (a)  if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or

                     (b)  if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients; or

                     (c)  if the label of the goods does not declare the presence of a therapeutically active ingredient; or

                    (ca)  if the therapeutic goods are medicine included in a class of medicine prescribed by the regulations for the purposes of this paragraph—if the medicine’s label does not contain the advisory statements specified under subsection (5A) in relation to the medicine; or

                     (d)  if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Australia; or

                     (e)  in prescribed cases.

          (5A)  The Minister may, by legislative instrument, specify advisory statements in relation to medicine for the purposes of paragraph (5)(ca).

          (5B)  For the purposes of subsection (5A), the Minister may specify different advisory statements for different medicines or different classes of medicine.

             (6)  A reference in this Act to an annual registration charge, an annual listing charge, an annual charge for inclusion in the Register or an annual licensing charge is a reference to such a charge imposed under the Therapeutic Goods (Charges) Act 1989.

             (7)  A reference to an offence against this Act includes a reference to:

                     (a)  an offence against the regulations; and

                     (b)  an offence against section 6 of the Crimes Act 1914, or section 11.1, 11.4 or 11.5 of the Criminal Code, in relation to an offence against this Act or the regulations; and

                     (c)  an offence against section 136.1, 137.1 or 137.2 of the Criminal Code in relation to this Act or the regulations.

          (7A)  For the purposes of this Act, a corresponding State law imposes a duty on a Commonwealth officer or Commonwealth authority if:

                     (a)  the corresponding State law confers a function or power on the officer or authority; and

                     (b)  the circumstances in which the function or power is conferred give rise to an obligation on the officer or authority to perform the function or to exercise the power.

3A  Declaration—member of European Community

             (1)  The Minister may declare, in writing, that a country specified in the declaration is a member of:

                     (a)  the European Community; or

                     (b)  the European Free Trade Association.

             (2)  A declaration under subsection (1) must be published in the Gazette.

3B  Declaration—country covered by non‑EC/EFTA MRA

             (1)  The Minister may declare, in writing, that a country specified in the declaration is covered by the non‑EC/EFTA MRA specified in the declaration.

             (2)  A declaration under subsection (1) must be published in the Gazette.

3C  Exempting monographs in pharmacopoeias

Exempting entire monographs

             (1)  The Minister may, by legislative instrument, determine that specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1).

Note:          For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

Exempting parts of monographs

             (2)  The Minister may, by legislative instrument, determine that specified statements in specified monographs in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1).

4  Objects of Act

             (1)  The objects of this Act are to do the following, so far as the Constitution permits:

                     (a)  provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:

                              (i)  used in Australia, whether produced in Australia or elsewhere; or

                             (ii)  exported from Australia;

                     (b)  to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia.

          (1A)  The reference in paragraph (1)(a) to the efficacy of therapeutic goods is a reference, if the goods are medical devices, to the performance of the devices as the manufacturer intended.

             (2)  This Act is therefore not intended to apply to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory to the extent that the law is capable of operating concurrently with this Act.

5  Act to bind Crown

                   This Act binds the Crown in right of the Commonwealth, of each of the States, of the Australian Capital Territory and of the Northern Territory, but nothing in this Act renders the Crown liable to be prosecuted for an offence or to be subject to civil proceedings for a contravention of a civil penalty provision.

5A  Application of the Criminal Code—extended geographical jurisdiction

                   Section 15.2 of the Criminal Code (extended geographical jurisdiction—category B) applies to offences against subsections 21A(1), (2) and (4) and sections 22A, 41FE, 42E and 42T.

6  Operation of Act

             (1)  This Act applies to:

                     (a)  things done by corporations; and

                     (b)  things done by natural persons or corporations in so far as those things are done:

                              (i)  in the course of, or in preparation for, trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories; or

                             (ii)  under a law of the Commonwealth relating to the provision of pharmaceutical or repatriation benefits; or

                            (iii)  in relation to the Commonwealth or in relation to an authority of the Commonwealth.

             (2)  Without limiting the effect of this Act apart from this subsection, this Act also has the effect it would have if the reference in paragraph (1)(a) to things done by corporations were confined to things done by trading corporations for the purposes of their trading activities.

6AAA  Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws

             (1)  A corresponding State law may confer functions or powers, or impose duties, on:

                     (a)  a Commonwealth officer; or

                     (b)  a Commonwealth authority.

             (2)  Subsection (1) does not authorise the conferral of a function or power, or the imposition of a duty, by a corresponding State law to the extent to which:

                     (a)  the conferral or imposition, or the authorisation, would contravene any constitutional doctrines restricting the duties that may be imposed on Commonwealth officers or Commonwealth authorities; or

                     (b)  the authorisation would otherwise exceed the legislative power of the Commonwealth.

             (3)  Subsection (1) does not extend to a function, power or duty of a kind specified in regulations made for the purposes of this subsection.

             (4)  This Act is not intended to exclude or limit the operation of a corresponding State law that confers any functions or powers, or imposes any duties, on a Commonwealth officer or Commonwealth authority to the extent to which that law:

                     (a)  is consistent with subsections (1) to (3); and

                     (b)  is capable of operating concurrently with this Act.

6AAB  When duty imposed

Application

             (1)  This section applies if a corresponding State law purports to impose a duty on a Commonwealth officer or Commonwealth authority.

State legislative power sufficient to support duty

             (2)  The duty is taken not to be imposed by this Act (or any other law of the Commonwealth) to the extent to which:

                     (a)  imposing the duty is within the legislative powers of the State concerned; and

                     (b)  imposing the duty by the corresponding State law is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority.

Note:          If this subsection applies, the duty will be taken to be imposed by force of the corresponding State law (the Commonwealth having consented under section 6AAA to the imposition of the duty by the corresponding State law).

Commonwealth legislative power sufficient to support duty but State legislative powers are not

             (3)  If, to ensure the validity of the purported imposition of the duty, it is necessary that the duty be imposed by a law of the Commonwealth (rather than by force of the corresponding State law), the duty is taken to be imposed by this Act to the extent necessary to ensure that validity.

             (4)  If, because of subsection (3), this Act is taken to impose the duty, it is the intention of the Parliament to rely on all powers available to it under the Constitution to support the imposition of the duty by this Act.

             (5)  The duty is taken to be imposed by this Act in accordance with subsection (3) only to the extent to which imposing the duty:

                     (a)  is within the legislative powers of the Commonwealth; and

                     (b)  is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority.

             (6)  To avoid doubt, neither this Act (nor any other law of the Commonwealth) imposes a duty on the Commonwealth officer or Commonwealth authority to the extent to which imposing such a duty would:

                     (a)  contravene any constitutional doctrine restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority; or

                     (b)  otherwise exceed the legislative power of the Commonwealth.

             (7)  Subsections (1) to (6) do not limit section 6AAA.

6AAC  Imposing duty under State law

             (1)  This section:

                     (a)  applies only for the purposes of the application of the provisions of this Act or another law of the Commonwealth (with or without modification) as a law of a State by a provision of a corresponding State law; and

                     (b)  does not apply for those purposes if the corresponding State law otherwise provides.

             (2)  If the corresponding State law purports to impose a duty on a Commonwealth officer or Commonwealth authority to do a particular thing, the duty is taken to be imposed by the corresponding State law to the extent to which imposing the duty:

                     (a)  is within the legislative powers of the State; and

                     (b)  is consistent with the constitutional doctrines restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority.

             (3)  To avoid doubt, the corresponding State law does not impose the duty on the Commonwealth officer or Commonwealth authority to the extent to which imposing the duty would:

                     (a)  contravene any constitutional doctrine restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority; or

                     (b)  otherwise exceed the legislative powers of the State.

             (4)  If imposing on the Commonwealth officer or Commonwealth authority the duty to do that thing would:

                     (a)  contravene any constitutional doctrine restricting the duties that may be imposed on a Commonwealth officer or Commonwealth authority; or

                     (b)  otherwise exceed the legislative powers of both the State and the Commonwealth;

the corresponding State law is taken instead to confer on the officer or authority a power to do that thing at the discretion of the officer or authority.

6AAD  Conferral of jurisdiction on federal courts

                   If:

                     (a)  a provision of a corresponding State law purports to apply a provision of a law of the Commonwealth (the applied provision) as a law of the State; and

                     (b)  the applied provision purports to confer jurisdiction in relation to a matter on a federal court;

the jurisdiction in relation to that matter is taken to be conferred on the court by this section.

6AAE  Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority

             (1)  If a corresponding State law confers on a Commonwealth officer or Commonwealth authority:

                     (a)  the function of including goods in the Register; or

                     (b)  the power to include goods in the Register;

the officer or authority may include the goods in the Register in accordance with the corresponding State law.

             (2)  If a corresponding State law authorises or requires a Commonwealth officer or Commonwealth authority to cancel the inclusion of goods in the Register, the officer or authority may cancel the inclusion of the goods in the Register in accordance with the corresponding State law.

             (3)  The inclusion of goods in the Register under subsection (1) does not subject any person to any liability whatever under this Act, except a liability under Part 6‑1.

             (4)  A Commonwealth officer or Commonwealth authority may make any notations in the Register that the officer or authority considers necessary to identify entries that relate to goods included in the Register under subsection (1).

             (5)  Goods may be included in the Register under subsection (1) even though the same goods have already been included in the Register under another provision of this Act.

             (6)  A reference in this section to the inclusion of goods in the Register is a reference to the inclusion of the goods:

                     (a)  in the part of the Register for goods known as registered goods; or

                     (b)  in the part of the Register for goods known as listed goods; or

                     (c)  in the part of the Register for medical devices included under Chapter 4.

6B  Review of certain decisions under State laws

             (1)  Application may be made to the Administrative Appeals Tribunal for review of a reviewable State decision.

             (2)  A decision made by the Secretary in the performance of a function, or the exercise of a power, conferred by a corresponding State law is a reviewable State decision for the purpose of this section if:

                     (a)  the law under which the decision was made provides for review by the Administrative Appeals Tribunal; and

                     (b)  the decision is declared by the regulations to be a reviewable decision for the purposes of this section.

             (3)  For the purposes of subsection (1), the Administrative Appeals Tribunal Act 1975 has effect as if a corresponding State law were an enactment.

6C  Fees payable to Commonwealth under State laws

             (1)  This section applies to fees payable to the Commonwealth under a State law in respect of the performance or exercise of functions or powers conferred by that law on the Secretary.

             (2)  The Secretary may make arrangements with the appropriate authority of a State, of the Australian Capital Territory or of the Northern Territory in relation to the payment to the Commonwealth of fees to which this section applies.

7  Declaration that goods are/are not therapeutic goods

             (1)  Where the Secretary is satisfied that particular goods or classes of goods:

                     (a)  are or are not therapeutic goods; or

                     (b)  when used, advertised, or presented for supply in a particular way, are or are not therapeutic goods;

the Secretary may, by order published in the Gazette, declare that the goods, or the goods when used, advertised, or presented for supply in that way, are or are not, for the purposes of this Act, therapeutic goods.

             (2)  The Secretary may exercise his or her powers under this section of his or her own motion or following an application made in writing to the Secretary.

             (3)  A declaration under this section takes effect on the day on which the declaration is published in the Gazette or on such later day as is specified in the order.

             (4)  If a declaration under this section:

                     (a)  is a declaration that particular goods or classes of goods are not therapeutic goods; and

                     (b)  applies wholly or partly to goods that, apart from this section, would be medical devices;

the goods are not medical devices, or are not medical devices when used, advertised, or presented for supply in the way specified in the declaration.

7A  Authorised persons

                   The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of this Act:

                     (a)  an officer of the Department, of another Department or of an authority of the Commonwealth;

                     (b)  an officer of:

                              (i)  a Department of State of a State; or

                             (ii)  a Department or administrative unit of the Public Service of a Territory; or

                            (iii)  an authority of a State or of a Territory;

                            being a Department, unit or authority that has functions relating to health matters or law enforcement matters.

7B  Kits

             (1)  A package and therapeutic goods in the package together constitute a kit for the purposes of this Act if:

                     (a)  the package and the therapeutic goods are for use as a unit; and

                     (b)  each item of the therapeutic goods consists of goods that are registered or listed or are exempt goods in relation to Part 3‑2; and

                     (c)  the package and therapeutic goods do not constitute a composite pack or a system or procedure pack.

             (2)  A package and therapeutic goods in the package together constitute a composite pack if:

                     (a)  the therapeutic goods are of 2 or more kinds; and

                     (b)  the package does not contain any medical devices or therapeutic devices; and

                     (c)  the therapeutic goods are for administration as a single treatment or as a single course of treatment; and

                     (d)  it is necessary that the therapeutic goods be combined before administration or that they be administered in a particular sequence.

             (3)  To avoid doubt, it is declared that a kit constitutes therapeutic goods.

7C  Secretary may arrange for use of computer programs to make decisions

             (1)  The Secretary may arrange for the use, under the Secretary’s control, of computer programs for any purposes for which the Secretary may make decisions under this Act or the regulations.

             (2)  A decision made by the operation of a computer program under such an arrangement is taken to be a decision made by the Secretary.

             (3)  The Secretary may substitute a decision (the substituted decision) for a decision (the initial decision) made by the operation of a computer program under such an arrangement if the Secretary is satisfied that the initial decision is incorrect.

             (4)  However, the substituted decision may only be made before the end of the period of 60 days beginning on the day the initial decision is made.

8  Power to obtain information with respect to therapeutic goods

             (1)  The Secretary may, by notice in writing given to a person who has imported into Australia or has supplied in Australia:

                     (a)  therapeutic goods; or

                     (b)  goods in relation to which the Secretary is considering making a declaration under section 7;

request the person to give to an officer of the Department identified in the notice, within such reasonable period as is specified in the notice, information required by the notice concerning the composition, indications, directions for use or labelling of the goods or concerning advertising material relating to the goods.

          (1A)  A notice under subsection (1) may require the information to be given:

                     (a)  in writing; or

                     (b)  in accordance with specified software requirements:

                              (i)  on a specified kind of data processing device; or

                             (ii)  by way of a specified kind of electronic transmission.

             (2)  A person must not fail to comply with a notice given to the person under this section.

Penalty:  60 penalty units.

             (3)  Subsection (2) does not apply if the person has a reasonable excuse.

Note:          The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.

             (4)  An offence under subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

9  Arrangements with States etc.

             (1)  The Minister may make arrangements with the appropriate Minister of a State, of the Australian Capital Territory or of the Northern Territory for the carrying out by that State or Territory, on behalf of the Commonwealth, of:

                     (a)  the evaluation of therapeutic goods for registration; or

                     (b)  the inspection of manufacturers of therapeutic goods; or

                     (c)  other functions under this Act or the regulations.

             (2)  An arrangement under this section may provide for the payment to a State or Territory of amounts in respect of the performance of functions under the arrangement.


 

Chapter 2Australian Register of Therapeutic Goods

  

  

9A  Australian Register of Therapeutic Goods

             (1)  The Secretary is to cause to be maintained a register, to be known as the Australian Register of Therapeutic Goods, for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans.

             (2)  Subject to subsection (3), the Register is to be kept in such form as the Secretary determines.

             (3)  The Register is to contain these 3 parts:

                     (a)  a part for goods to be known as registered goods; and

                     (b)  a part for goods to be known as listed goods; and

                     (c)  a part for medical devices included in the Register under Chapter 4.

             (4)  The regulations may prescribe:

                     (a)  the therapeutic goods, or the classes of therapeutic goods, that are required to be included in each part of the Register; and

                     (b)  the ways in which:

                              (i)  goods that are included in the part of the Register relating to registered goods may be transferred, or may be required to be transferred, to the part of the Register for listed goods; and

                             (ii)  goods that are included in the part of the Register relating to listed goods may be transferred, or may be required to be transferred, to the part of the Register for registered goods; and

                     (c)  the ways in which goods that have been assigned a registration or listing number may be assigned a different registration or listing number; and

                     (d)  the ways in which medical devices that have been assigned a device number may be assigned a different device number.

             (5)  The Minister may, by notice published in the Gazette:

                     (a)  require that specified therapeutic goods be included in the part of the Register for listed goods; and

                     (b)  specify the conditions subject to which such goods may be included in that part of the Register.

             (6)  If the regulations are amended to require any of those goods to be included in the part of the Register for listed or registered goods, then the Gazette notice ceases to have effect in respect of the goods included in the regulations.

9B  When registrations or listings of medical devices are taken to be cancelled

             (1)  The registration or listing of a medical device to which subsection 15A(5) applied is taken to be cancelled:

                     (a)  on the second anniversary of the day on which Chapter 4 commences; or

                     (b)  if the medical device is of a kind included in the Register under Chapter 4 before that second anniversary—when that inclusion takes effect.

             (2)  The registration or listing of any other medical device is taken to be cancelled at the time shown in the table:

 

Time of cancellation of registration or listing

 

Circumstances

Time

1

That kind of medical device is included in the Register under Chapter 4 before 4 October 2007 because of an application finally determined before that day

When that kind of medical device is included in the Register under Chapter 4

2

An effective application for a conformity assessment certificate relating to that kind of medical device is made, but not finally determined, before 4 October 2007

The end of 30 days after the application is finally determined or, if the application lapses, the later of the following times (or either of them if they are the same):

(a) the time the application lapses;

(b) the start of 4 October 2007

3

An effective application to include that kind of medical device in the Register under Chapter 4 is made, but not finally determined, before 4 October 2007, and item 2 does not apply

Whichever one of the following times applies, or the earlier of them:

(a) the time that kind of medical device is included in the Register under Chapter 4 (even if that time is before 4 October 2007);

(b) the time the application is finally determined, if the application is unsuccessful when it is finally determined;

or, if the application lapses, the later of the following times (or either of them if they are the same):

(c) the time the application lapses;

(d) the start of 4 October 2007

4

None of items 1, 2 and 3 applies

The start of 4 October 2007

Note:          4 October 2007 is the fifth anniversary of the day Chapter 4 commenced.

          (2A)  For the purposes of subsection (2), an application is finally determined at the first time both the following conditions are met:

                     (a)  a decision has been made under Part 4‑4 or 4‑5 whether or not to grant the conformity assessment certificate or include the kind of medical device in the Register (as appropriate);

                     (b)  there is no longer any possibility of a change in the outcome of the decision in terms of the grant (or not) of the conformity assessment certificate or the inclusion (or not) of the kind of medical device in the Register.

For the purposes of paragraph (b), ignore any possibility of a discretion being exercised, after the period has ended, to extend a period for seeking review by a tribunal or court of the decision or for starting other proceedings (including appeals) arising out of the application, the decision or the review.

Note:          In certain circumstances a decision may be taken to have been made under Part 4‑4 or Part 4‑5. For example, see section 41EH.

             (3)  This section does not prevent the Secretary from taking action under section 30.

9C  Inspection of entries in Register

             (1)  A person in relation to whom therapeutic goods are entered on the Register may make a written request to the Secretary for a copy of the entry in the Register in relation to the goods.

             (2)  If the person makes such a request, the Secretary must send to the person a copy of so much (if any) of that entry as is contained in any computer database maintained by the Department for purposes connected with the administration of this Act (other than any part of that entry that was supplied in confidence by another person).

             (3)  If the person makes such a request, then, instead of providing a copy of an entry to the person, the Secretary may, if the request is for the provision of an electronic copy, provide the information contained in the entry:

                     (a)  on a data processing device; or

                     (b)  by way of electronic transmission.

9D  Variation of entries in Register

             (1)  The Secretary may:

                     (a)  following a request by a person in relation to whom therapeutic goods are entered on the Register; or

                     (b)  on the Secretary’s own initiative;

vary the entry in the Register in relation to the goods if the entry contains information that is incomplete or incorrect.

             (2)  If:

                     (a)  the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary product information included in the entry in the Register that relates to the goods; and

                     (b)  the only effect of the variation would be:

                              (i)  to reduce the class of persons for whom the goods are suitable; or

                             (ii)  to add a warning, or precaution, that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;

the Secretary must vary the entry in accordance with the request.

             (3)  If:

                     (a)  the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and

                     (b)  subsection (2) does not apply to the request; and

                     (c)  the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used;

the Secretary may vary the entry in accordance with the request.

             (4)  If:

                     (a)  particular therapeutic goods cease to be medical devices because of a declaration under subsection 41BD(3); and

                     (b)  those goods are included in the Register under Chapter 4 as a kind of medical device;

the Secretary must move the entry relating to the goods from the part of the Register for medical devices to the part for goods to be known as registered goods or to the part for goods to be known as listed goods (whichever is applicable).

             (5)  In this section:

product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.

Note:          Variations to the Register also occur to give effect to limited cancellations of entries of kinds of medical devices from the Register: see subsection 41GO(2).

9E  Publication of list of goods on Register

                   The Secretary must, at least once every 12 months, publish a list of the therapeutic goods included in the Register.


 

Chapter 3Medicines and other therapeutic goods that are not medical devices

Note:       This Chapter still applies to medical devices while they are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.

Part 3‑1Standards

  

10  Determination of standards

             (1)  The Minister may, by legislative instrument, make an order determining that matters specified in the order constitute a standard for therapeutic goods or a class of therapeutic goods identified in the order (whether or not those goods are the subject of a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary).

Note:          Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

             (2)  Without limiting the generality of subsection (1), an order establishing a standard for therapeutic goods may:

                     (a)  be specified by reference to:

                              (i)  the quality of the goods; or

                             (ii)  the quantity of the goods when contained in specified containers; or

                            (iii)  procedures to be carried out in the manufacture of the goods; or

                            (iv)  a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary; or

                             (v)  a monograph in another publication approved by the Minister for the purposes of this subsection; or

                            (vi)  such a monograph as modified in a manner specified in the order establishing the standard; or

                           (vii)  a standard published by the Standards Australia International Limited; or

                           (viii)  such other matters as the Minister thinks fit; or

                     (b)  require that a matter relating to the standard be determined in accordance with a particular test; or

                     (c)  require that therapeutic goods or a class of therapeutic goods identified in the order be labelled or packaged in a manner, or kept in containers that comply with requirements, specified in the order.

             (3)  Without limiting the generality of paragraph (2)(c), the Minister may, in an order establishing a standard, direct that there be set out, in a manner specified in the order, on:

                     (a)  therapeutic goods or a class of therapeutic goods identified in the order; or

                     (b)  a container or package containing therapeutic goods or a class of therapeutic goods identified in the order; or

                     (c)  a label of therapeutic goods or a class of therapeutic goods identified in the order;

such particulars as are required by the order.

          (3A)  The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

Note:          Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

             (4)  The Minister must not make an order under subsection (1), or vary or revoke an order made under subsection (1), unless the Minister has consulted with respect to the proposed action with a committee established by the regulations to advise the Minister on standards.

10A  Application of standards to medical devices

                   A standard under section 10 does not apply to a medical device unless Part 3‑2 applies to the device.

Note:          Section 15A sets out when Part 3‑2 applies to a medical device.

13  Special provisions relating to standards

             (1)  For the purposes of this Act, if a statement (the main statement) in a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary refers to a statement in a monograph in another publication, the main statement is taken to include the other statement.

             (2)  If:

                     (a)  a standard under section 10 (the Ministerial standard) applies to therapeutic goods; and

                     (b)  requirements applicable to the goods are specified in a default standard; and

                     (c)  those requirements are inconsistent with the requirements specified in the Ministerial standard;

the requirements referred to in paragraph (b) are, so far as they are inconsistent, to be disregarded for the purposes of this Act.

             (3)  If:

                     (a)  a default standard applies to a class of therapeutic goods; and

                     (b)  another default standard applies to only some of the therapeutic goods within that class; and

                     (c)  those standards are inconsistent;

the standard referred to in paragraph (a) does not apply in relation to the goods referred to in paragraph (b).

             (4)  If:

                     (a)  therapeutic goods consist, or are represented to consist, of a mixture of ingredients or of a combination of component parts; and

                     (b)  a default standard is applicable to one or more of the ingredients or one or more of the component parts; and

                     (c)  a default standard is applicable to the mixture or combination;

the standard referred to in paragraph (b) does not apply in relation to the goods.

             (5)  If:

                     (a)  therapeutic goods consist, or are represented to consist, of a mixture of ingredients or of a combination of component parts; and

                     (b)  there is no standard applicable to the mixture or combination but a standard is applicable to one or more of the ingredients or one or more of the component parts;

the Minister may, by order published in the Gazette, determine that the standard does not apply to the goods. The order has effect accordingly.

             (6)  An order under subsection (5) is not a legislative instrument.

             (7)  For the purposes of this Act, in working out at a particular time if therapeutic goods conform with a default standard applicable to the goods, if:

                     (a)  after applying subsections (2) to (5), 2 or more default standards are applicable to the goods at that time; and

                     (b)  at that time, the goods conform with at least one of those standards but do not conform with at least one of those standards;

then the default standards that the goods do not conform with are taken not to apply to the goods at that time.

14  Criminal offences for importing, supplying or exporting goods that do not comply with standards

Offences relating to importing goods into Australia

             (1)  A person commits an offence if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the goods are imported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the goods are imported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; and

                     (d)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the goods do not conform with the standard.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the goods are imported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Exception

             (5)  Paragraphs (1)(a), (2)(a) and (4)(a) do not apply to goods that do not conform with a standard applicable to the goods by reason only of matters relating to labelling or packaging.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.

Offences relating to supplying goods for use in Australia

             (6)  A person commits an offence if:

                     (a)  the person supplies therapeutic goods for use in Australia; and

                     (b)  the goods are supplied without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A.

             (7)  A person commits an offence if:

                     (a)  the person supplies therapeutic goods for use in Australia; and

                     (b)  the goods are supplied without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods; and

                     (d)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the goods do not conform with the standard.

Penalty:  2,000 penalty units.

             (8)  Subsection (7) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (9)  A person commits an offence if:

                     (a)  the person supplies therapeutic goods for use in Australia; and

                     (b)  the goods are supplied without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to exporting goods from Australia

           (10)  A person commits an offence if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the goods are exported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia); and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (13) instead: see section 53A.

           (11)  A person commits an offence if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the goods are exported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia); and

                     (d)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the goods do not conform with the standard.

Penalty:  2,000 penalty units.

           (12)  Subsection (11) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

           (13)  A person commits an offence if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the goods are exported without the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia).

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Decisions on whether to give consent

           (14)  The Secretary must, as soon as practicable after making a decision to give a consent, cause particulars of the decision to be published in the Gazette.

           (15)  The Secretary must, within 28 days after making a decision to refuse to give a consent, notify the applicant in writing of the decision and of the reasons for the decision.

14A  Civil penalties for importing, supplying or exporting goods that do not comply with standards

Civil penalty relating to importing goods into Australia

             (1)  A person contravenes this subsection if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the person does not have the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging).

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to supplying goods for use in Australia

             (2)  A person contravenes this subsection if:

                     (a)  the person supplies therapeutic goods for use in Australia; and

                     (b)  the person does not have the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to exporting goods from Australia

             (3)  A person contravenes this subsection if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  the person does not have the consent in writing of the Secretary; and

                     (c)  the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia).

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Decisions on whether to give consent

             (4)  The Secretary must, as soon as practicable after making a decision to give a consent, cause particulars of the decision to be published in the Gazette.

             (5)  The Secretary must, within 28 days after making a decision to refuse to give a consent, notify the applicant in writing of the decision and of the reasons for the decision.

14B  Application of Customs Act 1901

                   Where:

                     (a)  the importation or exportation of goods is an offence under subsection 14(1), (2), (4), (10), (11) or (13) or a contravention of subsection 14A(1) or (3); and

                     (b)  the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the goods included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:

                     (c)  prohibited imports within the meaning of that Act; or

                     (d)  prohibited exports within the meaning of that Act;

as the case requires.

15  Criminal offences relating to breaching a condition of a consent

             (1)  The consent of the Secretary under section 14 or 14A may be given:

                     (a)  unconditionally or subject to conditions; or

                     (b)  in respect of particular goods or classes of goods.

             (2)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent; and

                     (c)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  2,000 penalty units.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

             (3)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent; and

                     (c)  the act or omission is likely to result in harm or injury to any person.

Penalty:  1,000 penalty units.

             (4)  Subsection (3) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent.

Penalty:  500 penalty units.

15AA  Civil penalty relating to breaching a condition of a consent

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent imposed under section 15.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.


 

Part 3‑2Registration and listing of therapeutic goods

Division 1Preliminary

15A  Application of this Part to medical devices

The general rule

             (1)  This Part does not apply to a medical device unless this section provides otherwise.

Previously registered or listed devices

             (2)  If a medical device is registered goods or listed goods before the commencement of this section, this Part continues to apply to the device unless the registration or listing is cancelled.

Note:          A registration or listing can be cancelled under section 30, or can be taken to be cancelled under section 9B.

Pending applications

             (3)  This Part continues to apply to a medical device if:

                     (a)  before the commencement of this section, an application was made under Part 3 for registration or listing of therapeutic goods that include that medical device; and

                     (b)  immediately before that commencement, the application was not yet finally determined; and

                     (c)  the application has not been, and is not, withdrawn either before or after that commencement.

However, this Part ceases to apply to the device if, having been registered goods or listed goods, the registration or listing is cancelled.

             (4)  For the purposes of paragraph (3)(b), an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.

Applications made within 2 years relating to certain medical devices

             (5)  This Part applies to a medical device if:

                     (a)  regulations made for the purposes of this section specified either:

                              (i)  the medical device classification applying to the kind of medical device that includes that device; or

                             (ii)  medical devices of that kind; and

                     (b)  during the period of 2 years after the commencement of this section, an application was made under Part 3‑2 for registration or listing of therapeutic goods that include that medical device.

However, this Part ceases to apply to the device if, having been registered goods or listed goods, the registration or listing is cancelled.

Note:          Medical devices that are registered or listed because of this subsection are taken to be cancelled 2 years after Chapter 4 commences, or before then if medical devices of that kind are included in the Register under Chapter 4: see subsection 9B(1).

Medical devices that are exempt goods

             (6)  This Part applies to a medical device, during the period of 2 years after the commencement of this section, if the device is exempt goods.

Existing approvals under section 19

             (7)  This Part continues to apply to a medical device if:

                     (a)  an approval or authorisation in force under section 19 applies to the device; and

                     (b)  that approval or authorisation was in force immediately before the commencement of this section.

New approvals under section 19

             (8)  This Part applies to a medical device if:

                     (a)  subsection (7) does not apply to the device; and

                     (b)  during the period of 2 years after the commencement of this section, an approval is granted or an authorisation is given under section 19 that applies to the device.

However, this subsection does not apply after the end of that period.

16  Therapeutic goods and gazetted groups

             (1)  For the purposes of this Part, therapeutic goods (other than medicine of the kind to which subsection (1A) applies) are to be taken to be separate and distinct from other therapeutic goods if they have:

                     (a)  a different formulation, composition or design specification; or

                     (b)  a different strength or size (disregarding pack size); or

                     (c)  a different dosage form or model; or

                     (d)  a different name; or

                     (e)  different indications; or

                      (f)  different directions for use; or

                     (g)  a different type of container (disregarding container size).

          (1A)  Medicines that are listable goods (other than export only medicines) are taken to be separate and distinct from other therapeutic goods if the medicines have:

                     (a)  different active ingredients; or

                     (b)  different quantities of active ingredients; or

                     (c)  a different dosage form; or

                     (d)  such other different characteristics as the regulations prescribe;

from the therapeutic goods.

             (2)  The Secretary may, by order published in the Gazette, determine that a group of therapeutic goods (not being medical devices or therapeutic devices) identified in the order is a gazetted therapeutic goods group because the goods within the group have common characteristics.

             (3)  The Secretary may, by order published in the Gazette, determine that a group of therapeutic goods (being therapeutic devices) identified in the order is a gazetted therapeutic devices group because the goods within the group:

                     (a)  have common characteristics; and

                     (b)  have been produced by the same manufacturer.

          (3A)  The Secretary may, by order published in the Gazette, determine that a group of kits identified in the order is a gazetted kits group.

             (4)  An order under subsection (2), (3) or (3A) may make provision for or in relation to a matter by applying, adopting or incorporating, with or without modification, a document as in force from time to time, if the document is:

                     (a)  published by the Department (whether in electronic form or otherwise); and

                     (b)  available for sale to the public; and

                     (c)  available for inspection (whether by using a visual display unit or otherwise) by the public at offices of the Department specified by the Secretary.

18  Exempt goods

             (1)  The regulations may, subject to such conditions (if any) as are specified in the regulations, exempt:

                     (a)  all therapeutic goods, except those included in a class of goods prescribed for the purposes of this paragraph; or

                     (b)  specified therapeutic goods; or

                     (c)  a specified class of therapeutic goods;

from the operation of this Part (except section 31A and sections 31C to 31F).

             (2)  An exemption in terms of paragraph (1)(a) has effect only in relation to such classes of persons as are prescribed for the purposes of this subsection.

             (3)  Where the regulations revoke an exemption, the revocation takes effect on the day, not being earlier than 28 days after the day on which the regulations are made, specified in the regulations.

18A  Exemption because of emergency

Minister’s power

             (1)  The Minister may exempt from the operation of Division 2 of this Part:

                     (a)  specified therapeutic goods; or

                     (b)  therapeutic goods in a specified class.

The exemption must be made in writing.

             (2)  The Minister may exempt goods under subsection (1) only if the Minister is satisfied that, in the national interest:

                     (a)  the exemption should be made so that the goods may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or

                     (b)  the exemption should be made so that the goods can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.

When the exemption has effect

             (3)  The exemption takes effect:

                     (a)  on the day on which the exemption is made; or

                     (b)  on a later day that is specified in the exemption.

             (4)  The exemption ceases to have effect:

                     (a)  at the end of the period specified by the Minister in the exemption as the period for which the exemption is to have effect; or

                     (b)  when the exemption is revoked;

whichever first occurs.

             (5)  The exemption ceases to have effect in relation to particular therapeutic goods:

                     (a)  when those goods become registered or listed goods; or

                     (b)  when the Minister varies the exemption by removing those goods from the exemption;

whichever first occurs.

             (6)  If the Minister revokes the exemption as mentioned in paragraph (4)(b), or varies the exemption as mentioned in paragraph (5)(b), the revocation or variation takes effect:

                     (a)  if the Minister states in the revocation or variation that the revocation or variation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the revocation or variation is made; or

                     (b)  in any other case—on the day specified by the Minister in the revocation or variation.

The day specified under paragraph (b) of this subsection must not be earlier than 28 days after the day on which the revocation or variation is made.

Note:          The revocation or variation must be made in writing, see subsection 33(3) of the Acts Interpretation Act 1901.

Conditions for the exemption

             (7)  The exemption is subject to conditions specified in the exemption about any of the following:

                     (a)  the period for which the exemption is to have effect;

                     (b)  the quantity of goods that are exempt;

                     (c)  the source of those goods;

                     (d)  the persons or class of persons who may import, manufacture, supply or export those goods;

                     (e)  the supply of those goods (including the persons or class of persons to whom goods may be supplied for use and the circumstances under which a stockpile of goods may be supplied for use);

                      (f)  the storage and security of those goods;

                     (g)  the keeping and disclosure of, and access to, records about those goods;

                     (h)  the disposal of those goods;

                      (i)  the manner in which any of those goods are to be dealt with if a condition of the exemption is breached;

                      (j)  any other matters that the Minister thinks appropriate.

Whether or not goods are exempt under this section is not affected by whether or not there is a breach of a condition of an exemption under this section in relation to those goods.

Note 1:       A person may commit an offence by breaching a condition of an exemption under this section, see subsections 20(2A) and (2C), 22(7AB) and (7AD), and 30H(1) and (3).

Note 2:       A person may also contravene a civil penalty provision, see section 22AA.

             (8)  The Minister may revoke or vary the conditions (including by imposing new conditions) after the exemption is made. The revocation or variation must be made in writing.

             (9)  A revocation or variation under subsection (8) takes effect:

                     (a)  if the Minister states in the revocation or variation that the revocation or variation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the revocation or variation is made; or

                     (b)  in any other case—on the day specified by the Minister in the revocation or variation.

The day specified under paragraph (b) must not be earlier than 28 days after the day on which the revocation or variation is made.

Exemption not a legislative instrument

          (9A)  An exemption under subsection (1) is not a legislative instrument.

Informing persons of exemption etc.

          (9B)  If the Minister makes an exemption under subsection (1), the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph (7)(d):

                     (a)  the exemption;

                     (b)  any revocation or variation of the exemption under this section.

Notification

           (10)  The Secretary must cause a document setting out particulars of:

                     (a)  an exemption covered by paragraph (2)(b); and

                     (b)  a revocation or variation under this section of an exemption covered by paragraph (2)(b);

to be published in the Gazette within 5 working days after the day on which the Minister makes the exemption, revocation or variation. However, an exemption, or a revocation or variation, is not invalid merely because of a failure to comply with this subsection.

Tabling

           (11)  The Minister must cause a document setting out particulars of:

                     (a)  an exemption covered by paragraph (2)(b); and

                     (b)  a revocation or variation under this section of an exemption covered by paragraph (2)(b);

to be tabled before each House of the Parliament within 5 sitting days of that House after the day on which the Minister makes the exemption, revocation or variation. However, an exemption, or a revocation or variation, is not invalid merely because of a failure to comply with this subsection.

Note:          There are other requirements in other parts of this Act about goods exempt under this section:

(a)           sections 20, 22 and 22AA (breach of a condition of the exemption);

(b)           sections 30F and 30FA (goods not conforming to standards etc.);

(c)           section 30G (disposal of unused goods);

(d)           section 30H (record keeping);

(e)           section 31AA (providing information to the Secretary);

(f)            sections 35, 35A, 39 and 41 (manufacturing goods that are exempt under this section);

(g)           section 46A (search of premises).

19  Exemptions for special and experimental uses

             (1)  The Secretary may, by notice in writing, grant an approval to a person for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods, listed goods or exempt goods:

                     (a)  for use in the treatment of another person; or

                     (b)  for use solely for experimental purposes in humans;

and such an approval may be given subject to such conditions as are specified in the notice of approval.

          (1A)  An approval for the purpose mentioned in paragraph (1)(b) is subject to the conditions (if any) specified in the regulations. Those conditions (if any) are in addition to any conditions imposed on the approval under subsection (1).

             (2)  An application for an approval must be made to the Secretary and must:

                     (a)  in the case of an application for use of the kind referred to in paragraph (1)(a)—be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and

                     (b)  in the case of an application for use of the kind referred to in paragraph (1)(b):

                              (i)  be made in writing; and

                             (ii)  be accompanied by such information relating to the goods the subject of the application as is required by the Secretary; and

                            (iii)  be accompanied by the prescribed evaluation fee.

             (3)  Without limiting the conditions to which an approval under subsection (1) may be made subject, those conditions may include a condition relating to the charges that may be made for the therapeutic goods to which the approval relates.

             (4)  Where an application for an approval is made, the Secretary must, after having considered the application and, in the case of an application for the use of therapeutic goods for experimental purposes in humans, after having evaluated the information submitted with the application, notify the applicant of the decision on the application within 28 days of making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

          (4A)  The use by a person for experimental purposes in humans of specified therapeutic goods that are the subject of an approval granted to someone else under paragraph (1)(b) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

                     (a)  the preconditions on the use of the goods for those purposes;

                     (b)  the principles to be followed in the use of the goods for those purposes;

                     (c)  the monitoring of the use, and the results of the use, of the goods for those purposes;

                     (d)  the circumstances in which the person must cease the use of the goods for those purposes.

             (5)  The Secretary may, in writing, authorise a specified medical practitioner to supply:

                     (a)  specified therapeutic goods for use in the treatment of humans; or

                     (b)  a specified class of such goods;

to the class or classes of recipients specified in the authority.

          (5A)  An authority may be given subject to the conditions (if any) specified in the authority.

          (5B)  The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (5) by giving to the person written notice of the conditions (or further conditions).

             (6)  An authority under subsection (5) may only be given:

                     (a)  to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and

                    (aa)  to a medical practitioner who has the approval of an ethics committee to supply the specified therapeutic goods or the specified class of such goods; and

                     (b)  in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph.

Paragraph (aa) does not apply in the exceptional circumstances (if any) prescribed by the regulations for the purposes of this subsection.

             (7)  The regulations may prescribe the circumstances in which therapeutic goods may be supplied under an authority under subsection (5).

             (9)  In this section, medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.

19A  Exemptions where unavailability etc. of therapeutic goods

             (1)  The Secretary may, by notice in writing, grant an approval to a person for the importation into Australia, or the supply in Australia, of specified therapeutic goods if the Secretary is satisfied that:

                     (a)  registered goods that could act as a substitute for the goods are unavailable or are in short supply; and

                     (b)  either:

                              (i)  the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or

                             (ii)  an application that complies with section 23 has been made under that section for registration of the goods; and

                     (c)  the goods are of a kind:

                              (i)  included in Schedule 10 of the Therapeutic Goods Regulations; or

                             (ii)  specified by the Secretary in a determination under subsection (4); and

                     (d)  the approval is necessary in the interests of public health.

             (2)  The Secretary may, by notice in writing, grant an approval to a person for the importation into Australia, or the supply in Australia, of specified therapeutic goods if the Secretary is satisfied that:

                     (a)  registered goods that could act as a substitute for the goods do not exist; and

                     (b)  an application that complies with section 23 has been made under that section for registration of the goods; and

                     (c)  the goods are of a kind:

                              (i)  included in Schedule 10 of the Therapeutic Goods Regulations; or

                             (ii)  specified by the Secretary in a determination under subsection (4); and

                     (d)  the approval is necessary in the interests of public health.

             (3)  The Secretary may, for the purposes of subparagraph (1)(b)(i), make written determinations specifying the foreign countries in which registration or approval for general marketing of the goods is a prerequisite for approval by the Secretary under this section.

             (4)  The Secretary may make written determinations specifying the kinds of goods that can be the subject of an approval under this section.

             (5)  Determinations under subsections (3) and (4) are legislative instruments.

             (6)  The Secretary may grant the approval subject to any conditions that are specified in the notice of approval.

             (7)  The Secretary may grant the approval for such period as is specified in the notice of approval.

             (8)  The approval lapses if:

                     (a)  the period specified in the notice of approval expires; or

                     (b)  a decision has been made under section 25 in relation to the goods.

             (9)  The approval lapses if:

                     (a)  the Secretary is satisfied that paragraph (1)(a), (b), (c) or (d), or paragraph (2)(a), (b), (c) or (d), as the case requires, no longer applies in relation to the goods, or that a condition of the approval has been contravened; and

                     (b)  the Secretary has given to the person to whom the approval was granted a notice stating that the Secretary is so satisfied.

           (10)  The lapsing of the approval on the expiry of the period specified in the notice of approval does not prevent another approval being granted under this section in relation to the goods before the lapsing of the first‑mentioned approval. The other approval may be expressed to take effect on the expiry of that period.

19B  Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods

Offences relating to importing, exporting, manufacturing or supplying goods for use in humans

             (1)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports into Australia therapeutic goods for use in humans; or

                             (ii)  exports from Australia therapeutic goods for use in humans; or

                            (iii)  manufactures in Australia therapeutic goods for use in humans; or

                            (iv)  supplies in Australia therapeutic goods for use in humans; and

                     (b)  none of the following subparagraphs applies in relation to the goods:

                              (i)  the goods are registered goods or listed goods in relation to the person;

                             (ii)  the goods are exempt goods;

                            (iii)  the goods are exempt under section 18A;

                            (iv)  the goods are the subject of an approval or authority under section 19;

                             (v)  the goods are the subject of an approval under section 19A; and

                     (c)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:       A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2:       A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.

             (2)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports into Australia therapeutic goods for use in humans; or

                             (ii)  exports from Australia therapeutic goods for use in humans; or

                            (iii)  manufactures in Australia therapeutic goods for use in humans; or

                            (iv)  supplies in Australia therapeutic goods for use in humans; and

                     (b)  none of the following subparagraphs applies in relation to the goods:

                              (i)  the goods are registered goods or listed goods in relation to the person;

                             (ii)  the goods are exempt goods;

                            (iii)  the goods are exempt under section 18A;

                            (iv)  the goods are the subject of an approval or authority under section 19;

                             (v)  the goods are the subject of an approval under section 19A; and

                     (c)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

Note:          A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports into Australia therapeutic goods for use in humans; or

                             (ii)  exports from Australia therapeutic goods for use in humans; or

                            (iii)  manufactures in Australia therapeutic goods for use in humans; or

                            (iv)  supplies in Australia therapeutic goods for use in humans; and

                     (b)  none of the following subparagraphs applies in relation to the goods:

                              (i)  the goods are registered goods or listed goods in relation to the person;

                             (ii)  the goods are exempt goods;

                            (iii)  the goods are exempt under section 18A;

                            (iv)  the goods are the subject of an approval or authority under section 19;

                             (v)  the goods are the subject of an approval under section 19A.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Defence if person was not the sponsor of the goods

             (5)  It is a defence to a prosecution under subsection (1), (2) or (4) if the defendant proves that the defendant was not the sponsor of the goods at the time of the importation, exportation, manufacture or supply, as the case may be.

Note:          The defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

Exception

             (6)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, or will not, directly result from:

                              (i)  the quality, safety or efficacy of the goods; or

                             (ii)  a matter relating to the labelling or packaging of the goods; or

                            (iii)  the improper use of the goods; or

                     (b)  harm or injury would not directly result from:

                              (i)  the quality, safety or efficacy of the goods; or

                             (ii)  a matter relating to the labelling or packaging of the goods; or

                            (iii)  the improper use of the goods.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

Application of Customs Act 1901

             (7)  Where:

                     (a)  the importation or exportation of goods is an offence under subsection (1), (2) or (4); and

                     (b)  the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the goods included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:

                     (c)  prohibited imports within the meaning of that Act; or

                     (d)  prohibited exports within the meaning of that Act;

as the case requires.

19C  Notice required to adduce evidence in support of exception under subsection 19B(6)

             (1)  If:

                     (a)  a defendant is committed for trial for an offence against subsection 19B(1); or

                     (b)  an offence against subsection 19B(1) is to be heard and determined by a court of summary jurisdiction;

the committing magistrate or the court must:

                     (c)  inform the defendant of the requirements of this section; and

                     (d)  cause a copy of this section to be given to the defendant.

             (2)  A defendant must not, without leave of the court, adduce evidence in support of the exception under subsection 19B(6) unless:

                     (a)  if paragraph (1)(a) applies—more than 21 days before the trial begins; or

                     (b)  if paragraph (1)(b) applies—more than 21 days before the hearing of the offence begins;

he or she gives notice of particulars of the exception.

             (3)  A defendant must not, without leave of the court, call any other person to give evidence in support of the exception unless:

                     (a)  the notice under subsection (2) includes the name and address of the person or, if the name and address is not known to the defendant at the time he or she gives the notice, any information in his or her possession that might be of material assistance in finding the person; and

                     (b)  if the name or the address is not included in the notice—the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address; and

                     (c)  if the name or address is not included in the notice, but the defendant subsequently ascertains the name or address or receives information that might be of material assistance in finding the person—the defendant immediately gives notice of the name, address or other information, as the case may be; and

                     (d)  if the defendant is told by or on behalf of the prosecutor that the person has not been found by the name, or at the address, given by the defendant:

                              (i)  the defendant immediately gives notice of any information in the defendant’s possession that might be of material assistance in finding the person; or

                             (ii)  if the defendant later receives any such information—the defendant immediately gives notice of the information.

             (4)  A notice purporting to be given under this section on behalf of the defendant by his or her legal practitioner is, unless the contrary is proved, taken as having been given with the authority of the defendant.

             (5)  Any evidence tendered to disprove that the exception applies may, subject to direction by the court, be given before or after evidence is given in support of the exception.

             (6)  A notice of particulars of the exception must be given, in writing, to the Director of Public Prosecutions. A notice is taken as having been given if it is:

                     (a)  delivered to or left at the Office of the Director of Public Prosecutions; or

                     (b)  sent by certified mail addressed to the Director of Public Prosecutions at the Office of the Director of Public Prosecutions.

             (7)  In this section:

Director of Public Prosecutions means a person holding office as, or acting as, the Director of Public Prosecutions under the Director of Public Prosecutions Act 1983.

19D  Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods

Civil penalty relating to importing, exporting, manufacturing or supplying goods for use in humans

             (1)  A person contravenes this subsection if:

                     (a)  the person does any of the following:

                              (i)  imports into Australia therapeutic goods for use in humans;

                             (ii)  exports from Australia therapeutic goods for use in humans;

                            (iii)  manufactures in Australia therapeutic goods for use in humans;

                            (iv)  supplies in Australia therapeutic goods for use in humans; and

                     (b)  none of the following subparagraphs applies in relation to the goods:

                              (i)  the goods are registered goods or listed goods in relation to the person;

                             (ii)  the goods are exempt goods;

                            (iii)  the goods are exempt under section 18A;

                            (iv)  the goods are the subject of an approval or authority under section 19;

                             (v)  the goods are the subject of an approval under section 19A.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Note:          A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.

Exception if person was not the sponsor of the goods

             (2)  Subsection (1) does not apply if the person proves that he or she was not the sponsor of the goods at the time of the importation, exportation, manufacture or supply, as the case may be.

Civil penalty relating to the importing of registered or listed goods

             (3)  A person contravenes this subsection if:

                     (a)  therapeutic goods are registered or listed in relation to the person (other than listed goods that are therapeutic devices); and

                     (b)  the person imports the goods into Australia; and

                     (c)  the registration number or listing number of the goods is not set out on the label of the goods in the prescribed manner before the goods are supplied in Australia.

Maximum civil penalty:

                     (a)  for an individual—200 penalty units; and

                     (b)  for a body corporate—2,000 penalty units.

Civil penalty relating to the supply of registered or listed goods

             (4)  A person contravenes this subsection if:

                     (a)  therapeutic goods are registered or listed in relation to the person (other than listed goods that are therapeutic devices); and

                     (b)  the person supplies the goods in Australia; and

                     (c)  the registration number or listing number of the goods is not set out on the label of the goods in the prescribed manner.

Maximum civil penalty:

                     (a)  for an individual—200 penalty units; and

                     (b)  for a body corporate—2,000 penalty units.

Application of Customs Act 1901

             (5)  Where:

                     (a)  the importation or exportation of goods contravenes subsection (1); and

                     (b)  the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the goods included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:

                     (c)  prohibited imports within the meaning of that Act; or

                     (d)  prohibited exports within the meaning of that Act;

as the case requires.

20  Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A

          (1B)  A person is guilty of an offence if:

                     (a)  the person is the sponsor of therapeutic goods for use in humans; and

                     (b)  the person:

                              (i)  imports the goods into Australia; or

                             (ii)  exports the goods from Australia; or

                            (iii)  manufactures the goods in Australia; or

                            (iv)  supplies the goods in Australia; and

                     (c)  the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:

                              (i)  the manufacturer of the goods;

                             (ii)  premises used in the manufacture of the goods.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

          (1C)  For the purposes of paragraph (1B)(c):

                     (a)  a manufacturer is properly notified to the Secretary if:

                              (i)  the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and

                     (b)  premises are properly notified to the Secretary if:

                              (i)  the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods.

          (2A)  A person commits an offence if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the goods are exempt under section 18A; and

                     (c)  the importation breaches a condition of the exemption.

Penalty:  Imprisonment for 4 years or 240 penalty units, or both.

          (2B)  Strict liability applies to paragraph (2A)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

          (2C)  A person commits an offence if:

                     (a)  the person imports therapeutic goods into Australia; and

                     (b)  the goods are exempt under section 18A; and

                     (c)  the importation breaches a condition of the exemption.

Penalty:  60 penalty units.

          (2D)  An offence under subsection (2C) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

20A  Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification

             (1)  A person contravenes this section if:

                     (a)  the person does any of the following:

                              (i)  imports therapeutic goods into Australia;

                             (ii)  exports therapeutic goods from Australia;

                            (iii)  manufactures therapeutic goods in Australia;

                            (iv)  supplies therapeutic goods in Australia; and

                     (b)  the person is the sponsor of the goods for use in humans; and

                     (c)  the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:

                              (i)  the manufacturer of the goods;

                             (ii)  premises used in the manufacture of the goods.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Meaning of properly notified

             (2)  For the purposes of paragraph (1)(c):

                     (a)  a manufacturer is properly notified to the Secretary if:

                              (i)  the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and

                     (b)  premises are properly notified to the Secretary if:

                              (i)  the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or

                             (ii)  the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods.

21  Offence relating to wholesale supply

                   A person must not supply in Australia therapeutic goods for use in humans (other than listable devices), being goods of which the person is not a sponsor, to another person who is not the ultimate consumer of the goods unless:

                     (a)  the goods are registered goods or listed goods; or

                     (b)  the goods are exempt goods; or

                    (ba)  the goods are exempt under section 18A; or

                     (c)  the goods are the subject of an approval or authority under section 19; or

                     (d)  the goods are the subject of an approval under section 19A.

Penalty:  120 penalty units.

21A  General criminal offences relating to this Part

Offences for making a false or misleading statement

             (1)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with a certification of any matter under subsection 26A(2); and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the medicine has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the medicine, if the medicine were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with a certification of any matter under subsection 26A(2); and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  the use of the medicine, if the medicine were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with a certification of any matter under subsection 26A(2); and

                     (c)  the statement is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to breaching a condition of registration or listing of therapeutic goods

             (5)  A person commits an offence if:

                     (a)  therapeutic goods are registered or listed in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the registration or listing of the goods; and

                     (d)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence if:

                     (a)  therapeutic goods are registered or listed in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the registration or listing of the goods; and

                     (d)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (8)  A person commits an offence if:

                     (a)  therapeutic goods are registered or listed in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the registration or listing of the goods.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to the supply of therapeutic goods in breach of authority etc.

             (9)  A person commits an offence if:

                     (a)  the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and

                     (b)  the person supplies those goods; and

                     (c)  any of the following applies:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7); and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7).

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(7A) instead: see section 53A.

           (10)  A person commits an offence if:

                     (a)  the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and

                     (b)  the person supplies those goods; and

                     (c)  any of the following applies:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7); and

                     (d)  the use of the goods, if goods were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 19(7).

Penalty:  2,000 penalty units.

           (11)  Subsection (10) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

Offences relating to using therapeutic goods without approval etc.

           (12)  A person commits an offence if:

                     (a)  the person uses therapeutic goods; and

                     (b)  the goods are used:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans; and

                     (c)  the goods are not:

                              (i)  exempt goods; or

                             (ii)  listed goods; or

                            (iii)  registered goods; or

                            (iv)  goods exempt under section 18A; or

                             (v)  goods that are the subject of an approval under section 19A; and

                     (d)  the goods are not used in accordance with:

                              (i)  an approval or authority under section 19; or

                             (ii)  a condition applicable under regulations made for the purposes of subsection 19(4A); and

                     (e)  either:

                              (i)  if the person used the goods in the treatment of another person—the use of the goods has resulted in, or will result in, harm or injury to that person; or

                             (ii)  if the person used the goods solely for experimental purposes in humans—the use of the goods has resulted in, or will result in, harm or injury to any of those persons.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(8) instead: see section 53A.

           (13)  A person commits an offence if:

                     (a)  the person uses therapeutic goods; and

                     (b)  the goods are used:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans; and

                     (c)  the goods are not:

                              (i)  exempt goods; or

                             (ii)  listed goods; or

                            (iii)  registered goods; or

                            (iv)  goods exempt under section 18A; or

                             (v)  goods that are the subject of an approval under section 19A; and

                     (d)  the goods are not used in accordance with:

                              (i)  an approval or authority under section 19; or

                             (ii)  a condition applicable under regulations made for the purposes of subsection 19(4A); and

                     (e)  either:

                              (i)  if the person used the goods in the treatment of another person—the use of the goods, if the goods were used, is likely to result in harm or injury to that person; or

                             (ii)  if the person used the goods solely for experimental purposes in humans—the use of the goods, if the goods were used, is likely to result in harm or injury to any of those persons.

Penalty:  2,000 penalty units.

           (14)  Subsection (13) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

21B  General civil penalties relating to this Part

Civil penalty for making a false or misleading statement

             (1)  A person contravenes this subsection if the person, in or in connection with a certification of any matter under subsection 26A(2), makes a statement that is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to breaching a condition of registration or listing of therapeutic goods

             (2)  A person contravenes this subsection if:

                     (a)  therapeutic goods are registered or listed in relation to the person; and

                     (b)  the person does an act or omits to do an act that breaches a condition of the registration or listing of the goods.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty for falsely representing therapeutic goods

             (3)  A person contravenes this subsection if:

                     (a)  the person represents therapeutic goods that are not included in the Register as being so included; or

                     (b)  the person represents therapeutic goods that are not exempt goods as being exempt goods; or

                     (c)  the person represents therapeutic goods that are not goods exempt under section 18A as being goods exempt under that section; or

                     (d)  the person represents therapeutic goods that are included in one part of the Register as being included in another part of the Register; or

                     (e)  the person represents therapeutic goods that are not the subject of an approval or authority under section 19 as being the subject of such an approval or authority; or

                      (f)  the person represents therapeutic goods that are not the subject of an approval under section 19A as being the subject of such an approval.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

22  General offences relating to this Part

             (1)  A person must not set out or cause to be set out, on a container or package that contains therapeutic goods or on a label of goods of that kind, a number that purports to be the registration number or listing number of the goods in relation to a particular person if the number is not that number.

Penalty:  60 penalty units.

             (5)  A person commits an offence if:

                     (a)  the person, by any means, advertises therapeutic goods for an indication; and

                     (b)  the therapeutic goods are included in the Register; and

                     (c)  the indication is not an indication accepted in relation to that inclusion.

Penalty:  60 penalty units.

             (6)  A person must not make a claim, by any means, that the person or another person can arrange the supply of therapeutic goods (not being exempt goods or goods exempt under section 18A) that are not registered goods or listed goods.

Penalty:  60 penalty units.

             (7)  A person is guilty of an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission results in the breach of:

                              (i)  a condition of an exemption applicable under regulations made for the purposes of subsection 18(1); or

                             (ii)  a condition of an approval under section 19; or

                            (iii)  a condition applicable under regulations made for the purposes of subsection 19(4A); or

                            (iv)  a condition of an approval under section 19A.

       (7AA)  An offence against subsection (7) is punishable on conviction by a fine of not more than 60 penalty units.

        (7AB)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to therapeutic goods; and

                     (b)  the goods are exempt under section 18A; and

                     (c)  the act or omission results in the breach of a condition of the exemption; and

                     (d)  the act or omission is likely to cause a serious risk to public health.

Penalty:  Imprisonment for 5 years or 2,000 penalty units, or both.

Note 1:       A person may commit an offence against subsection 20(2A) or (2C), or contravene section 22AA (a civil penalty provision), by breaching a condition of an exemption of therapeutic goods under section 18A that relates to the importation of the goods.

Note 2:       A person may commit an offence against subsection 30H(1) or (3) by breaching a condition of an exemption of therapeutic goods under section 18A that relates to records about the goods.

        (7AC)  Strict liability applies to paragraph (7AB)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

       (7AD)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to therapeutic goods; and

                     (b)  the goods are exempt under section 18A; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  Imprisonment for 4 years or 240 penalty units, or both.

        (7AE)  Strict liability applies to paragraph (7AD)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

          (7A)  A person to whom an authority under subsection 19(5) has been granted must not supply the therapeutic goods to which the authority relates except in accordance with:

                     (a)  the authority; and

                    (aa)  the conditions (if any) to which the authority is subject; and

                     (b)  any regulations made for the purpose of subsection 19(7).

Penalty:  500 penalty units.

             (8)  A person must not use therapeutic goods, other than exempt goods, listed goods, registered goods, goods exempt under section 18A or goods that are the subject of an approval under section 19A:

                     (a)  for use in the treatment of another person; or

                     (b)  for use solely for experimental purposes in humans;

except in accordance with an approval or authority under section 19 or a condition applicable under regulations made for the purposes of subsection 19(4A).

Penalty:  500 penalty units.

22AA  Civil penalty for breaching a condition of an exemption

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act in relation to therapeutic goods; and

                     (b)  the goods are exempt under section 18A; and

                     (c)  the act or omission breaches a condition of the exemption.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

22A  Criminal offences for false statements in applications for registration

             (1)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with an application for registration of therapeutic goods; and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with an application for registration of therapeutic goods; and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in or in connection with an application for registration of therapeutic goods; and

                     (c)  the statement is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

22B  Civil penalty for false statements in applications for registration

                   A person contravenes this section if the person in or in connection with an application for registration of therapeutic goods, makes a statement that is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.


 

Division 2Registration and listing

23  Applications generally

             (1)  An application for registration or listing of therapeutic goods must:

                     (a)  be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and

                     (b)  be delivered to an office of the Department specified by the Secretary.

             (2)  An application is not effective unless:

                     (a)  the prescribed application fee has been paid; and

                     (b)  the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and

                     (c)  if the Secretary so requires—the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods.

             (3)  An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

24  Applications for registration

             (1)  Where an application is made for the registration of therapeutic goods in accordance with section 23 and the goods are goods that are required to be registered, a fee specified in or determined in accordance with the regulations is payable by the applicant in respect of the evaluation of the goods for registration, and the Secretary must notify each such applicant of the amount of the evaluation fee.

             (2)  Subject to section 24D, an application for registration of therapeutic goods lapses if:

                     (a)  any part of the evaluation fee payable in respect of those goods remains unpaid at the end of the period of 2 months after the day on which the amount became due and payable; or

                     (b)  the application contains information that is inaccurate or misleading in a material particular; or

                     (c)  information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a requirement under section 31, is inaccurate or misleading in a material particular; or

                     (d)  the applicant fails to comply with a requirement under section 31 to give information consisting of individual patient data in relation to the goods.

             (3)  In this section, individual patient data, in relation to therapeutic goods, means information, derived from clinical trials, relating to individuals before, during and after the administration of the goods to those individuals, including, but not limited to, demographic, biochemical and haematological information.

24A  When evaluation fee due for payment

                   Subject to sections 24B and 24D, an evaluation fee under section 24 payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

24B  Payment of evaluation fee by instalments

             (1)  The regulations may provide for the payment of an evaluation fee under section 24 to be made by such instalments and at such times as are ascertained in accordance with the regulations, and the evaluation fee is due and payable accordingly.

             (2)  Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24 by instalments if any part of an instalment of:

                     (a)  that or any other evaluation fee under section 24 payable by the person; or

                     (b)  any assessment fee under section 41LA payable by the person;

was unpaid immediately after the time when it became due for payment.

             (3)  Subsection (2) does not limit the generality of subsection (1).

24C  Recovery of evaluation fee

                   An evaluation fee under section 24 may be recovered by the Commonwealth as a debt due to the Commonwealth.

24D  Reduction of evaluation fee where evaluation not completed within prescribed period

             (1)  This section applies to an application under section 23 in relation to therapeutic goods for the evaluation of which a period is prescribed under paragraph 63(2)(da).

             (2)  Nothing in section 24, 24A or 24B requires the applicant to pay more than three‑quarters of the evaluation fee before the completion of the evaluation of the goods.

             (3)  If the evaluation is not completed within the period referred to in subsection (1), this Act has effect as if the evaluation fee were reduced to three‑quarters of the fee that, under the regulations, would have been the evaluation fee.

             (4)  If:

                     (a)  the evaluation is completed within the period referred to in subsection (1); and

                     (b)  part of the evaluation fee under section 24 is unpaid when the evaluation is completed;

that part becomes due and payable on the completion of the evaluation.

             (5)  For the purposes of subsections (2), (3) and (4), the evaluation is to be taken to be completed when the applicant is notified according to subsection 25(3) or (4) of the Secretary’s decision on the application.

             (6)  Despite subsection (5), if:

                     (a)  the Secretary has given the applicant all evaluation reports relating to the application; and

                     (b)  the Secretary has given those reports, or proposes to give those reports, to a committee established under the regulations to advise the Secretary on applications to register therapeutic goods to which subsection (1) applies; and

                     (c)  the applicant withdraws the application after being given the reports, and before the end of the period mentioned in subsection (1);

the evaluation is taken for the purposes of subsections (2), (3) and (4) to be completed immediately before the time of withdrawal.

24E  Deemed refusal of application

             (1)  This section applies in the case of an application under section 23 in relation to therapeutic goods for the evaluation of which a period is prescribed under paragraph 63(2)(da).

             (2)  If, at the end of the period referred to in subsection (1), the evaluation has not been completed, the applicant may give the Secretary written notice that the applicant wishes to treat the application as having been refused.

             (3)  A notice under subsection (2) may be given at any time before the evaluation is completed.

             (4)  Where a notice has been given, this Act (except for subsection 60(5)) has effect as if:

                     (a)  the Secretary had decided not to register the goods the subject of the application; and

                     (b)  the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and

                     (c)  the Minister’s decision had been made on the day on which notice was given to the Secretary under subsection (2).

25  Evaluation and registration of therapeutic goods

             (1)  Where:

                     (a)  an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23; and

                     (b)  there is no part of an evaluation fee under section 24 in respect of those goods that:

                              (i)  is due and payable by the person; and

                             (ii)  remains unpaid; and

                     (c)  the person has complied with any requirements made by the Secretary under section 31 in relation to the goods;

the Secretary must evaluate the goods for registration having regard to:

                     (d)  whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and

                     (e)  whether the presentation of the goods is acceptable; and

                      (f)  whether the goods conform to any standard applicable to the goods, or any requirements relating to advertising applicable under Part 5‑1 or under the regulations; and

                     (g)  if a step in the manufacture of the goods has been carried out outside Australia—whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable; and

                     (h)  if the goods have been manufactured in Australia—whether the goods have been manufactured in accordance with Part 3‑3; and

                      (j)  whether the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; and

                     (ja)  whether all of the manufacturers of the goods are nominated as manufacturers of the goods in the application; and

                     (k)  such other matters (if any) as the Secretary considers relevant.

Note:          The Secretary must not use protected information when evaluating therapeutic goods for registration: see section 25A.

             (2)  In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include:

                     (a)  whether the applicant has provided:

                              (i)  if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the goods; or

                            (ia)  if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country declared by the Minister under section 3B to be covered by a non‑EC/EFTA MRA—a non‑EC/EFTA attestation of conformity, for the non‑EC/EFTA MRA, in relation to the goods; or

                             (ii)  in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the goods is of an acceptable standard; and

                     (b)  whether the applicant has agreed to provide, where the Secretary considers inspection of the manufacturing procedures used in the manufacture of the goods to be necessary:

                              (i)  funds for the carrying out of that inspection by the Department; and

                             (ii)  evidence that the manufacturer has agreed to such an inspection.

          (2A)  An evaluation under this section of goods in relation to which a period has been prescribed under paragraph 63(2)(da) must be completed within that period.

          (2B)  If therapeutic goods are exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.

          (2C)  If a person is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3‑3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.

          (2D)  If:

                     (a)  therapeutic goods were made outside Australia; and

                     (b)  had the goods been made in Australia, they would have been exempt from the operation of Part 3‑3;

subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.

           (2E)  A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:

                     (a)  the general standards of manufacturing practice of a particular manufacturer; or

                     (b)  the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.

           (2F)  For the purposes of subsection (2E), a Convention country is a country that is a party to the Mutual Recognition Convention.

          (2G)  Information referred to in subsection (2E) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 3‑3 of this Act.

             (3)  If:

                     (a)  the therapeutic goods are therapeutic devices; and

                     (b)  the evaluation of the goods for registration has been completed;

the Secretary must:

                     (c)  notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

                     (d)  if the decision is to register the goods—include the goods in the Register and give the applicant a certificate of registration.

             (4)  If:

                     (a)  the therapeutic goods are not therapeutic devices; and

                     (b)  the evaluation of the goods for registration has been completed;

the Secretary must:

                     (c)  notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and, in the case of a decision not to register the goods, of the reasons for the decision; and

                     (d)  if the decision is to register the goods:

                              (i)  notify the applicant in writing that the goods will be included in the Register if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

                             (ii)  include the goods in the Register and give the applicant a certificate of registration if the applicant gives the Secretary either the certificate required under subsection 26B(1) or a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application.

To avoid doubt, if the applicant gives the Secretary the certificate required under subsection 26B(1) or a notice that a certificate under that subsection is not required in relation to the application, the Secretary must include the goods in the Register under subparagraph (d)(ii) without inquiring into the correctness of the certificate or the notice.

             (5)  The registration of therapeutic goods commences on the day specified for the purpose in the certificate of registration.

25A  When the Secretary must not use protected information

             (1)  When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.

             (2)  Information is protected information if:

                     (a)  the information was given to the Secretary in relation to an application to register therapeutic goods (the new goods):

                              (i)  not being therapeutic devices; and

                             (ii)  consisting of, or containing, an active component; and

                     (b)  the information is about the active component and is not available to the public; and

                     (c)  when the application to register the new goods was lodged:

                              (i)  no other therapeutic goods consisting of, or containing, that active component were included in the Register; and

                             (ii)  no such therapeutic goods had been included in the Register at any time before then; and

                     (d)  the new goods became registered on or after the commencement of this subsection; and

                     (e)  5 years have not passed since the day the new goods became registered; and

                      (f)  the person in relation to whom the new goods are registered has not given the Secretary permission in writing for the Secretary to use the information.

             (3)  For the purposes of subsection (2), an active component, in relation to therapeutic goods, is a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods.

25B  Registration of therapeutic device to which EC/EFTA attestation of conformity applies

             (1)  If:

                     (a)  an application is made in accordance with section 23 for the registration of a therapeutic device in relation to a person; and

                     (b)  the applicant gives to the Secretary an EC/EFTA attestation of conformity as to the matters that would require evaluation under subsection 25(1) if that subsection applied in relation to the device;

the Secretary must register the device unless the Secretary considers that the device may compromise the health or safety of users.

             (2)  The Secretary must notify the applicant in writing of his or her decision on the application within 28 days of the making of the decision. If the Secretary decides not to register the device, the notice must contain the reasons for that decision.

             (3)  If the Secretary decides to register the device, the Secretary must:

                     (a)  include the device in the Register; and

                     (b)  give to the applicant a certificate of registration.

             (4)  The registration of the device commences on the day specified for the purpose in the certificate of registration.

26  Listing of therapeutic goods

             (1)  Where:

                     (a)  an application is made for the listing of therapeutic goods in relation to a person in accordance with section 23; and

                    (aa)  if goods are not therapeutic devices—the application is accompanied by either:

                              (i)  the certificate required under subsection 26B(1); or

                             (ii)  a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

                     (b)  the person has complied with any requirements made by the Secretary under section 31 in relation to the goods; and

                    (ba)  the goods are not goods which may be listed under section 26A;

then, subject to section 26AA, the Secretary is not to refuse to list the goods in relation to the person except where the Secretary is satisfied that:

                     (c)  the goods are not eligible for listing; or

                     (d)  the goods are not safe for the purposes for which they are to be used; or

                     (e)  the presentation of the goods is unacceptable; or

                    (ea)  the goods contain a component or ingredient that is specified in a determination under subsection 26BE(1) that applies in relation to the goods; or

                    (eb)  the goods contain a component or ingredient:

                              (i)  that is specified in a determination under subsection 26BE(2) that applies in relation to the goods; and

                             (ii)  that exceeds the permitted concentration of that component or ingredient, or exceeds the permitted total amount of that component or ingredient, that is specified in that determination; or

                      (f)  the goods do not conform to a standard applicable to the goods or to a requirement relating to advertising applicable under Part 5‑1 or under the regulations; or

                     (g)  if a step in the manufacture of the goods (not being therapeutic devices other than devices prescribed for the purposes of this paragraph) has been carried out outside Australia—the manufacturing and quality control procedures used in the manufacture of the goods are not acceptable; or

                     (h)  if the goods have been manufactured in Australia—the goods have been manufactured contrary to Part 3‑3; or

                      (j)  if the goods have been manufactured in Australia, or imported into Australia, solely for export—a relevant authority of the country to which the goods are to be exported has not confirmed its willingness to accept the goods and:

                              (i)  the goods have been refused registration or listing for supply in Australia; or

                             (ii)  the Secretary requires such a confirmation for a reason other than because the goods have been refused registration or listing; or

                     (k)  the goods do not comply with prescribed quality or safety criteria; or

                    (m)  the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; or

                     (n)  one or more of the manufacturers of the goods are not nominated as manufacturers of the goods in the application.

          (1A)  To avoid doubt, if:

                     (a)  an application is made for the listing of therapeutic goods in relation to a person in accordance with section 23; and

                     (b)  the application is accompanied by either:

                              (i)  the certificate required under subsection 26B(1); or

                             (ii)  a notice that a certificate under that subsection is not required in relation to the application; and

                     (c)  the other requirements in subsection (1) are met;

the Secretary must list the goods under subsection (1) without inquiring into the correctness of the certificate or the notice.

             (2)  In making a decision for the purposes of paragraph (1)(g), the matters that may be taken into account include:

                     (a)  whether the applicant has provided:

                              (i)  if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the goods; or

                            (ia)  if the goods are not therapeutic devices and a step in the manufacture of the goods has been carried out in a country declared by the Minister under section 3B to be covered by a non‑EC/EFTA MRA—a non‑EC/EFTA attestation of conformity, for the non‑EC/EFTA MRA, in relation to the goods; or

                             (ii)  in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the goods is of an acceptable standard; and

                     (b)  whether the applicant has agreed to provide, where the Secretary considers inspection of the manufacturing procedures used in the manufacture of the goods to be necessary:

                              (i)  funds for the carrying out of that inspection by the Department; and

                             (ii)  evidence that the manufacturer has agreed to such an inspection.

          (2A)  If therapeutic goods are exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.

          (2B)  If a person is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3‑3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.

          (2C)  If:

                     (a)  therapeutic goods were made outside Australia; and

                     (b)  had the goods been made in Australia, they would have been exempt from the operation of Part 3‑3;

subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.

          (2D)  A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:

                     (a)  the general standards of manufacturing practice of a particular manufacturer; or

                     (b)  the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.

           (2E)  For the purposes of subsection (2D), a Convention country is a country that is a party to the Mutual Recognition Convention.

           (2F)  Information referred to in subsection (2D) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 3‑3 of this Act.

             (3)  Where an application is made, the Secretary must notify the applicant in writing of his or her decision on the application within 28 days of the making of the decision and, in the case of a decision not to list the goods, of the reasons for the decision.

             (4)  As soon as practicable after an applicant has been informed that therapeutic goods in respect of which an application was made are acceptable for listing, the Secretary must give to the applicant a certificate of listing of the goods, and the listing of the goods commences on the day specified for the purpose in the certificate.

26AA  Listing of therapeutic device to which EC/EFTA attestation of conformity applies

             (1)  If:

                     (a)  an application is made in accordance with section 23 for the listing of a therapeutic device in relation to a person; and

                     (b)  the applicant gives to the Secretary an EC/EFTA attestation of conformity as to the matters specified in paragraphs 26(1)(c) to (m) in relation to the device;

the Secretary must list the device in relation to the person unless the Secretary considers that the device may compromise the health or safety of users.

             (2)  The Secretary must notify the applicant in writing of his or her decision within 28 days of the making of the decision. If the Secretary decides not to list the device, the notice must contain the reasons for that decision.

             (3)  If the Secretary decides to list the device, the Secretary must:

                     (a)  include the device in the Register; and

                     (b)  give to the applicant a certificate of listing.

             (4)  The listing of the device commences on the day specified for the purpose in the certificate of listing.

26A  Listing of certain medicines

             (1)  If:

                     (a)  an application is made for the listing of medicine in relation to a person in accordance with section 23; and

                     (b)  the application is accompanied by either:

                              (i)  the certificate required under subsection 26B(1); or

                             (ii)  a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application; and

                     (c)  the requirements of subsection (2) and (where applicable) subsections (2A), (3) and (4A) have been complied with; and

                     (d)  the medicine is not export only medicine; and

                     (e)  the medicine is not one that has previously had its registration or listing cancelled;

the Secretary must list the medicine in relation to the person.

          (1A)  To avoid doubt, if:

                     (a)  an application is made for the listing of a medicine in relation to a person in accordance with section 23; and

                     (b)  the application is accompanied by either:

                              (i)  the certificate required under subsection 26B(1); or

                             (ii)  a notice that a certificate under that subsection is not required in relation to the application; and

                     (c)  the other requirements in subsection (1) are met;

the Secretary must list the medicine under subsection (1) without inquiring into the correctness of the certificate or the notice.

             (2)  The applicant must certify that:

                     (a)  the medicine is eligible for listing; and

                     (b)  the medicine is safe for the purposes for which it is to be used; and

                     (c)  the presentation of the medicine is not unacceptable; and

                    (ca)  if a determination under section 26BB applies in relation to the medicine—the only active ingredients the medicine contains are active ingredients specified in that determination in relation to the medicine; and

                    (cb)  if:

                              (i)  the medicine contains an active ingredient that is specified in a determination under section 26BB that applies in relation to the medicine; and

                             (ii)  that determination specifies a permitted concentration of the active ingredient or a permitted total amount of the active ingredient;

                            the active ingredient does not exceed that permitted concentration or that permitted total amount; and

                    (cc)  if a determination under subsection 26BE(1) applies in relation to the medicine—the medicine does not contain a component or ingredient specified in that determination in relation to the medicine; and

                    (cd)  if the medicine contains a component or ingredient that is specified in a determination under subsection 26BE(2) that applies in relation to the medicine—the component or ingredient does not exceed the permitted concentration of that component or ingredient, or the permitted total amount of that component or ingredient, that is specified in that determination; and

                     (d)  the medicine conforms to every standard (if any) applicable to the medicine and to every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and

                     (e)  if the medicine has been manufactured in Australia—each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step; and

                      (f)  the medicine complies with all prescribed quality or safety criteria that are applicable to the medicine; and

                    (fa)  the medicine’s specifications comply with any requirements that are prescribed by the regulations for the purposes of this paragraph and that are applicable to the medicine; and

                    (fb)  the medicine’s label:

                              (i)  complies with any requirements that are prescribed by the regulations for the purposes of this subparagraph and that are applicable to the medicine; and

                             (ii)  does not make a claim that is inconsistent with any claim made by the applicant in relation to the medicine in, or in connection with, the application; and

                    (fc)  the applicant holds information or evidence showing the medicine’s specifications will be maintained under the conditions set out on the medicine’s label until the medicine’s expiry date; and

                     (g)  the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and

                     (h)  all the manufacturers of the medicine are nominated as manufacturers in the application; and

                      (i)  the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and

                      (j)  the applicant holds information or evidence to support any claim that the applicant makes relating to the medicine; and

                     (k)  the information included in or with the application is correct.

          (2A)  The applicant must also certify any other matters prescribed by the regulations for the purposes of this subsection.

             (3)  Subject to subsection (7), if a step in the manufacture of the medicine has been carried out outside Australia, the Secretary must have certified, prior to the application being made, that the manufacturing and quality control procedures used in each such step are acceptable.

             (4)  In deciding whether so to certify for the purposes of subsection (3), the matters that may be taken into account include:

                     (a)  whether the applicant has provided:

                              (i)  if a step in the manufacture of the medicine has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the medicine; or

                            (ia)  if a step in the manufacture of the medicine has been carried out in a country declared by the Minister under section 3B to be covered by a non‑EC/EFTA MRA—a non‑EC/EFTA attestation of conformity, for the non‑EC/EFTA MRA, in relation to the medicine; or

                             (ii)  in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the medicine is of an acceptable standard; and

                     (b)  whether the applicant has agreed to provide, if the Secretary considers inspection of the manufacturing procedures used in the manufacture of the medicine to be necessary:

                              (i)  funds for the carrying out of that inspection by the Department; and

                             (ii)  evidence that the manufacturer has agreed to such an inspection; and

                     (c)  whether the applicant has complied with any requirements made by the Secretary under section 31 in relation to the manufacture or preparation of the medicine.

          (4A)  If the medicine includes any ingredient of animal origin, the Secretary must have certified, prior to the application being made, that he or she is satisfied of the safety of the ingredient.

             (5)  If a medicine is exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the medicine, subsection (2) has effect, in relation to the medicine, as if paragraph (2)(e) were omitted.

             (6)  If a person (the manufacturer) is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of a medicine, subsection (2) has effect, in relation to the medicine, as if the reference in paragraph (2)(e) to a person who is the holder of a licence were a reference to the manufacturer to the extent that Part 3‑3 applies to the manufacturer in relation to the manufacture of the medicine.

             (7)  If:

                     (a)  a medicine was made outside Australia; and

                     (b)  had the medicine been made in Australia, it would have been exempt from the operation of Part 3‑3;

subsection (3) does not apply in relation to the medicine.

             (9)  As soon as practicable after a medicine has been listed under this section, the Secretary must give to the applicant a certificate of listing of the medicine. The listing of the medicine commences on the day specified for the purpose in the certificate.

26B  Certificates required in relation to patents

          (1A)  A certificate is required under subsection (1) in relation to an application for registration or listing of therapeutic goods only if:

                     (a)  the applicant is required to submit evidence or information to establish the safety or efficacy of the goods as part of the process of applying for registration or listing; and

                     (b)  in order to satisfy that requirement, the applicant relies (in whole or in part) on evidence or information that another person submitted to the Secretary:

                              (i)  to establish the safety or efficacy of other therapeutic goods that have already been registered or listed; and

                             (ii)  as part of the process of applying for the registration or listing of those other goods.

             (1)  The certificate required under this subsection is either:

                     (a)  a certificate to the effect that the applicant, acting in good faith, believes on reasonable grounds that it is not marketing, and does not propose to market, the therapeutic goods in a manner, or in circumstances, that would infringe a valid claim of a patent that has been granted in relation to the therapeutic goods; or

                     (b)  a certificate to the effect that:

                              (i)  a patent has been granted in relation to the therapeutic goods; and

                             (ii)  the applicant proposes to market the therapeutic goods before the end of the term of the patent; and

                            (iii)  the applicant has given the patentee notice of the application for registration or listing of the therapeutic goods under section 23.

The certificate must be signed by, or on behalf of, the applicant and must be in a form approved by the Secretary.

             (2)  A person is guilty of an offence if:

                     (a)  the person gives a certificate required under subsection (1); and

                     (b)  the certificate is false or misleading in a material particular.

Penalty:  1,000 penalty units.

             (3)  For the purposes of this section, a patent is taken to have been granted in relation to therapeutic goods if marketing the goods without the authority of the patentee would constitute an infringement of the patent.

             (4)  In this section:

patent has the same meaning as in the Patents Act 1990.

26BA  Approved form for notices

                   An approval of a form for a notice for the purposes of subsection 25(4), 26(1) or 26A(1) may require or permit the notice to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

26BB  Permissible active ingredients

             (1)  The Minister may, by legislative instrument, make a determination specifying:

                     (a)  active ingredients in relation to medicine; and

                     (b)  either or both of the following:

                              (i)  permitted concentrations of some or all of those ingredients;

                             (ii)  permitted total amounts of some or all of those ingredients.

Note:          Under section 26A, a person seeking the listing of medicine must certify that the only active ingredients the medicine contains are active ingredients specified in such a determination. If relevant, the person must also certify that an active ingredient does not exceed the permitted concentration of the ingredient or the permitted total amount of the ingredient.

Scope of determination

             (2)  A determination under this section may make different provision for different classes of medicine.

Incorporation of instruments

             (3)  Despite subsection 14(2) of the Legislative Instruments Act 2003, a determination under this section may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time.

26BC  Variation of list of active ingredients—Minister’s initiative

                   The Minister may, on his or her own initiative and by legislative instrument, vary a determination under section 26BB.

26BD  Variation of list of active ingredients—application by person

             (1)  A person may apply to the Minister for a variation of a determination under section 26BB.

             (2)  An application under subsection (1) must:

                     (a)  be made in accordance with a form approved by the Secretary; and

                     (b)  set out the variation sought; and

                     (c)  be delivered to an office of the Department specified in the form; and

                     (d)  be accompanied by the prescribed application fee.

             (3)  If an application is made under subsection (1) and any applicable prescribed evaluation fee has been paid, the Minister may, by legislative instrument, vary the determination.

Further information

             (4)  The Minister may, by notice in writing given to the person, require the person to give to the Minister, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice.

Applications or information may be given electronically

             (5)  An approval of a form mentioned in paragraph (2)(a), or a notice mentioned in subsection (4), may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

26BE  Prohibited or limited components or ingredients

Prohibited components or ingredients

             (1)  The Minister may, by legislative instrument, make a determination specifying either or both of the following in relation to therapeutic goods:

                     (a)  components;

                     (b)  ingredients.

Note 1:       Under section 26, the Secretary may refuse to list therapeutic goods if the goods contain a component or ingredient specified in such a determination.

Note 2:       Under section 26A, a person seeking the listing of medicine must certify that the medicine does not contain a component or ingredient specified in such a determination.

Limited components or ingredients

             (2)  The Minister may, by legislative instrument, make a determination specifying either or both of the following in relation to therapeutic goods:

                     (a)  components and either or both of the following:

                              (i)  permitted concentrations of those components;

                             (ii)  permitted total amounts of those components;

                     (b)  ingredients and either or both of the following:

                              (i)  permitted concentrations of those ingredients;

                             (ii)  permitted total amounts of those ingredients.

Note 1:       Under section 26, the Secretary may refuse to list therapeutic goods if the goods contain a component or ingredient that exceeds the permitted concentration of that component or ingredient or exceeds the permitted total amount of that component or ingredient.

Note 2:       Under section 26A, a person seeking the listing of medicine must certify that the medicine does not contain a component or ingredient that exceeds the permitted concentration of that component or ingredient or exceeds the permitted total amount of that component or ingredient.

Scope of determination

             (3)  A determination under this section may make different provision for different classes of therapeutic goods.

Incorporation of instruments

             (4)  Despite subsection 14(2) of the Legislative Instruments Act 2003, a determination under this section may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time.

Variation

             (5)  The Minister may, by legislative instrument, vary a determination under subsection (1) or (2).

26C  Certificates required in relation to patent infringement proceedings

             (1)  This section applies if:

                     (a)  a person gives a certificate required under subsection 26B(1) in relation to therapeutic goods; and

                     (b)  another person (the second person) intends to commence proceedings under the Patents Act 1990 against the person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings).

             (2)  The second person, before the date upon which the proceedings are commenced, must give to the Secretary and to the person referred to in paragraph (1)(a) the certificate required by subsection (3).

             (3)  The certificate required by this subsection is a certificate to the effect that the proceedings:

                     (a)  are to be commenced in good faith; and

                     (b)  have reasonable prospects of success; and

                     (c)  will be conducted without unreasonable delay.

The certificate must be signed by, or on behalf of, the second person and must be in a form approved by the Secretary.

             (4)  For the purpose of paragraph (3)(b), proceedings have reasonable prospects of success if:

                     (a)  the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that he or she would be entitled to be granted final relief by the court against the person referred to in paragraph (1)(a) for infringement by that person of the patent; and

                     (b)  the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that each of the claims, in respect of which infringement is alleged, is valid; and

                     (c)  the proceedings are not otherwise vexatious or unreasonably pursued.

             (5)  The person referred to in paragraph (1)(a), with leave of the court, or the Attorney‑General, may apply to a prescribed court for an order that the second person pay to the Commonwealth a pecuniary penalty if the second person gives a certificate required under subsection (3) and:

                     (a)  the certificate is false or misleading in a material particular; or

                     (b)  the second person breaches an undertaking given in the certificate.

          (5A)  A pecuniary penalty ordered under subsection (5) must not exceed $10,000,000.

             (6)  When determining the extent of a pecuniary penalty to be ordered pursuant to subsection (5), the court must take into account:

                     (a)  any profit obtained by the second person; and

                     (b)  any loss or damage suffered by any person;

by reason of the second person exploiting the patent during the proceedings.

             (7)  For the avoidance of doubt, subsection (6) does not limit the matters the court may take into account when determining a pecuniary penalty ordered pursuant to subsection (5).

             (8)  If:

                     (a)  the second person has sought and obtained in the proceedings an interlocutory injunction restraining the person referred to in paragraph (1)(a) from infringing a patent; and

                     (b)  section 26D does not apply; and

                     (c)  a prescribed court declares that the second person has given a certificate required under subsection (3); and

                     (d)  a prescribed court declares that:

                              (i)  the certificate is false or misleading in a material particular; or

                             (ii)  the second person has breached an undertaking given in the certificate;

the prescribed court may, pursuant to this section, order that the second person pay to the Commonwealth, a State or a Territory compensation for any damages sustained or costs incurred by the Commonwealth, a State or a Territory as a result of the grant of the interlocutory injunction.

             (9)  In this section:

prescribed court has the same meaning as in the Patents Act 1990.

26D  Requirements for interlocutory injunction

             (1)  This section applies where:

                     (a)  an applicant gives notice to a patentee in accordance with subparagraph 26B(1)(b)(iii); and

                     (b)  the patentee and/or its exclusive licensee (in this section the party or parties is or are referred to as the patentee) applies to a prescribed court for an interlocutory injunction to restrain the applicant from marketing the therapeutic goods the subject of the application on the ground that such conduct will constitute an infringement of its patent.

             (2)  An application for interlocutory relief in accordance with subsection (1) may not be instituted unless the patentee has first notified the Attorney‑General of the Commonwealth, or of a State or of a Territory, in writing of the application.

             (3)  The Attorney‑General of the Commonwealth shall be deemed to be a party to any proceedings commenced in accordance with subsection (1) unless the Attorney‑General gives written notice to the prescribed court that he or she does not desire to be a party.

             (4)  If an interlocutory injunction is granted pursuant to an application made as described in subsection (1) and:

                     (a)  the patentee subsequently discontinues the principal proceedings without the consent of the other parties thereto; or

                     (b)  the principal proceedings are dismissed; and

                     (c)  in either case, the prescribed court declares that:

                              (i)  the patentee did not have reasonable grounds, in all the circumstances known to the patentee or which ought reasonably have been known to the patentee:

                                        (A)  to believe that it would be granted final relief by the prescribed court against the applicant referred to in paragraph (1)(a) for infringement by that person of the patent; or

                                        (B)  (in addition to the fact of grant of the patent), for believing that each of the claims, in respect of which infringement is alleged in the proceedings, would have a reasonable prospect of being held to be valid if challenged by the applicant referred to in paragraph (1)(a); or

                             (ii)  the application for the interlocutory injunction was otherwise vexatious or not reasonably made or pursued;

the prescribed court may, in addition to any other relief which it believes should be granted to any person, make any of the orders described in subsection (5).

             (5)  If the prescribed court makes a declaration pursuant to paragraph (4)(c), the prescribed court may, pursuant to the usual undertaking as to damages given by the patentee to the prescribed court to obtain the interlocutory injunction:

                     (a)  assess and award compensation to the applicant referred to in paragraph (1)(a) against whom the interlocutory injunction was made:

                              (i)  on the basis of an account of the gross profits of the patentee arising from the sale by it in Australia of the therapeutic goods the subject of the interlocutory injunction, during the period of the interlocutory injunction, without requiring the said applicant to establish or quantify its actual loss; or

                             (ii)  on such other basis as the court determines to be appropriate; and

                     (b)  award to the Commonwealth compensation for any damages sustained, or costs incurred, by it as a result of the grant of the interlocutory injunction; and

                     (c)  award to a State or a Territory compensation for any damages sustained, or costs incurred, by it as a result of the grant of the interlocutory injunction.

             (6)  In this section:

prescribed court has the same meaning as in the Patents Act 1990.

27  Registration or listing number

             (1)  Where the Secretary includes therapeutic goods (other than grouped therapeutic goods) in the Register, the Secretary is to assign a unique registration or listing number to the goods.

             (2)  Where the Secretary includes grouped therapeutic goods in the Register, the Secretary is to assign a single, unique registration or listing number to the grouped therapeutic goods.

28  Conditions of registration or listing

             (1)  The registration or listing of therapeutic goods is subject to the conditions set out in a determination under subsection (2).

             (2)  The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1), being conditions that relate to:

                     (a)  the manufacture of the goods; or

                     (b)  the custody, use, supply, disposal or destruction of the goods; or

                     (c)  the keeping of records relating to the goods; or

                     (d)  matters dealt with in, or matters additional to matters dealt with in, standards applicable to the goods; or

                     (e)  such other matters relating to the goods as the Minister thinks appropriate.

          (2A)  Without limiting subsection (2), different conditions may be specified for:

                     (a)  the registration of therapeutic goods; and

                     (b)  the listing of therapeutic goods; and

                     (c)  different classes of therapeutic goods.

          (2B)  If the Secretary includes therapeutic goods in the Register in relation to a person, the Secretary may, by notice in writing given to the person, impose conditions on the registration or listing of those goods.

             (3)  The Secretary may, by notice in writing given to the person in relation to whom therapeutic goods are registered or listed, impose new conditions on the registration or listing or vary or remove conditions imposed under subsection (2B) or this subsection.

          (3A)  The Secretary’s power under subsection (3) may be exercised at the request of the person concerned or of the Secretary’s own motion. A request must be accompanied by the prescribed fee.

             (4)  The imposition or variation or removal of a condition under subsection (3) takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 28 days after the notice is given to the person.

             (5)  In addition to any conditions imposed under subsection (1), (2B) or (3), the registration or listing of therapeutic goods (the subject goods) is subject to the conditions that the person in relation to whom the subject goods are registered or listed will:

                    (aa)  not supply a batch of the subject goods in Australia, or export a batch of the subject goods from Australia, after the expiry date for the goods; and

                    (ab)  not, by any means, advertise the subject goods for an indication other than those accepted in relation to the inclusion of the goods in the Register; and

                     (a)  allow an authorised person:

                              (i)  to enter, at any reasonable time, premises at which the person deals with the subject goods; and

                             (ii)  while on those premises, to inspect those premises and any therapeutic goods on those premises and to examine, take measurements of, conduct tests on or take samples of any therapeutic goods on those premises or any thing on those premises that relates to any therapeutic goods; and

                            (iii)  while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

                     (b)  if requested to do so by an authorised person, produce to the person such documents relating to the subject goods as the person requires and allow the person to copy the documents; and

                     (c)  in relation to each batch of the subject goods—keep a record, at least until the end of the period of 12 months after the expiry date for the goods, of all of the manufacturers involved in the manufacture of that batch; and

                     (d)  if requested to do so by an authorised person, make any such record available to the authorised person for inspection:

                              (i)  at or before the time the authorised person requests, or (if the authorised person requests) immediately; and

                             (ii)  either in electronic form or in paper form, as the authorised person requests; and

                     (e)  comply, in relation to the subject goods, with any reporting requirements that are prescribed; and

                      (f)  if a manufacturer who was not nominated as a manufacturer of the subject goods in the application for the registration or listing of the goods becomes a manufacturer of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the manufacturer becomes a manufacturer of the goods; and

                     (g)  if premises that were not nominated as premises to be used in the manufacture of the subject goods in the application become premises used in the manufacture of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the premises are first used for that purpose.

          (5A)  In addition to any conditions imposed under subsection (1), (2B), (3) or (5), the listing of a medicine under section 26A is subject to a condition that the person in relation to whom the medicine is listed will deliver a reasonable number of samples of the medicine if the Secretary so requests:

                     (a)  within the period specified in the request; and

                     (b)  in accordance with any other requirements specified in the request.

The period specified in the request must include at least 10 working days.

          (5B)  The listing of a medicine under section 26A is subject to a condition that:

                     (a)  each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3‑3 in relation to that step; and

                     (b)  each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3) or 28A(2).

          (5C)  Subsection (5B) does not apply if the medicine is exempt from the operation of Part 3‑3.

             (6)  If:

                     (a)  in, or in connection with, an application for the listing of therapeutic goods, a claim is made by the applicant in relation to the goods; and

                     (b)  the claim is included in the Register in respect of the goods;

the listing of the goods is subject to the following conditions:

                     (c)  a condition that the sponsor of the goods had, at the time when the claim was made, information or evidence that supported the claim and complied with the requirements (if any) of the regulations;

                     (d)  a condition that the sponsor retains the information or evidence at all times while the goods remain listed;

                     (e)  a condition that, at any time while the goods remain listed, the sponsor will, if asked to do so by the Secretary, give the information or evidence to the Secretary.

             (7)  The regulations may prescribe the amount, standard or type of information or evidence required for the purposes of paragraph (6)(c).

28A  Certification of manufacturing steps outside Australia following application for listing

             (1)  The person in relation to whom medicine is listed under section 26A may apply to the Secretary for a certification under this section of a step in the manufacture of the medicine that is to be carried out outside Australia.

Note:          The listing of medicine is subject to the condition that each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3) or subsection (2) of this section: see subsection 28(5B).

             (2)  If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable. The Secretary must give the person written notice of the certification.

             (3)  In deciding whether to give the certification, subsection 26A(4) applies in a way corresponding to the way in which it applies for the purposes of subsection 26A(3).

29  Duration of registration or listing

                   Where goods are included in the Register in relation to a person, the goods remain so included until their registration or listing is cancelled under this Part.

Note:          The goods are taken not to be included in the Register while their registration or listing is suspended: see section 29G.

29A  Criminal offence for failing to notify adverse effects etc. of goods

             (1)  As soon as a person in relation to whom therapeutic goods are registered or listed becomes aware of information of a kind mentioned in subsection (2) relating to the goods, the person must give the information to the Secretary in writing.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (2)  The information with which subsection (1) is concerned is information of the following kinds:

                     (a)  information that contradicts information already furnished by the person under this Act;

                     (b)  information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;

                     (c)  information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as the application for registration or listing of the goods or information already furnished by the person under this Act suggests;

                     (d)  information that indicates that the quality, safety or efficacy of the goods is unacceptable.

29AA  Civil penalty for failing to notify adverse effects etc. of goods

             (1)  A person contravenes this section if:

                     (a)  therapeutic goods are registered or listed in relation to a person; and

                     (b)  the person becomes aware of information of a kind mentioned in subsection (2) relating to the goods; and

                     (c)  the person does not give the information to the Secretary in writing as soon as he or she becomes aware of it.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

             (2)  The information with which subsection (1) is concerned is information of the following kinds:

                     (a)  information that contradicts information already given by the person under this Act;

                     (b)  information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;

                     (c)  information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as the application for registration or listing of the goods or information already given by the person under this Act suggests;

                     (d)  information that indicates that the quality, safety or efficacy of the goods is unacceptable.

29B  Notification of adverse effects etc. where application withdrawn or lapses

             (1)  If an application for registration or listing of goods is withdrawn or lapses, the Secretary may give the applicant written notice requiring the applicant:

                     (a)  to inform the Secretary in writing whether the applicant is aware of any information of a kind mentioned in subsection 29A(2) or 29AA(2) relating to the goods; and

                     (b)  if the applicant is aware of such information, to give the information to the Secretary in writing.

             (2)  Notice under subsection (1) may be given within 14 days after an application is withdrawn or lapses.

             (3)  A person must comply with the requirements of a notice under subsection (1) within 30 days after the notice is given to the person.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (4)  A person must not, in purported compliance with a notice under subsection (1), give information that is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

29C  Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses

Civil penalty for failing to comply with requirements of a notice

             (1)  A person contravenes this subsection if the person does not comply with the requirements of a notice under subsection 29B(1) within 30 days after the day on which the notice is given to the person.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

Civil penalty for giving false or misleading information in purported compliance with requirements of a notice

             (2)  A person contravenes this subsection if the person, in purported compliance with a notice under subsection 29B(1), gives information that is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

29D  Suspension of registration or listing

             (1)  The Secretary may, by written notice given to a person in relation to whom therapeutic goods are included in the Register, suspend the registration or listing of the goods if:

                     (a)  the Secretary is satisfied that:

                              (i)  there is a potential risk of death, serious illness or serious injury if the therapeutic goods continue to be included in the Register; and

                             (ii)  it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the therapeutic goods would not cause a potential risk of death, serious illness or serious injury if the therapeutic goods were to continue to be included in the Register; or

                     (b)  the Secretary is satisfied that it is likely that there are grounds for cancelling the registration or listing of the goods under paragraph 30(1)(da), (e) or (f) or subsection 30(1A), (1C) or (2).

Notice of proposed suspension in some cases

             (2)  However, before suspending the registration or listing of the goods because of paragraph (1)(b), the Secretary must:

                     (a)  inform the person by written notice that the Secretary proposes the suspension and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

             (3)  The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

Period of suspension

             (4)  A notice under subsection (1) must specify the period of the suspension. The period must not exceed 6 months.

Note:          Section 29E deals with when the suspension takes effect and extensions of the suspension.

Publication in Gazette

             (5)  As soon as practicable after giving a notice under subsection (1), the Secretary must cause to be published in the Gazette a notice setting out particulars of the suspension.

29E  When suspension takes effect etc.

             (1)  A suspension under section 29D takes effect:

                     (a)  if the notice under subsection 29D(1) states that the suspension is necessary to prevent a potential risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (2)  The suspension has effect until:

                     (a)  the Secretary revokes it under section 29F; or

                     (b)  the end of:

                              (i)  the period specified in the notice under subsection 29D(4); or

                             (ii)  if the period is extended under subsection (3) of this section, the period as so extended.

Extension of suspension

             (3)  The Secretary may, by written notice given to the person, extend the period specified in the notice under subsection 29D(4) by a further specified period not exceeding 6 months.

Publication in Gazette

             (4)  As soon as practicable after giving a notice under subsection (3), the Secretary must cause to be published in the Gazette a notice setting out particulars of the extension.

29F  Revocation of suspension

             (1)  The Secretary must revoke a suspension under section 29D, by written notice given to the person in relation to whom the therapeutic goods are included in the Register, if the Secretary is satisfied that:

                     (a)  the ground on which the registration or listing of the therapeutic goods was suspended no longer applies; and

                     (b)  there are no other grounds for suspending the registration or listing of the therapeutic goods.

             (2)  The Secretary’s power to revoke the suspension may be exercised:

                     (a)  if the person in relation to whom the therapeutic goods are included in the Register applies in writing to the Secretary; or

                     (b)  on the Secretary’s own initiative.

Publication in Gazette

             (3)  As soon as practicable after giving a notice under subsection (1), the Secretary must cause to be published in the Gazette a notice setting out particulars of the revocation.

Notice of refusal to revoke suspension

             (4)  If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision; and

                     (b)  state in the notice the reasons for the decision.

29G  Effect of suspension

             (1)  If the registration or listing of therapeutic goods is suspended under section 29D, the goods are taken, for the purposes of this Act (other than sections 28, 29A, 29AA, 29E, 29F, 30 and 31), not to be included in the Register while the suspension has effect.

Note:          Dealing in therapeutic goods that are not included in the Register may be an offence or may contravene a civil penalty provision: see Division 1.

             (2)  While the suspension has effect, the Secretary’s power under section 30 to cancel the registration or listing of the therapeutic goods is not affected.

30  Cancellation of registration or listing

             (1)  The Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:

                     (a)  it appears to the Secretary that failure to cancel the registration or listing would create an imminent risk of death, serious illness or serious injury; or

                     (b)  the goods become exempt goods; or

                     (c)  the person requests in writing the cancellation of the registration or listing; or

                     (d)  the goods contain substances that are prohibited imports for the purposes of the Customs Act 1901; or

                    (da)  the person has refused or failed to comply with the condition to which the inclusion of the goods is subject under paragraph 28(5)(d):

                              (i)  if the person was requested under that paragraph to make the record in question available at or before a requested time—before the end of the period of 24 hours after that time; or

                             (ii)  if the person was requested under that paragraph to make the record in question available immediately—within 24 hours after the request was made; or

                     (e)  in the case of a medicine listed under section 26A, it appears to the Secretary that any of the certifications under paragraph 26A(2)(a), (ca), (cb), (cc), (cd), (e) or (g) are incorrect or (if applicable) the requirements under subsection 26A(3) or (4A) are not fulfilled; or

                      (f)  both of the following apply:

                              (i)  under the regulations, an authority constituted by or under the regulations gives a direction to, or makes a requirement of, the person in relation to an advertisement of the goods to ensure that advertising complies with the Therapeutic Goods Advertising Code;

                             (ii)  the person does not comply with the direction or requirement.

          (1A)  The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A, cancel the listing of the medicine if:

                     (a)  the medicine is not eligible for listing; or

                     (b)  the medicine is exempt; or

                     (c)  there is a serious breach, involving the medicine, of the requirements relating to advertising applicable under Part 5‑1 or under the regulations, and the Secretary is satisfied that:

                              (i)  the breach is significant; and

                             (ii)  as a result of the breach, the presentation of the medicine is misleading to a significant extent.

          (1B)  However, paragraph (1A)(c) does not apply to medicines that are manufactured in Australia for export only, or are imported into Australia for export only.

          (1C)  The Secretary may, by notice in writing given to a person in relation to whom a medicine is listed under section 26A, cancel the listing of the medicine if:

                     (a)  the Secretary, under section 31, gives to the person a notice requiring the person to give to the Secretary information or documents relating to the medicine; and

                     (b)  the notice is given for the purposes of ascertaining whether the medicine should have been listed; and

                     (c)  the person fails to comply with the notice within 20 working days after the notice is given.

             (2)  Subject to subsection (3), the Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:

                     (a)  it appears to the Secretary that the quality, safety or efficacy of the goods is unacceptable; or

                     (b)  the goods have changed so that they have become separate and distinct from the goods as so included; or

                    (ba)  in the case of a medicine listed under section 26A, it appears to the Secretary that any of the certifications under paragraph 26A(2)(b), (c), (d), (f), (fa), (fb), (fc), (h), (i), (j) or (k) or subsection 26A(2A) are incorrect; or

                     (c)  the sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (other than the condition under paragraph 28(5)(d)); or

                    (ca)  the person has contravened subsection 29A(1) or 29AA(1) in relation to the goods; or

                     (d)  the goods become required to be included in the other part of the Register; or

                     (e)  the goods do not conform to a standard applicable to the goods or to a requirement relating to advertising applicable to the goods under Part 5‑1 or under the regulations; or

                      (f)  the annual registration or listing charge is not paid within 28 days after it becomes payable.

             (3)  Where the Secretary proposes to cancel the registration or listing of goods in relation to a person under subsection (2) otherwise than as a result of a failure to pay the annual registration or listing charge, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes to cancel that registration or listing and set out the reasons for that proposed action; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed action.

             (4)  Where a person makes submissions in accordance with paragraph (3)(b), the Secretary is not to make a decision relating to the cancellation until the Secretary has taken the submissions into account.

          (4A)  The Secretary must, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration of the goods if the Secretary becomes aware that protected information was used when evaluating the goods for registration.

             (5)  Where the Secretary cancels the registration or listing of goods in relation to a person, the goods cease to be registered or listed:

                     (a)  if the cancellation is effected under subsection (1), (1A) or (1C)—on the day on which the notice of cancellation is given to the person; or

                     (b)  in any other case—on such later day as is specified in the notice.

30A  Revocation of cancellation of registration or listing upon request

             (1)  If:

                     (a)  the Secretary cancels the registration or listing of therapeutic goods because of the request of a person made under paragraph 30(1)(c); and

                     (b)  before the end of the period of 90 days beginning on the day the goods ceased to be registered or listed, the person requests, in writing, the Secretary to revoke the cancellation; and

                     (c)  the request is accompanied by the prescribed application fee;

the Secretary may, by notice in writing given to the person, revoke the cancellation.

             (2)  If the cancellation is revoked, the cancellation is taken never to have occurred.

30C  Consultation with Gene Technology Regulator

             (1)  This section applies to an application for listing or registration of a therapeutic good under section 23 if the therapeutic good is, or contains, a GM product or a genetically modified organism.

             (2)  Subject to subsection (5), the Secretary must give written notice to the Gene Technology Regulator:

                     (a)  stating that the application has been made; and

                     (b)  requesting the Gene Technology Regulator to give advice about the application.

             (3)  If the Secretary gives the Gene Technology Regulator a notice under subsection (2), the Gene Technology Regulator may give written advice to the Secretary about the application.

             (4)  The advice is to be given within the period specified in the notice.

             (5)  If an advice from the Gene Technology Regulator is in force under section 30D in relation to a class of therapeutic goods, the Secretary is not required to notify the Regulator under this section in relation to an application for listing or registration of a therapeutic good belonging to that class.

30D  Secretary may seek advice about classes of GM products or genetically modified organisms

             (1)  The Secretary may request advice from the Gene Technology Regulator in relation to:

                     (a)  therapeutic goods that consist of, or that contain, a GM product belonging to a class of GM products specified in the request; or

                     (b)  therapeutic goods that consist of, or that contain, a genetically modified organism belonging to a class of genetically modified organisms specified in the request.

             (2)  A request for advice under subsection (1) must specify the matters to which the advice is to relate.

             (3)  If the Secretary requests advice from the Gene Technology Regulator under subsection (1), the Gene Technology Regulator may provide written advice in relation to the matters specified in the request.

             (4)  If the Gene Technology Regulator gives advice to the Secretary under subsection (3), the advice remains in force until it is withdrawn by the Gene Technology Regulator by written notice given to the Secretary.

30E  Secretary to take advice into account

                   If the Secretary receives advice from the Gene Technology Regulator:

                     (a)  in response to a notice under section 30C within the period specified in the notice; or

                     (b)  under section 30D;

the Secretary must:

                     (c)  ensure that the advice is taken into account in making a decision on the application to which the notice relates, or on an application to which the advice under section 30D relates, as the case requires; and

                     (d)  inform the Gene Technology Regulator of the decision on the application.


 

Division 2APublic notification and recovery of therapeutic goods

30EA  Public notification and recovery of therapeutic goods

             (1)  The Secretary may, in writing, impose requirements, relating to therapeutic goods, on a person if:

                     (a)  any of the circumstances referred to in the second column of an item in the following table occur in relation to the goods; and

                     (b)  the person is referred to in the third column of that item.

 

Circumstances in which requirements may be imposed

Item

Circumstance relating to therapeutic goods

Person subject to requirements

1.

The goods are supplied while they are registered goods or listed goods, but they do not conform with a standard applicable to the goods

The person in relation to whom the goods are included in the Register

2.

The goods are supplied while they are registered goods or listed goods, but the manufacturing principles have not been observed in the manufacture of the goods

The person in relation to whom the goods are included in the Register

3.

The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

(c) they are the subject of an approval or authority under section 19; or

(d) they are the subject of an approval under section 19A;

but they do not conform with a standard applicable to the goods

The person supplying the goods

4.

The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

(c) they are the subject of an approval or authority under section 19; or

(d) they are the subject of an approval under section 19A;

but the manufacturing principles have not been observed in the manufacture of the goods

The person supplying the goods

5.

The goods are supplied in contravention of subsection 19B(1), (2) or (4), 19D(1) or 42E(1) or section 42EA

The person supplying the goods

5A.

The goods are supplied while they are registered goods or listed goods, but it appears to the Secretary that the quality, safety or efficacy of the goods is unacceptable or that the presentation of the goods is unacceptable

The person in relation to whom the goods are included in the Register

6.

The goods are supplied while they are registered goods or listed goods, but one or more steps in the manufacture of the goods has been carried out by a manufacturer while the manufacturer did not hold a licence that was in force

The person in relation to whom the goods are included in the Register

6A.

The registration or listing of the goods has been suspended under this Part

The person in relation to whom the goods were included in the Register

7.

The registration or listing of the goods has been cancelled under this Part

The person in relation to whom the goods were included in the Register

             (2)  The requirements may be one or more of the following:

                     (a)  to take specified steps, in the specified manner and within such reasonable period as is specified, to recover therapeutic goods that have been distributed;

                     (b)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to therapeutic goods;

                     (c)  to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of therapeutic goods.

             (3)  If the circumstances referred to in paragraph (1)(a) apply only to a batch of therapeutic goods, the Secretary may limit the imposition of the requirements to the therapeutic goods included in that batch.

             (4)  A requirement to recover therapeutic goods under this section does not apply to therapeutic goods that cannot be recovered because they have been administered to, or applied in the treatment of, a person.

30EB  Publication of requirements

                   The Secretary must cause to be published in the Gazette, as soon as practicable after imposing a requirement under section 30EA, a notice setting out particulars of the requirement.

30EC  Criminal offences for non‑compliance with requirements

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 30EA; and

                     (c)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 30EA; and

                     (c)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 30EA.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

30ECA  Civil penalty for non‑compliance with requirements

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 30EA.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

30ED  Powers of suspension and cancellation unaffected

                   Imposition of a requirement under section 30EA does not affect the Secretary’s power to suspend or cancel the registration or listing of therapeutic goods under this Part.


 

Division 3General

30F  Criminal offences for goods exempt under section 18A not conforming to standards etc.

             (1)  This section applies if:

                     (a)  therapeutic goods of a particular kind are exempt under section 18A; and

                     (b)  a person supplies a batch of goods of that kind; and

                     (c)  the Secretary is satisfied that the goods included in that batch:

                              (i)  do not conform to a standard applicable to goods of that kind; or

                             (ii)  are otherwise not fit to be used for their intended purposes.

             (2)  The Secretary may, by written notice given to the person, require the person to take steps to recover the goods included in that batch (except any of those goods that cannot be recovered because they have been administered to, or applied in the treatment of, a person).

             (3)  The notice may specify one or more of the following requirements:

                     (a)  the steps to be taken to recover the goods;

                     (b)  the manner in which the steps are to be taken;

                     (c)  a reasonable period within which the steps are to be taken.

             (4)  The Secretary must, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette.

Written notice is not a legislative instrument

          (4A)  A written notice given to a person by the Secretary under this section is not a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Offences

          (4B)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement; and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the person failed to comply with that requirement.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

          (4C)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement; and

                     (d)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the person failed to comply with that requirement.

Penalty:  2,000 penalty units.

          (4D)  Subsection (4C) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (5)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (6)  For the purposes of an offence against subsection (5), strict liability applies to the following physical elements of circumstances:

                     (a)  that the notice concerned is given under subsection (2);

                     (b)  that the particular requirement concerned is a requirement mentioned in subsection (3).

Note:          For strict liability, see section 6.1 of the Criminal Code.

30FA  Civil penalty for goods exempt under section 18A not conforming to standards etc.

                   A person contravenes this section if:

                     (a)  the Secretary gives a notice to the person under subsection 30F(2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection 30F(3); and

                     (c)  the person does not comply with the requirement.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

30G  Disposal of unused goods exempt under section 18A

             (1)  This section applies to particular therapeutic goods if:

                     (a)  an exemption in relation to those goods under section 18A ceases to have effect otherwise than because those goods have become registered goods or listed goods (see paragraph 18A(5)(a)); and

                     (b)  those goods have not been used before the exemption so ceases to have effect.

             (2)  The Secretary may arrange for the disposal of any of those goods in accordance with the regulations.

             (3)  Regulations made for the purposes of subsection (2) may set out the methods by which those goods are to be stored, supplied, destroyed, exported or otherwise disposed of.

             (4)  A method set out in the regulations under subsection (3) must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of those goods.

30H  Record for goods exempt under section 18A

             (1)  A person commits an offence if:

                     (a)  there are therapeutic goods that are exempt under section 18A; and

                     (b)  a condition of the exemption:

                              (i)  requires the person to keep a record about those goods; or

                             (ii)  specifies the manner in which the person must keep the record; and

                     (c)  the person does an act or omits to do an act in relation to those goods; and

                     (d)  the act or omission results in the breach of that condition of the exemption.

Penalty:  240 penalty units.

             (2)  Strict liability applies to paragraph (1)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (3)  A person commits an offence if:

                     (a)  there are therapeutic goods that are exempt under section 18A; and

                     (b)  a condition of the exemption:

                              (i)  requires the person to keep a record about those goods; or

                             (ii)  specifies the manner in which the person must keep the record; and

                     (c)  the person does an act or omits to do an act in relation to those goods; and

                     (d)  the act or omission results in the breach of that condition of the exemption.

Penalty:  60 penalty units.

             (4)  An offence under subsection (3) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

31  Secretary may require information

             (1)  The Secretary may, by notice in writing given to a person:

                    (aa)  who is an applicant for the registration of therapeutic goods; or

                    (ab)  in relation to whom therapeutic goods are registered; or

                    (ac)  in relation to whom therapeutic goods were, at any time during the previous 5 years, registered;

require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:

                     (a)  the formulation of the goods;

                     (b)  the composition of the goods;

                     (c)  the design specifications of the goods;

                     (d)  the quality of the goods;

                     (e)  the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;

                      (f)  the presentation of the goods;

                     (g)  the safety and efficacy of the goods for the purposes for which they are to be used;

                     (h)  the conformity of the goods to a requirement relating to advertising applicable under Part 5‑1 or under the regulations;

                      (j)  the regulatory history of the goods in another country;

                     (k)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

          (1A)  If a notice is given under subsection (1) to a person covered by paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were registered.

             (2)  The Secretary may, by notice in writing given to a person:

                    (aa)  who is an applicant for the listing of therapeutic goods; or

                    (ab)  in relation to whom therapeutic goods are listed; or

                    (ac)  in relation to whom therapeutic goods were, at any time during the previous 5 years, listed;

require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:

                     (a)  the formulation of the goods;

                     (b)  the composition of the goods;

                     (c)  the design specifications of the goods;

                     (d)  the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods;

                     (e)  the presentation of the goods;

                      (f)  the safety of the goods for the purposes for which they are to be used;

                     (g)  the conformity of the goods to a standard applicable to the goods, or to a requirement relating to advertising applicable to the goods under Part 5‑1 or under the regulations;

                     (h)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

          (2A)  If a notice is given under subsection (2) to a person covered by paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were listed.

             (3)  An approval of a form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

             (4)  A person commits an offence if:

                     (a)  the person is given a notice under this section; and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

          (4A)  Subsection (4) does not apply if the person has a reasonable excuse.

Note:          The defendant bears an evidential burden in relation to the matter in subsection (4A). See subsection 13.3(3) of the Criminal Code.

             (5)  An offence under subsection (4) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

          (5A)  A person commits an offence if:

                     (a)  a medicine is listed under section 26A in relation to the person; and

                     (b)  the person provides information in purported compliance with a notice under section 31 relating to the medicine; and

                     (c)  the information is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the medicine has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the medicine, if the medicine were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (6) instead: see section 53A.

          (5B)  A person commits an offence if:

                     (a)  a medicine is listed under section 26A in relation to the person; and

                     (b)  the person provides information in purported compliance with a notice under section 31 relating to the medicine; and

                     (c)  the information is false or misleading in a material particular; and

                     (d)  the use of the medicine, if the medicine were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

          (5C)  Subsection (5B) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (6)  A person in relation to whom a medicine is listed under section 26A must not, in purported compliance with a notice under this section relating to the medicine, provide information that is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

31AAA  Civil penalty for providing false or misleading information in relation to medicines listed under section 26A

                   A person contravenes this section if:

                     (a)  a medicine is listed under section 26A in relation to the person; and

                     (b)  the person provides information in purported compliance with a notice under section 31 relating to the medicine; and

                     (c)  the information is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

31A  Secretary may require information etc. about goods exempt under section 18

Exempt goods for use for experimental purposes in humans

             (1)  If therapeutic goods are exempt under subsection 18(1) from the operation of this Part (except this section and sections 31C to 31F) to allow for their use for experimental purposes in humans, the Secretary may give the sponsor of the goods a written notice requiring the sponsor to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of the goods;

                     (b)  the handling of the goods;

                     (c)  the monitoring of the supply of the goods;

                     (d)  the results of the supply of the goods;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Statement by medical practitioner about medicine

             (2)  If a medicine is exempt under subsection 18(1) from the operation of this Part (except this section and sections 31C to 31F) because a medical practitioner has signed a statement in accordance with regulation 12A of the Therapeutic Goods Regulations 1990, the Secretary may give the medical practitioner a written notice requiring the medical practitioner to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the condition of the person to whom the medicine is to be given or is given;

                     (b)  the supply of the medicine;

                     (c)  the handling of the medicine;

                     (d)  the monitoring of the supply of the medicine;

                     (e)  the results of the supply of the medicine;

                      (f)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to medicines of that kind.

Compliance period

             (3)  A notice under subsection (1) or (2) must specify a reasonable period within which the person to whom the notice is given must comply with it. The period must be at least 14 days starting on the day on which the notice is given.

Information may need to be given in accordance with specified software requirements

             (4)  A notice under subsection (1) or (2) may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

31AA  Secretary may require information etc. about goods exempt under section 18A

             (1)  This section applies to a person who is required to comply with a condition of an exemption of therapeutic goods under section 18A.

             (2)  The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of any of those goods;

                     (b)  the handling of any of those goods;

                     (c)  the monitoring of the supply of any of those goods;

                     (d)  the results of the supply of any of those goods;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph.

Compliance period

             (3)  The notice must specify a reasonable period within which the person must comply with it. The period must be at least 14 days starting on the day on which the notice is given.

Information may need to be given in accordance with specified software requirements

             (4)  The notice may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

31B  Secretary may require information relating to approvals and authorities under section 19

Approval under subsection 19(1)

             (1)  The Secretary may give to a person who is granted an approval under subsection 19(1) in relation to specified therapeutic goods a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of the goods;

                     (b)  the handling of the goods;

                     (c)  the monitoring of the supply of the goods;

                     (d)  the results of the supply of the goods;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Approval under subsection 19(1)—use by another person

             (2)  The Secretary may give to a person using specified therapeutic goods that are the subject of an approval granted to someone else under paragraph 19(1)(b) a written notice requiring the person to give to the Secretary specified information or documents relating to either of both of the following:

                     (a)  the use of the goods;

                     (b)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Authority under subsection 19(5)

             (3)  The Secretary may give to a person who is granted an authority under subsection 19(5) in relation to specified therapeutic goods, or a specified class of therapeutic goods, a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of the goods;

                     (b)  the handling of the goods;

                     (c)  the monitoring of the supply of the goods;

                     (d)  the results of the supply of the goods;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.

Compliance period

             (4)  A notice under subsection (1), (2) or (3) must specify a reasonable period within which the person to whom the notice is given must comply with it. The period must be at least 14 days starting on the day on which the notice is given.

Information may need to be given in accordance with specified software requirements

             (5)  A notice under subsection (1), (2) or (3) may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

31C  Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B

                   A person commits an offence if:

                     (a)  the person is given a notice under section 31A, 31AA or 31B; and

                     (b)  the person fails to comply with the notice.

Penalty:  400 penalty units.

Note:          The privilege against self incrimination is not a reasonable excuse for the purposes of this section. However, the information given, and the fact that a document was given under this section (and other information, documents or things obtained because of giving the information or document) generally cannot be used in a prosecution (see section 31F).

31D  False or misleading information

             (1)  A person to whom a notice is given under section 31A, 31AA or 31B is guilty of an offence if:

                     (a)  the person gives information to the Secretary in compliance or purported compliance with the notice; and

                     (b)  the person does so knowing that the information:

                              (i)  is false or misleading; or

                             (ii)  omits any matter or thing without which the information is misleading.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (2)  Subsection (1) does not apply as a result of subparagraph (1)(b)(i) if the information is not false or misleading in a material particular.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (2).

             (3)  Subsection (1) does not apply as a result of subparagraph (1)(b)(ii) if the information did not omit any matter or thing without which the information is misleading in a material particular.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (3).

31E  False or misleading documents

             (1)  A person is guilty of an offence if:

                     (a)  the person produces a document to the Secretary; and

                     (b)  the person does so knowing that the document is false or misleading; and

                     (c)  the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA or 31B.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (2)  Subsection (1) does not apply if the document is not false or misleading in a material particular.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (2).

             (3)  Subsection (1) does not apply to a person who produces a document if the document is accompanied by a written statement signed by the person or, in the case of a body corporate, by a competent officer of the body corporate:

                     (a)  stating that the document is, to the knowledge of the first‑mentioned person, false or misleading in a material particular; and

                     (b)  setting out, or referring to, the material particular in which the document is, to the knowledge of the first‑mentioned person, false or misleading.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (3).

31F  Self‑incrimination

             (1)  A person is not excused from giving information or a document under a notice given under section 31A, 31AA or 31B on the ground that the giving of the information or document would tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given; or

                     (b)  the giving of the document; or

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or document;

is not admissible in evidence in:

                     (d)  criminal proceedings against the individual, except proceedings under, or arising out of, section 31D or 31E; or

                     (e)  proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.


 

Part 3‑3Manufacturing of therapeutic goods

  

33A  Application of this Part to medical devices

                   This Part does not apply to a medical device unless Part 3‑2 applies to the device.

Note:          Section 15A sets out when Part 3‑2 applies to a medical device.

34  Exempt goods and exempt persons

             (1)  The regulations may exempt therapeutic goods or a class of therapeutic goods identified in the regulations from the operation of this Part.

             (2)  The regulations may exempt a person identified in the regulations from the operation of this Part in relation to the manufacture or a step in the manufacture of therapeutic goods or a class of therapeutic goods identified in the regulations.

             (3)  Where the regulations revoke an exemption, the revocation takes effect on the day, not being earlier than 28 days after the day on which the regulations are made, as is specified in the regulations.

35  Criminal offences relating to manufacturing therapeutic goods

             (1)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and

                     (b)  the goods are for supply for use in humans; and

                     (c)  none of the following applies:

                              (i)  the goods are exempt goods;

                             (ii)  the person is an exempt person in relation to the manufacture of the goods;

                            (iii)  the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises; and

                     (d)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the person carried out the step in the manufacture of the goods.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and

                     (b)  the goods are for supply for use in humans; and

                     (c)  none of the following applies:

                              (i)  the goods are exempt goods;

                             (ii)  the person is an exempt person in relation to the manufacture of the goods;

                            (iii)  the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises; and

                     (d)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the person carried out the step in the manufacture of the goods.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and

                     (b)  the goods are for supply for use in humans; and

                     (c)  none of the following applies:

                              (i)  the goods are exempt goods;

                             (ii)  the person is an exempt person in relation to the manufacture of the goods;

                            (iii)  the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and

                     (b)  the goods are for supply for use in humans; and

                     (c)  the goods are exempt under section 18A; and

                     (d)  the person is not the holder of a licence that:

                              (i)  is in force; and

                             (ii)  authorises the carrying out of that step in relation to the goods at those premises; and

                     (e)  either:

                              (i)  the use of the goods has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the goods, if the goods were used, would result in harm or injury to any person; and

                      (f)  the harm or injury has resulted, will result, or would result, because the person carried out the step in the manufacture of the goods.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A.

             (6)  Strict liability applies to paragraph (5)(c).

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (7)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and

                     (b)  the goods are for supply for use in humans; and

                     (c)  the goods are exempt under section 18A; and

                     (d)  the person is not the holder of a licence that:

                              (i)  is in force; and

                             (ii)  authorises the carrying out of that step in relation to the goods at those premises; and

                     (e)  the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and

                      (f)  the harm or injury would be likely to result because the person carried out the step in the manufacture of the goods.

Penalty:  2,000 penalty units.

             (8)  Subsection (7) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (9)  A person commits an offence if:

                     (a)  the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and

                     (b)  the goods are for supply for use in humans; and

                     (c)  the goods are exempt under section 18A; and

                     (d)  the person is not the holder of a licence that:

                              (i)  is in force; and

                             (ii)  authorises the carrying out of that step in relation to the goods at those premises.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

           (10)  Strict liability applies to paragraph (9)(c).

Note:          For strict liability, see section 6.1 of the Criminal Code.

35A  Civil penalties relating to manufacturing therapeutic goods

             (1)  A person contravenes this subsection if:

                     (a)  the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and

                     (b)  the goods are for supply for use in humans; and

                     (c)  the goods are not exempt under section 18A; and

                     (d)  none of the following applies:

                              (i)  the goods are exempt goods;

                             (ii)  the person is an exempt person in relation to the manufacture of the goods;

                            (iii)  the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

             (2)  A person contravenes this subsection if:

                     (a)  the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and

                     (b)  the goods are for supply for use in humans; and

                     (c)  the goods are exempt under section 18A; and

                     (d)  the person is not the holder of a licence that:

                              (i)  is in force; and

                             (ii)  authorises the carrying out of that step in relation to the goods at those premises.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

35B  Criminal offences relating to breaching a condition of a licence

             (1)  A person commits an offence if:

                     (a)  the person holds a licence; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the licence; and

                     (d)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person holds a licence; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the licence; and

                     (d)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person holds a licence; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the licence.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

35C  Civil penalty relating to breaching a condition of a licence

                   A person contravenes this section if:

                     (a)  the person holds a licence; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the licence.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

36  Manufacturing principles

             (1)  The Minister may, from time to time, determine written principles to be observed in the manufacture of therapeutic goods for use in humans.

             (2)  The manufacturing principles may relate to:

                     (a)  the standards to be maintained, and the equipment to be used, at premises used for the manufacturing of therapeutic goods for use in humans; or

                     (b)  procedures for quality assurance and quality control to be employed in the manufacturing of therapeutic goods for use in humans; or

                     (c)  the qualifications and experience required of persons employed in the manufacture of therapeutic goods for use in humans; or

                     (d)  the manufacturing practices to be employed in the manufacturing of therapeutic goods for use in humans; or

                     (e)  other matters relevant to the quality, safety and efficacy of therapeutic goods for use in humans that are manufactured in Australia;

and may include codes of good manufacturing practice.

             (3)  The Minister may, before taking action under subsection (1) in relation to the manufacturing principles, obtain advice from a committee established by the regulations on the action that should be taken under that subsection as to the principles to be observed in the manufacture of therapeutic goods for use in humans.

             (4)  Manufacturing principles are legislative instruments.

37  Application for licence

             (1)  An application for a licence must:

                     (a)  be made in accordance with a form approved by the Secretary; and

                     (b)  identify the therapeutic goods or classes of therapeutic goods that the applicant proposes to manufacture; and

                     (c)  in accordance with subsections (1A) and (1B), identify one or more manufacturing sites that will be used in the manufacture of those goods; and

                     (d)  identify the steps in the manufacture of those goods that the applicant proposes to carry out under the licence; and

                    (da)  if the applicant proposes to carry out steps in the manufacture of blood or blood components under the licence—contain information relating to those steps set out in regulations made for the purposes of this paragraph; and

                     (e)  state the names, qualifications and experience of the persons who are to have control of the production of the goods and of the quality control measures that are to be employed; and

                      (f)  be delivered to an office of the Department specified in the form; and

                     (g)  be accompanied by the prescribed application fee.

Manufacturing sites

          (1A)  Subject to subsection (1B), an application under subsection (1) must relate to one manufacturing site only. This does not prevent other applications from relating to other manufacturing sites.

          (1B)  If an applicant is of the view that, having regard to the guidelines under section 38A, a licence could be granted covering 2 or more manufacturing sites, the applicant may:

                     (a)  identify those sites in the application; and

                     (b)  state the applicant’s reasons for the applicant’s view.

Further information

             (2)  The Secretary may, by notice in writing given to an applicant for a licence, require the applicant:

                     (a)  to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice; or

                     (b)  to allow an authorised person, at any reasonable time specified in the notice, to inspect each manufacturing site identified in the application and the equipment, processes and facilities that will be used in the manufacture of the goods, or other goods at that site.

Applications or information may be given electronically

             (3)  An approval of a form mentioned in paragraph (1)(a), or a notice mentioned in subsection (2), may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

38  Grant of licence

             (1)  Where:

                     (a)  a person has made an application to carry out steps in the manufacture of therapeutic goods at one or more manufacturing sites; and

                     (b)  the prescribed application fee has been paid; and

                     (c)  any applicable prescribed inspection fees have been paid; and

                     (d)  the applicant has complied with any requirements made by the Secretary under subsection 37(2) in relation to the application;

the Secretary must grant the applicant a licence covering one or more manufacturing sites specified in the licence unless the Secretary is satisfied that:

                     (e)  the applicant will be unable to comply with the manufacturing principles; or

                      (f)  one or more of the manufacturing sites identified in the application are not satisfactory for the manufacture of the goods; or

                     (g)  at least one of the following persons:

                              (i)  the applicant;

                             (ii)  a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant’s affairs;

                            (iii)  if the applicant is a body corporate—a major interest holder of the body corporate;

                            has, within the 10 years immediately before the application:

                            (iv)  been convicted of an offence against this Act or a corresponding State law; or

                             (v)  been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                            (vi)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

                           (vii)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                           (viii)  breached a condition of a manufacturing licence; or

                            (ix)  had a manufacturing licence suspended or revoked; or

                             (x)  been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

                     (h)  any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

Interpretation

          (1A)  A reference in paragraph (1)(g) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

                     (a)  section 19B of the Crimes Act 1914; or

                     (b)  a corresponding provision of a law of a State or Territory.

Note:          Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

       (1AA)  Paragraph (1)(g) does not limit paragraph (1)(h).

          (1B)  In paragraph (1)(g):

manufacturing licence means:

                     (a)  a licence granted under this Part; or

                     (b)  a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods.

Special circumstances justifying grant of licence

             (2)  Notwithstanding paragraph (1)(g), the Secretary may grant a licence to an applicant who, apart from this subsection, could not be granted a licence because of that paragraph if, in the opinion of the Secretary, special circumstances make it appropriate to do so.

Guidelines

          (2A)  The Secretary must have regard to the guidelines under section 38A in granting licences under this section.

What the licence authorises

          (2B)  For each manufacturing site covered by a licence, the Secretary must authorise, in the licence, the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.

Note 1:       For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901.

Note 2:       Sections 40A and 40B deal with variation of authorisations.

Notice of decision

             (3)  Where the Secretary grants or refuses to grant a licence to an applicant, the Secretary must:

                     (a)  give the applicant written notice of the decision; and

                     (b)  in the case of a refusal—include in the notice the reasons for the refusal.

Publication in Gazette

             (4)  Where the Secretary grants a licence, the Secretary must cause particulars of the decision to be published in the Gazette as soon as is practicable after the decision is made.

38A  Guidelines for multi‑site licences

                   The Secretary must, by legislative instrument, make guidelines setting out the circumstances in which a licence may cover 2 or more manufacturing sites.

38B  Splitting multi‑site licences

             (1)  This section applies if a licence (the old licence):

                     (a)  either:

                              (i)  was in force under this Part immediately before the commencement of this section; or

                             (ii)  was suspended under this Part immediately before that commencement; and

                     (b)  related to premises that comprise 2 or more sites (the old sites).

             (2)  As soon as practicable after the commencement of this section, the Secretary must:

                     (a)  by writing, revoke the old licence; and

                     (b)  on the day that the Secretary revokes the old licence, grant new licences (each of which is a new licence) to the holder of the old licence which, when considered together, cover the old sites.

The Secretary must give the holder written notice of the revocation and grant.

Note:          Subsections (5) and (6) deal with when each new licence commences and when the old licence ends.

Guidelines

             (3)  The Secretary must have regard to the guidelines under section 38A in granting licences under this section.

Application of this Part

             (4)  Subject to this section, subsections 38(2B) and (4) and sections 39 to 41A apply to a new licence in the same way as they apply to a licence granted under section 38.

Note:          This means, for example, that:

(a)    the Secretary must give a manufacturing site authorisation under subsection 38(2B) in relation to each manufacturing site covered by a new licence; and

(b)    the Secretary may impose conditions on a new licence under subsection 40(1) and the statutory conditions under subsection 40(4) will apply to a new licence; and

(c)    the Secretary may revoke or suspend a new licence under section 41.

Commencement of new licence

             (5)  The day specified under subsection 39(1) for the commencement of each new licence granted to the holder of the old licence must be the day (the transition day) after the day each new licence is granted.

Note:          Subsection (7) deals with suspending a new licence from the transition day.

When revocation of old licence takes effect

             (6)  The revocation of the holder’s old licence takes effect immediately before the start of the transition day.

Suspension of new licence

             (7)  If:

                     (a)  subparagraph (1)(a)(ii) applies in relation to an old licence; and

                     (b)  the period of suspension of the old licence is due to end at the end of a day (the relevant day) after the transition day;

the Secretary may, on the day that the Secretary grants a new licence to the holder of the old licence and by notice in writing given to the holder, suspend the new licence for a period starting on the transition day and ending at the end of the relevant day.

             (8)  Subsection 41(2) does not apply in relation to a suspension under subsection (7) of this section. However, subsections 41(4) to (6) do apply in relation to the suspension.

             (9)  To avoid doubt, subsection (7) does not prevent subsection 41(1) from applying in relation to a new licence.

Licence charges

           (10)  Subsection 4(2) of the Therapeutic Goods (Charges) Act 1989 does not apply in relation to a new licence for the financial year in which the new licence is granted.

No review of revocation of old licence

           (11)  The revocation of the old licence is taken not to be an initial decision for the purposes of section 60.

39  Term of licence

             (1)  A licence commences on the day specified in the licence and remains in force until it is revoked or suspended.

             (2)  If:

                     (a)  the licence covers therapeutic goods that are exempt under section 18A; and

                     (b)  those goods cease to be exempt under that section before the licence is revoked;

the licence ceases to be in force in relation to those goods when those goods cease to be exempt under that section.

Note:          An exemption under section 18A may cease to have effect only in relation to some of the goods covered by the exemption, see subsection 18A(5).

40  Conditions of licences

             (1)  A licence may be granted subject to such conditions relating to the manufacture of the goods as the Secretary thinks appropriate.

             (2)  The Secretary may, by notice in writing given to the holder of a licence, impose new conditions on the licence or vary or remove existing conditions.

             (3)  The imposition or variation of a condition under subsection (2) takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 28 days after the notice is given to the person.

             (4)  In addition to any conditions imposed under subsection (1) or (2), each licence is, except as otherwise specified in the licence, subject to the conditions that the holder of the licence will:

                     (a)  ensure that:

                              (i)  the goods conform to any standard applicable to the goods; and

                             (ii)  the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence; and

                    (aa)  if:

                              (i)  the holder of the licence carries out, or proposes to carry out, steps in the manufacture of blood or blood components under the licence; and

                             (ii)  regulations made for the purposes of this paragraph set out particular information relating to those steps;

                            comply with a request by the Secretary to provide such information, in accordance with those regulations; and

                    (ab)  as soon as the holder of the licence becomes aware of information of a kind mentioned in subsection (5), give the information to the Secretary in writing; and

                    (ac)  give the Secretary the information specified in a notice under subsection (6) within the period, and in the manner, specified in the notice; and

                     (b)  allow an authorised person:

                              (i)  to enter, at any reasonable time, each manufacturing site covered by the licence; and

                             (ii)  while at such a site, to inspect the site, any therapeutic goods at the site and the processes relating to the manufacture of therapeutic goods at the site and to examine, take measurements of, conduct tests on or take samples of any therapeutic goods at the site or any thing at the site that relates to any therapeutic goods; and

                            (iii)  while at such a site, to make any still or moving image or any recording of that site or those goods or processes; and

                     (c)  where an authorised person enters a site as mentioned in subparagraph (b)(i), require the holder or his or her employees at that site to answer questions relating to procedures carried out at that site; and

                     (d)  if requested to do so by an authorised person:

                              (i)  produce to the person such documents relating to the manufacture of therapeutic goods manufactured at that site as the person requires and allow the person to copy the documents; or

                             (ii)  produce to the person for examination any batch samples kept by the holder; and

                     (e)  comply with such other conditions (if any) as are specified in the regulations for the purposes of this section.

             (5)  The information with which paragraph (4)(ab) is concerned is information of the following kinds:

                     (a)  information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;

                     (b)  information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as was suggested by:

                              (i)  the application for registration or listing of the goods; or

                             (ii)  information already furnished by the holder of the licence under this Act; or

                            (iii)  if the holder of the licence is not the sponsor of the goods—information already furnished by the sponsor of the goods under this Act;

                     (c)  information that indicates that the quality, safety or efficacy of the goods is unacceptable.

             (6)  The Secretary may, by notice in writing given to the holder of a licence, require the holder to give the Secretary, within the specified period and in the specified manner, specified information to be used by the Secretary in deciding whether to revoke or suspend the licence under section 41 in the circumstances referred to in paragraph 41(1)(a).

             (7)  The period specified in a notice given under subsection (6) must be at least 14 days after the notice is given.

40A  Variation of manufacturing site authorisations—Secretary’s own initiative

             (1)  The Secretary may, on his or her own initiative and by notice in writing given to the holder of a licence, vary a manufacturing site authorisation in relation to the licence.

             (2)  A variation under subsection (1) takes effect:

                     (a)  if the notice states that the variation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the holder; or

                     (b)  in any other case—on the day specified in the notice (which must not be earlier than 28 days after the notice is given to the holder).

40B  Variation of licences—application by licence holder

Addition of manufacturing sites

             (1)  If the holder of a licence is of the view that, having regard to the guidelines under section 38A, the licence could cover one or more additional manufacturing sites, the holder may apply to the Secretary for a variation of the licence so that it covers one or more additional manufacturing sites specified in the application.

             (2)  An application under subsection (1) must:

                     (a)  be made in accordance with a form approved by the Secretary; and

                     (b)  identify the therapeutic goods or classes of therapeutic goods that the holder proposes to manufacture at each additional manufacturing site specified in the application; and

                     (c)  identify the steps in the manufacture of those goods that the holder proposes to carry out under the licence; and

                     (d)  if the holder proposes to carry out steps in the manufacture of blood or blood components under the licence—contain information relating to those steps set out in regulations made for the purposes of paragraph 37(1)(da); and

                     (e)  state the names, qualifications and experience of the persons who are to have control of the manufacture of the goods and of the quality control measures that are to be employed; and

                      (f)  be delivered to an office of the Department specified in the form; and

                     (g)  be accompanied by the prescribed application fee.

             (3)  If an application is made under subsection (1) and any applicable prescribed inspection fees have been paid, the Secretary may, by notice in writing given to the holder of the licence, vary the licence so that the licence covers each additional manufacturing site specified in the notice.

             (4)  For each manufacturing site specified under subsection (3), the Secretary must, in the notice under that subsection, vary the licence to authorise the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.

Note 1:       For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901.

Note 2:       Section 40A and subsections (6) to (9) of this section deal with variation of authorisations.

             (5)  A variation under subsection (3) or (4) takes effect on the day on which the notice is given to the holder.

Variation of manufacturing site authorisations

             (6)  The holder of a licence may apply to the Secretary for a variation of a manufacturing site authorisation in relation to the licence.

             (7)  An application under subsection (6) must:

                     (a)  be made in accordance with a form approved by the Secretary; and

                     (b)  set out the variation sought; and

                     (c)  be delivered to an office of the Department specified in the form; and

                     (d)  be accompanied by the prescribed application fee.

             (8)  If an application is made under subsection (6) and any applicable prescribed inspection fees have been paid, the Secretary may, by notice in writing given to the holder of the licence, vary the manufacturing site authorisation.

             (9)  A variation under subsection (8) takes effect on the day on which the notice is given to the holder.

Further information

           (10)  The Secretary may, by notice in writing given to the holder of a licence who has made an application under subsection (1) or (6), require the holder:

                     (a)  to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice; or

                     (b)  to allow an authorised person, at any reasonable time specified in the notice, to inspect each manufacturing site identified in the application and the equipment, processes and facilities that will be used in the manufacture of therapeutic goods at that site.

Applications or information may be given electronically

           (11)  An approval of a form mentioned in paragraph (2)(a) or (7)(a), or a notice mentioned in subsection (10), may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41  Revocation and suspension of licences

             (1)  Subject to subsection (2), the Secretary may, by notice in writing given to the holder of a licence, revoke the licence, or suspend the licence for a period specified in the notice, if:

                     (a)  at least one of the following persons:

                              (i)  the holder;

                             (ii)  a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder’s affairs;

                            (iii)  if the holder is a body corporate—a major interest holder of the body corporate;

                            has:

                            (iv)  been convicted of an offence against this Act or a corresponding State law; or

                             (v)  been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                            (vi)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

                           (vii)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                           (viii)  breached a condition of a manufacturing licence; or

                            (ix)  had a manufacturing licence suspended or revoked; or

                             (x)  been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

                     (d)  the holder requests in writing that the licence be revoked or suspended, as the case may be; or

                     (e)  the holder ceases to carry on the business of manufacturing the goods to which the licence relates; or

                    (ea)  the holder contravenes a manufacturing site authorisation in relation to the licence; or

                      (f)  the annual licensing charge, or any applicable prescribed inspection fees, have not been paid within 28 days after they become payable; or

                     (g)  the goods are exempt under section 18A and the holder has breached a condition of the exemption in relation to those goods; or

                     (h)  any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

          (1A)  A reference in paragraph (1)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

                     (a)  section 19B of the Crimes Act 1914; or

                     (b)  a corresponding provision of a law of a State or Territory.

Note:          Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

          (1B)  Paragraph (1)(a) does not limit paragraph (1)(h).

          (1C)  In paragraph (1)(a):

manufacturing licence means:

                     (a)  a licence granted under this Part; or

                     (b)  a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods.

             (2)  Where the Secretary proposes to revoke a licence or suspend a licence otherwise than at the request of the holder of the licence, the Secretary must, unless the Secretary considers that failure to revoke or suspend the licence immediately would create an imminent risk of death, serious illness or serious injury:

                     (a)  by notice in writing given to the holder, inform the holder of the action that the Secretary proposes to take and of the reasons for that proposed action; and

                     (b)  except where the proposed action is to be taken as a result of a failure to pay the annual licensing charge or an applicable prescribed inspection fee—give the holder an opportunity to make, within such reasonable time as is specified in the notice, submissions to the Secretary in relation to the proposed action.

             (3)  Where the holder makes submissions in accordance with paragraph (2)(b), the Secretary is not to make a decision relating to the revocation or suspension of the licence before taking into account the submissions.

             (4)  A licence may be revoked notwithstanding that the licence is suspended.

             (5)  Where a licence is suspended, the Secretary may, by notice in writing given to the holder of the licence, revoke the suspension.

             (6)  Where the Secretary revokes or suspends a licence, the Secretary must cause particulars of the decision to be published in the Gazette as soon as is practicable after the decision is made.

41AA  Spent convictions scheme

                   Nothing in section 40 or 41 affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

41AAA  Transfer of licences

             (1)  The regulations may make provision for and in relation to the transfer of licences.

             (2)  Regulations made for the purposes of subsection (1) may make provision for and in relation to:

                     (a)  the making of an application for the transfer of a licence; and

                     (b)  the payment of a fee in respect of an application; and

                     (c)  the assessment of an application; and

                     (d)  the conditions of a licence upon the transfer of the licence; and

                     (e)  the review of decisions made under the regulations.

             (3)  Subsection (2) does not limit subsection (1).

41A  Publication of list of manufacturers etc.

                   The Secretary may, from time to time and in such manner as the Secretary determines, publish a list of the persons who are licensed under this Part, the classes of goods to which the licences relate, the steps of manufacture that the licences authorise and the addresses of the manufacturing sites to which the licences relate.


 

Chapter 4Medical devices

Note:       This Chapter does not apply, and Chapter 3 (Medicines and other therapeutic goods that are not medical devices) still applies, to medical devices that are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.

Part 4‑1Introduction

Division 1Overview of this Chapter

41B  General

                   The purpose of this Chapter is to ensure the safety and satisfactory performance of medical devices. It does this by:

                     (a)  setting out particular requirements for medical devices; and

                     (b)  establishing administrative processes principally aimed at ensuring those requirements are met; and

                     (c)  providing for enforcement through a series of offences and civil penalty provisions.

41BA  Requirements for medical devices (Parts 4‑2 and 4‑3)

                   The requirements for medical devices are:

                     (a)  essential principles (that are about the safety and performance characteristics of medical devices); and

                     (b)  conformity assessment procedures (that are mainly about the application of quality management systems).

Note:          Medical device standards may be made under Division 2 of Part 4‑2, and conformity assessment standards may be made under Division 2 of Part 4‑3, but they are not requirements.

41BB  Administrative processes (Parts 4‑4 to 4‑10)

                   The administrative processes under this Chapter are:

                     (a)  issuing conformity assessment certificates for some manufacturers of medical devices; and

                     (b)  including medical devices in the Register; and

                     (c)  suspending or cancelling entries of medical devices from the Register; and

                    (ca)  exempting medical devices from various provisions of this Chapter to deal with emergency situations; and

                     (d)  exempting medical devices from the requirement to be included in the Register; and

                     (e)  obtaining information about medical devices; and

                      (f)  requiring public notification of problems with medical devices, and recovery of such devices.

Note:          Part 4‑10 provides for assessment fees to be payable in some circumstances.

41BC  Enforcement (Part 4‑11)

                   Part 4‑11 contains offences and civil penalty provisions that are aimed at ensuring that:

                     (a)  the requirements for medical devices are complied with; and

                     (b)  the administrative processes under this Chapter (particularly the inclusion of medical devices in the Register) are followed.

Note:          There are some offences and civil penalty provisions in Parts 4‑4 to 4‑9. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications).


 

Division 2Interpretation

41BD  What is a medical device

             (1)  A medical device is:

                     (a)  any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

                              (i)  diagnosis, prevention, monitoring, treatment or alleviation of disease;

                             (ii)  diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

                            (iii)  investigation, replacement or modification of the anatomy or of a physiological process;

                            (iv)  control of conception;

                            and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

                    (aa)  any instrument, apparatus, appliance, material or other article specified under subsection (2A); or

                    (ab)  any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or

                     (b)  an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).

Note:          Declarations under subsection (3) exclude articles from the scope of this definition. Declarations under section 7 can also have this effect: see subsection 7(4).

             (2)  For the purposes of paragraph (1)(a), the purpose for which an instrument, apparatus, appliance, material or other article (the main equipment) is to be used is to be ascertained from the information supplied, by the person under whose name the main equipment is or is to be supplied, on or in any one or more of the following:

                     (a)  the labelling on the main equipment;

                     (b)  the instructions for using the main equipment;

                     (c)  any advertising material relating to the main equipment;

                     (d)  technical documentation describing the mechanism of action of the main equipment.

          (2A)  The Secretary may, by notice published in the Gazette, specify a particular instrument, apparatus, appliance, material or other article for the purposes of paragraph (1)(aa). The notice is not a legislative instrument.

          (2B)  The Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, materials or other articles for the purposes of paragraph (1)(ab).

             (3)  The Secretary may, by order published in the Gazette, declare that a particular instrument, apparatus, appliance, material or other article, or that a particular class of instruments, apparatus, appliances, materials or other articles, are not, for the purposes of this Act, medical devices.

Note:          A declaration under this section does not stop articles from being therapeutic goods.

             (4)  A declaration under this section takes effect on the day on which the declaration is published in the Gazette or on such later day as is specified in the order.

41BE  Kinds of medical devices

General

             (1)  For the purposes of this Chapter, a medical device is taken to be of the same kind as another medical device if they:

                     (a)  have the same sponsor; and

                     (b)  have the same manufacturer; and

                     (c)  have the same device nomenclature system code (see subsection (3)); and

                     (d)  have the same medical device classification; and

                     (e)  are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question.

Unique medical devices

             (2)  If a medical device is not of the same kind as any other medical device:

                     (a)  this Chapter applies in relation to the device as if it were a kind of medical device; and

                     (b)  references in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.

Device nomenclature codes

             (3)  The Minister may, by legislative instrument, determine device nomenclature codes for medical devices.

41BEA  Excluded purposes

                   The Secretary may, by legislative instrument, specify purposes for the purposes of paragraph 41FD(ia) and subsection 41FF(1A).

41BF  System or procedure packs

             (1)  A package and therapeutic goods in the package are a system or procedure pack if:

                     (a)  the package and the therapeutic goods are for use as a unit, either in combination as a system or in a medical or surgical procedure; and

                     (b)  the package contains at least one medical device; and

                     (c)  the package and the therapeutic goods do not constitute a composite pack.

             (2)  To avoid doubt, a system or procedure pack is a medical device.

41BG  Manufacturers of medical devices

             (1)  The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.

             (2)  If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person’s name, does one or more of the following using ready‑made products:

                     (a)  assembles the device;

                     (b)  packages the device;

                     (c)  processes the device;

                     (d)  fully refurbishes the device;

                     (e)  labels the device;

                      (f)  assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:

                              (i)  the labelling on the device;

                             (ii)  the instructions for using the device;

                            (iii)  any advertising material relating to the device;

                            (iv)  technical documentation describing the mechanism of action of the device.

             (3)  However, a person is not the manufacturer of a medical device if:

                     (a)  the person assembles or adapts the device for an individual patient; and

                     (b)  the device has already been supplied by another person; and

                     (c)  the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:

                              (i)  the labelling on the device;

                             (ii)  the instructions for using the device;

                            (iii)  any advertising material relating to the device;

                            (iv)  technical documentation describing the mechanism of action of the device.

             (4)  A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.

41BH  Meaning of compliance with essential principles

             (1)  A medical device complies, for the purposes of this Chapter (including Part 4‑11), with the essential principles if and only if it does not contravene any of the essential principles.

             (2)  However, a medical device is also taken, for the purposes of this Chapter (other than Part 4‑11), to comply with the essential principles if:

                     (a)  the medical device complies with one or more medical device standards that apply to it; and

                     (b)  the medical device contravenes the essential principles only in respect of a part or parts of the essential principles to which that medical device standard, or one or more of those medical device standards, relate.

             (3)  For the purposes of this section, a medical device standard relates to a part or parts of the essential principles only if the standard specifies that part or parts.

41BI  Meaning of non‑application of conformity assessment procedures

             (1)  A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied to a medical device if:

                     (a)  there has been a contravention of the conformity assessment procedures; and

                     (b)  the contravention relates, wholly or partly, to that device or its manufacture.

             (2)  However, for the purposes of this Chapter (other than Part 4‑11), subsection (1) does not apply if:

                     (a)  the quality management system applied in the manufacture of the medical device complies with one or more conformity assessment standards that apply to it; and

                     (b)  the contravention is only in respect of a part or parts of the conformity assessment procedures to which that conformity assessment standard, or one or more of those conformity assessment standards, relate.

             (3)  For the purposes of this section, a conformity assessment standard relates to a part or parts of the conformity assessment procedures only if the standard specifies that part or parts.


 

Division 3Application provisions

41BJ  Application of this Chapter to medical devices covered by Part 3‑2

             (1)  This Chapter does not apply to a medical device if section 15A applies to the device, except for purposes connected with:

                     (a)  applications for including the medical device in the Register under this Chapter; or

                     (b)  including the medical device in the Register under this Chapter.

Note:          Section 15A sets out the circumstances in which Part 3‑2 applies or continues to apply to medical devices.

             (2)  However, if an exemption under section 34 applied to a medical device, or the manufacturer of the device, immediately before the commencement of this Chapter:

                     (a)  Parts 4‑3 and 4‑4, and Division 2 of Part 4‑11, apply in relation to the device after the end of the period of 2 years after that commencement; and

                     (b)  Parts 4‑8, 4‑9 and 4‑10, and Divisions 3 and 4 of Part 4‑11, apply in relation to the device, to the extent that they relate to any of the provisions referred to in paragraph (a), after the end of that period.

41BK  Application of the Criminal Code

                   Chapter 2 of the Criminal Code applies to all offences against this Chapter.

Note:          Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.


 

Part 4‑2Essential principles and medical device standards

  

41C  What this Part is about

The essential principles set out the requirements relating to the safety and performance characteristics of medical devices. Compliance with applicable medical device standards is not required, but it is one way to establish compliance with essential principles.

Note:          Dealing in medical devices that do not comply with the essential principles may be an offence or may contravene a civil penalty provision: see Division 1 of Part 4‑11.

Division 1Essential principles

41CA  Essential principles

             (1)  The regulations may set out requirements for medical devices.

             (2)  These requirements are to be known as the essential principles.


 

Division 2Medical device standards

41CB  Medical device standards

             (1)  The Minister may, by legislative instrument, make an order determining that:

                     (a)  matters specified in the order constitute a medical device standard for kinds of medical devices identified in the order; and

                     (b)  medical devices of those kinds that comply with the standard are to be treated as complying with those parts of the essential principles specified in the standard.

Note:          Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

             (2)  The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

41CC  Content of medical device standards

             (1)  Without limiting the scope of section 41CB, an order establishing a medical device standard for kinds of medical devices may be specified by reference to:

                     (a)  the safety or performance characteristics of the devices; or

                     (b)  a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary; or

                     (c)  a monograph in a publication approved by the Minister for the purposes of this subsection; or

                     (d)  such a monograph as modified in a manner specified in the order; or

                     (e)  a standard published by a standards organisation; or

                      (f)  such other matters as the Minister thinks fit.

             (2)  For the purposes of paragraph (1)(e), these are standards organisations:

                     (a)  Standards Australia International Limited;

                     (b)  the International Organisation for Standardization;

                     (c)  the International Electrotechnical Commission;

                     (d)  the European Committee for Standardization;

                     (e)  the European Committee for Electrotechnical Standardization;

                      (f)  any other organisation declared by the Minister by notice published in the Gazette.

41CD  Inconsistencies between medical device standards

             (1)  A medical device standard that:

                     (a)  applies to a kind of medical device; and

                     (b)  is inconsistent with another medical device standard that applies only to some of the devices of that kind;

is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).

             (2)  A medical device standard that applies to a kind of medical device that consists of a combination of component parts takes precedence over any medical device standard that applies to the component parts.


 

Part 4‑3Conformity assessment procedures

  

41D  What this Part is about

The conformity assessment procedures set out the requirements relating to the application of quality management systems for medical devices, and other requirements imposed on manufacturers.

Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied to medical devices.

Note 1:       Dealing in medical devices that have not had the conformity assessment procedures applied may be an offence or may contravene a civil penalty provision: see Division 2 of Part 4‑11.

Note 2:       See section 41BI on applying the conformity assessment procedures.

Division 1Conformity assessment procedures

41DA  Conformity assessment procedures

             (1)  The regulations may set out requirements relating to the obligations of manufacturers of medical devices.

             (2)  These requirements are to be known as the conformity assessment procedures.

             (3)  The conformity assessment procedures, or any part of the conformity assessment procedures, may:

                     (a)  be limited in their application to one or more medical device classifications; or

                     (b)  apply differently to different medical device classifications, different kinds of medical devices or different manufacturers.

             (4)  Without limiting subsection (1), the regulations may relate to all or any of the following:

                     (a)  application of quality management systems for the manufacture of medical devices;

                     (b)  certification of compliance with the essential principles, or the quality management systems for the manufacture of medical devices;

                     (c)  notification of, and assessment of, changes to a manufacturer’s product range, product design or quality management systems;

                     (d)  declarations to be made by manufacturers of medical devices that conformity assessment procedures have been applied to the devices;

                     (e)  marks to be affixed to medical devices indicating the application of the conformity assessment procedures to the devices;

                      (f)  monitoring and inspecting the design of medical devices or the manufacturing processes for medical devices;

                     (g)  monitoring the performance of medical devices;

                     (h)  corrective action required in relation to the design, manufacture, packaging, labelling and supply of medical devices;

                      (i)  keeping records of the manufacture of medical devices, the design of medical devices or the manufacturing processes for medical devices.

41DB  Medical device classifications

                   The regulations may specify:

                     (a)  classifications, to be known as medical device classifications, applying to medical devices or kinds of medical devices; and

                     (b)  matters in relation to the classification of medical devices or kinds of medical devices.


 

Division 2Conformity assessment standards

41DC  Conformity assessment standards

             (1)  The Minister may, by legislative instrument, make an order determining that:

                     (a)  matters specified in the order constitute a conformity assessment standard for quality management systems identified in the order; and

                     (b)  a quality management system that complies with the standard is to be treated as having had applied to it those parts of the conformity assessment procedures specified in the standard.

Note:          Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

             (2)  A conformity assessment standard may be limited to particular kinds of medical devices.

             (3)  The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

41DD  Content of conformity assessment standards

             (1)  Without limiting the scope of section 41DC, an order establishing a conformity assessment standard for a kind of medical device may be specified by reference to:

                     (a)  procedures to be carried out under the quality management systems for the design, manufacture and final inspection of the devices; or

                     (b)  a standard published by a standards organisation; or

                     (c)  such other matters as the Minister thinks fit.

             (2)  For the purposes of paragraph (1)(b), these are standards organisations:

                     (a)  Standards Australia International Limited;

                     (b)  the International Organisation for Standardization;

                     (c)  the European Committee for Standardization;

                     (d)  any other organisation declared by the Minister by notice published in the Gazette.

41DE  Inconsistencies between conformity assessment standards

                   A conformity assessment standard that:

                     (a)  identifies quality management systems to which it applies; and

                     (b)  is inconsistent with another conformity assessment standard that applies only to particular kinds of medical devices;

is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).


 

Part 4‑4Conformity assessment certificates

  

41E  What this Part is about

The Secretary can issue a conformity assessment certificate (which may be limited to some medical devices) in respect of a manufacturer of medical devices, signifying one or more of these:

               (a)     that relevant quality management systems have been applied to the device;

               (b)     the essential principles for the device have been complied with;

               (c)     other certification requirements of the conformity assessment procedures have been met.

Note:          A conformity assessment certificate may be required before a valid application can be made for including a kind of medical device in the Register under this Chapter: see subsection 41FC(2).

Division 1Issuing conformity assessment certificates

41EA  When conformity assessment certificates are required

                   The regulations may prescribe:

                     (a)  kinds of manufacturers in respect of whom a conformity assessment certificate must be issued before valid applications can be made for kinds of medical devices, manufactured by those manufacturers, to be included in the Register; or

                     (b)  kinds of medical devices in respect of which a conformity assessment certificate must be issued before valid applications can be made for those kinds of medical devices to be included in the Register.

Note:          The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices: see subsection 41LA(2).

41EB  Applications

             (1)  An application for a conformity assessment certificate must:

                     (a)  be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and

                     (b)  be delivered to an office of the Department specified by the Secretary.

Note:          A conformity assessment fee is payable under section 41LA for consideration of the application.

             (2)  An application is not effective if:

                     (a)  the prescribed application fee has not been paid; or

                     (b)  the application contains information that is false or misleading in a material particular.

Note:          A person might also commit an offence, or contravene a civil penalty provision, if the person makes a statement in an application that is false or misleading in a material particular: see sections 41EI and 41EIA.

             (3)  An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

             (4)  The Secretary may, by written notice given to an applicant for a conformity assessment certificate, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect:

                     (a)  the premises (including premises outside Australia) and equipment, processes and facilities that are being or will be used to manufacture medical devices of the kind in question; and

                     (b)  any other kinds of medical devices on those premises.

41EC  Considering applications

             (1)  If the application is made in accordance with section 41EB, the Secretary must decide whether to issue the conformity assessment certificate.

             (2)  In deciding whether to issue the certificate, the Secretary must consider some or all aspects of whether the conformity assessment procedures relating to one or more of the following have been applied to the medical device:

                     (a)  the application of quality management systems for the manufacture of medical devices;

                     (b)  the certification of compliance with the essential principles;

                     (c)  any other requirement of the conformity assessment procedures specified in regulations made for the purposes of this subsection.

             (3)  In deciding whether to issue the certificate, the Secretary must also consider:

                     (a)  whether at least one of the following persons:

                              (i)  the applicant;

                             (ii)  a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant’s affairs;

                            (iii)  if the applicant is a body corporate—a major interest holder of the body corporate;

                            has, within the 10 years immediately before the application:

                            (iv)  been convicted of an offence against this Act or a corresponding State law; or

                             (v)  been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                            (vi)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

                           (vii)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                           (viii)  breached a condition of a conformity assessment certificate; or

                            (ix)  had a conformity assessment certificate suspended or revoked; or

                             (x)  been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

                     (b)  whether any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

             (4)  A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

                     (a)  section 19B of the Crimes Act 1914; or

                     (b)  a corresponding provision of a law of a State or Territory.

Note:          Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

             (5)  Paragraph (3)(a) does not limit paragraph (3)(b).

41ED  Time for making decisions on applications

                   If the application relates to the issuing of a conformity assessment certificate in relation to which a period has been prescribed under paragraph 63(2)(dc), a decision on the application must be made within that period, unless the application lapses under section 41EG.

41EE  Procedure following making a decision whether to issue certificate

             (1)  After making a decision whether to issue a conformity assessment certificate, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days; and

                     (b)  if the decision is not to issue the certificate—state in the notice the reasons for the decision; and

                     (c)  if the decision is to issue the certificate and all assessment fees that are due and payable for the application have been paid:

                              (i)  issue the certificate to the manufacturer in relation to whom the application was made; and

                             (ii)  give the applicant a copy of the certificate (if the applicant is not the manufacturer).

             (2)  A conformity assessment certificate must specify whether it covers:

                     (a)  all medical devices manufactured by the manufacturer; or

                     (b)  only specified medical devices manufactured by the manufacturer.

41EF  Duration of certificate

             (1)  The conformity assessment certificate commences on the day specified for the purpose in the certificate.

             (2)  A conformity assessment certificate has effect at all times:

                     (a)  unless the certificate is suspended under Division 3; or

                     (b)  until the end of the period (if any) specified in the certificate; or

                     (c)  until the certificate is revoked under Division 4.

41EG  Lapsing of applications

                   An application for a conformity assessment certificate lapses if:

                     (a)  the applicant does not deliver to the office to which the application was made such information (in a form approved in writing by the Secretary) as will allow the certificate to be issued; or

                     (b)  the applicant does not comply with a requirement by the Secretary to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates; or

                     (c)  the applicant fails to comply with a notice under section 41JA to give to the Secretary information within a further 10 working days from the day specified in the notice; or

                     (d)  information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a notice under section 41JA, is false or misleading in a material particular; or

                     (e)  the applicant fails to allow an authorised person to carry out any inspection as required under subsection 41EB(4); or

                      (f)  the applicant fails to pay an assessment fee for the application within the period, specified in the regulations, after being notified of the decision to issue a conformity assessment certificate under section 41EE.

41EH  Treating applications as having been refused

             (1)  The applicant for an application for a conformity assessment certificate may give the Secretary written notice that the applicant wishes to treat the application as having been refused if:

                     (a)  a period is prescribed under paragraph 63(2)(dc) for making a decision on the application; and

                     (b)  at the end of the period, the applicant has not been notified of a decision whether to issue the certificate.

             (2)  The notice may be given at any time before the applicant is notified of the decision.

             (3)  If a notice has been given, this Act (except for subsection 60(5)) has effect as if:

                     (a)  the Secretary had decided not to issue the certificate; and

                     (b)  the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and

                     (c)  the Minister’s decision had been made on the day on which notice was given to the Secretary.

41EI  Criminal offences for making a false statement

             (1)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is made in or in connection with an application for a conformity assessment certificate; and

                     (c)  the person knows that the statement is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the kind of medical device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the kind of medical device, if the kind of medical device were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is in or in connection with an application for a conformity assessment certificate; and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  the use of the kind of medical device, if the kind of medical device were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is in or in connection with an application for a conformity assessment certificate; and

                     (c)  the person knows that the statement is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

41EIA  Civil penalty for making a false statement

                   A person contravenes this section if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with an application for a conformity assessment certificate.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.


 

Division 2Conditions

Note:       Breaching conditions of the conformity assessment certificate may lead to suspension or revocation of the certificate (see Divisions 3 and 4), may be an offence (see subsections 41MN(5), (6) and (8)), and may contravene a civil penalty provision (see subsection 41MNA(2)).

41EJ  Automatic conditions on conformity assessment certificates

Entry and inspection powers

             (1)  A conformity assessment certificate is subject to the conditions that the manufacturer in respect of whom the certificate is issued will:

                     (a)  allow an authorised person:

                              (i)  to enter, at any reasonable time, premises (including premises outside Australia) at which the person or any other person deals with medical devices of a kind covered by the certificate; and

                             (ii)  while on those premises, to inspect those premises and medical devices of any kind on those premises and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of medical devices of any kind on those premises or any thing on those premises that relates to medical devices of any kind; and

                            (iii)  while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

                     (b)  if requested to do so by an authorised person:

                              (i)  produce to the person such documents relating to devices of a kind covered by the certificate, or to the manufacturer’s quality management system, as the person requires; and

                             (ii)  allow the person to copy the documents.

Review

             (2)  A conformity assessment certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will cooperate in any review by the Secretary of the certificate to determine whether the conformity assessment procedures relating to the following matters have been applied to the kinds of medical devices covered by the certificate:

                     (a)  the application of quality management systems for the manufacture of medical devices;

                     (b)  the certification of compliance with the essential principles;

                     (c)  any other requirement of the conformity assessment procedures specified in the regulations made for the purposes of subsection 41EC(2).

Notification of substantial changes

             (3)  A conformity assessment certificate is subject to the condition that the person in respect of whom the certificate is issued will notify the Secretary, in writing, of any plan for substantial changes to:

                     (a)  quality management systems; or

                     (b)  the product range covered by those systems; or

                     (c)  the product design of kinds of medical devices;

in respect of which the certificate is issued.

Fees

             (4)  A conformity assessment certificate is subject to the condition that the applicant for the certificate will pay a fee, prescribed in the regulations, for a review under subsection (2), when the fee becomes due and payable.

             (5)  The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices.

Conditions in regulations

          (5A)  A conformity assessment certificate is subject to any conditions prescribed by the regulations for the purposes of this subsection.

Conditions do not limit other conditions

             (6)  A condition imposed under this section is in addition to any conditions imposed under this Division.

41EK  Conditions imposed when conformity assessment certificates are issued

                   If the Secretary issues a conformity assessment certificate in respect of a manufacturer, the Secretary may, in writing, impose conditions on the certificate in respect of:

                     (a)  one or more kinds of medical devices covered by the certificate; or

                     (b)  the manufacturer’s quality management system.

41EL  Conditions imposed after issuing a conformity assessment certificate

             (1)  The Secretary may, by written notice given to a manufacturer in respect of whom a conformity assessment certificate has been issued:

                     (a)  impose new conditions on the certificate in respect of:

                              (i)  one or more kinds of medical devices covered by the certificate; or

                             (ii)  the manufacturer’s quality management system; or

                     (b)  vary or remove existing conditions.

The power may be exercised at the request of the applicant for the certificate or on the Secretary’s own initiative.

             (2)  The imposition or variation of a condition under this section takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.


 

Division 3Suspension of conformity assessment certificates

Note:       Suspension of a conformity assessment certificate leads to suspension from the Register of the kinds of medical devices to which the certificate applied (see subsection 41GF(1)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)).

41EM  Suspension of conformity assessment certificates

             (1)  The Secretary may, by written notice given to the person in relation to whom a conformity assessment certificate is issued, suspend the certificate if the Secretary is satisfied that it is likely that there are grounds for revoking the certificate under section 41ET.

             (2)  The suspension may be limited to some medical devices of that kind, as specified in the notice.

             (3)  The notice must specify the period of the suspension. The period must not exceed 6 months.

Note:          The period of the suspension may be extended under section 41EO.

41EN  Notice of proposed suspension

             (1)  However, before suspending a conformity assessment certificate, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the suspension and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

             (2)  The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (1)(b).

             (3)  This section does not apply if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury.

41EO  Duration of suspension

             (1)  The suspension takes effect:

                     (a)  if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (2)  The suspension has effect until:

                     (a)  the Secretary revokes it under section 41EP; or

                     (b)  the expiry of:

                              (i)  the period specified in the notice under section 41EM; or

                             (ii)  if the period is extended under subsection (3) of this section, the period as so extended.

Note:          Unless a suspension of a conformity assessment certificate has been revoked, the certificate is automatically revoked: see section 41ER.

             (3)  If a person in relation to whom a kind of medical device is included in the Register shows that he or she has taken steps to address the grounds for revoking the certificate under section 41ET, the Secretary may, by written notice given to the person, extend the period specified in the notice under section 41EM by a further specified period not exceeding 6 months.

41EP  Revocation of suspension

             (1)  The Secretary must revoke the suspension if the Secretary is satisfied that:

                     (a)  the ground on which the conformity assessment certificate was suspended no longer applies; and

                     (b)  there are no other grounds for suspending the certificate.

             (2)  The Secretary’s power to revoke the suspension may be exercised:

                     (a)  if:

                              (i)  the manufacturer in relation to whom the conformity assessment certificate was issued; or

                             (ii)  the person who applied for the certificate (if the applicant was not the manufacturer);

                            applies in writing to the Secretary; or

                     (b)  on the Secretary’s own initiative.

             (3)  After revoking the suspension, the Secretary must, within 20 working days after the revocation, give written notice of the revocation to the person in relation to whom the conformity assessment certificate was issued.

             (4)  If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

                     (b)  state in the notice the reasons for the decision.

41EQ  Powers of revocation of conformity assessment certificates unaffected

             (1)  This Division does not affect the Secretary’s powers to revoke a conformity assessment certificate under Division 4.

             (2)  To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates, the suspension ceases to have effect.


 

Division 4Revocation of conformity assessment certificates

Note:       Revocation of a conformity assessment certificate leads to cancellation of the entry from the Register of the kinds of medical devices to which the certificate applied (see paragraph 41GK(b)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)).

41ER  Automatic revocation of conformity assessment certificates

                   The Secretary must, by written notice given to the person in relation to whom a conformity assessment certificate is issued, revoke the certificate if:

                     (a)  the certificate has been suspended under section 41EM; and

                     (b)  the period applying to the suspension under subsection 41EM(3) or 41EO(3) (as the case requires) expires before the suspension is revoked under section 41EP.

41ES  Immediate revocation of conformity assessment certificates

                   The Secretary may, by written notice given to the manufacturer in relation to whom a conformity assessment certificate is issued, revoke the certificate if the manufacturer requests in writing the revocation of the certificate.

41ET  Revocation of conformity assessment certificates after notice of proposed revocation

             (1)  The Secretary may, by written notice given to the person in relation to whom a conformity assessment certificate is issued, revoke the certificate if:

                     (a)  the conformity assessment procedures have not been applied to medical devices of a kind to which the certificate applies; or

                     (b)  the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject; or

                     (c)  the Secretary gives to the person a notice under section 41JA that requires the person to give to the Secretary information or documents and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or

                     (d)  the manufacturer in respect of whom the certificate is issued no longer manufactures any of the kinds of medical devices to which the certificate applies; or

                     (e)  at least one of the following persons:

                              (i)  the person (the holder) in relation to whom the certificate is issued;

                             (ii)  a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder’s affairs;

                            (iii)  if the holder is a body corporate—a major interest holder of the body corporate;

                            has:

                            (iv)  been convicted of an offence against this Act or a corresponding State law; or

                             (v)  been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                            (vi)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or

                           (vii)  been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or

                           (viii)  breached a condition of a conformity assessment certificate; or

                            (ix)  had a conformity assessment certificate suspended or revoked; or

                             (x)  been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or

                      (f)  any other circumstances prescribed by the regulations for the purposes of this paragraph exist.

          (1A)  A reference in paragraph (1)(e) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:

                     (a)  section 19B of the Crimes Act 1914; or

                     (b)  a corresponding provision of a law of a State or Territory.

Note:          Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

          (1B)  Paragraph (1)(e) does not limit paragraph (1)(f).

             (2)  However, before revoking the certificate, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the revocation and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation.

             (3)  The Secretary is not to make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

             (4)  Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

41EU  Limiting revocation of conformity assessment certificates to some medical devices of a particular kind

             (1)  If the Secretary is satisfied that the ground for revoking a conformity assessment certificate applies only to:

                     (a)  some of the kinds of medical devices to which the certificate applies; or

                     (b)  some medical devices of the kinds to which the certificate applies;

the Secretary must limit the revocation to the medical devices to which that ground or any other ground for revocation applies.

             (2)  If the revocation of the certificate is so limited, the Secretary must vary the certificate so that it no longer applies to the medical devices referred to in subsection (1).

41EV  Publication of revocation etc. of conformity assessment certificates

                   The Secretary must cause to be published in the Gazette, as soon as practicable after revoking a conformity assessment certificate, or varying a conformity assessment certificate under subsection 41EU(2), a notice setting out particulars of the revocation or variation.

41EW  Date of effect of revocation etc. of conformity assessment certificates

                   If the Secretary revokes a conformity assessment certificate, or varies a conformity assessment certificate under subsection 41EU(2), the revocation or variation has effect:

                     (a)  if the revocation is under section 41ER or 41ES, or the variation relates to a ground of revocation in section 41ER or 41ES—on the day on which the notice of revocation or variation is given to the person in relation to whom the certificate was issued; or

                     (b)  in any other case—on such later day as is specified in the notice.


 

Part 4‑5Including medical devices in the Register

  

41F  What this Part is about

Kinds of medical devices can be included in the Register if they comply with the essential principles, and conformity assessment procedures have been applied to the kinds of devices (and certain other requirements are complied with).

Inclusions in the Register are subject to certain automatic conditions and the Secretary may impose further conditions.

Division 1Including medical devices in the Register

41FA  What this Division is about

Kinds of medical devices are usually included in the Register automatically once a proper application is made, together with the required certification. However, applications may be selected for audit, which involves checking some or all aspects of the application and certification.

Note 1:       In some cases, an application relating to a kind of medical device will not be effective unless that kind of device is covered by a conformity assessment certificate under Part 4‑4: see paragraph 41FC(2)(c).

Note 2:       Dealing in medical devices of a kind not included in the Register may be an offence or may contravene a civil penalty provision: see Division 3 of Part 4‑11.

41FB  How this Division works

                   This diagram shows how this Division applies to an application for a kind of medical device to be included in the Register.

 

           

Subdivision AApplications

41FC  Applications

             (1)  An application for a kind of medical device to be included in the Register must:

                     (a)  be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and

                     (b)  be delivered to an office of the Department specified by the Secretary.

             (2)  An application is not effective if:

                     (a)  the application is not made in accordance with subsection (1); or

                     (b)  the prescribed application fee has not been paid; or

                     (c)  regulations made for the purposes of section 41EA require the manufacturer of the kind of device to have a conformity assessment certificate relating to the kind of medical device before an application under this section can be made, and no such certificate is in force; or

                     (d)  the application contains information that is false or misleading in a material particular.

Note:          A person might also commit an offence, or contravene a civil penalty provision, if the person makes a statement in an application that is false or misleading in a material particular: see sections 41FE and 41FEA.

             (3)  An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41FD  Matters to be certified

                   The applicant must certify that:

                     (a)  devices of the kind in question are medical devices; and

                     (b)  devices of that kind are intended for a specified purpose, as ascertained under subsection 41BD(2); and

                     (c)  the kind of device is correctly classified according to the medical device classifications; and

                     (d)  devices of that kind comply with the essential principles; and

                     (e)  the applicant:

                              (i)  has available sufficient information to substantiate that compliance with the essential principles; or

                             (ii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                      (f)  an appropriate conformity assessment procedure has been applied to devices of that kind; and

                     (g)  the applicant:

                              (i)  has available sufficient information to substantiate the application of those conformity assessment procedures; or

                             (ii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                     (h)  devices of that kind comply with every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and

                      (i)  devices of that kind do not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and

                     (ia)  devices of that kind are not to be used exclusively for one or more of the purposes specified under section 41BEA; and

                      (j)  the information included in or with the application is complete and correct.

Note:          See section 41BH on compliance with the essential principles and section 41BI on applying the conformity assessment procedures.

41FE  Criminal offences for making a false statement

             (1)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the person knows that the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD; and

                     (d)  either:

                              (i)  the use of the kind of medical device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the kind of medical device, if the kind of medical device were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD; and

                     (d)  the use of the kind of medical device, if the kind of medical device were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the person knows that the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

41FEA  Civil penalty for making a false statement

                   A person contravenes this section if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is false or misleading in a material particular; and

                     (c)  the statement is in or in connection with:

                              (i)  an application for including a kind of medical device in the Register under this Chapter; or

                             (ii)  a certification or purported certification under section 41FD.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Subdivision BIncluding kinds of medical devices in the Register

41FF  Obligation to include kinds of medical devices in the Register

             (1)  If:

                     (a)  an application is made in accordance with section 41FC for a kind of medical device to be included in the Register in relation to a person; and

                     (b)  the requirements of section 41FD have been complied with;

the Secretary must include the kind of device in the Register in relation to the person, unless the application has been selected under section 41FH for audit.

          (1A)  However, the Secretary must not include the kind of device in the Register in relation to the person if the Secretary is satisfied that the kind of device is to be used exclusively for one or more of the purposes specified under section 41BEA.

             (2)  As soon as practicable after the kind of device has been included in the Register, the Secretary must give to the applicant a certificate of the inclusion of the kind of device in the Register.

             (3)  The certificate must specify the day on which the inclusion of the kind of device in the Register commences.

41FG  Notification of unsuccessful applications

                   The Secretary must notify the applicant in writing, within 20 working days after receiving an application under subsection 41FC(1), if an application for a kind of medical device to be included in the Register is unsuccessful.

Subdivision CAuditing of applications

41FH  Selecting applications for auditing

             (1)  The Secretary:

                     (a)  must select for auditing any application for a kind of medical device to be included in the Register that is an application of the kind prescribed by the regulations; and

                     (b)  may select for auditing any other application for a kind of medical device to be included in the Register.

Note:          An application audit assessment fee is payable in respect of any application that the Secretary must select for auditing: see Part 4‑10.

             (2)  If an application is selected for auditing:

                     (a)  the Secretary must, within 20 working days after the application is made, give the applicant a written notice that:

                              (i)  informs the applicant of the selection; and

                             (ii)  requests the applicant to provide any further information necessary for the auditing of the application; and

                     (b)  the application must be dealt with under this Subdivision and not under Subdivision B.

41FI  Auditing of applications

             (1)  In auditing the application, the Secretary may consider all or some aspects of one or both of the following matters:

                     (a)  whether the application is in accordance with Subdivision A;

                     (b)  whether matters as to which the applicant has certified under section 41FD are correct.

             (2)  The Secretary must decide to include the kind of device to which the application relates in the Register, in relation to the person to whom the application relates, if the Secretary is satisfied as to all such aspects considered in the audit.

             (3)  The Secretary must decide not to include the kind of device to which the application relates in the Register if the Secretary is not so satisfied.

41FJ  Procedure following audits

                   After auditing the application, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

                     (b)  if the decision is not to include the kind of device to which the application relates in the Register—state in the notice the reasons for the decision; and

                     (c)  if the decision is to include the kind of device in the Register and all assessment fees for the application that are due and payable have been paid:

                              (i)  include the kind of device in the Register, in relation to the person in relation to whom the application was made; and

                             (ii)  give the applicant a certificate of the inclusion of the kind of device in the Register.

41FK  Lapsing of applications

                   An application that has been selected for auditing lapses if:

                     (a)  the applicant does not deliver to the office to which the application was made such information (in a form approved in writing by the Secretary) as will allow the audit of the application; or

                     (b)  the applicant does not comply with a requirement by the Secretary to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates; or

                     (c)  the applicant fails to comply with a notice under section 41JA to give information relating to devices of that kind to the Secretary within a further 10 working days from the day specified in the notice; or

                     (d)  information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a requirement under section 41JA, is false or misleading in a material particular; or

                     (e)  the applicant fails to pay an assessment fee for the application within the period, specified in the regulations, after being notified of the decision to include the kind of medical device in the Register under section 41FJ.

Subdivision DMiscellaneous

41FL  Device number

                   If a kind of medical device is included in the Register, the Secretary is to assign a unique device number to it.

41FM  Duration of inclusion in the Register

             (1)  The inclusion of a kind of medical device in the Register commences on the day specified for the purpose in the certificate under section 41FF.

             (2)  The inclusion of a kind of medical device in the Register has effect at all times:

                     (a)  unless the kind of device is suspended from the Register under Division 1 of Part 4‑6; or

                     (b)  until entry of the kind of device is cancelled from the Register under Division 2 of Part 4‑6.


 

Division 2Conditions

Note:       Breaching conditions of the inclusion of a kind of medical device may lead to suspension or cancellation of the entry of the kind of device from the Register (see Part 4‑6), may be an offence (see subsections 41MN(1), (2) and (4)), and may contravene a civil penalty provision (see subsection 41MNA(1)).

41FN  Conditions applying automatically

Entry and inspection powers

             (1)  The inclusion of a kind of medical device in the Register is subject to the conditions that the person in relation to whom the kind of device is included in the Register:

                     (a)  allow an authorised person:

                              (i)  to enter, at any reasonable time, any premises (including premises outside Australia) at which that person or any other person deals with medical devices of that kind; and

                             (ii)  while on those premises, to inspect those premises and medical devices of any kind on those premises and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of medical devices of any kind on those premises or any thing on those premises that relates to medical devices of any kind; and

                            (iii)  while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

                     (b)  if requested to do so by an authorised person, produce to the person such documents relating to devices of the kind included in the Register as the person requires and allow the person to copy the documents.

Delivery of samples

             (2)  The inclusion of a kind of medical device in the Register is subject to a condition that the person in relation to whom the kind of device is included in the Register will deliver a reasonable number of samples of the kind of device if the Secretary so requests:

                     (a)  within the period specified in the request; and

                     (b)  in accordance with any other requirements specified in the request.

The period specified in the request must include at least 10 working days.

Availability etc. of information

             (3)  The inclusion of a kind of medical device in the Register is subject to conditions that:

                     (a)  at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:

                              (i)  has available sufficient information to substantiate compliance with the essential principles; or

                             (ii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                     (b)  at all times while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register:

                              (i)  has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device; or

                             (ii)  has available information relating to changes to the kind of medical device, the product range, and quality management system, of the manufacturer of the device; or

                            (iii)  has procedures in place, including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and

                     (c)  at any time while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register will, if asked to do so by the Secretary, give the information to the Secretary; and

                     (d)  the person in relation to whom the kind of device is included in the Register will give information of a kind mentioned in subsection 41MP(2) or 41MPA(2) to the Secretary within the period specified in the regulations; and

                     (e)  the person in relation to whom the kind of device is included in the Register will give the manufacturer of the kind of medical device information relevant to:

                              (i)  the manufacturer’s obligations under the conformity assessment procedures; and

                             (ii)  whether medical devices of that kind comply with the essential principles.

             (4)  The regulations may prescribe the amount, standard or kind of information or evidence required for the purposes of paragraphs (3)(c), (d) and (e).

Advertising material

             (5)  The inclusion of a kind of medical device in the Register is subject to a condition that advertising material relating to medical devices of that kind is consistent with the intended purpose as certified under section 41FD.

Conditions do not limit other conditions

             (6)  A condition imposed under this section is in addition to any conditions imposed under this Division.

41FO  Conditions imposed when kinds of medical devices are included in the Register

             (1)  If the Secretary includes a kind of medical device in the Register in relation to a person, the Secretary may, in writing, impose conditions on the inclusion of the kind of device in the Register.

             (2)  Conditions referred to in subsection (1) may relate to:

                     (a)  manufacture of devices of that kind; or

                     (b)  custody, intended purpose, supply, disposal or destruction of devices of that kind; or

                     (c)  keeping of records relating to devices of that kind, including records relating to the tracking and location of devices of that kind after their supply; or

                     (d)  matters dealt with in, or matters additional to matters dealt with in, the essential principles; or

                     (e)  such other matters relating to devices of that kind as the Secretary thinks appropriate.

41FP  Conditions imposed after kinds of medical devices are included in the Register

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register:

                     (a)  impose new conditions on including the kind of device in the Register under this Chapter; or

                     (b)  vary or remove existing conditions.

The power may be exercised at the person’s request or on the Secretary’s own initiative.

             (2)  The imposition or variation of a condition under this section takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.


 

Part 4‑6Suspension and cancellation from the Register

Division 1Suspension from the Register

Subdivision AGeneral power of suspension

41G  What this Part is about

Inclusions in the Register may be suspended in certain circumstances, such as when a conformity assessment certificate is suspended. A kind of medical device that is suspended is taken not to be included in the Register for most purposes.

Inclusions in the Register may also be cancelled in certain circumstances.

41GA  Suspension of kinds of medical devices from the Register

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if:

                     (a)  the Secretary is satisfied that:

                              (i)  there is a potential risk of death, serious illness or serious injury if the kind of device continues to be included in the Register; and

                             (ii)  it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the kind of device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register; or

                     (b)  the Secretary is satisfied that it is likely that there are grounds for cancelling the entry of the kind of device from the Register under Division 2 (other than under paragraph 41GL(a) or (d) or section 41GM).

             (2)  The suspension may be limited to some medical devices of that kind, as specified in the notice.

             (3)  The notice must specify the period of the suspension. The period must not exceed 6 months.

Note:          The period of the suspension may be extended under section 41GC.

             (4)  The Secretary must cause to be published in the Gazette, as soon as practicable after the suspension, a notice setting out particulars of the suspension.

41GB  Notice of proposed suspension must be given in certain cases

             (1)  However, before suspending a kind of medical device from the Register because it is likely that there are grounds for cancelling the entry of the kind of device from the Register under section 41GN, the Secretary must:

                     (a)  inform the person by written notice that the Secretary proposes the suspension and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

             (2)  The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (1)(b).

41GC  Duration of suspension

             (1)  The suspension takes effect:

                     (a)  if the notice under subsection 41GA(1) states that the suspension is necessary to prevent a potential risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (2)  The suspension has effect until:

                     (a)  the Secretary revokes it under section 41GD; or

                     (b)  the end of:

                              (i)  the period specified in the notice under subsection 41GA(3); or

                             (ii)  if the period is extended under subsection (3) of this section, the period as so extended.

Note:          Unless a suspension of a kind of medical device has been revoked, the entry of the kind of medical device is automatically cancelled from the Register: see section 41GK.

             (3)  If a person in relation to whom a kind of medical device is included in the Register shows that he or she has taken steps to remove the grounds for cancelling the entry of the kind of device from the Register under section 41GN, the Secretary may, by written notice given to the person, extend the period specified in the notice under subsection 41GA(1) by a further specified period not exceeding 6 months.

             (4)  The Secretary must cause to be published in the Gazette, as soon as practicable after the extension, a notice setting out particulars of the extension.

41GD  Revocation of suspension

             (1)  The Secretary must revoke the suspension if the Secretary is satisfied that:

                     (a)  the ground on which the kind of medical device concerned was suspended from the Register no longer applies; and

                     (b)  there are no other grounds for suspending the kind of device from the Register.

             (2)  The Secretary’s power to revoke the suspension may be exercised:

                     (a)  if the person in relation to whom the kind of medical device concerned is included in the Register applies in writing to the Secretary; or

                     (b)  on the Secretary’s own initiative.

             (3)  After revoking the suspension, the Secretary must:

                     (a)  within 20 working days after the revocation, give written notice of the revocation to the person in relation to whom the kind of medical device concerned is included in the Register; and

                     (b)  as soon as practicable after the revocation, cause to be published in the Gazette a notice setting out particulars of the revocation.

             (4)  If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

                     (b)  state in the notice the reasons for the decision.

41GE  Treating applications for revocation as having been refused

             (1)  The applicant for the suspension to be revoked may give the Secretary written notice that the applicant wishes to treat the application as having been refused if:

                     (a)  a period is prescribed under paragraph 63(2)(dd) for the Secretary to make a decision on the application; and

                     (b)  at the end of the period, the Secretary has not made a decision.

             (2)  The notice may be given at any time before the Secretary makes a decision on the application.

             (3)  If a notice has been given, this Act (except for subsection 60(5)) has effect as if:

                     (a)  the Secretary had decided not to revoke the suspension; and

                     (b)  the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and

                     (c)  the Minister’s decision had been made on the day on which notice was given to the Secretary.

Subdivision BSuspension as a result of suspension under Part 4‑4

41GF  Suspension of kinds of medical devices from the Register

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if the conformity assessment certificate applying to that kind of device is suspended under Division 3 of Part 4‑4.

             (2)  If the suspension under Division 3 of Part 4‑4 is limited to some medical devices of that kind, the suspension under this section is taken to be limited to the same extent.

             (3)  The Secretary must cause to be published in the Gazette, as soon as practicable after the suspension, a notice setting out particulars of the suspension.

41GG  Duration of suspension

             (1)  The suspension takes effect on the day on which the notice is given to the person.

             (2)  The suspension has effect until the Secretary revokes it under section 41GH.

41GH  Revocation of suspension

             (1)  The Secretary must revoke the suspension if:

                     (a)  the suspension under Division 3 of Part 4‑4 ceases to have effect; and

                     (b)  the Secretary is satisfied that there are no other grounds for suspending the kind of device from the Register.

.            (2)  After revoking the suspension, the Secretary must:

                     (a)  within 20 working days after the revocation, give written notice of the revocation to the person in relation to whom the kind of medical device concerned is included in the Register; and

                     (b)  as soon as practicable after the revocation, cause to be published in the Gazette a notice setting out particulars of the revocation.

Subdivision CEffect of suspension

41GI  Effect of suspension

                   If all or some medical devices of a particular kind are suspended, they are taken, for the purposes of this Act (other than Division 2 of Part 4‑5, this Division and Part 4‑8), not to be included in the Register while the suspension has effect.

Note:          Dealing in medical devices that are not included in the Register may be an offence or may contravene a civil penalty provision: see Division 3 of Part 4‑11.

41GJ  Powers of cancellation from Register unaffected

             (1)  This Subdivision does not affect the Secretary’s powers to cancel the entry of kinds of medical devices from the Register under Division 2.

             (2)  To the extent that a suspension under this Division relates to medical devices to which such a cancellation relates, the suspension ceases to have effect.


 

Division 2Cancellation of entries from the Register

41GK  Automatic cancellation of entries of kinds of medical devices from the Register

                   The Secretary must, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the kind of device has been suspended from the Register under section 41GA, and the period applying to the suspension under subsection 41GA(3) or 41GC(3) (as the case requires) expires before the suspension is revoked under section 41GD; or

                     (b)  a conformity assessment certificate applying to that kind of device is revoked under Division 4 of Part 4‑4.

41GL  Immediate cancellation of entries of kinds of medical devices from the Register

                   The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the Secretary is satisfied that there would be an imminent risk of death, serious illness or serious injury if the kind of device continues to be included in the Register; or

                     (b)  devices of that kind are no longer therapeutic goods; or

                     (c)  devices of that kind are no longer medical devices; or

                     (d)  the person requests in writing the cancellation of the entry of the kind of device from the Register; or

                     (e)  the Secretary is satisfied that a statement made in or in connection with:

                              (i)  the application for including the kind of device in the Register; or

                             (ii)  the certification or purported certification under section 41FD relating to the application;

                            was false or misleading in a material particular; or

                      (f)  the annual charge payable under subsection 4(1B) of the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of device in the Register is not paid within 20 working days after it becomes payable; or

                     (g)  both of the following apply:

                              (i)  under the regulations, an authority constituted by or under the regulations gives a direction to, or makes a requirement of, the person in relation to an advertisement of the kind of device to ensure that advertising complies with the Therapeutic Goods Advertising Code;

                             (ii)  the person does not comply with the direction or requirement; or

                     (h)  there is a serious breach, involving the kind of device, of the requirements relating to advertising applicable under Part 5‑1 or under the regulations, and the Secretary is satisfied that:

                              (i)  the breach is significant; and

                             (ii)  as a result of the breach, the presentation of devices of that kind is misleading to a significant extent.

41GM  Cancellation of entries of kinds of medical devices from the Register after section 41JA notice

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the Secretary gives to the person a notice under section 41JA requiring the person to give to the Secretary information or documents relating to the kind of device; and

                     (b)  the notice under section 41JA is given for the purposes of ascertaining whether the kind of device should have been included in the Register; and

                     (c)  the person fails to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.

             (2)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  the Secretary gives to the person a notice under section 41JA requiring the person to give to the Secretary information or documents relating to whether medical devices of that kind are being:

                              (i)  supplied in Australia; or

                             (ii)  imported into Australia; or

                            (iii)  exported from Australia; and

                     (b)  either:

                              (i)  the information or documents given are to the effect that medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia; or

                             (ii)  the person fails to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice.

41GN  Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:

                     (a)  medical devices that were devices of that kind when the kind of device was included in the Register have changed so those medical devices are no longer devices of that kind; or

                     (b)  the person in relation to whom the kind of medical device is included in the Register refuses or fails to comply with a condition to which that inclusion is subject; or

                     (c)  the Secretary gives to the person a notice under section 41JA:

                              (i)  that requires the person to give to the Secretary information or documents relating to the kind of device; and

                             (ii)  in respect of which section 41GM does not apply;

                            and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or

                     (d)  the person contravenes subsection 41MP(1) or 41MPA(1) in relation to the kind of device; or

                     (e)  the Secretary is satisfied that the safety or performance of the kind of device is unacceptable; or

                      (f)  the Secretary is satisfied that any certification, or part of a certification, under section 41FD in relation to the application for inclusion of the kind of device in the Register is incorrect, or is no longer correct, in a material particular.

Note:       The matters that must be certified under section 41FD include compliance with the essential principles and the application of conformity assessment procedures, being able to substantiate the compliance and application, and compliance with advertising requirements.

             (2)  However, before cancelling the entry of the kind of device from the Register, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the cancellation and set out the reasons for it; and

                     (b)  give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed cancellation.

             (3)  The Secretary is not to make a decision relating to the proposed cancellation until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

41GO  Limiting cancellation of entries from Register to some medical devices of a particular kind

             (1)  If the Secretary is satisfied that the ground for cancelling the entry of a kind of medical device from the Register applies only to some medical devices of that kind, the Secretary must limit the cancellation to the medical devices to which that ground or any other ground for cancellation applies.

             (2)  If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind, the Secretary:

                     (a)  must vary the entry in the Register accordingly; and

                     (b)  must not delete the entry from the Register because of the cancellation.

41GP  Publication of cancellation of entry from Register

                   The Secretary must cause to be published in the Gazette, as soon as practicable after cancelling an entry from the Register of a kind of medical device, or of some devices of a particular kind, a notice setting out particulars of the cancellation.

41GQ  Date of effect of cancellation of entries from Register

                   If the Secretary cancels an entry of a kind of medical device, or some devices of a particular kind, from the Register, the cancellation has effect:

                     (a)  if the cancellation is under section 41GK or 41GL—on the day on which the notice of cancellation is given to the person in relation to whom the kind of device was included in the Register; or

                     (b)  in any other case—on such later day as is specified in the notice, being a day not earlier than 20 working days after the notice is given to the person.


 

Part 4‑6AExempting medical devices to deal with emergencies

  

41GR  What this Part is about

The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies.

Note 1:       There are offences and civil penalty provisions related to the making of exemptions under this Part: see Division 3A of Part 4‑11.

Note 2:       Some of the other provisions of this Act about medical devices exempt under this Part are:

(a)           section 41JCA (providing information to the Secretary); and

(b)           section 41KA (public notification and recovery of medical devices); and

(c)           section 46A (search of premises).

41GS  Minister may make exemptions

             (1)  The Minister may, by writing, exempt specified kinds of medical devices from the operation of the following:

                     (a)  Division 1 of Part 4‑2 (essential principles);

                     (b)  Division 1 of Part 4‑3 (conformity assessment procedures);

                     (c)  Part 4‑4 (conformity assessment certificates);

                     (d)  Part 4‑5 (including medical devices in the Register).

             (2)  The Minister may make an exemption under subsection (1) only if the Minister is satisfied that, in the national interest, the exemption should be made so that:

                     (a)  the devices may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or

                     (b)  the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.

Period of exemption

             (3)  An exemption under subsection (1) comes into force:

                     (a)  on the day the exemption is made; or

                     (b)  on a later day specified in the exemption.

             (4)  An exemption under subsection (1) remains in force for the period specified in the exemption, unless revoked earlier.

Note:          Section 41GU deals with variation and revocation of the exemption.

Effect of inclusion of kind of medical device in the Register

             (5)  An exemption under subsection (1) ceases to have effect in relation to a particular kind of medical device when that kind of medical device becomes included in the Register under Part 4‑5.

Exemption not a legislative instrument

             (6)  An exemption under subsection (1) is not a legislative instrument.

Disregard section 41BE

             (7)  For the purposes of this Act, disregard section 41BE in working out the kinds of medical devices covered by an exemption under subsection (1) of this section.

41GT  Conditions of exemptions

                   An exemption under section 41GS is subject to conditions specified in the exemption about any of the following:

                     (a)  the quantity of medical devices that are exempt;

                     (b)  the source of those medical devices;

                     (c)  the persons or class of persons who may import, manufacture, supply or export those medical devices;

                     (d)  the supply of those medical devices (including the persons or class of persons to whom medical devices may be supplied for use and the circumstances under which a stockpile of medical devices may be supplied for use);

                     (e)  the storage and security of those medical devices;

                      (f)  the keeping and disclosure of, and access to, records about those medical devices;

                     (g)  the disposal of those medical devices;

                     (h)  the manner in which any of those medical devices are to be dealt with if a condition of the exemption is breached;

                      (i)  any other matters that the Minister thinks appropriate.

Whether or not medical devices are exempt under section 41GS is not affected by whether or not there is a breach of a condition under this section in relation to those medical devices.

Note 1:       There are offences and civil penalty provisions related to the breach of a condition of an exemption: see Division 3A of Part 4‑11.

Note 2:       Section 41GU deals with variation and revocation of the conditions.

41GU  Variation or revocation of exemption

Variation of exemption

             (1)  The Minister may, by writing, vary an exemption made under section 41GS by removing specified kinds of medical devices from the exemption.

Revocation of exemption

             (2)  The Minister may, by writing, revoke an exemption made under section 41GS.

Variation or revocation of conditions

             (3)  The Minister may, by writing:

                     (a)  vary the conditions of an exemption made under section 41GS (including by imposing new conditions); or

                     (b)  revoke the conditions of an exemption made under section 41GS.

When variation or revocation takes effect

             (4)  A variation or revocation under this section takes effect:

                     (a)  if the Minister states in the variation or revocation that the variation or revocation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day the variation or revocation is made; or

                     (b)  in any other case—on a later day specified in the variation or revocation (which must not be earlier than 28 days after the day the variation or revocation is made).

41GV  Informing persons of exemption etc.

                   If the Minister makes an exemption under section 41GS, the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph 41GT(c):

                     (a)  the exemption;

                     (b)  any variation or revocation of the exemption under section 41GU.

41GW  Notification and tabling

Notification

             (1)  The Secretary must cause a notice setting out particulars of the following:

                     (a)  an exemption made under section 41GS because of paragraph 41GS(2)(b);

                     (b)  a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b);

to be published in the Gazette within 5 working days after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.

Tabling

             (2)  The Minister must cause a document setting out particulars of the following:

                     (a)  an exemption made under section 41GS because of paragraph 41GS(2)(b);

                     (b)  a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b);

to be tabled in each House of the Parliament within 5 sitting days of that House after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.

41GY  Disposal of unused medical devices

             (1)  This section applies to a medical device if:

                     (a)  an exemption under section 41GS in relation to that kind of medical device ceases to have effect otherwise than because that kind of medical device becomes included in the Register under Part 4‑5; and

                     (b)  the medical device has not been used before the exemption so ceases to have effect.

             (2)  The Secretary may arrange for the disposal of the medical device in accordance with the regulations.

             (3)  Regulations made for the purposes of subsection (2) may set out the methods by which the medical device is to be stored, supplied, destroyed, exported or otherwise disposed of.

             (4)  A method set out in the regulations under subsection (3) must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.


 

Part 4‑7Other exemptions from including medical devices in the Register

  

41H  What this Part is about

In addition to Part 4‑6A, there are 3 other kinds of exemptions from the prohibitions in Division 3 of Part 4‑11 on dealing in medical devices that are not included in the Register:

               (a)     medical devices exempted under the regulations;

               (b)     approval for medical devices to be used for special treatment of individuals or for experimental purposes;

               (c)     authorisation of particular medical practitioners to supply specified medical devices.

41HA  Devices exempted from inclusion in the Register

             (1)  The regulations may exempt from the operation of Division 3 of Part 4‑11:

                     (a)  all medical devices, except those medical devices of the kinds prescribed for the purposes of this paragraph; or

                     (b)  specified kinds of medical devices.

Note:          Division 3 of Part 4‑11 contains offences and civil penalty provisions relating to dealing in medical devices that are not included in the Register.

             (2)  An exemption may be subject to conditions that are prescribed in the regulations.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

             (3)  An exemption under paragraph (1)(a) has effect only for classes of persons prescribed in the regulations for the purposes of this subsection.

             (4)  If the regulations revoke an exemption, the revocation takes effect on the day specified. The day must not be earlier than 20 working days after the day on which the regulations are made.

41HB  Exemptions for special and experimental uses

             (1)  The Secretary may grant a written approval to a person for:

                     (a)  the importation into Australia; or

                     (b)  the exportation from Australia; or

                     (c)  the supply in Australia;

of a specified medical device or kind of medical device (other than medical devices included in the Register or exempt devices):

                     (d)  for use in the treatment of another person; or

                     (e)  for use solely for experimental purposes in humans.

             (2)  The approval may be given subject to conditions specified in the approval, including a condition relating to charging for medical devices of the kinds in question.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

             (3)  In addition, the regulations may prescribe conditions that apply to a person’s approval to use specified kinds of medical devices solely for experimental purposes in humans. The conditions may relate to one or more of the following:

                     (a)  the preconditions on another person’s use of devices of those kinds for those purposes;

                     (b)  the principles to be followed in another person’s use of devices of those kinds for those purposes;

                     (c)  the monitoring of another person’s use, and the results of that use, of devices of those kinds for those purposes;

                     (d)  the circumstances in which that other person must cease using devices of those kinds for those purposes.

             (4)  An application to use specified medical devices in the treatment of another person must be accompanied by any information about the devices that is required by the Secretary.

             (5)  An application to use specified kinds of medical devices solely for experimental purposes in humans must:

                     (a)  be made in writing; and

                     (b)  be accompanied by any information about the kinds of devices that is required by the Secretary; and

                     (c)  be accompanied by the prescribed fee.

             (6)  The Secretary must:

                     (a)  consider any application under this section; and

                     (b)  assess any information submitted with the application; and

                     (c)  notify the applicant, within 20 working days of making the decision:

                              (i)  of the decision; and

                             (ii)  in the case of a decision not to grant the approval—of the reasons for the decision.

             (7)  The use by a person for experimental purposes in humans of specified kinds of medical devices that are the subject of an approval granted to someone else under paragraph (1)(e) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

                     (a)  the preconditions on the use of devices of those kinds for those purposes;

                     (b)  the principles to be followed in the use of devices of those kinds for those purposes;

                     (c)  the monitoring of the use, and the results of the use, of devices of those kinds for those purposes;

                     (d)  the circumstances in which the person must cease the use of devices of those kinds for those purposes.

Note:          Breach of the conditions may be an offence: see subsection 41MN(9).

41HC  Exemptions for medical practitioners

             (1)  The Secretary may authorise, in writing, a specified medical practitioner to supply specified kinds of medical devices for use in the treatment of humans to a specified class of recipients.

             (2)  An authority may be given subject to conditions specified in the authority.

             (3)  The Secretary may impose conditions (or further conditions) on a person’s authority by giving the person written notice of the conditions.

             (4)  An authority may only be given:

                     (a)  to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and

                     (b)  to a medical practitioner who has the approval of an ethics committee to supply the specified kinds of medical devices or the specified class of such devices; and

                     (c)  in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph.

However, the regulations may prescribe exceptional circumstances in which paragraph (b) does not apply.

             (5)  The regulations may prescribe circumstances in which medical devices may be supplied under an authority.

             (7)  In this section:

medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.


 

Part 4‑8Obtaining information

  

41J  What this Part is about

The Secretary may seek information or documents relating to:

•      the application of conformity assessment procedures;

•      compliance with the essential principles;

•      compliance with other requirements;

•      distribution of, and other matters relating to, medical devices covered by exemptions under Part 4‑6A or Part 4‑7.

Note:          There are additional obligations relating to notifying defects in medical devices: see sections 41MP, 41MPA, 41MQ and 41MR.

Division 1Information relating to compliance with requirements and other matters

41JA  Secretary may require information

             (1)  The Secretary may, by written notice given to a person:

                     (a)  who is an applicant for a conformity assessment certificate that would relate to a kind of medical device; or

                     (b)  who holds a conformity assessment certificate that relates to a kind of medical device; or

                    (ba)  who held, at any time during the notice period under subsection (2), a conformity assessment certificate that related to a kind of medical device; or

                     (c)  who is an applicant for the inclusion of a kind of medical device in the Register; or

                     (d)  in relation to whom a kind of medical device is included in the Register; or

                    (da)  in relation to whom a kind of medical device was, at any time during the notice period under subsection (2), included in the Register;

require the person to give to the Secretary information or documents, relating to devices of that kind, that are relevant to one or more of the following:

                     (e)  whether the devices comply with the essential principles;

                      (f)  whether the conformity assessment procedures have been applied to the devices;

                     (g)  whether the devices comply with conditions (if any) imposed on a conformity assessment certificate issued in respect of the device or the inclusion of the device in the Register;

                     (h)  whether the devices comply with every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations;

                      (i)  if the kind of medical device is included in the Register in relation to the person—whether medical devices of that kind are being:

                              (i)  supplied in Australia; or

                             (ii)  imported into Australia; or

                            (iii)  exported from Australia;

                     (ia)  the safety and efficacy of the devices for the purposes for which they are to be used;

                     (ib)  the regulatory history of the devices in another country;

                      (j)  any other matter prescribed by the regulations for the purposes of this paragraph.

       (1AA)  If a notice is given under subsection (1) to a person covered by paragraph (1)(ba), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the person held the certificate.

        (1AB)  If a notice is given under subsection (1) to a person covered by paragraph (1)(da), then paragraphs (1)(e) to (j) (to the extent to which they are relevant) apply in relation to the period the kind of medical device was included in the Register.

          (1A)  The Secretary may, by written notice given to a person who is an applicant for a conformity assessment certificate, require the person to give to the Secretary such further information concerning the application as is specified in the notice.

          (1B)  Requirements under subsections (1) and (1A) may be included in the same notice.

          (1C)  The Secretary may, by written notice given to a person who holds a conformity assessment certificate, require the person to give to the Secretary specified information to be used by the Secretary in deciding whether to suspend the certificate under section 41EM, or to revoke the certificate under section 41ET, in relation to the circumstances referred to in paragraph 41ET(1)(e).

          (1D)  Requirements under subsections (1) and (1C) may be included in the same notice.

             (2)  For the purposes of paragraphs (1)(ba) and (da), the notice period is the period:

                     (a)  of the length specified in the regulations; and

                     (b)  ending on the day before the Secretary gives the notice under subsection (1).

             (3)  Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

41JB  Complying with the Secretary’s requirements

             (1)  The person must give the information or documents to the Secretary:

                     (a)  within such reasonable time, being not less than 10 working days from the day on which the notice is given, as is specified in the notice; and

                     (b)  in such form as is specified in the notice.

             (2)  The form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

Offence for failing to comply with a notice

             (3)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

Note:          Failure to comply with the notice might also lead to suspension or revocation of a conformity assessment certificate (see Divisions 3 and 4 of Part 4‑4) or suspension or cancellation of the entry of a kind of medical device in the Register (see Part 4‑6).

Offences for giving false or misleading information in purported compliance with a notice

             (4)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA in relation to a kind of medical device; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the kind of medical device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the kind of medical device, if the kind of medical device were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (7) instead: see section 53A.

             (5)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA in relation to a kind of medical device; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular; and

                     (d)  the use of the kind of medical device, if the kind of medical device were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (6)  Subsection (5) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (7)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

41JBA  Civil penalty for giving false or misleading information in purported compliance with a notice

                   A person contravenes this section if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person gives information in purported compliance with the notice; and

                     (c)  the information is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41JC  Self‑incrimination

             (1)  A person is not excused from giving information or a document under section 41JB on the ground that to do so would tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given; or

                     (b)  the giving of the document; or

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or document;

is not admissible in evidence in:

                     (d)  criminal proceedings against the individual, except proceedings under, or arising out of, subsection 41JB(4), (5) or (7); or

                     (e)  proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision, except civil proceedings under, or arising out of, section 41JBA.


 

Division 2Information relating to medical devices covered by exemptions

41JCA  Secretary may require information etc. about medical devices exempt under Part 4‑6A

             (1)  This section applies to a person who is required to comply with a condition of an exemption of a kind of medical device under section 41GS.

             (2)  The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of that kind;

                     (b)  the handling of devices of that kind;

                     (c)  the monitoring of the supply of devices of that kind;

                     (d)  the results of the supply of devices of that kind;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of that kind.

             (3)  The notice must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (4)  The notice may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JD  Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register

             (1)  The Secretary may give the sponsor of kinds of medical devices exempted under subsection 41HA(1) from Division 3 of Part 4‑11, a written notice requiring the sponsor to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of those kinds;

                     (b)  the handling of devices of those kinds;

                     (c)  the monitoring of the supply of devices of those kinds;

                     (d)  the results of the supply of devices of those kinds;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

             (2)  If a medical device is exempt under subsection 41HA(1) because a medical practitioner has signed a statement in accordance with regulations made for the purposes of this section, the Secretary may give the medical practitioner a written notice requiring the medical practitioner to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the condition of the person to whom the medical device is to be given or is given;

                     (b)  the supply of the device;

                     (c)  the handling of the device;

                     (d)  the monitoring of the supply of the device;

                     (e)  the results of the supply of the device;

                      (f)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to medical devices of that kind.

             (3)  A notice under this section must specify a reasonable period within which the person must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (4)  A notice under this section may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JE  Secretary may require information relating to approvals under section 41HB

Approval under subsection 41HB(1)

             (1)  The Secretary may give to a person granted an approval under subsection 41HB(1) (special and experimental uses), in relation to specified kinds of medical devices, a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of those kinds;

                     (b)  the handling of devices of those kinds;

                     (c)  the monitoring of the supply of devices of those kinds;

                     (d)  the results of the supply of devices of those kinds;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

Approval under subsection 41HB(1)—use by another person

             (2)  The Secretary may give to a person using specified kinds of medical devices, that are the subject of an approval granted to someone else under paragraph 41HB(1)(e) (use solely for experimental purposes in humans), a written notice requiring the person to give to the Secretary specified information or documents relating to either of both of the following:

                     (a)  the use of devices of those kinds;

                     (b)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

Compliance period

             (3)  A notice under this section must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given.

Information may need to be given in accordance with specified software requirements

             (4)  A notice under this section may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JF  Secretary may require information relating to authorities under section 41HC

             (1)  The Secretary may give to a person who is granted an authority under section 41HC (exemptions for medical practitioners), in relation to specified kinds of medical devices, a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

                     (a)  the supply of devices of those kinds;

                     (b)  the handling of devices of those kinds;

                     (c)  the monitoring of the supply of devices of those kinds;

                     (d)  the results of the supply of devices of those kinds;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

             (2)  The notice must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given.

             (3)  The notice may require information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

41JG  Criminal offences for failing to give information or documents sought under this Division

                   A person commits an offence if:

                     (a)  the person is given a notice under section 41JCA, 41JD, 41JE or 41JF; and

                     (b)  the person fails to comply with the notice.

Penalty:  400 penalty units.

Note:          The privilege against self incrimination is not a reasonable excuse for the purposes of this section. However, section 41JJ limits the use in prosecutions of information etc. obtained under sections 41JCA, 41JD, 41JE and 41JF.

41JH  False or misleading information

                   A person to whom a notice is given under section 41JCA, 41JD, 41JE or 41JF is guilty of an offence if:

                     (a)  the person gives information to the Secretary; and

                     (b)  the person knows that the information:

                              (i)  is false or misleading; or

                             (ii)  omits any matter or thing without which the information is misleading; and

                     (c)  the information is given in compliance or purported compliance with the notice.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

41JI  False or misleading documents

             (1)  A person is guilty of an offence if:

                     (a)  the person produces a document to the Secretary; and

                     (b)  the person knows that the document is false or misleading; and

                     (c)  the document is produced in compliance or purported compliance with a notice given under section 41JCA, 41JD, 41JE or 41JF.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (2)  Subsection (1) does not apply to a person who produces a document if the document is accompanied by a written statement signed by the person or, in the case of a body corporate, by a competent officer of the body corporate:

                     (a)  stating that the document is, to the knowledge of the first‑mentioned person, false or misleading in a material particular; and

                     (b)  setting out, or referring to, the material particular in which the document is, to the knowledge of the first‑mentioned person, false or misleading.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (2) (see subsection 13.3(3) of the Criminal Code).

41JJ  Self‑incrimination

             (1)  A person is not excused from giving information or a document under a notice given under section 41JCA, 41JD, 41JE or 41JF on the ground that to do so would tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given; or

                     (b)  the giving of the document; or

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or document;

is not admissible in evidence in:

                     (d)  criminal proceedings against the individual, except proceedings under, or arising out of, section 41JH or 41JI; or

                     (e)  proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision.


 

Part 4‑9Public notification and recovery of medical devices

  

41K  What this Part is about

The Secretary can require action to recover medical devices, or to inform the public about medical devices, that do not comply with requirements or cannot lawfully be supplied.

41KA  Public notification and recovery of medical devices

             (1)  The Secretary may, in writing, impose requirements, relating to a kind of medical device, on a person if:

                     (a)  any of the circumstances referred to in the second column of an item in the following table occur in relation to the kind of device; and

                     (b)  the person is referred to in the third column of that item of the table.

 

Circumstances in which requirements may be imposed

Item

Circumstance relating to a kind of medical device

Person subject to requirements

1.

It is supplied while it is included in the Register, but medical devices of that kind do not comply with the essential principles

The person in relation to whom it is included in the Register

2.

It is supplied while it is included in the Register, but the conformity assessment procedures have not been applied to medical devices of that kind

The person in relation to whom it is included in the Register

3.

It is supplied while:

(a) medical devices of that kind are exempt devices; or

(b) there is an approval under section 41HB relating to devices of that kind; or

(c) there is an authority under section 41HC relating to devices of that kind;

but medical devices of that kind do not comply with the essential principles

The person supplying the kind of medical device

4.

It is supplied while:

(a) medical devices of that kind are exempt devices; or

(b) there is an approval under section 41HB relating to devices of that kind; or

(c) there is an authority under section 41HC relating to devices of that kind;

but the conformity assessment procedures have not been applied to medical devices of that kind

The person supplying the kind of medical device

5.

It is supplied while:

(a) it is not included in the Register; and

(aa) it is not covered by an exemption in force under section 41GS; and

(b) it is not an exempt device; and

(c) there is not an approval under section 41HB relating to devices of that kind; and

(d) there is not an authority under section 41HC relating to devices of that kind.

The person supplying the kind of medical device

5A.

It is supplied while it is covered by an exemption in force under section 41GS, and the Secretary is satisfied that it is not fit to be used for its intended purpose

The person supplying the kind of medical device

5B.

It is supplied while it is included in the Register, but it appears to the Secretary that the quality, safety or performance of medical devices of that kind is unacceptable

The person in relation to whom the kind of medical device is included in the Register

6.

It has been suspended from the Register

The person in relation to whom it was included in the Register

7.

Its entry has been cancelled from the Register

The person in relation to whom it was included in the Register

             (2)  The requirements may be one or both of the following:

                     (a)  to take specified steps, in the specified manner and within such reasonable period as is specified, to recover medical devices of that kind that have been distributed;

                     (b)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to medical devices of that kind.

             (3)  If the circumstances referred to in paragraph (1)(a) apply only to some medical devices of that kind, the Secretary may limit the imposition of the requirements to the medical devices of that kind to which those circumstances apply.

             (4)  A requirement to recover medical devices under this section does not apply to a medical device that cannot be recovered because it has been administered to, or applied in the treatment of, a person.

41KB  Publication of requirements

                   The Secretary must cause to be published in the Gazette, as soon as practicable after imposing a requirement under section 41KA, a notice setting out particulars of the requirement.

41KC  Criminal offences for failing to comply with requirements relating to a kind of medical device

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 41KA; and

                     (c)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 41KA; and

                     (c)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 41KA.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

41KCA  Civil penalty for failing to comply with requirements relating to a kind of medical device

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission contravenes a requirement imposed on the person under section 41KA.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41KD  Powers of suspension and cancellation unaffected

                   Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:

                     (a)  suspend the entry of a kind of medical device, or some medical devices of a particular kind, from the Register under Part 4‑6; or

                     (b)  cancel the entry of a kind of medical device, or some medical devices of a particular kind, in the Register under Part 4‑6.


 

Part 4‑10Assessment fees

  

41L  What this Part is about

Conformity assessment fees must be paid for consideration of applications for conformity assessment certificates. Application audit assessment fees must be paid for auditing applications that are required to be selected for auditing under paragraph 41FH(1)(a).

41LA  Assessment fees

             (1)  A conformity assessment fee specified in or determined in accordance with the regulations is payable by a person in respect of consideration of an application for a conformity assessment certificate under Part 4‑4.

             (2)  The regulations may prescribe different levels of conformity assessment fees in relation to any one or more of the following:

                     (a)  different kinds of manufacturers;

                     (b)  different kinds of medical devices;

                     (c)  different parts of the conformity assessment procedures that are considered in relation to an application for a conformity assessment certificate under Part 4‑4.

             (3)  An application audit assessment fee specified in or determined in accordance with the regulations is payable by a person in respect of the auditing of an application for inclusion of a kind of medical device in the Register under Part 4‑5, if paragraph 41FH(1)(a) required the Secretary to select the application for audit.

             (4)  The regulations may prescribe different levels of application audit assessment fees in relation to any one or more of the following:

                     (a)  different kinds of manufacturers;

                     (b)  different kinds of medical devices;

                     (c)  different levels of assessment of kinds of medical devices.

             (5)  The application audit assessment fee payable because of subsection (3) is payable only in respect of considering the matters set out in subsection 41FI(1).

41LB  When assessment fee due for payment

                   Subject to sections 41LC and 41LE, an assessment fee payable by an applicant is due and payable on the day, and in the manner, specified in the regulations.

41LC  Payment of assessment fee by instalments

             (1)  The regulations may provide for the payment of an assessment fee to be made by such instalments and at such times as are ascertained in accordance with the regulations, and the assessment fee is due and payable accordingly.

             (2)  Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an assessment fee by instalments if any part of an instalment of:

                     (a)  that or any other assessment fee payable by the person; or

                     (b)  any evaluation fee under section 24 payable by the person;

was unpaid immediately after the time when it became due for payment.

             (3)  Subsection (2) does not limit the generality of subsection (1).

41LD  Recovery of assessment fee

                   An assessment fee may be recovered by the Commonwealth as a debt due to the Commonwealth.

41LE  Reduction of conformity assessment fee where decision not made within prescribed period

             (1)  Nothing in section 41LA, 41LB or 41LC requires the applicant to pay more than 3/4 of the conformity assessment fee before the making of the decision if:

                     (a)  the application is for the issuing of a conformity assessment certificate under Part 4‑4; and

                     (b)  consideration of the application will involve an examination of the design of medical devices; and

                     (c)  a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.

             (2)  If the decision is not made within that period, the conformity assessment fee is 3/4 of the fee that, apart from this subsection, would have been the conformity assessment fee.

             (3)  If:

                     (a)  the decision is made within that period; and

                     (b)  part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;

that part becomes due and payable on the making of the decision.

             (4)  For the purposes of this section, a decision is taken to be made on the application when the applicant is notified under subsection 41EE(1) of the Secretary’s decision on the application.


 

Part 4‑11Offences and civil penalty provisions relating to medical devices

  

41M  What this Part is about

This Part contains offences and civil penalty provisions that are aimed at ensuring that:

•      the essential principles are complied with (see Division 1);

•      the conformity assessment procedures have been applied to kinds of medical devices (see Division 2);

•      administrative processes put in place by Parts 4‑4 to 4‑9 are followed (see Divisions 3, 3A and 4).

Note:          There are also some offences and civil penalty provisions in the earlier Parts of this Chapter. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications).

Division 1Non‑compliance with essential principles

41MA  Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles

Offences relating to importing a medical device

             (1)  A person commits an offence if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the device does not comply with the essential principles.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the device does not comply with the essential principles.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to supplying a medical device

             (5)  A person commits an offence if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if device were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the device does not comply with the essential principles.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the device does not comply with the essential principles.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (8)  A person commits an offence if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to exporting a medical device

             (9)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the exportation; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the device does not comply with the essential principles.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (12) instead: see section 53A.

           (10)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the exportation; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the device does not comply with the essential principles.

Penalty:  2,000 penalty units.

           (11)  Subsection (10) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

           (12)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the exportation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Exception

           (13)  Paragraphs (9)(b), (10)(b) and (12)(b) do not apply to the extent that the essential principles in question relate to labelling medical devices for supply in Australia.

Note:          A defendant bears an evidential burden in relation to the matters in this subsection: see subsection 13.3(3) of the Criminal Code.

41MAA  Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles

Civil penalty relating to importing a medical device

             (1)  A person contravenes this subsection if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to supplying a medical device

             (2)  A person contravenes this subsection if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to exporting a medical device

             (3)  A person contravenes this subsection if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the exportation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41MB  Exceptions

             (1)  Sections 41MA and 41MAA do not apply if:

                     (a)  the medical device complies with one or more medical device standards that apply to it; and

                     (b)  the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles to which that medical device standard, or one or more of those medical device standards, relate.

Note:          Medical device standards are determined under Division 2 of Part 4‑2.

             (2)  For the purposes of this section, a medical device standard relates to a part or parts of the essential principles only if the standard specifies that part or parts.

Note 1:       In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).

Note 2:       In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.

41MC  Criminal offences relating to breaching a condition of a consent

             (1)  The consent of the Secretary under section 41MA or 41MAA may be given:

                     (a)  unconditionally or subject to conditions; or

                     (b)  in respect of particular medical devices or kinds of medical devices.

             (2)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent; and

                     (c)  the act or omission has resulted, or will result in, harm or injury to any person.

Penalty:  2,000 penalty units.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

             (3)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent; and

                     (c)  the act or omission is likely to result in harm or injury to any person.

Penalty:  1,000 penalty units.

             (4)  Subsection (3) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent.

Penalty:  500 penalty units.

41MCA  Civil penalty relating to breaching a condition of a consent

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a condition of a consent imposed under section 41MC.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

41MD  Treating medical devices as prohibited imports or exports

                   If:

                     (a)  the importation or exportation of a medical device is an offence under subsection 41MA(1), (2), (4), (9), (10) or (12) or a contravention of subsection 41MAA(1) or (3); and

                     (b)  the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the device included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:

                     (c)  prohibited imports within the meaning of that Act; or

                     (d)  prohibited exports within the meaning of that Act;

as the case requires.


 

Division 2Failure to apply conformity assessment procedures

41ME  Criminal offences for failing to apply conformity assessment procedures—manufacturers

Offences relating to supplying a medical device

             (1)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the conformity assessment procedures have not been applied to the device.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to exporting a medical device

             (5)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the conformity assessment procedures have not been applied to the device.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (8)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

41MEA  Civil penalties for failing to apply conformity assessment procedures—manufacturers

Civil penalty relating to supplying a medical device

             (1)  A person contravenes this subsection if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  the person has manufactured the device; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Civil penalty relating to exporting a medical device

             (2)  A person contravenes this subsection if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the person has manufactured the device; and

                     (c)  the conformity assessment procedures have not been applied to the device; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41MF  Criminal offences for failing to apply conformity assessment procedures—sponsors

Offences relating to supplying a medical device

             (1)  A person commits an offence if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                    (ba)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (c)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (d)  the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                     (c)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to exporting a medical device

             (3)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                    (ba)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (c)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (d)  the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (4)  A person commits an offence if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the conformity assessment procedures have not been applied to the device; and

                     (c)  the device is not of a kind covered by an exemption in force under section 41GS.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Exception

             (5)  This section does not apply if the defendant was not the sponsor of the device at the time of the supply or exportation, as the case may be.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.

41MG  Exceptions

             (1)  Sections 41ME, 41MEA and 41MF do not apply to the extent that:

                     (a)  the quality management systems applied to the medical device comply with one or more conformity assessment standards that apply to them; and

                     (b)  the conformity assessment procedures have not been applied to the device only in respect of a part or parts of the conformity assessment procedures to which one or more of those conformity assessment standards relate.

Note:          Conformity assessment standards are determined under Division 2 of Part 4‑3.

             (2)  For the purposes of this section, a conformity assessment standard relates to a part or parts of the conformity assessment procedures only if the standard specifies that part or parts.

Note 1:       In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).

Note 2:       In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.

41MH  Criminal offence for making false statements in declarations

                   A person is guilty of an offence if:

                     (a)  the person makes a statement in or in connection with a declaration, relating to the application of conformity assessment procedures to a medical device that the person has manufactured; and

                     (b)  the statement is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

41MHA  Civil penalty for making false statements in declarations

                   A person contravenes this section if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person makes a statement in or in connection with a declaration relating to the application of conformity assessment procedures to the device; and

                     (c)  the statement is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.


 

Division 3Medical devices not included in the Register and related matters

41MI  Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register

             (1)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports a medical device into Australia; or

                             (ii)  exports a medical device from Australia; or

                            (iii)  supplies a medical device in Australia; or

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC; and

                     (c)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports a medical device into Australia; or

                             (ii)  exports a medical device from Australia; or

                            (iii)  supplies a medical device in Australia; or

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC; and

                     (c)  the use of the device, if the device were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports a medical device into Australia; or

                             (ii)  exports a medical device from Australia; or

                            (iii)  supplies a medical device in Australia; or

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (5)  Strict liability applies to paragraph (4)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

Defence if person was not the sponsor of the goods

             (6)  It is a defence to a prosecution under subsection (1), (2) or (4) if the defendant proves that the defendant was not the sponsor of the device at the time of the importation, exportation, supply, or manufacture, as the case may be.

Note:          A defendant bears a legal burden in relation to the matters in subsection (6): see section 13.4 of the Criminal Code.

Exception

             (7)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, or will not, directly result from:

                              (i)  the quality, safety or performance of the medical device; or

                             (ii)  a matter relating to the labelling or packaging of the medical device; or

                            (iii)  the improper use of the medical device; or

                     (b)  harm or injury would not directly result from:

                              (i)  the quality, safety or performance of the medical device; or

                             (ii)  a matter relating to the labelling or packaging of the medical device; or

                            (iii)  the improper use of the medical device.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (7): see subsection 13.3(3) of the Criminal Code.

41MIA  Notice required to adduce evidence in support of exception under subsection 41MI(7)

             (1)  If:

                     (a)  a defendant is committed for trial for an offence against subsection 41MI(1); or

                     (b)  an offence against subsection 41MI(1) is to be heard and determined by a court of summary jurisdiction;

the committing magistrate or the court must:

                     (c)  inform the defendant of the requirements of this section; and

                     (d)  cause a copy of this section to be given to the defendant.

             (2)  A defendant must not, without leave of the court, adduce evidence in support of the exception under subsection 41MI(7) unless:

                     (a)  if paragraph (1)(a) applies—more than 21 days before the trial begins; or

                     (b)  if paragraph (1)(b) applies—more than 21 days before the hearing of the offence begins;

he or she gives notice of particulars of the exception.

             (3)  A defendant must not, without leave of the court, call any other person to give evidence in support of the exception unless:

                     (a)  the notice under subsection (2) includes the name and address of the person or, if the name and address is not known to the defendant at the time he or she gives the notice, any information in his or her possession that might be of material assistance in finding the person; and

                     (b)  if the name or the address is not included in the notice—the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address; and

                     (c)  if the name or address is not included in the notice, but the defendant subsequently ascertains the name or address or receives information that might be of material assistance in finding the person—the defendant immediately gives notice of the name, address or other information, as the case may be; and

                     (d)  if the defendant is told by or on behalf of the prosecutor that the person has not been found by the name, or at the address, given by the defendant:

                              (i)  the defendant immediately gives notice of any information in the defendant’s possession that might be of material assistance in finding the person; or

                             (ii)  if the defendant later receives any such information—the defendant immediately gives notice of the information.

             (4)  A notice purporting to be given under this section on behalf of the defendant by his or her legal practitioner is, unless the contrary is proved, taken as having been given with the authority of the defendant.

             (5)  Any evidence tendered to disprove that the exception applies may, subject to direction by the court, be given before or after evidence is given in support of the exception.

             (6)  A notice of particulars of the exception must be given, in writing, to the Director of Public Prosecutions. A notice is taken as having been given if it is:

                     (a)  delivered to or left at the Office of the Director of Public Prosecutions; or

                     (b)  sent by certified mail addressed to the Director of Public Prosecutions at the Office of the Director of Public Prosecutions.

             (7)  In this section:

Director of Public Prosecutions means a person holding office as, or acting as, the Director of Public Prosecutions under the Director of Public Prosecutions Act 1983.

41MIB  Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register

             (1)  A person contravenes this section if:

                     (a)  the person does any of the following:

                              (i)  imports a medical device into Australia;

                             (ii)  exports a medical device from Australia;

                            (iii)  supplies a medical device in Australia;

                            (iv)  manufactures a medical device in Australia; and

                     (b)  none of the following subparagraphs apply in relation to the device:

                              (i)  the device is of a kind included in the Register in relation to the person;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Exception

             (2)  Subsection (1) does not apply if the defendant proves that the defendant was not the sponsor of the device at the time of the importation, exportation, supply, or manufacture, as the case may be.

41MJ  Treating medical devices as prohibited imports or exports

                   If:

                     (a)  the importation or exportation of a medical device is an offence under subsection 41MI(1), (2) or (4) or a contravention of section 41MIB; and

                     (b)  the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

the Customs Act 1901 has effect as if the device included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:

                     (c)  prohibited imports within the meaning of that Act; or

                     (d)  prohibited exports within the meaning of that Act;

as the case requires.

41MK  Wholesale supply of medical devices not included in the Register

                   A person is guilty of an offence if:

                     (a)  the person supplies a medical device in Australia; and

                     (b)  none of the following subparagraphs applies in relation to the device:

                              (i)  the device is of a kind included in the Register;

                            (ia)  the device is of a kind covered by an exemption in force under section 41GS;

                             (ii)  the device is an exempt device;

                            (iii)  the device is the subject of an approval under section 41HB or an authority under section 41HC; and

                     (c)  the person to whom the device is supplied is not the ultimate consumer of the device.

Penalty:  120 penalty units.

41ML  False advertising about medical devices

                   A person commits an offence if:

                     (a)  the person, by any means, advertises a medical device as being for a purpose; and

                     (b)  the device is of a kind included in the Register; and

                     (c)  the purpose is not a purpose accepted in relation to that inclusion.

Penalty:  60 penalty units.

41MLA  Civil penalty for making misrepresentations about medical devices

             (1)  A person contravenes this section if:

                     (a)  the person makes a representation of a kind referred to in subsection (2); and

                     (b)  the representation is false or misleading.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

             (2)  Subsection (1) applies to the following representations:

                     (a)  representations that medical devices are of a kind included in the Register;

                     (b)  representations that medical devices are exempt devices;

                     (c)  representations that medical devices are the subject of an approval under section 41HB or an authority under section 41HC.

41MM  Claims about arranging supplies of medical devices not included in the Register

                   A person is guilty of an offence if:

                     (a)  the person claims, by any means, that the person or another person can arrange the supply of medical devices; and

                     (b)  the devices are not:

                              (i)  medical devices of a kind included in the Register; or

                             (ii)  exempt devices.

Penalty:  60 penalty units.

41MN  Criminal offences relating to breaches of conditions

Offences relating to breaching a condition of the inclusion of a kind of medical device in the Register

             (1)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register; and

                     (d)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register; and

                     (d)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to breaching a condition of a conformity assessment certificate

             (5)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate; and

                     (d)  the act or omission has resulted in, or will result in, harm or injury to a person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate; and

                     (d)  the act or omission is likely to result in harm or injury to a person.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (8)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offence relating to breaching a condition of an exemption or approval, or a condition applicable under regulations

             (9)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches:

                              (i)  a condition of an exemption applicable under regulations made for the purposes of section 41HA; or

                             (ii)  a condition of an approval under section 41HB; or

                            (iii)  a condition applicable under regulations made for the purposes of subsection 41HB(7).

Penalty:  60 penalty units.

41MNA  Civil penalties for breaching conditions

             (1)  A person contravenes this subsection if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

             (2)  A person contravenes this subsection if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the conformity assessment certificate.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.


 

Division 3AOffences and civil penalties related to exemptions under Part 4‑6A

41MNB  Criminal offences for breaching a condition of an exemption

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption; and

                     (d)  the act or omission is likely to cause a serious risk to public health.

Penalty:  Imprisonment for 5 years or 2,000 penalty units, or both.

             (2)  Strict liability applies to paragraph (1)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (3)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  Imprisonment for 4 years or 240 penalty units, or both.

             (4)  Strict liability applies to paragraph (3)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  60 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

41MNC  Civil penalty for breaching a condition of an exemption

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

41MND  Civil penalty for making misrepresentations about medical devices

                   A person contravenes this section if:

                     (a)  the person makes a representation that medical devices are of a kind covered by an exemption in force under section 41GS; and

                     (b)  the representation is false or misleading.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.


 

Division 4Other offences and civil penalty provisions

41MO  Criminal offences for misusing medical devices exempted for special or experimental uses

             (1)  A person commits an offence if:

                     (a)  the person has been granted an authority under section 41HC relating to a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind:

                              (i)  otherwise than in accordance with the authority; or

                             (ii)  otherwise than in accordance with any conditions to which the authority is subject; or

                            (iii)  otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5); and

                     (c)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (d)  the harm or injury has resulted, will result, or would result, because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person has been granted an authority under section 41HC relating to a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind:

                              (i)  otherwise than in accordance with the authority; or

                             (ii)  otherwise than in accordance with any conditions to which the authority is subject; or

                            (iii)  otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5); and

                     (c)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (d)  the harm or injury would be likely to result because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A person commits an offence if:

                     (a)  the person has been granted an authority under section 41HC relating to a specified kind of medical device; and

                     (b)  the person supplies a medical device of that kind:

                              (i)  otherwise than in accordance with the authority; or

                             (ii)  otherwise than in accordance with any conditions to which the authority is subject; or

                            (iii)  otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).

Penalty:  500 penalty units.

             (5)  A person commits an offence if:

                     (a)  the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and

                     (b)  the person uses a medical device of that kind:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans;

                            otherwise than in accordance with the approval; and

                     (c)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence if:

                     (a)  the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and

                     (b)  the person uses a medical device of that kind:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans;

                            otherwise than in accordance with the approval; and

                     (c)  the use of the device, if the device were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (8)  A person commits an offence if:

                     (a)  the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and

                     (b)  the person uses a medical device of that kind:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans;

                            otherwise than in accordance with the approval.

Penalty:  500 penalty units.

41MP  Criminal offence for failing to notify adverse events etc.

             (1)  A person is guilty of an offence if:

                     (a)  the person is a person in relation to whom a kind of medical device is included in the Register; and

                     (b)  the person knows that particular information is information of a kind mentioned in subsection (2); and

                     (c)  the person fails to give that information to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (2)  The information with which subsection (1) is concerned is information of the following kinds:

                     (a)  information relating to:

                              (i)  any malfunction or deterioration in the characteristics or performance of the kind of device; or

                             (ii)  any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or

                            (iii)  any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;

                            that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;

                     (b)  information relating to any technical or medical reason for a malfunction or deterioration of a kind referred to in subparagraph (a)(i) that has led the manufacturer to take steps to recover devices of that kind that have been distributed;

                     (c)  information that indicates that a device of that kind does not comply with the essential principles;

                     (d)  information that indicates that a certificate (other than one issued under this Act) used for the purpose of an application under subsection 41FC(1) to signify:

                              (i)  compliance with the essential principles; or

                             (ii)  the application of relevant conformity assessment procedures to a particular device;

                            has been restricted, suspended, revoked or is no longer in effect.

41MPA  Civil penalty for failing to notify adverse events etc.

             (1)  A person contravenes this section if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the information is of a kind mentioned in subsection (2); and

                     (c)  the person does not give information of a kind mentioned in subsection (2) to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

             (2)  The information with which subsection (1) is concerned is information of the following kinds:

                     (a)  information relating to:

                              (i)  any malfunction or deterioration in the characteristics or performance of the kind of device; or

                             (ii)  any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or

                            (iii)  any use in accordance with, or contrary to,