Contents
Part 1—Preliminary 1
1............................ Name of Regulations.......................................................... 1
2............................ Interpretation....................................................................... 1
2A......................... Authorised officers........................................................... 13
3............................ Corresponding State law................................................... 14
3AA...................... Unacceptable presentation of therapeutic goods—prescribed class of medicine 14
3A......................... Unacceptable presentations............................................... 15
3B.......................... Definitions relating to goods comprising etc. human cells and tissues 15
Part 2—Advertisements 16
Division 1—Application of Part 16
4............................ Application of Part 2......................................................... 16
4A......................... Interpretation..................................................................... 16
Division 3—General provisions about advertising therapeutic goods 17
6AA...................... Prescribed committees...................................................... 17
6B.......................... Prohibited and required representations............................ 17
7............................ Prescribed goods for advertising offence and civil penalty 17
7A......................... Publisher exception for civil penalty provisions............... 18
Division 4—Generic information about ingredients or components of therapeutic goods 19
8............................ Compliance with the Code................................................ 19
Part 2A—Patient information 20
9A......................... Information about certain therapeutic goods to be supplied 20
9B.......................... Information about therapeutic goods manufactured using human embryos 21
Part 2C—Australian Register of Therapeutic Goods 22
Division 2C.1—Registered and listed therapeutic goods 22
10.......................... Goods to be included in parts of the Register (Act s 9A). 22
10AAA................. Variation of entries in Register—registered complementary medicines and registered OTC medicines.......................................................................... 22
10AAB.................. Variation of entries in Register—prescription medicines other than biological medicines.......................................................................................... 25
10AAC.................. Variation of entries in Register—biological medicines..... 32
10AAD................. Variation of entries in Register—biologicals.................... 35
10AA.................... Prescribed requests for variations of entries in Register... 36
10AB..................... Change of person in whose name goods are listed or registered 37
10AC..................... Change of name of person................................................ 38
10B........................ Transfers within the Register............................................ 39
10C........................ Re‑assignment of registration or listing numbers.............. 40
10D....................... Notice of reassignment of registration or listing numbers. 41
Division 2C.2—Medical devices included in the Register under Chapter 4 42
10E........................ Goods to be included in part of the Register for medical devices (Act s 9A) 42
10F........................ Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act.......................................................... 42
10FA..................... Change of name of person................................................ 43
Division 2C.3—Biologicals included in the Register 45
10G....................... Goods to be included in the part of the Register for biologicals 45
10H....................... Change of person for whom a biological is included in the Register under Part 3‑2A of the Act.................................................................................... 45
10HA.................... Change of name of person................................................ 46
10I......................... Re‑assignment of biological numbers............................... 47
10J......................... Notice of reassignment of biological numbers.................. 47
Part 2CA—Prohibition on import, export or manufacture of certain therapeutic goods—international agreements 48
Division 1—Prescribed international agreements 48
10JA...................... Prescribed international agreements.................................. 48
Division 2—Prohibition on importation of mercury 49
10JB...................... Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation 49
Division 3—Prohibition on export of mercury 50
10JC...................... Export of a therapeutic good that is mercury is prohibited unless approved by the Secretary before exportation............................................................. 50
Division 4—Applications to import or export mercury 51
10JD...................... Applications to import or export mercury......................... 51
10JE...................... When approval may be granted—importation................... 51
10JF...................... When approval may be granted—export........................... 51
Division 5—Mercury‑added products 53
10JG...................... Import, export and manufacture of therapeutic goods that are mercury‑added products.......................................................................................... 53
10JH...................... Manufacture of therapeutic goods containing mercury‑added products 53
Part 2D—Provisional determinations for medicine 54
10K........................ Applications for provisional determinations..................... 54
10L........................ Provisional determinations................................................ 54
Part 2E—Scientific advice about aspects of quality, safety or efficacy of medicine 55
10M....................... Scientific advice about aspects of quality, safety or efficacy of medicine 55
Part 3—Registration, inclusion, listing and exemption of therapeutic goods 56
11.......................... Characteristics that separate and distinguish certain medicines from other therapeutic goods.......................................................................................... 56
11A....................... Characteristics that separate and distinguish certain biologicals from other biologicals.......................................................................................... 56
12.......................... Exempt goods................................................................... 57
12A....................... Unapproved medicines and biological—exemption in life‑threatening cases 58
12AAB.................. Disposal of unused emergency goods and unused emergency biologicals 59
12AA.................... Applications for special and experimental uses................. 60
12AB..................... Goods imported etc for experimental uses........................ 60
12AC..................... Powers of authorised officers in relation to goods imported etc for experimental uses.......................................................................................... 61
12AD.................... Use of goods for experimental purposes—specified conditions 61
12B........................ Exemptions for certain uses—medicines.......................... 62
12C........................ Exemptions for health practitioners—biologicals.............. 74
15.......................... Application of registration or listing number to goods...... 74
15AA.................... Clinical trial registries....................................................... 75
15A....................... Conditions of registration and listing of medicines........... 75
16AA.................... Information or documents that Secretary may require....... 75
16AB..................... Specified periods.............................................................. 76
Part 3A—Applications for evaluation 77
Division 1—Preliminary 77
16A....................... Interpretation—working day............................................. 77
Division 1A—Goods mentioned in Part 1 of Schedule 10 78
16C........................ Applications for registration—notification of effectiveness and period for completing evaluations—general......................................................... 78
16D....................... Applications for variations—notification of effectiveness and period for deciding applications—general........................................................ 78
16DA.................... Conditions for periods for regulations 16C and 16D........ 79
16E........................ Applications for variations—effect of failure to decide applications within specified period.......................................................................................... 81
16F........................ Applications for variations—shorter period for deciding applications 81
16G....................... Applications for registration—shorter period for completing evaluations 82
Division 2—Applications for evaluation of substances 83
16GA.................... Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act.......................................................................................... 83
Division 3—Class 2, Class 3 and Class 4 biologicals 84
16GC..................... Notification of preliminary assessment of applications and periods within which certain evaluations must be made................................................. 84
16GD.................... Notification of effective request and period within which certain applications must be decided.......................................................................................... 84
16GE..................... Failure to decide an application within specified time....... 84
16GF..................... Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act.................................................................................... 84
Division 4—Complementary medicines and certain other listed medicines 86
16GG.................... Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made............................... 86
16GH.................... Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed 87
16GI...................... Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made.......................................................................................... 88
16GIA................... Period for paying evaluation fee for application under subsection 26BD(1) of the Act.......................................................................................... 90
16GJ...................... Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications............................. 90
Part 3B—Designated orphan drugs 92
16H....................... Application to designate medicine as orphan drug............ 92
16J......................... Designation of medicine as orphan drug........................... 92
16K........................ Period during which designation is in force...................... 94
16L........................ Extension of designation................................................... 94
16M....................... Revocation of designation................................................. 95
Part 3C—Therapeutic goods (priority applicant) determinations 96
16P........................ Application of Part............................................................ 96
16Q....................... Application for therapeutic goods (priority applicant) determination 96
16R........................ Making of therapeutic goods (priority applicant) determination 96
16S........................ Period during which therapeutic goods (priority applicant) determination is in force.......................................................................................... 97
16T........................ Revocation of therapeutic goods (priority applicant) determination 98
Part 3D—Biologicals (priority applicant) determinations 99
16U....................... Application of Part............................................................ 99
16V....................... Application for biologicals (priority applicant) determination 99
16W....................... Making of biologicals (priority applicant) determination.. 99
16X....................... Period during which biologicals (priority applicant) determination is in force 100
16Y....................... Revocation of biologicals (priority applicant) determination 101
Part 4—Licensing of manufacturers 102
17.......................... Exempt goods for the purposes of subsection 34(1) of the Act 102
18.......................... Exempt Persons.............................................................. 102
19.......................... Requirements for licence holders.................................... 102
20.......................... Conditions of licences..................................................... 102
21.......................... Persons having control of production etc to be named.... 103
22.......................... Transfer of licences......................................................... 104
Part 5—Examination, testing and analysis of goods 106
23.......................... Interpretation................................................................... 106
24.......................... Authorised officer—powers and duties.......................... 106
25.......................... Appointment of analysts and official analysts and powers of official analysts 107
26.......................... Taking of samples for testing.......................................... 107
26A....................... Receiving samples for testing......................................... 108
27.......................... Examination and testing of sample.................................. 108
28.......................... Tests for determining conformity with a standard or compliance with essential principles........................................................................................ 109
29.......................... Certificate of responsible analyst.................................... 109
30.......................... Review of results of examination and analysis............... 110
31.......................... Payment for samples....................................................... 112
32.......................... Offences relating to analysis etc...................................... 112
33.......................... Identity cards.................................................................. 113
Part 5A—Exceptional release 114
33A....................... Prescribed circumstances under which biologicals may be imported, exported or supplied........................................................................................ 114
33B........................ Conditions for supply of biologicals............................... 114
33C........................ Report on release of nonconforming biological.............. 115
Part 6—Committees 116
Division 1A—Advisory Committee on Medicines 116
35.......................... Establishment.................................................................. 116
35A....................... Functions........................................................................ 116
35B........................ Membership.................................................................... 116
Division 1D—Advisory Committee on Medical Devices 118
38.......................... Establishment.................................................................. 118
38A....................... Functions........................................................................ 118
38B........................ Membership.................................................................... 118
Division 1E—Advisory Committee on Complementary Medicines 120
39.......................... Establishment.................................................................. 120
39A....................... Functions........................................................................ 120
39B........................ Membership.................................................................... 120
Division 1EA—Advisory Committee on Biologicals 122
39C........................ Establishment.................................................................. 122
39D....................... Functions........................................................................ 122
39E........................ Membership.................................................................... 122
Division 1EB—Advisory Committee on Vaccines 123
39F........................ Establishment.................................................................. 123
39G....................... Functions........................................................................ 123
39H....................... Membership.................................................................... 123
Division 1F—General 125
40.......................... Application of this Division............................................ 125
41.......................... Appointment of members............................................... 125
41A....................... Appointment of the chair................................................ 125
41B........................ Resignation or vacancy................................................... 125
41C........................ Termination of appointment............................................ 125
41D....................... Leave of absence............................................................. 126
41E........................ Acting members.............................................................. 126
41F........................ Committee procedures.................................................... 126
41G....................... Meetings......................................................................... 126
41H....................... Presiding member........................................................... 127
41I......................... Quorum.......................................................................... 127
41J......................... Voting............................................................................. 127
42.......................... Miscellaneous................................................................. 127
Division 3A—Advisory Committee on Medicines Scheduling 129
Subdivision 3A.1—Preliminary 129
42ZCA.................. Definitions for Division 3A............................................ 129
Subdivision 3A.2—Constitution of Committee 129
42ZCB................... Membership of Committee............................................. 129
42ZCC................... Committee members....................................................... 129
42ZCD.................. Appointed members........................................................ 129
42ZCE................... Nominated members....................................................... 130
42ZCF................... Appointment of the Chair and acting Chair..................... 130
42ZCG.................. Resignation or vacancy................................................... 131
42ZCH.................. Termination of appointment............................................ 131
42ZCI.................... Leave of absence............................................................. 131
42ZCJ.................... Acting members.............................................................. 131
Subdivision 3A.3—Committee meetings 132
42ZCK................... Committee meetings........................................................ 132
42ZCL................... Meeting procedure.......................................................... 132
42ZCM.................. Presiding member........................................................... 132
42ZCN.................. Quorum.......................................................................... 133
42ZCO.................. Voting............................................................................. 133
42ZCP................... Miscellaneous................................................................. 133
Division 3B—Advisory Committee on Chemicals Scheduling 135
Subdivision 3B.1—Preliminary 135
42ZCQ.................. Definitions for Division 3B............................................ 135
Subdivision 3B.2—Constitution of Committee 135
42ZCR................... Membership of Committee............................................. 135
42ZCS................... Committee members....................................................... 135
42ZCT................... Appointed members........................................................ 135
42ZCU.................. Nominated members....................................................... 136
42ZCV.................. Appointment of the Chair and acting Chair..................... 136
42ZCW.................. Resignation or vacancy................................................... 137
42ZCX.................. Termination of appointment............................................ 137
42ZCY.................. Leave of absence............................................................. 137
42ZCZ................... Acting members.............................................................. 137
Subdivision 3B.3—Committee meetings 138
42ZCZA................ Committee meetings........................................................ 138
42ZCZB................ Meeting procedure—general........................................... 138
42ZCZC................ Presiding member........................................................... 138
42ZCZD................ Quorum.......................................................................... 139
42ZCZE................. Voting............................................................................. 139
42ZCZF................. Miscellaneous................................................................. 139
Division 3C—Joint meetings 141
42ZCZG................ Joint meetings................................................................. 141
42ZCZH................ Procedure for joint meetings........................................... 141
Division 3D—Procedure for amending the current Poisons Standard 142
Subdivision 3D.1—Preliminary 142
42ZCZI.................. Definitions for Division 3D............................................ 142
Subdivision 3D.2—Procedure if proposed amendment referred to expert advisory committee 142
42ZCZJ................. Application..................................................................... 142
42ZCZK................ Proposed amendment to be referred to expert advisory committee 143
42ZCZL................. Consideration of public submissions.............................. 143
42ZCZM............... Committee to advise Secretary........................................ 144
42ZCZN................ Interim decision of Secretary.......................................... 144
42ZCZO................ Secretary may make final decision if no interim decision required 144
42ZCZP................. Call for further submissions........................................... 144
42ZCZQ................ Reconsideration of interim decision................................ 144
42ZCZR................ Final decision if there is an interim decision................... 145
42ZCZS................. Publication of final decision............................................ 145
Subdivision 3D.3—Procedure if proposed amendments not referred to expert advisory committee 145
42ZCZT................. Application..................................................................... 145
42ZCZU................ Final decision without interim decision........................... 146
42ZCZV................ Interim decision required if Secretary decides not to amend as requested 146
42ZCZW............... Final decision if there is interim decision........................ 146
42ZCZX................ Publication of final decision............................................ 146
Part 7—Charges for registration, listing and inclusion, licences, exemptions, costs and fees 147
Division 1—Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences 147
Subdivision 1—Preliminary 147
43AAA................. Meaning of turnover and when turnover is of low value 147
Subdivision 1A—Time for payment of certain annual charges 147
43AAB.................. Time for payment of certain annual charges.................... 147
Subdivision 2—Exemption from liability to pay certain annual charges—therapeutic goods other than IVD devices 148
43AAAA.............. Application..................................................................... 148
43AABA............... Purpose of this Subdivision............................................ 148
43AABB............... Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015 148
43AAC.................. Exemption from liability to pay certain annual charges—2015‑16 financial year 149
43AAD................. Exemption from liability to pay certain annual charges—financial years commencing on or after 1 July 2016............................................................. 153
43AAE.................. Exemption from liability to pay certain annual charges—late notice that turnover was of low value............................................................................... 153
43AAF.................. Person may notify Secretary that turnover of goods for financial year will not be of low value........................................................................................ 155
43AAG................. Secretary may notify person that annual charge is payable if turnover is not of low value........................................................................................ 155
Subdivision 2A—Exemption from liability to pay annual charge—IVD devices 157
43AAGA.............. Purpose of this Subdivision............................................ 157
43AAGB............... Exemption from liability to pay annual charge—2017‑18 financial year 157
43AAGC............... Exemption from liability to pay annual charge—financial years commencing on or after 1 July 2018..................................................................... 158
43AAGD.............. Exemption from liability to pay annual charge—late notice that turnover was of low value........................................................................................ 159
43AAGE............... Person may notify Secretary that turnover of IVD device for financial year will not be of low value............................................................................... 160
43AAGF............... Secretary may notify person that annual charge is payable if turnover is not of low value........................................................................................ 160
Subdivision 2B—Waiver of certain annual charges 162
43AAGG.............. Purpose of Subdivision.................................................. 162
43AAH................. Waiver of certain annual charges.................................... 162
Subdivision 3—Charges for licensing 164
43AAJ................... Licensing charge—reduction in certain circumstances.... 164
Division 2—Fees and costs 165
43.......................... Fees................................................................................ 165
43A....................... When is no application fee payable?............................... 165
43AA.................... Fee for evaluation—refund in certain circumstances....... 166
43AB..................... Circumstances in which inspection fee covered by annual charge 166
43AC..................... Refund of fees where no evaluation undertaken—registered OTC medicines 166
43ACA.................. Refund of fees where no evaluation undertaken—certain registered and listed medicines........................................................................................ 166
43AD.................... Fee for therapeutic goods (priority applicant) determination application—refund in certain circumstances.................................................................. 167
43AE..................... Fee for application for provisional determination relating to medicine—refund in certain circumstances.................................................................. 167
43AF..................... Fee for request for variation of certain registered and listed medicines—refund in certain circumstances.................................................................. 168
44.......................... Testing of samples—recovery of costs........................... 168
45.......................... Waiver or reduction of fees............................................. 168
45AA.................... Payment of fees in instalments........................................ 171
Part 8—Miscellaneous 173
46A....................... Delegation under the Act................................................ 173
46.......................... Release of information.................................................... 173
47.......................... Delegation—powers and functions under these Regulations 174
47A....................... Delegation—powers under paragraphs 19(1)(a), 32CK(1)(d) and 41HB(1)(d) of the Act........................................................................................ 174
47B........................ Provision of information concerning medicines, biologicals and medical devices 175
48.......................... Review of decisions........................................................ 176
Part 9—Transitional 180
Division 1—Transitional provisions relating to the Therapeutic Goods Amendment Regulations 2010 (No. 1) 180
48A....................... Definitions...................................................................... 180
48B........................ Application of 2010 Amendment Regulations................ 180
Division 2—Transitional provisions relating to the Therapeutic Goods Amendment Regulation 2012 (No. 3) 181
49.......................... Transitional..................................................................... 181
Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 182
50.......................... Application..................................................................... 182
Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 183
51.......................... Application..................................................................... 183
Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017 184
52.......................... Definitions...................................................................... 184
53.......................... Transitional—continuing application of evaluation fees for variations of permissible ingredients determinations.............................................. 184
54.......................... Transitional—existing orphan drug designations............ 184
55.......................... Transitional—pending orphan drug designation applications.. 184
56.......................... Transitional—fee waivers in relation to certain designations 185
Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017 186
57.......................... Definitions...................................................................... 186
58.......................... Application—statements in relation to unapproved medicines and biologicals 186
59.......................... Transitional—approval of form for statements............... 186
Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 187
60.......................... Application provisions.................................................... 187
61.......................... Operation of Schedule 2—complementary medicines..... 187
62.......................... Saving provision............................................................. 187
Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 188
63.......................... Application of amendments............................................ 188
Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018 189
64.......................... Definitions...................................................................... 189
65.......................... Transitional provisions—exemptions from Parts 3‑2 and 3‑2A of the Act 189
66.......................... Transitional provisions—exemptions from Part 3‑3 of the Act 190
Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 191
67.......................... Application..................................................................... 191
Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 192
68.......................... Application and transitional provisions........................... 192
Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 193
Subdivision A—Definitions 193
69.......................... Definitions...................................................................... 193
Subdivision B—Faecal microbiota transplant products 193
70.......................... Faecal microbiota transplant products—Division 4 of Part 3‑2A of the Act 193
71.......................... Faecal microbiota transplant products—Part 3‑3 of the Act 194
Subdivision C—Consumer medicine information documents 194
72.......................... Consumer medicine information documents................... 194
Subdivision D—Handling and testing of samples 195
73.......................... Handling and testing of samples..................................... 195
Subdivision E—Fee waivers and refunds for certain requests relating to prescription opioids 195
74.......................... Fee waivers and refunds for certain requests relating to prescription opioids 195
Subdivision F—Clinical trials 196
75.......................... Clinical trials................................................................... 196
Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 197
76.......................... Approving supply of therapeutic goods under authorised prescriber scheme 197
77.......................... Preliminary assessment of applications for variation of permissible ingredients determination........................................................................................ 197
Division 14—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021 198
78.......................... Exempt goods................................................................. 198
Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 199
79.......................... Application of amendments made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021..................................... 199
Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 200
80.......................... Nicotine vaping products................................................ 200
81.......................... Access to medicines in emergency situations.................. 200
82.......................... Consumer medicine information documents................... 200
83.......................... Approving supply of therapeutic goods under authorised prescriber scheme 200
Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 201
84.......................... Amendments made by Division 1 of Part 2 of Schedule 1 201
85.......................... Amendments made by Division 2 of Part 2 of Schedule 1 201
Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 202
86.......................... Extemporaneously‑compounded medicinal cannabis products 202
Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 203
87.......................... Reconsideration of decisions.......................................... 203
Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 204
88.......................... Exempt goods................................................................. 204
89.......................... Fee for requests to vary entries in Register..................... 204
Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 205
90.......................... Clinical trials................................................................... 205
Schedule 1—Part 2 does not apply to members of an Australian branch of one of these bodies 206
Schedule 2—Prohibited and required representations 208
Part 1—Prohibited representations 208
Part 2—Required representations 210
Part 3—Vitamins referred to in Item 3 of Part 1 of this Schedule 211
Schedule 3—Therapeutic goods required to be included in the part of the Register for goods known as registered goods or as provisionally registered goods 212
Part 1—Medicines 212
Part 3—Therapeutic goods attracting no fee under Division 1 or 2 of Part 3‑2 of the Act 213
Schedule 4—Therapeutic goods required to be included in the part of the Register for listed goods 214
Schedule 5—Therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act 217
Schedule 5A—Therapeutic goods exempt from operation of Parts 3‑2 and 3‑2A of Act subject to conditions 221
Schedule 5B—Disposal of unused emergency goods and unused emergency biologicals 231
1............................ Early end of exemption—notice of goods held............... 231
1A......................... Early cessation of exemption—notice of biologicals held 231
2............................ Expiration of period of exemption—notice of goods held 231
2A......................... Expiration of period of exemption—notice of biologicals held 232
3............................ Storage and disposal of unused emergency goods and unused emergency biologicals........................................................................................ 232
4............................ Direction for disposal of unused emergency goods and unused emergency biologicals........................................................................................ 232
5............................ Relocation of unused emergency goods and unused emergency biologicals 233
6............................ Disposal of unused emergency goods and unused emergency biologicals—destruction........................................................................................ 233
7............................ Disposal of unused emergency goods and unused emergency biologicals—export 234
8............................ Disposal of unused emergency goods and unused emergency biologicals—supply........................................................................................ 234
9............................ Owner to be paid for goods or biologicals supplied....... 235
10.......................... Records about unused emergency goods and unused emergency biologicals 235
11.......................... Failure to comply with this Schedule.............................. 235
Schedule 7—Therapeutic goods exempt from the operation of Part 3‑3 of the Act unless supplied as pharmaceutical benefits 236
Schedule 8—Persons exempt from the operation of Part 3‑3 of the Act 239
Schedule 9—Fees—therapeutic goods other than biologicals 241
Part 1—Interpretation 241
1............................ Definitions...................................................................... 241
2............................ Part 2 fees do not apply in relation to applications etc. covered by Part 3 or 4 243
Part 2—Table of fees other than for applications etc. covered by Part 3 or 4 244
3............................ Table of fees................................................................... 244
Part 3—Table of fees for applications etc. in relation to certain OTC medicines 255
4............................ Table of fees................................................................... 255
Part 4—Table of fees for applications etc. in relation to certain complementary medicines and certain other listed medicines 257
5............................ Table of fees................................................................... 257
Schedule 9A—Fees—biologicals 259
Part 1—Interpretation of table 259
1............................ Definitions...................................................................... 259
Part 2—Table of fees 260
Schedule 10—Therapeutic goods for evaluation 263
Part 1—Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch 263
Part 2—Evaluation of complementary medicines by the Complementary and OTC Medicines Branch 264
Part 3—Evaluation of non‑prescription and other medicines by the Complementary and OTC Medicines Branch 265
Schedule 12—Consumer medicine information documents 266
1............................ General requirements...................................................... 266
2............................ Specific requirements—document enclosed within packaging etc. 266
3............................ Specific requirements—document not enclosed within packaging etc. 266
Schedule 13—Consumer medicine information documents 267
1............................ General requirements...................................................... 267
2............................ Specific requirements—document enclosed within packaging etc. 267
3............................ Specific requirements—document not enclosed within packaging etc. 267
Schedule 14—Designated active ingredients 268
Schedule 16—Classes of biologicals 269
1A......................... Class 1 biologicals.......................................................... 269
1............................ Class 4 biologicals.......................................................... 269
Endnotes 270
Endnote 1—About the endnotes 270
Endnote 2—Abbreviation key 271
Endnote 3—Legislation history 272
Endnote 4—Amendment history 279
Part 1—Preliminary
1 Name of Regulations
These Regulations are the Therapeutic Goods Regulations 1990.
2 Interpretation
In these Regulations, unless the contrary intention appears:
active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.
AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.
analysis includes examination and testing.
antiseptic means a substance:
(a) that is recommended by its manufacturer for:
(i) dermal application; or
(ii) application to the mucous membranes of a person or an animal:
(A) to kill micro organisms; or
(B) to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
(b) that is not represented to be suitable for internal use.
Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.
Note 1: The Australian Approved Names List includes:
(a) Australian Approved Names—Chemicals List; and
(b) Australian Approved Names—Biological Lists; and
(c) the Herbal Substances AAN List.
Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.
authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.
Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.
biological medicine means:
(a) a medicine (other than an antibiotic) that is:
(i) a vaccine, a peptide, a protein or polysaccharide‑based; and
(ii) derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and
(iii) of a kind specified in item 1 of Part 1 of Schedule 10; or
(b) a medicine that is a human blood product of a kind mentioned in Appendix A in Part 5 of the Poisons Standard.
biologicals (priority applicant) determination has the meaning given by subsection 32DEA(2) of the Act.
C1 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C1 (section 23) application has the meaning given by Part 1 of Schedule 9.
C2 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C2 (section 23) application has the meaning given by Part 1 of Schedule 9.
C3 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C3 (section 23) application has the meaning given by Part 1 of Schedule 9.
C4 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C4 (section 23) application has the meaning given by Part 1 of Schedule 9.
changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.
Class 1 biological means a biological that is mentioned in Schedule 16 as a Class 1 biological.
Note: At the time these Regulations commenced, there were no Class 1 biologicals.
Class 1 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class 2 biological means a biological:
(a) that:
(i) has been subjected to only minimal manipulation; and
(ii) is only for homologous use; and
(iii) is not mentioned in Schedule 16 as a Class 1, 3 or 4 biological; or
(b) that is mentioned in Schedule 16 as a Class 2 biological.
Class 2 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class 3 biological means a biological:
(a) that is not a Class 1, 2 or 4 biological; or
(b) that is mentioned in Schedule 16 as a Class 3 biological.
Class 3 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class III medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class 4 biological means a biological that is mentioned in Schedule 16 as a Class 4 biological.
Class 4 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.
designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.
designated orphan drug means a medicine in relation to which a designation under regulation 16J is in force.
disinfectant means a substance:
(a) that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
(b) that is not represented by the manufacturer to be suitable for internal use.
expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.
faecal microbiota transplant product means a thing that:
(a) comprises, contains or is derived from human stool; and
(b) is for introduction into a person for a therapeutic use.
Finance Minister means the Minister who administers the Public Governance, Performance and Accountability Act 2013.
fungicide means a chemical agent that kills a fungus or spores of a fungus.
generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):
(a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and
(b) has the same pharmaceutical form; and
(c) is bioequivalent; and
(d) has the same safety and efficacy properties.
gene therapy means the in vivo transfer of DNA or RNA into the cells of human recipients.
herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):
(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and
(b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.
high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.
homoeopathic preparation means a preparation:
(a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
(b) prepared according to the practices of homoeopathic pharmacy using the methods of:
(i) serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
(ii) serial trituration in lactose.
homologous use: see regulation 3B.
hospital grade disinfectant means a disinfectant that is represented to be suitable for therapeutic use:
(a) in premises used for:
(i) the investigation or treatment of a disease, ailment or injury; or
(ii) procedures that are carried out involving the penetration of the human skin; or
(b) in connection with:
(i) the business of beauty therapy or hairdressing; or
(ii) the practice of podiatry;
but does not include:
(c) an antibacterial clothes preparation; or
(d) a sanitary fluid; or
(e) a sanitary powder; or
(f) a sanitiser.
household grade disinfectant means a disinfectant that is not:
(a) an antibacterial clothes preparation; or
(b) a hospital grade disinfectant; or
(c) a sanitary fluid; or
(d) a sanitary powder; or
(e) a sanitiser.
immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.
IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:
(a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or
(b) an evaluation of:
(i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and
(ii) the quality of the ingredient based on a monograph contained in a default standard.
IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:
(a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and
(b) an independent evaluation of the quality of the ingredient.
IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:
(a) an evaluation of the quality of an ingredient based on:
(i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or
(ii) a monograph contained in a default standard; and
(b) an independent evaluation of the safety of the ingredient.
IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
in‑house IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
IVD device means an IVD medical device:
(a) that is:
(i) a Class 1 IVD medical device; or
(ii) a Class 2 IVD medical device; or
(iii) a Class 3 IVD medical device; or
(iv) a Class 4 IVD medical device; and
(b) that is not an in‑house IVD medical device.
IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
joint replacement medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).
L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:
(a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:
(i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and
(ii) has the same pharmaceutical form; and
(iii) is bioequivalent; and
(iv) has the same safety and efficacy properties; or
(b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:
(a) either:
(i) the application requires an independent evaluation of the efficacy of the medicine; or
(ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and
(b) the application is not an L(A)1 application or an L(A)2 application.
L(A)C1 (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
(a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
(b) is of a kind specified in the changes table as an L(A)C1 (section 9D) level change.
L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:
(a) the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an L(A)C1 (section 23) level change.
L(A)C2 (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
(a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
(b) is of a kind specified in the changes table as an L(A)C2 (section 9D) level change.
L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:
(a) the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an L(A)C2 (section 23) level change.
L(A)CN (section 9D) request means a request under subsection 9D(1), (2) or (3) of the Act for a variation that:
(a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and
(b) is of a kind specified in the changes table as an L(A)CN (section 9D) level change.
L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:
(a) the new medicine is a changed form of a medicine (the existing medicine) listed under section 26AE of the Act; and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an L(A)CN (section 23) level change.
medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).
mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.
mercury‑added products means the products listed in Part 1 of Annex A to the Minamata Convention that contain mercury, but does not include:
(a) products essential for civil protection and military uses; or
(b) products for research, calibration of instrumentation, or for use as reference standards; or
(c) if no feasible mercury‑free alternative for replacement is available—the following:
(i) switches and relays;
(ii) cold cathode fluorescent lamps and external electrode fluorescent lamps for electronic displays;
(iii) measuring devices; or
(d) products used in traditional or religious practices; or
(e) vaccines containing thiomersal as preservatives.
Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.
Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).
minimal manipulation: see regulation 3B.
mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.
N1 application has the meaning given by Part 1 of Schedule 9.
N2 application has the meaning given by Part 1 of Schedule 9.
N3 application has the meaning given by Part 1 of Schedule 9.
N4 application has the meaning given by Part 1 of Schedule 9.
N5 application has the meaning given by Part 1 of Schedule 9.
new dosage form medicine means a medicine that:
(a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and
(b) has an indication in common with that other medicine; and
(c) does not have the same dosage form as that other medicine.
new indications medicine means a prescription medicine that:
(a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and
(b) does not have the same indications as that other medicine.
new prescription medicine means a prescription medicine that contains:
(a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or
(b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.
nicotine vaping product means a medicine that:
(a) contains nicotine in solution; and
(b) is a finished product; and
(c) is intended to be vaporised, and administered by inhalation, using a vaping device.
nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:
(a) a standard applicable to the biological; or
(b) any manufacturing requirements under the Act for the biological.
non‑Minamata mercury means any of the following:
(a) mercury to be used for laboratory‑scale research or as a reference standard;
(b) naturally occurring trace quantities of mercury present in:
(i) products such as non‑mercury metals, ores or mineral products (including coal); or
(ii) products derived from the products mentioned in subparagraph (i);
(c) unintentional trace quantities of mercury in chemical products.
open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.
Note: For container, see Act, subs 3(1).
original cells or tissues: see regulation 3B.
OTC medicine means therapeutic goods mentioned in Part 3 of Schedule 10.
pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.
Poisons Standard has the same meaning as current Poisons Standard.
Practice Guideline has the meaning given by paragraph 12AB(2)(a).
principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.
quarter means a period of 3 months commencing on 1 January, 1 April, 1 July or 1 October in a year.
RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).
RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.
RCM3 application means an application made under section 23 of the Act to register a complementary medicine, if:
(a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or
(b) the application requires an independent evaluation of one of the following:
(i) the safety of the medicine;
(ii) the quality of the medicine;
(iii) the efficacy of the medicine.
RCM4 application means an application made under section 23 of the Act to register a complementary medicine, if:
(a) the application requires an independent evaluation of 2 of the following:
(i) the safety of the medicine;
(ii) the quality of the medicine;
(iii) the efficacy of the medicine; or
(b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or
(c) the application is for a medicine that is registered and is for one or more of the following:
(i) an extension of indications of the medicine;
(ii) new directions for use of the medicine;
(iii) an increase in the target population for the medicine.
RCM5 application means an application made under section 23 of the Act to register a complementary medicine, if:
(a) either:
(i) the application requires an independent evaluation of the safety, quality and efficacy of the medicine; or
(ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and
(b) the application is not an RCM1 application, an RCM2 application, an RCM3 application or an RCM4 application.
RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.
RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC1 (section 23) level change.
RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.
RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC2 (section 23) level change.
RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.
RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC3 (section 23) level change.
RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.
RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:
(a) the new medicine is a changed form of a registered complementary medicine (the existing medicine); and
(b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and
(c) the change is of a kind specified in the changes table as an RCMC4 (section 23) level change.
Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.
sample includes part of a sample.
serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:
(a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or
(b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.
specialist has the same meaning as in the Health Insurance Act 1973.
sporicide means a chemical agent that:
(a) kills bacterial spores; and
(b) has the potential to act as a sterilising agent after prolonged contact with an inanimate object.
Standard AS/NZS means a joint Australian and New Zealand Standard published by, or on behalf of, Standards Australia and the body known as Standards New Zealand.
Note: Section 2B of the Acts Interpretation Act 1901 defines Standards Australia.
sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.
submission has the meaning given by subclause 1(2) in Part 1 of Schedule 9.
TGA notifications process guidance document means Version 3.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 1 July 2018).
Note: The TGA notifications process guidance document could in 2018 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).
the Act means the Therapeutic Goods Act 1989.
Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.
therapeutic goods (priority applicant) determination has the meaning given by subsection 25AAA(2) of the Act.
trade name, for therapeutic goods of a particular kind, means the commercial name:
(a) given to goods of that kind by the manufacturer; and
(b) under which the goods are supplied.
traditional use, for a designated active ingredient, means use of the designated active ingredient that:
(a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and
(b) accords with well‑established procedures of preparation, application and dosage.
tuberculocide means a chemical agent that kills Mycobacterium tuberculosis and related acid‑fast bacteria.
turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).
unused emergency biological means a biological to which section 32CG of the Act applies.
unused emergency goods means goods to which section 30G of the Act applies.
virucide means a chemical agent that renders a virus non‑infective.
Note: For the definitions of the following terms, see subsection 3(1) of the Act:
· medicine
· poison
· product information
· Secretary.
2A Authorised officers
The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:
(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.
3 Corresponding State law
(1) In this regulation:
the Regulations means:
(a) the Therapeutic Goods Regulations 1990; and
(b) the Therapeutic Goods (Medical Devices) Regulations 2002.
(3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:
(a) the Poisons and Therapeutic Goods Act 1966 (NSW);
(b) the Poisons and Therapeutic Goods Regulation 2008 (NSW);
(ba) the Therapeutic Goods (Victoria) Act 2010 (Vic);
(baa) the Therapeutic Goods Act 2019 (Qld);
(bab) the Therapeutic Goods Regulation 2021 (Qld);
(bb) the Controlled Substances Act 1984 (SA);
(bc) the Controlled Substances (Poisons) Regulations 2011 (SA);
(c) the Therapeutic Goods Act 2001 (Tas);
(d) the Therapeutic Goods Regulations 2002 (Tas);
(e) Medicines, Poisons and Therapeutic Goods Act 2008 (ACT);
(f) Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT);
(g) Medicines, Poisons and Therapeutic Goods Act 2012 (NT);
(h) Medicines, Poisons and Therapeutic Goods Regulations 2014 (NT).
3AA Unacceptable presentation of therapeutic goods—prescribed class of medicine
For paragraph 3(5)(ca) of the Act, a prescribed class of medicine is medicine for supply in Australia that is not:
(a) a product of a kind mentioned in Part 1 of Schedule 10; or
(b) a medicine that satisfies the following requirements:
(i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;
(ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);
(iii) the medicine complies with the terms of the Secretary’s consent mentioned in subparagraph (ii); or
(c) a medicine that satisfies the following requirements:
(i) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act;
(ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or
(d) a medicine that satisfies the following requirements:
(i) the medicine only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act;
(ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.
3A Unacceptable presentations
(1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.
(2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.
3B Definitions relating to goods comprising etc. human cells and tissues
(1) This regulation applies to goods that comprise, contain, or are derived from human cells or tissues.
(2) The human cells or tissues are the original cells or tissues.
(3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.
(4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.
Part 2—Advertisements
Division 1—Application of Part
4 Application of Part 2
(1) This Part applies to advertisements to which Part 5‑1 of the Act applies.
(2) For subsection 42AA(2) of the Act, the bodies mentioned in Schedule 1 are prescribed.
4A Interpretation
A term used in this Part and in Part 5‑1 of the Act has the same meaning in this Part as it has in Part 5‑1 of the Act.
Note: See section 42B of the Act for definitions of terms used in Part 5‑1 of the Act.
Division 3—General provisions about advertising therapeutic goods
6AA Prescribed committees
For paragraph 42DF(4)(b) of the Act, the following committees are prescribed:
(a) Advisory Committee on Medicines;
(b) Advisory Committee on Complementary Medicines;
(c) Advisory Committee on Medical Devices;
(d) Advisory Committee on Vaccines.
6B Prohibited and required representations
Prohibited representations
(1) For the purposes of subsection 42DJ(1) of the Act:
(a) the representations in column 2 of an item in the table in Part 1 of Schedule 2 are specified; and
(b) the therapeutic goods in column 3 of that item are specified.
Note: Under subsection 42DJ(1) of the Act, those representations about those goods are prohibited representations.
Required representations
(2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.
7 Prescribed goods for advertising offence and civil penalty
For the purposes of subsections 42DL(12) and 42DLB(9) of the Act, the therapeutic goods are the following:
(a) therapeutic goods that are the subject of an approval or authority under section 19 of the Act;
(b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;
(c) medicines covered by an exemption under subregulation 12A(1);
(d) therapeutic goods specified in item 1 of Schedule 5;
(e) therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A;
(f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;
(g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);
(h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;
(i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;
(j) therapeutic goods that:
(i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and
(ii) are extemporaneously compounded for a particular person for therapeutic application to that person.
7A Publisher exception for civil penalty provisions
For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.
Division 4—Generic information about ingredients or components of therapeutic goods
8 Compliance with the Code
For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.
Note: The application of those sections is affected by sections 5 and 6 of the Code.
Part 2A—Patient information
9A Information about certain therapeutic goods to be supplied
(1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.
Penalty: 10 penalty units.
Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.
(1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.
Note: For strict liability, see section 6.1 of the Criminal Code.
(1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.
Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).
(1A) The sponsor of therapeutic goods that are:
(a) specified in Schedule 3 of the Poisons Standard; and
(b) approved for registration on or after 4 July 1995; and
(c) included in the Register;
must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.
Penalty: 10 penalty units.
(1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).
Note: For strict liability, see section 6.1 of the Criminal Code.
(2) For the purposes of subregulation (1) or (1A), information must be provided:
(a) in the primary pack in which the therapeutic goods are supplied; or
(b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.
9B Information about therapeutic goods manufactured using human embryos
(1) A sponsor of therapeutic goods (other than medical devices) commits an offence if:
(a) the sponsor supplies the goods on or after 1 July 2004; and
(b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and
(c) the goods are of a kind specified in Part 1 of Schedule 10; and
(d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and
(e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.
Penalty: 10 penalty units.
(2) Strict liability applies to the physical elements mentioned in paragraphs (1)(c), (d) and (e).
(3) The information in relation to the therapeutic goods must be included in:
(a) the consumer medicine information document required under regulation 9A; and
(b) the product information in relation to the goods.
(4) In this regulation:
human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.
human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.
(5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.
Part 2C—Australian Register of Therapeutic Goods
Division 2C.1—Registered and listed therapeutic goods
10 Goods to be included in parts of the Register (Act s 9A)
For paragraph 9A(4)(a) of the Act:
(a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and
(aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and
(b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.
10AAA Variation of entries in Register—registered complementary medicines and registered OTC medicines
Kinds of variations
(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.
Conditions
(2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:
(a) the variation reflects a change that will be made to, or in relation to, the medicine;
(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.
| Kinds of variations—registered complementary medicines and registered OTC medicines |
| Column 1 | Column 2 | Column 3 |
| Item | Variation | Code |
| 1 | The addition of a flash including the term “new” or “value pack” to a label or package insert for the medicine | LLN |
| 2 | If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert for the medicine | LSP |
| 3 | A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive | PSC |
| 4 | A decrease in the shelf life of the medicine included in a label or package insert for the medicine | PSR |
| 5 | A reduction or removal of an overage for an active ingredient of the medicine | AOV |
| 6 | A change to the type of starch (if any) used as an excipient in the medicine | EST |
| 7 | Either of the following: (a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard; (b) if the specifications for the medicine include in‑house tests—the replacement of those tests with a default standard | QFP |
| 8 | Either of the following: (a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard; (b) if the specifications for the starting materials of the medicine include in‑house tests—the replacement of those tests with a default standard | QSP |
| 9 | If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made: (a) if the material is polyvinyl chloride—a change to: (i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or (ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene; (b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene; (c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability | KBL |
| 10 | If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made: (a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass; (b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass; (c) if the material is polyethylene: (i) an increase in the material’s density; or (ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre; (d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre; (e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre | KBT |
| 11 | A change to the closure system for the medicine, unless: (a) the closure system also functions as a metering component of the medicine; or (b) the change involves a change to the pump, or components of the pump, of a metered‑dose aerosol | KCL |
| 12 | If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack | KRR |
| 13 | If the medicine is non‑sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine | AMS |
| 14 | If the medicine is non‑sterile, the manufacture of the medicine at an additional site | MMA |
| 15 | The cessation of the manufacture of the medicine by a manufacturer | MMD |
| 16 | A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine | MSD |
| 17 | A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine | LFT |
| 18 | Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for: (a) use of the medicine; or (b) use of a measuring device; or (c) use of an applicator | RGN |
| 19 | A change to the location of a graphic on the panel of a label for the medicine if: (a) there is no change to the size, shape or colour of the graphic; and (b) the change does not involve reformatting text | LGM |
| 20 | If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine | PSN |
| 21 | If the medicine is in a liquid or semi‑solid dosage form, the addition of a new pack size that is within the pack size range for the medicine | PLN |
| 22 | The deletion of a pack size for the medicine | PSD |
| 23 | If the medicine is sterile: (a) the addition of a manufacturer of the medicine for the performance of any of the following steps: (i) release for supply; (ii) secondary packaging; (iii) chemical, physical or microbial testing; or (b) the inclusion of the performance of any of the steps mentioned in paragraph (a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine | MSS |
| 24 | If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if: (a) other means of accurately measuring the dose are readily available; and (b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and (c) there are no changes to the directions for use of the medicine | KMO |
10AAB Variation of entries in Register—prescription medicines other than biological medicines
Kinds of variations
(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.
Conditions
(2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:
(a) the variation reflects a change that will be made to, or in relation to, the medicine;
(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.
| Kinds of variations—prescription medicines other than biological medicines |
| Column 1 | Column 2 | Column 3 |
| Item | Variation | Code |
| 1 | A change to the container or closure system used to store a non‑sterile active pharmaceutical ingredient of the medicine | ACCS |
| 2 | A change to the synthesis of an active pharmaceutical ingredient of the medicine if: (a) the ingredient is not a synthetic polypeptide; and (b) the ingredient is not prepared by fermentation; and (c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and (d) the Directorate: (i) has issued a revised certificate of suitability in relation to the ingredient; or (ii) has declared that the ingredient does not require a revised certificate of suitability | ACEP |
| 3 | A change to the size of a manufacturing batch of a non‑sterile active pharmaceutical ingredient, or a non‑sterile intermediate of such an ingredient, of the medicine | AMBS |
| 4 | The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site | AMCS |
| 5 | The introduction, revision or discontinuation of: (a) an in‑process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or (b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate | AMIT |
| 7 | If an active pharmaceutical ingredient of the medicine is manufactured by multi‑step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation): (a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or (b) the manufacture of such an intermediate at an additional site | AMMF |
| 8 | The transfer of the manufacture of a non‑sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if: (a) the ingredient is not prepared by fermentation; and (b) the ingredient is a pure chemical entity; and (c) the ingredient is prepared: (i) by chemical synthesis; or (ii) through isolation from a natural source | AMTA |
| 9 | A change to a non‑biological method used for assaying or residual solvent testing (including testing for water) any of the following: (a) an active pharmaceutical ingredient of the medicine; (b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient | ASAM |
| 10 | Either of the following: (a) a shortening of the re‑test period for an active pharmaceutical ingredient of the medicine; (b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine | ASDR |
| 11 | A change to an identification test used in relation to: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient | ASID |
| 12 | A change to the specifications for: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient; if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent | ASNL |
| 13 | A change, resulting from the addition of a new test and its associated limits, to the specifications for: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient | ASNT |
| 14 | A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | ASPT |
| 15 | A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form | DMBS |
| 16 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) semi‑solid or liquid; and (b) not a modified release dosage form | DMEL |
| 17 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) nasal or oral inhalation; and (b) not a modified release dosage form | DMEO |
| 18 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) solid; and (b) not a modified release dosage form | DMES |
| 19 | The introduction, revision or discontinuation of: (a) an in‑process control test applied during the manufacture of the medicine; or (b) a limit associated with an in‑process control test applied during the manufacture of the medicine | DMIT |
| 20 | A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form | DMRO |
| 21 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) sterile; and (b) not a modified release dosage form | DMSE |
| 22 | The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site | DMDM |
| 23 | Any of the following: (a) if the dosage form of the medicine is sterile: (i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or (ii) the performance of those things at an additional site; (b) if the dosage form of the medicine is not sterile: (i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or (ii) the performance of those things at an additional site | DMPL |
| 24 | If the dosage form of the medicine is: (a) non‑sterile semi‑solid or non‑sterile liquid; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site | DMSL |
| 25 | If the dosage form of the medicine is: (a) non‑sterile oral, or non‑sterile nasal, inhalation; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site | DMSO |
| 26 | If the dosage form of the medicine is: (a) non‑sterile solid; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site | DMSS |
| 27 | Either of the following: (a) a change to the location of a site where either of the following are performed in relation to the medicine: (i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing); (ii) release for supply; (b) the performance of either of the following in relation to the medicine at an additional site: (i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing); (ii) release for supply | DMTR |
| 28 | A change to a non‑biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical | DSAM |
| 29 | A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine | DSID |
| 30 | A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine | DSIP |
| 31 | A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent | DSNL |
| 32 | The addition of a new test and limits associated with the test to the specifications for the medicine | DSNT |
| 33 | A minor change to a method used to test physiochemical parameters of the medicine | DSPL |
| 34 | A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | DSPT |
| 35 | A change to a method used to test the sterility of the medicine | DSST |
| 36 | If: (a) the medicine is not administered by the parenteral, ophthalmic or intra‑tracheal route; and (b) the source of an excipient in the medicine is Category IC ruminant tissue; any of the following: (c) a change in the source of the excipient to a non‑animal source; (d) a change in the manufacturing process of the excipient; (e) a change to the location of a manufacturing site | EMRS |
| 37 | A change to a method used to assay an excipient in the medicine | ESAM |
| 38 | A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient | ESIP |
| 39 | A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent | ESNL |
| 40 | A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine | ESNT |
| 41 | A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | ESPT |
| 42 | A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine | CCCA |
| 43 | A change to the size or shape of a container or closure system for the medicine if the medicine is non‑sterile | CCSS |
| 44 | Any of the following changes to the specifications for a container or closure system for the medicine: (a) the inclusion of a new test; (b) making a limit more stringent; (c) the deletion of a test procedure; (d) a minor change to a test method | CCST |
| 45 | If the dosage form of the medicine is non‑sterile, and solid or semi‑solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine | CMDT |
| 46 | An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is: (a) non‑sterile; and (b) solid, semi‑solid, semi‑liquid or liquid | CMIT |
| 47 | A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection 10(1) of the Act that applies to the medicine) | LQAE |
| 48 | A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation | LQAT |
| 49 | A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large‑volume injection | LQHI |
| 50 | A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch | LQRT |
| 51 | A change to a label for the medicine to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous | LWAH |
| 52 | A change to a label for the medicine to include a warning or cautionary statement if: (a) the Secretary, under subsection 9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and (b) the Secretary, under subsection 25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection 25AA(1) of the Act to add that warning or cautionary statement | LWSR |
| 53 | A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine | ASPC |
| 54 | A minor change to: (a) the manufacture of an active pharmaceutical ingredient of the medicine; or (b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine; if the change does not affect any step taken to sterilise the ingredient or intermediate | AMMC |
| 55 | A change to a label for the medicine that deletes text from side or rear panels if: (a) the text is present elsewhere on the label for the medicine; and (b) repetition of the information on the panel is not required by an order in force under subsection 10(1) of the Act, or a condition imposed by or under section 28 of the Act, that applies to the medicine | LPDR |
| 56 | A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine | LPCS |
| 57 | A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery | LPCL |
| 58 | A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form | LPDG |
| 59 | A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form | LPCP |
| 60 | A change to a label for the medicine to include: (a) simple instructions or information relating to the packaging of the medicine; or (b) information describing a change in appearance of the dosage form | LPIA |
| 61 | A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine | LPOP |
| 62 | A change to a label for the medicine as a consequence of: (a) a variation, under subsection 9D(3) of the Act, of the entry in the Register that relates to the medicine; or (b) a condition imposed, under subsection 28(3) of the Act, on the listing or registration of the medicine | LOCI |
| 63 | A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance” | LPRP |
| 64 | A change to a label for the medicine to include a QR code, if the link is: (a) to a website owned by the person in relation to whom the medicine is included in the Register; and (b) to information that is non‑promotional | LPQR |
| 65 | A change to a label for the medicine to include information about a patient support program | LPPS |
10AAC Variation of entries in Register—biological medicines
Kinds of variations
(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.
Conditions
(2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:
(a) the variation reflects a change that will be made to, or in relation to, the medicine;
(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.
| Kinds of variations—biological medicines |
| Column 1 | Column 2 | Column 3 |
| Item | Variation | Code |
| 1 | A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent | PSNL |
| 2 | A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine | PSQC |
| 3 | The release for supply of the medicine at an additional site | PMRS |
| 4 | A reduction in the column life of columns used in the purification process for the medicine | PPCR |
| 5 | A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma‑derived | PPHR |
| 6 | A change to the manufacturer of a filter used in a fermentation process for the medicine | FPFM |
| 7 | The introduction of more stringent internal controls on a fermentation process for the medicine | FPNC |
| 8 | A reduction in the time required to culture and harvest the cell line for the medicine | FPRP |
| 9 | A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine | PFCR |
| 10 | The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine | PFSC |
| 11 | A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent | ISNL |
| 12 | A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the drug substance or excipient; or (b) an order in force under subsection 10(1) of the Act that applies to the drug substance or excipient | ISPT |
| 13 | A change to a method used for testing a drug substance or excipient of the medicine if: (a) the change is to adopt a method in a default standard; and (b) the test is not for viral safety | ISAM |
| 14 | A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard | PSNT |
| 15 | A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | PSPT |
| 16 | A minor change to a physicochemical test method used for testing the medicine | PMPL |
| 17 | The replacement of an in‑house reference standard with another if the protocol and acceptance criteria for establishing a replacement in‑house reference standard have been approved by the Therapeutic Goods Administration | IRSR |
| 18 | A change to a label for the medicine that deletes text from a side or rear panel if: (a) the text is present elsewhere on the label for the medicine; and (b) repetition of the information on the panel is not required by an order in force under subsection 10(1) of the Act, or a condition imposed by or under section 28 of the Act, that applies to the medicine | LPDR |
| 19 | A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine | LPCS |
| 20 | A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery | LPCL |
| 21 | A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form | LPDG |
| 22 | A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form | LPCP |
| 23 | A change to a label for the medicine to include: (a) simple instructions or information relating to the packaging of the medicine; or (b) information describing a change in appearance of the dosage form | LPIA |
| 24 | A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine | LPOP |
| 25 | A reduction in the shelf life of the drug substance of the medicine | ASRS |
| 26 | A reduction in the shelf life of the medicine | PSLD |
| 27 | The introduction of anti‑tamper packaging if the packaging material is not in contact with the medicine | PPAT |
| 28 | Either or both of the following changes to the manufacture of the medicine: (a) removal of a temperature excursion; (b) reduction in the time spent out of refrigeration or freezer storage | PSET |
| 29 | The addition of a storage condition for the medicine | PSAR |
| 30 | A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed | OAMS |
10AAD Variation of entries in Register—biologicals
Kinds of variations
(1) For the purposes of paragraph 9D(3AC)(b) of the Act, a variation:
(a) of an entry in the Register that relates to a biological; and
(b) that is listed in the table in subregulation (2);
is specified.
Conditions
(2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:
(a) the variation reflects a change that will be made to, or in relation to, the biological;
(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.
| Kinds of variations—biologicals |
| Item | Column 1 Variation | Column 2 Code |
| 1 | A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the biological; or (b) an order in force under subsection 10(1) of the Act that applies to the biological | PT |
| 2 | A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent | DS |
| 3 | A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease | TK |
| 4 | A change to a critical material used in the manufacture of the biological if: (a) the critical parameters for the changed material are equivalent or of greater quality; and (b) the material is not of human or animal origin; and (c) the material is not an excipient; and (d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material | SM |
| 5 | The introduction of more stringent limits to an in‑process control test applied during the manufacture of the biological | MI |
| 6 | The removal of a product if the biological is a Class 2 biological | BR |
| 7 | The addition of a site at which secondary packaging or storage of the biological is performed | MA |
| 8 | A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological: (a) quality control testing; (b) infectious disease testing | MT |
| 9 | The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site | MR |
| 10 | The introduction of more stringent limits to a release test applied during the manufacture of the biological | BS |
| 11 | A reduction in the shelf life or shipping timeframe of the biological | BT |
| 12 | A change to the label or supporting documentation for the biological to: (a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or (b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient | LC |
10AA Prescribed requests for variations of entries in Register
(1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:
(a) the definition of C1 (section 9D) application;
(b) the definition of C2 (section 9D) application;
(c) the definition of C3 (section 9D) application;
(d) the definition of C4 (section 9D) application;
(da) the definition of L(A)C1 (section 9D) request;
(db) the definition of L(A)C2 (section 9D) request;
(dc) the definition of L(A)CN (section 9D) request;
(e) the definition of RCMC1 (section 9D) request;
(f) the definition of RCMC2 (section 9D) request;
(g) the definition of RCMC3 (section 9D) request;
(h) the definition of RCMC4 (section 9D) request.
(2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.
10AB Change of person in whose name goods are listed or registered
Application
(1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.
Death of person
(2) If the relevant person dies, the legal personal representative (the notifying person) of the dead person:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.
Bankruptcy of person
(3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.
Winding up of body corporate
(4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.
Transfer or assignment of business
(5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:
(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and
(b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.
Secretary may request further information
(6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.
Secretary must amend the Register and provide new certificate
(7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:
(a) amend the Register accordingly; and
(b) as soon as practicable after amending the Register:
(i) inform the person of the amendment; and
(ii) make available to the person a certificate of registration or listing.
10AC Change of name of person
Application
(1) This regulation applies in relation to a person in relation to whom therapeutic goods are registered or listed.
Change of name of person
(2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.
Secretary may request further information
(3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.
Secretary must amend the Register and provide new certificate
(4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:
(a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and
(b) as soon as practicable after entering the new name:
(i) inform the person that the new name has been entered in the Register; and
(ii) make available to the person a new certificate of registration or listing.
10B Transfers within the Register
(1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:
(a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or
(b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.
(2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:
(a) to transfer the entry for the goods to the part of the Register for listed goods; or
(b) to retain the entry in the part of the Register for registered goods.
(3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.
(4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:
(a) listed goods; or
(b) registered goods; or
(c) medical devices.
(5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.
(6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:
(a) are included in the Register as a medical device under Chapter 4 of the Act; and
(b) cease to be a medical device because of a declaration under subsection 41BD(3) of the Act; and
(c) are a biological.
(7) An application under subregulation (1), (3), (4) or (6) must be made:
(a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or
(b) in any other case—within 15 months after the day when the goods:
(i) became subject to inclusion in the part of the Register for registered goods; or
(ii) were specified by the Secretary to be a biological under subsection 32A(2) of the Act.
Penalty: 5 penalty units.
(8) An offence under subregulation (7) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(9) In determining a period of notice for paragraph (7)(a), the Secretary must consider:
(a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and
(b) the reasons for the transfer in relation to the protection of the public.
(10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:
(a) expiry of the time for making the application under subregulation (7); or
(b) if an application is made—when the application is determined.
(11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.
10C Re‑assignment of registration or listing numbers
(1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.
(2) An application:
(a) must be made in writing to the Secretary and delivered to an office of the Department; and
(b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and
(c) may contain a nomination referred to in subparagraph (6)(b)(ii).
(3) The Secretary may assign to therapeutic goods that:
(a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and
(b) are not grouped therapeutic goods when:
(i) the application is decided; or
(ii) an order is made under section 16 of the Act in relation to the goods;
a registration or listing number that is not assigned to other therapeutic goods or grouped therapeutic goods.
(5) The Secretary must assign to therapeutic goods that:
(a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and
(b) are grouped therapeutic goods when:
(i) the application is decided; or
(ii) an order is made under section 16 of the Act in relation to the goods;
a registration or listing number in accordance with subregulation (6).
(6) The Secretary:
(a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and
(b) must assign to those goods a registration or listing number that:
(i) was assigned, or last assigned, to the goods; and
(ii) is nominated by the person in whose name the goods are registered or listed;
not being a registration or listing number that is assigned to other therapeutic goods or grouped therapeutic goods.
10D Notice of reassignment of registration or listing numbers
The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.
Division 2C.2—Medical devices included in the Register under Chapter 4
10E Goods to be included in part of the Register for medical devices (Act s 9A)
For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.
10F Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act
Application
(1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.
Death of person
(2) If the relevant person dies, the legal personal representative (the notifying person) of the dead person:
(a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.
Bankruptcy of person
(3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:
(a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.
Winding up of body corporate
(4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:
(a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.
Transfer or assignment of business
(5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:
(a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and
(b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.
Secretary may request further information
(6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.
Secretary must amend the Register and provide new certificate
(7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:
(a) amend the Register accordingly; and
(b) as soon as practicable after amending the Register:
(i) inform the person of the amendment; and
(ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.
10FA Change of name of person
Application
(1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.
Change of name of person
(2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.
Secretary may request further information
(3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.
Secretary must amend the Register and provide new certificate
(4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:
(a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and
(b) as soon as practicable after entering the new name:
(i) inform the person that the new name has been entered in the Register; and
(ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.
Division 2C.3—Biologicals included in the Register
10G Goods to be included in the part of the Register for biologicals
For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.
10H Change of person for whom a biological is included in the Register under Part 3‑2A of the Act
Application
(1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.
Death of person
(2) If the relevant person dies, the legal personal representative (the notifying person) of the dead person:
(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.
Bankruptcy of person
(3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:
(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.
Winding up of body corporate
(4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:
(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.
Transfer or assignment of business
(5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:
(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and
(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.
Secretary may request further information
(6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.
Secretary must amend the Register and provide new certificate
(7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:
(a) amend the Register accordingly; and
(b) as soon as practicable after amending the Register:
(i) inform the person of the amendment; and
(ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.
10HA Change of name of person
Application
(1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.
Change of name of person
(2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.
Secretary may request further information
(3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.
Secretary must amend the Register and provide new certificate
(4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:
(a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and
(b) as soon as practicable after entering the new name:
(i) inform the person that the new name has been entered in the Register; and
(ii) make available to the person a new certificate of the inclusion of the biological in the Register under that Part.
10I Re‑assignment of biological numbers
(1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.
(2) The application:
(a) must be made in writing to the Secretary and delivered to an office of the Department; and
(b) must have with it written information in sufficient detail to allow the application to be properly considered.
(3) The Secretary may assign to the biological a biological number that is not assigned to another biological.
10J Notice of reassignment of biological numbers
The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.
Part 2CA—Prohibition on import, export or manufacture of certain therapeutic goods—international agreements
Division 1—Prescribed international agreements
10JA Prescribed international agreements
(1) For the purposes of subsection 9K(1) of the Act, the Minamata Convention is prescribed.
(2) For the purposes of subsection 9K(3) of the Act, the Minamata Convention is prescribed.
(3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.
Division 2—Prohibition on importation of mercury
10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation
For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.
Division 3—Prohibition on export of mercury
10JC Export of a therapeutic good that is mercury is prohibited unless approved by the Secretary before exportation
For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.
Division 4—Applications to import or export mercury
10JD Applications to import or export mercury
(1) A person may apply to the Secretary for approval:
(a) to import into Australia a therapeutic good that is mercury from a non‑party to the Minamata Convention; or
(b) to export from Australia a therapeutic good that is mercury.
(2) An application must:
(a) be in the form approved by the Secretary for the purposes of this paragraph; and
(b) include the information required by the form; and
(c) be accompanied by the fee (if any) mentioned in Part 2 of Schedule 9 for the application.
(3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).
(4) The Secretary may approve a form for the purposes of paragraph (2)(a).
10JE When approval may be granted—importation
The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:
(a) either:
(i) Australia has provided the exporting party with written consent to the import; or
(ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and
(b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.
10JF When approval may be granted—export
Export to a Party to the Minamata Convention
(1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :
(a) the importing Party has provided its written consent to the export; and
(b) the mercury is to be exported:
(i) for a use allowed to the importing Party under the Minamata Convention; or
(ii) for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.
Export to a non‑party to the Minamata Convention
(2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:
(a) its written consent to the export; and
(b) its written certification demonstrating that:
(i) it has measures in place to ensure the protection of human health and the environment; and
(ii) it has measures in place to ensure compliance with Articles 10 and 11 of the Minamata Convention; and
(iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.
Division 5—Mercury‑added products
10JG Import, export and manufacture of therapeutic goods that are mercury‑added products
For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.
10JH Manufacture of therapeutic goods containing mercury‑added products
For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.
Part 2D—Provisional determinations for medicine
10K Applications for provisional determinations
For the purposes of subsection 22C(1) of the Act, the kinds of medicine are the following:
(a) new prescription medicine;
(b) new indications medicine.
10L Provisional determinations
(1) For the purposes of subsection 22D(2) of the Act, the criteria are all of the following:
(a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(b) either:
(i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or
(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;
(c) there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance;
(d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.
(2) However, paragraphs (1)(b) and (c) do not apply if:
(a) the application under subsection 22C(1) of the Act is made on or after the commencement of this subregulation; and
(b) an indication of the medicine is the treatment or prevention of the disease known as coronavirus disease (COVID‑19).
Part 2E—Scientific advice about aspects of quality, safety or efficacy of medicine
10M Scientific advice about aspects of quality, safety or efficacy of medicine
For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.
Part 3—Registration, inclusion, listing and exemption of therapeutic goods
11 Characteristics that separate and distinguish certain medicines from other therapeutic goods
(1) For paragraph 16(1A)(d) of the Act, different characteristics are:
(a) a different name; or
(b) different indications; or
(c) a different excipient; or
(d) for medicines that contain any restricted ingredients:
(i) a different quantity of a restricted ingredient that is an excipient; or
(ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or
(iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.
(2) A substance is a restricted ingredient if:
(a) it is an ingredient in a relevant medicine; and
(b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:
(i) Schedule 4;
(ii) the Poisons Standard;
(iii) a condition imposed under section 28 of the Act;
(iv) a standard under section 10 of the Act;
(vi) any other provision in these Regulations or in the Act that deals with eligibility of medicines for listing.
(3) In this regulation:
relevant medicine means a medicine that is listable goods or listed goods and that is not an export only medicine.
11A Characteristics that separate and distinguish certain biologicals from other biologicals
(1) For section 32AB of the Act:
(a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:
(i) applicable standards;
(ii) intended clinical use;
(iii) principal manufacturer; and
(b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:
(i) product name;
(ii) dosage form;
(iii) formulation or composition;
(iv) therapeutic indication;
(v) type of container, regardless of container size;
(vi) principal manufacturer.
(1A) However, a biological is not separate and distinct from other biologicals under subregulation (1) if:
(a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and
(b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.
(2) In this regulation:
principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.
12 Exempt goods
(1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:
(a) Part 3‑2 (except sections 30EA, 31A and 31C to 31F);
(b) Division 4 of Part 3‑2A.
(2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:
(a) Part 3‑2 (except sections 30EA, 31A and 31C to 31F);
(b) Division 4 of Part 3‑2A.
(3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.
(4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.
Limited exemptions
(5) For therapeutic goods exempt under paragraph (a) of item 5 of the table in Schedule 5, the exemption is subject to the condition that the exemption only has effect in relation to the importation.
(6) For therapeutic goods exempt under paragraph (b) of item 5 of the table in Schedule 5, the exemption is subject to the condition that the exemption only has effect in relation to the manufacture.
(7) For therapeutic goods exempt under paragraph (c) of item 5 of the table in Schedule 5, the exemption is subject to the condition that the exemption only has effect in relation to the supply by the intermediate supplier.
12A Unapproved medicines and biological—exemption in life‑threatening cases
(1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).
(1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.
(2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:
(a) the medicine or biological is to be given to a person who satisfies the following criteria:
(i) the person is a Category A patient (as defined in subregulation (5)); and
(ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and
(iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and
(b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.
(2A) An approval of a form referred to in subparagraph (2)(a)(iii) 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.
(3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.
Penalty: 10 penalty units.
(3A) An offence under subregulation (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) This regulation does not affect the operation of regulation 12.
(5) In this regulation:
Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.
12AAB Disposal of unused emergency goods and unused emergency biologicals
(1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.
(2) Nothing in this regulation or in Schedule 5B is taken to prevent a disposal of unused emergency goods if:
(a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):
(i) registered goods or listed goods; or
(ii) exempt goods under section 18 of the Act; or
(iii) goods that are the subject of an approval or authority under section 19 of the Act; or
(iv) goods that are the subject of an approval under section 19A of the Act; and
(b) the disposal is in accordance with other provisions of the Act and these Regulations relevant to the goods.
(3) Nothing in this regulation or in Schedule 5B is taken to prevent a disposal of an unused emergency biological if:
(a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):
(i) included in the Register under Part 3‑2A of the Act; or
(ii) exempt under subsection 32CA(2) of the Act; or
(iii) the subject of an approval or authority under section 32CK or 32CM of the Act; or
(iv) the subject of an approval under section 32CO of the Act; and
(b) the disposal is in accordance with other provisions of the Act and these Regulations relevant to the biological.
12AA Applications for special and experimental uses
Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:
(a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and
(b) the name of, and the contact details for, the principal investigator for each trial; and
(c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and
(d) information about whether or not any conditions specified by the committee have been met.
12AB Goods imported etc for experimental uses
(1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.
(2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:
(a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and
(b) a written undertaking:
(i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and
(ii) allow an authorised officer to do the things mentioned in regulation 12AC.
12AC Powers of authorised officers in relation to goods imported etc for experimental uses
(1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:
(a) enter a site of the trial; and
(b) search the site and any thing on the site; and
(c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and
(d) take photographs, make video recordings or make sketches of the site or any thing on the site; and
(e) inspect any book, record or document on the site that relates to the trial; and
(f) request the principal investigator to:
(i) answer any questions put by the authorised officer; and
(ii) produce any book, record or document requested by the authorised officer.
(2) An authorised officer is not entitled to do a thing mentioned in subregulation (1) if:
(a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and
(b) the authorised officer fails to comply with the request.
Note: For identity cards, see section 52 of the Act.
(3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.
(4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.
12AD Use of goods for experimental purposes—specified conditions
For subsections 19(4A) and 32CL(1) of the Act, the following conditions are specified:
(a) the use of therapeutic goods in a clinical trial must be in accordance with the Practice Guideline;
(b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;
(c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;
(d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:
(i) the protocol mentioned in paragraph (b); or
(ii) any condition subject to which approval for the use was given.
12B Exemptions for certain uses—medicines
(1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.
(1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:
(a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and
(b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.
(1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:
(a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and
(b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and
(c) the medicine is in the dosage form specified in column 3 of that item; and
(d) the medicine is to be administered by the route specified in column 4 of that item; and
(e) the supply is for the indication specified in column 5 of that item.
| Specified therapeutic goods |
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
| Item | Active ingredient | Dosage form | Route of administration | Indication |
| 2 | allergens—multiple, various (including control solutions) | drops | intradermal | confirmation of suspected allergic reactions |
| 3 | allergens – multiple, various (including control solutions) | drops | skin prick | confirmation of suspected allergic reactions |
| 4 | amiloride | tablet | oral | treatment of hypokalaemia |
| 4A | argipressin | injection | intravenous | (a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or (b) treatment of uterine fibroids |
| 5 | betaxolol 0.25% (preservative free) | eye drops | ophthalmic | treatment of elevated intraocular pressure where other treatments are inappropriate |
| 6 | bismuth subcitrate | tablet | oral | treatment of resistant Helicobacter Pylori infection |
| 7 | buspirone | tablet | oral | treatment of generalised anxiety disorders |
| 8 | calcitriol | liquid | oral | prevention of hypophosphatemic rickets in children; or treatment of hypoparathyroidism (with severe hypocalcaemia) |
| 9 | carbidopa | tablet | oral | premedication for F‑18 DOPA imaging |
| 10 | colecalciferol | capsule | oral | treatment of severe vitamin D deficiency and prevention of osteoporosis |
| 11 | colecalciferol | injection | intramuscular | treatment of severe vitamin D deficiency and prevention of osteoporosis |
| 12 | cinnarizine | tablet | oral | treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease). |
| 13 | clobetasol propionate 0.05% | cream | topical | treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed |
| 14 | clobetasol propionate 0.05% | lotion | topical | treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed |
| 15 | clobetasol propionate 0.05% | ointment | topical | treatment, or prolongation of flare‑free intervals, of dermatitis/eczema where other treatments have failed |
| 16 | clofazimine | capsule | oral | treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed mycobacterium avium paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non‑tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist |
| 17 | cyclopentolate, 0.2%, and phenylephrine, 1% | eye drops | ophthalmic | production of mydriasis |
| 18 | ciclosporin, 0.05% | eye drops, emulsion | ophthalmic | treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome) |
| 19 | deflazacort | tablet | oral | treatment of Duchenne muscular dystrophy |
| 20 | dehydrated ethanol (alcohol) 96% ‑ 100% | ampoule | topical | treatment of progressive keratoconus and intra‑operative use in superficial keratectomy (single use per procedure) |
| 21 | dexamethasone (preservative free) | eye drops | ophthalmic | treatment of inflammatory conditions of the eye that are non‑infected and steroid responsive in patients sensitive to preservative‑containing formulations |
| 22 | diazoxide | tablet | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma |
| 23 | diazoxide | capsule | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma |
| 24 | diazoxide | suspension | oral | treatment of hypoglycaemia, hyperinsulinaemia, Beckwith‑Weiderman Syndrome or insulinoma |
| 25 | diflunisal | tablet | oral | treatment of amyloidosis |
| 26 | dimethyl sulfoxide (DMSO) | solution | intravesical | symptomatic relief of interstitial cystitis |
| 26A | disulfiram | tablet | oral | deterrent to alcohol consumption |
| 27 | doxycycline | injection | intralesional | sclerotherapy of lymphatic malformations |
| 28 | F‑18 DCFPyl (PSMA) | injection | intravenous | prostate cancer imaging study |
| 29 | F‑18 myocardial perfusion tracer (18F flurpiridaz) | injection | intravenous | myocardial perfusion study |
| 30 | F‑18 NaF (sodium fluoride) | injection | intravenous | bone study |
| 30A | famotidine | injection | intravenous | prevention and management of hypersensitivity reactions to chemotherapy |
| 31 | flunarizine | tablet | oral | treatment of vestibular disorders or prophylactic treatment of migraine |
| 32 | flunarizine | capsule | oral | treatment of vestibular disorders or prophylactic treatment of migraine |
| 33 | furazolidone | tablet | oral | treatment of resistant Helicobacter Pylori infection |
| 34 | Gallium‑68
(Ga‑68) Galligas | aerosol | inhalation | lung ventilation study |
| 35 | Gallium‑68
(Ga‑68) ‑ MAA | injection | intravenous | lung perfusion study |
| 36 | Gallium‑68 prostate specific membrane antigen (PSMA) | injection | intravenous | (a) prostate cancer imaging study (b) PET CT gallium‑68 PSMA whole body uptake study |
| 36A | ganciclovir | gel | ophthalmic | treatment of cytomegalovirus |
| 37 | glycopyrronium bromide | tablet | oral | treatment of excessive salivation in patients with neurological conditions |
| 38 | hyoscine hydrobromide | patch | transdermal | treatment of excessive salivation |
| 39 | hypertonic sodium chloride, 5 % | eye ointment | ophthalmic | temporary relief of corneal oedema (hypertonicity) |
| 40 | hypertonic sodium chloride, 5% | eye drops | ophthalmic | temporary relief of corneal oedema (hypertonicity) |
| 40A | iloprost | injection | intravenous infusion | (a) treatment of patients with severe disabling Raynaud’s phenomenon; or (b) treatment of peripheral ischaemia |
| 41 | indigo carmine | injection | intravenous | intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures |
| 42 | indocyanine green dye | injection | intravenous | intra‑operative diagnostic use |
| 42AA | interferon alpha‑2b | eye drops | ophthalmic | treatment of ocular surface squamous neoplasia |
| 42A | ketotifen | tablet | oral | treatment of allergic conditions |
| 43 | levofloxacin | tablet | oral | treatment of resistant Helicobacter Pylori infection or drug resistant tuberculosis |
| 44 | levomepromazine | tablet | oral | treatment of nausea and vomiting or agitation |
| 45 | levomepromazine | injection | subcutaneous | treatment of nausea and vomiting or agitation |
| 45A | lifitegrast | eye drops | ophthalmic | treatment of dry eye disease |
| 46A | lutetium‑177 (Lu 177) dotatate | injection | intravenous | treatment of somatostatin receptor‑positive gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) |
| 46B | lutetium‑177 (Lu 177) prostate specific membrane antigen (PSMA) | injection | intravenous | treatment of metastatic castration‑resistant prostate cancer |
| 48 | melatonin | syrup | oral | treatment of sleep disorders |
| 49 | melatonin | capsule | oral | treatment of sleep disorders |
| 50 | melatonin | immediate release tablet | oral | treatment of sleep disorders |
| 51 | melatonin | lozenge | oral | treatment of sleep disorders |
| 51A | metolazone | tablet | oral | treatment of fluid overload |
| 52 | mexiletine | tablet | oral | treatment of ventricular arrhythmia or myotonic disorders |
| 53 | mexiletine | capsule | oral | treatment of ventricular arrhythmia or myotonic disorders |
| 54 | moxifloxacin 0.5% | eye drops | ophthalmic | treatment of refractory bacterial conjunctivitis |
| 55 | nadolol | tablet | oral | treatment of ventricular tachycardia or long QT Syndrome |
| 56 | natamycin 5% | eye drops | ophthalmic | treatment of refractory fungal blepharitis, conjunctivitis or keratitis |
| 57 | neomycin | tablet | oral | sepsis prevention for colorectal operation |
| 58 | nicotine in solution, salt or base form | liquid or solid | inhalation | smoking cessation |
| 58A | nifedipine | immediate release tablet | oral | (a) treatment of preterm labour; or (b) treatment of pre‑eclampsia |
| 58B | nifedipine | capsule | oral | (a) treatment of preterm labour; or (b) treatment of pre‑eclampsia |
| 59 | nitazoxanide | tablet | oral | treatment of giardiasis, cryptosporidiosis or blastocystis |
| 60 | nitazoxanide | suspension | oral | treatment of giardiasis, cryptosporidiosis or blastocystis |
| 61 | paromomycin | capsule | oral | antiprotozoal treatment of any of the following amoebic infections: (a) blastocystis hominis; (b) dientomoeba fragilis; (c) entamoeba histolytica; (d) parasite infection |
| 62 | pimozide | tablet | oral | treatment of schizophrenia, chronic psychosis or Tourette syndrome |
| 63 | pristinamycin | tablet | oral | treatment of confirmed methicillin‑resistant Staphylococcus aureus or vancomycin‑resistant enterococci infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or treatment of refractory or resistant mycoplasma genitalium infections; or treatment of other infections as prescribed by an infectious disease specialist |
| 63A | progesterone | injection | subcutaneous | treatment of progesterone deficiency |
| 63B | progesterone in oil | injection | intramuscular | treatment of progesterone deficiency |
| 64 | pyrazinamide | tablet | oral | treatment of tuberculosis |
| 65 | riboflavin, 0.1% in 20% dextran | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
| 66 | riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC) | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
| 67 | riboflavin, 0.1% in sodium chloride | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
| 68 | riboflavin, 0.22% in sodium chloride | eye drops | ophthalmic | intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus |
| 69 | ripasudil 0.4% | eye drops | ophthalmic | treatment of refractory corneal oedema or refractory glaucoma |
| 70 | sodium benzoate | tablet | oral | treatment of urea cycle disorders |
| 71 | tacrolimus 0.03% | ointment | topical | treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in children |
| 72 | tacrolimus 0.1% | ointment | topical | treatment, or prolongation of flare‑free intervals, of moderate to severe atopic dermatitis/eczema in adults |
| 72A | Technetium‑99m (99m Tc) prostate specific membrane antigen (PSMA)‑I&S | injection | intravenous | prostate cancer imaging study |
| 75 | tetracycline | capsule | oral | treatment of resistant Helicobacter Pylori infection |
| 76 | tetracycline | tablet | oral | treatment of resistant Helicobacter Pylori infection |
| 77 | tick‑borne encephalitis vaccine | injection | intramuscular | prevention of tick‑borne encephalitis |
| 78 | tinidazole | tablet | oral | treatment of trichomonas vaginalis infections of the genito‑urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or prevention of infection of the surgical site |
| 78A | tizanidine | capsule | oral | treatment of spasticity where other treatments have failed |
| 78B | tizanidine | tablet | oral | treatment of spasticity where other treatments have failed |
| 79 | triamcinolone acetonide | suspension for injection | ophthalmic | treatment of non‑infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post‑operative macular oedema (cataract surgery) |
| 80 | verteporfin | powder for injection | intravenous infusion | photosensitisation for photodynamic therapy |
| 81 | yttrium‑90 (Y‑90) Citrate | injection | intraarticular | radiosynovectomy treatment |
(1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:
(a) the circumstances specified in column 2 of an item in the following table exist in relation to the medicine; and
(b) the medicine is in the dosage form specified in column 3 of that item; and
(c) the medicine is to be administered by the route specified in column 4 of that item; and
(d) the supply is for the indication specified in column 5 of that item.
| Specified therapeutic goods |
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
| Item | Circumstances | Dosage form | Route of administration | Indication |
| 1 | (a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and (b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | liquid | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients |
| 2 | (a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and (b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | capsule | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients |
| 3 | (a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | liquid | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients |
| 4 | (a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | capsule | oral | (a) treatment of refractory chronic pain in adult patients; or (b) treatment of refractory anxiety in adult patients |
| 5 | (a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | liquid | oral | treatment of refractory chronic pain in adult patients |
| 6 | (a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and (b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and (c) the medicine contains no other active ingredients | capsule | oral | treatment of refractory chronic pain in adult patients |
(2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.
(3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.
(5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.
(6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:
(a) the person’s initials, date of birth and gender;
(b) each medical condition in relation to which the medicine was supplied;
(c) each indication of the medicine in relation to which the medicine was supplied;
(d) each active ingredient of the medicine;
(e) the dosage form of the medicine;
(f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;
(g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;
(h) the practitioner’s name, AHPRA number and contact details;
(i) the health profession in which the practitioner is registered or licensed to practise;
(j) the address of the practitioner’s principal place of practice.
12C Exemptions for health practitioners—biologicals
(1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.
(2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:
(a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and
(b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.
(3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.
(4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.
(5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:
(a) the person’s initials, date of birth and gender;
(b) each medical condition in relation to which the biological was supplied;
(c) each indication of the biological in relation to which the biological was supplied;
(d) a description of the biological, including the following:
(i) the product name of the biological;
(ii) each active ingredient of the biological;
(iii) the route of administration of the biological;
(e) the practitioner’s name, AHPRA number and contact details;
(f) the health profession in which the practitioner is registered or licensed to practise;
(g) the address of the practitioner’s principal place of practice.
15 Application of registration or listing number to goods
(1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:
(b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and
(c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:
(i) “AUST R” in the case of registered goods; and
(ii) unless subparagraph (iii) applies—“AUST L” in the case of listed goods; and
(iii) “AUST L(A)” in the case of goods listed under section 26AE of the Act;
the numbers and letters in each case being not less than 1 millimetre in height.
(2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.
15AA Clinical trial registries
For the purposes of subparagraph 26AF(2)(b)(ii) of the Act, the following registries are prescribed:
(a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;
(b) the database known as ClinicalTrials.gov, as the database exists from time to time.
15A Conditions of registration and listing of medicines
For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.
16AA Information or documents that Secretary may require
Information or documents relating to registered goods
(1) For paragraph 31(1)(k) of the Act, the following matters are prescribed:
(a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;
(b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.
Information or documents relating to listed goods
(2) For paragraph 31(2)(h) of the Act, the following matters are prescribed:
(a) the efficacy of the goods for the purposes for which the goods are to be used;
(b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;
(c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.
Information or documents relating to biologicals
(3) For paragraph 32JA(1)(p) of the Act, the following matters are prescribed:
(a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;
(b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.
16AB Specified periods
For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:
(a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;
(b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;
(c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.
Part 3A—Applications for evaluation
Division 1—Preliminary
16A Interpretation—working day
(1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.
(2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:
(a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:
(i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or
(ii) if subsection 31(1B) or (1C) of the Act applies:
(A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or
(B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.
(b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and
(c) any other period to which the applicant or sponsor agrees in writing for the purposes of this subregulation.
Division 1A—Goods mentioned in Part 1 of Schedule 10
16C Applications for registration—notification of effectiveness and period for completing evaluations—general
Application of this regulation
(1) This regulation applies if the Secretary receives an application:
(a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and
(b) to which regulation 16G does not apply.
Giving notification whether application has passed preliminary assessment
(2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.
Period for completing evaluation in relation to application
(3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:
(a) if the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or
(b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or
(c) otherwise—255 working days;
beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.
16D Applications for variations—notification of effectiveness and period for deciding applications—general
Application of this regulation
(1) This regulation applies if the Secretary receives an application:
(a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and
(b) to which regulation 16F does not apply.
Giving notification of effectiveness of application
(2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.
Period for completing evaluation in relation to application
(3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:
(a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or
(b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or
(c) otherwise—255 working days;
beginning on the day the Secretary sends the notification that states that the application is effective.
16DA Conditions for periods for regulations 16C and 16D
Conditions for 175 day period
(1) For the purposes of paragraphs 16C(3)(a) and (b) and 16D(3)(a) and (b), the conditions are the following:
(a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;
(c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;
(d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;
(e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;
(f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;
(g) if the evaluation medicine is a generic product in comparison to a registered medicine:
(i) the indications of the evaluation medicine are identical to the indications of the registered medicine; and
(ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;
(h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;
(i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;
(j) the assessment mentioned in paragraph (i):
(i) is complete and unredacted; and
(ii) is in English; and
(iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and
(iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and
(v) includes the competent regulatory authority’s final decision; and
(vi) includes any certifications or authentications of reports relating to the approval; and
(vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).
Conditions for 120 day period
(2) For the purposes of paragraphs 16C(3)(a) and (b) and 16D(3)(a) and (b), the conditions are the following:
(aa) the approval for the acceptable foreign approved medicine:
(i) is in force; and
(ii) was given not more than 12 months before the date of the application in relation to the evaluation;
(a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;
(b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;
(c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;
(d) no additional information is required to complete the evaluation, other than:
(i) the label and product information for the evaluation medicine; and
(ii) the risk management plan (if any) for the evaluation medicine.
Determining foreign countries or foreign jurisdictions
(3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.
16E Applications for variations—effect of failure to decide applications within specified period
The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.
16F Applications for variations—shorter period for deciding applications
(1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:
(a) the specifications for the active ingredient, finished product or excipients; or
(b) the method of manufacture of the active ingredient; or
(c) the manufacturing procedure for the finished product; or
(d) the site of manufacture of the active ingredient or the finished product; or
(e) the shelf life; or
(f) the storage conditions; or
(g) the labelling; or
(h) any other particular that is not a particular mentioned in subsection 16(1) of the Act.
(2) This regulation does not apply to an application that:
(a) in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data; or
(b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.
(3) In the case of an application to which this regulation applies, the Secretary must:
(a) decide the application and notify the applicant of the decision; or
(b) raise an objection concerning the application;
within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.
(4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.
(5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.
16G Applications for registration—shorter period for completing evaluations
(1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:
(a) the application is received by the Secretary on or after 1 July 1992; and
(b) the application requires an evaluation under section 25 of the Act; and
(c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.
(2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.
(3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.
Division 2—Applications for evaluation of substances
16GA Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act
(1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:
(a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;
(b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.
(2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.
Exemption from fee
(3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.
Division 3—Class 2, Class 3 and Class 4 biologicals
16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made
(1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.
(2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.
(3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).
16GD Notification of effective request and period within which certain applications must be decided
(1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.
(2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.
(3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.
16GE Failure to decide an application within specified time
The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.
16GF Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act
(1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:
(a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;
(b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.
(2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.
Division 4—Complementary medicines and certain other listed medicines
16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made
(1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.
(2) If the Secretary receives a request of a kind mentioned in column 1 of an item in the following table:
(a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and
(b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.
| Notification of effective requests and period within which decisions must be made |
| Item | Column 1 Kind of request | Column 2 Notification of effective requests | Column 3 Decision on request |
| 1A | L(A)C1 (section 9D) request | Within 40 working days after the Secretary receives the request | Within 30 working days after the Secretary notifies the applicant that the request has been accepted |
| 1B | L(A)C2 (section 9D) request | Within 40 working days after the Secretary receives the request | Within 120 working days after the Secretary notifies the applicant that the request has been accepted |
| 1 | RCMC2 (section 9D) request | Within 40 working days after the Secretary receives the request | Within 64 working days after the Secretary notifies the applicant that the request has been accepted |
| 2 | RCMC3 (section 9D) request | Within 40 working days after the Secretary receives the application | Within 120 working days after the Secretary notifies the applicant that the request has been accepted |
| 3 | RCMC4 (section 9D) request | Within 40 working days after the Secretary receives the application | Within 170 working days after the Secretary notifies the applicant that the request has been accepted |
(3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.
16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed
(1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:
(a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and
(b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.
| Notification of preliminary assessment of application and period within which evaluations must be completed |
| Item | Column 1 Kind of application | Column 2 Notification of preliminary assessment | Column 3 Completion of evaluation |
| 1 | L(A)1 application | Within 40 working days after the Secretary receives the application | Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 2 | L(A)2 application | Within 40 working days after the Secretary receives the application | Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 3 | L(A)3 application | Within 40 working days after the Secretary receives the application | Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 3A | L(A)C1 (section 23) application | Within 40 working days after the Secretary receives the application | Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 3B | L(A)C2 (section 23) application | Within 40 working days after the Secretary receives the application | Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 4 | RCM1 application | Within 40 working days after the Secretary receives the application | Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 5 | RCM2 application | Within 40 working days after the Secretary receives the application | Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 6 | RCM3 application | Within 40 working days after the Secretary receives the application | Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 7 | RCM4 application | Within 40 working days after the Secretary receives the application | Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 8 | RCM5 application | Within 40 working days after the Secretary receives the application | Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 9 | RCMC1 (section 23) application | Within 40 working days after the Secretary receives the application | Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 10 | RCMC2 (section 23) application | Within 40 working days after the Secretary receives the application | Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 11 | RCMC3 (section 23) application | Within 40 working days after the Secretary receives the application | Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
| 12 | RCMC4 (section 23) application | Within 40 working days after the Secretary receives the application | Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment |
(2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.
16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made
(1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:
(a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and
(b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.
| Notification of preliminary assessment of applications and period within which decisions on recommendations must be made |
| Item | Column 1 Kind of application | Column 2 Notification of preliminary assessment | Column 3 Decision on recommendation |
| 1 | IN1 application | Within 40 working days after the Secretary receives the application | The period of 70 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
| 2 | IN2 application | Within 40 working days after the Secretary receives the application | The period of 120 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
| 3 | IN3 application | Within 40 working days after the Secretary receives the application | The period of 150 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
| 4 | IN4 application | Within 40 working days after the Secretary receives the application | The period of 180 working days beginning on the later of the following days: (a) the day the Secretary notifies the applicant that the application has passed preliminary assessment; (b) the day the evaluation fee is paid for the application |
(1A) If:
(a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and
(b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and
(c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and
(d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:
(i) have already been made under subsection 26BD(1) of the Act in relation to that ingredient; and
(ii) have already been the subject of notices given under subsection 26BD(5) of the Act; and
(iii) have not been finally determined;
then a decision on whether to make a recommendation on the current application must be made within the period of:
(e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or
(f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or
(g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or
(h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.
(1B) For the purposes of this regulation, the start day is:
(a) the day after all the related applications have been finally determined, unless paragraph (b) applies; or
(b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.
(1C) For the purposes of this regulation, 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.
(2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.
16GIA Period for paying evaluation fee for application under subsection 26BD(1) of the Act
For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.
16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications
The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:
(a) an IN1 application;
(b) an IN2 application;
(c) an IN3 application;
(d) an L(A)2 application;
(e) an RCM2 application;
(f) an RCM3 application;
(g) an RCM4 application.
Part 3B—Designated orphan drugs
16H Application to designate medicine as orphan drug
(1) The sponsor of a medicine may apply to the Secretary to designate, in writing, the medicine as an orphan drug.
(2) An application under subregulation (1) must be in a form approved, in writing, by the Secretary.
16J Designation of medicine as orphan drug
(1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:
(a) consider the application; and
(b) decide either:
(i) to designate the medicine as an orphan drug; or
(ii) to refuse to designate the medicine as an orphan drug.
(2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:
(a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or
(b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.
General criteria
(3) The following criteria are specified in relation to a medicine that is not a new dosage form medicine:
(a) the application is for only one indication of the medicine;
(b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);
(c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;
(d) at least one of the following applies:
(i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;
(ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;
(iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;
(e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:
(i) the Secretary;
(ii) the United States Food and Drug Administration;
(iii) the European Medicines Agency;
(iv) Health Canada;
(v) the Medicines and Healthcare products Regulatory Agency of the United Kingdom;
(f) either:
(i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or
(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.
New dosage form medicines
(4) The following criteria are specified in relation to a new dosage form medicine:
(a) the application is for only one indication of the medicine;
(b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;
(d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:
(i) the Secretary;
(ii) the United States Food and Drug Administration;
(iii) the European Medicines Agency;
(iv) Health Canada;
(v) the Medicines and Healthcare products Regulatory Agency of the United Kingdom;
(e) either:
(i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or
(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.
Publication of decision
(5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:
(a) the name of the sponsor of the medicine;
(b) the indication referred to in paragraph (3)(a) or (4)(a);
(c) the dosage form of the medicine;
(d) that the medicine is a designated orphan drug.
Notification of decision
(6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.
16K Period during which designation is in force
(1) A designation under regulation 16J of a medicine as an orphan drug:
(a) comes into force when it is made; and
(b) remains in force for a period of 6 months.
(2) Subregulation (1) has effect subject to regulations 16L and 16M.
16L Extension of designation
(1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.
(2) An application under subregulation (1) to extend a designation must:
(a) be in a form approved, in writing, by the Secretary; and
(b) be made at least 28 days before the designation would cease to be in force.
(3) On receiving an application under subregulation (1) to extend a designation, the Secretary must decide either:
(a) to extend the designation; or
(b) to refuse to extend the designation.
(4) The Secretary may extend the designation if:
(a) the Secretary has not previously extended the designation; and
(b) the Secretary is satisfied that:
(i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or
(ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and
(c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.
Notification of decision
(5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.
16M Revocation of designation
(1) The Secretary may, by written notice given to the sponsor of a designated orphan drug, revoke the designation:
(a) on application by the sponsor; or
(b) if the Secretary is satisfied that:
(i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or
(ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.
(2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.
Part 3C—Therapeutic goods (priority applicant) determinations
16P Application of Part
For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.
16Q Application for therapeutic goods (priority applicant) determination
(1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.
(2) An application under subregulation (1) must:
(a) be in writing; and
(b) be in a form approved, in writing, by the Secretary; and
(c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
(3) An application under subregulation (1) is taken not to have been made unless:
(a) the application meets the requirements in subregulation (2); and
(b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.
Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.
16R Making of therapeutic goods (priority applicant) determination
(1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:
(a) consider the application; and
(b) decide either:
(i) to make the determination; or
(ii) to refuse to make the determination.
Criteria
(2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:
(a) the medicine is:
(i) a new prescription medicine; or
(ii) a new indications medicine;
(b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(c) either:
(i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or
(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;
(d) there is substantial evidence demonstrating that the medicine provides a major therapeutic advance.
Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.
Information to be specified in determination
(3) The determination must specify:
(a) the person who, as a result of section 25AAA of the Act, is the priority applicant; and
(b) each active ingredient of the medicine to which the determination relates; and
(c) the priority indication of the medicine.
Notification of decision
(4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.
16S Period during which therapeutic goods (priority applicant) determination is in force
(1) A therapeutic goods (priority applicant) determination in relation to a medicine:
(a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and
(b) subject to subregulation (2) and regulation 16T, remains in force for 6 months.
(2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
(a) the priority applicant withdraws the application; or
(b) the application lapses in accordance with subsection 24(2) of the Act; or
(c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or
(d) the application is finally determined.
Note: See subsection 23B(3) of the Act for when an application passes preliminary assessment.
16T Revocation of therapeutic goods (priority applicant) determination
(1) The Secretary may revoke a therapeutic goods (priority applicant) determination in relation to a medicine if:
(a) either:
(i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or
(ii) the priority applicant has made such an application, but the application does not pass preliminary assessment; and
(b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.
Note: See subsection 23B(3) of the Act for when an application passes preliminary assessment.
(2) The revocation must be by written notice given by the Secretary to the priority applicant.
Part 3D—Biologicals (priority applicant) determinations
16U Application of Part
For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.
16V Application for biologicals (priority applicant) determination
(1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological.
(2) An application under subregulation (1) must:
(a) be in writing; and
(b) be in a form approved, in writing, by the Secretary; and
(c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
(3) An application under subregulation (1) is taken to not have been made unless:
(a) the application meets the requirements in subregulation (2); and
(b) the fee prescribed in item 2A in Part 2 of Schedule 9A for making the application has been paid.
16W Making of biologicals (priority applicant) determination
(1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:
(a) consider the application; and
(b) decide either:
(i) to make the determination; or
(ii) to refuse to make the determination.
Criteria
(2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:
(a) the biological is separate and distinct from biologicals included in the Register;
(b) either:
(i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or
(ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;
(c) either:
(i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or
(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;
(d) there is substantial evidence demonstrating that the biological provides a major therapeutic advance.
Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.
Information to be specified in the determination
(3) The determination must specify:
(a) the person who, as a result of section 32DEA of the Act, is the priority applicant; and
(b) each active ingredient of the biological to which the determination relates; and
(c) the priority indication of the biological.
Notification of decision
(4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.
(5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.
16X Period during which biologicals (priority applicant) determination is in force
(1) A biologicals (priority applicant) determination in relation to a biological:
(a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and
(b) subject to subregulation (2) and regulation 16Y, remains in force for 6 months.
(2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
(a) the priority applicant withdraws the application; or
(b) the application lapses in accordance with section 32DH of the Act; or
(c) the application is finally determined.
Note: See subsection 32DDA(3) of the Act for when an application passes preliminary assessment.
16Y Revocation of biologicals (priority applicant) determination
(1) The Secretary may revoke a biologicals (priority applicant) determination in relation to a biological if:
(a) either:
(i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or
(ii) the priority applicant has made such an application, but the application does not pass preliminary assessment; and
(b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.
Note: See subsection 32DDA(3) of the Act for when an application passes preliminary assessment.
(2) The revocation must be by written notice given by the Secretary to the priority applicant.
Part 4—Licensing of manufacturers
17 Exempt goods for the purposes of subsection 34(1) of the Act
(1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.
(2) If:
(a) therapeutic goods that are exempt from the operation of Part 3‑3 of the Act cease to be exempt; and
(b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;
the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.
18 Exempt Persons
For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.
19 Requirements for licence holders
For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:
(a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and
(b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:
(i) the production of the goods; and
(ii) the quality control measures that are to be employed in the manufacture of the goods.
20 Conditions of licences
For the purposes of section 40 of the Act, the following are conditions to which each licence is subject:
(a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;
(b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:
(i) keep records showing:
(A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and
(B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and
(C) details of the tests performed on the goods and the results of those tests; and
(D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and
(ii) where the goods to which the licence relates are produced in identifiable batches:
(A) assign a batch number to each batch of the goods; and
(B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and
(iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and
(iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control;
(c) the licence holder must comply with the provisions of Part 5 in relation to the taking of samples by authorised officers.
21 Persons having control of production etc to be named
If:
(a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and
(b) the licence is granted; and
(c) the applicant wishes to replace the nominated person with another person;
then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.
22 Transfer of licences
(1) If a person who was the holder of a licence dies, the legal personal representative of the dead person:
(a) is taken to be the holder of the licence; and
(b) must notify the Secretary, in writing, of the death not later than 3 months after it occurred.
(2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:
(a) is taken to be the holder of the licence; and
(b) must notify the Secretary, in writing, of the bankruptcy not later than 3 months after the person became bankrupt.
(3) If a body corporate that is the holder of a licence is being wound up, the liquidator of the body corporate:
(a) is taken to be the holder of the licence; and
(b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.
(4) If:
(a) a person agrees to dispose of a business relating to the manufacture, distribution or sale of therapeutic goods; and
(b) it is agreed that the disposal of that business is to include a transfer of a licence held by that person;
then:
(c) the person who acquires that business is taken to be the holder of the licence; and
(d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.
(4A) If a person who is the holder of a licence:
(a) changes his, her or its name; or
(b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;
the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.
(4B) The licence has effect as if it had been granted to the holder in the holder’s new name.
(5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.
(7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.
(8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.
Part 5—Examination, testing and analysis of goods
23 Interpretation
(1) In this Part, unless the contrary intention appears:
analyst means a person appointed by the Secretary as an analyst (except an official analyst) under regulation 25.
appropriately fastened and sealed: see subregulation (2).
official analyst means a person appointed by the Secretary as an official analyst under regulation 25.
responsible analyst, in relation to the analysis of a sample of therapeutic goods, means an analyst or official analyst who is nominated as a responsible analyst for the sample under paragraph 25(3)(c).
samples officer means an officer of the Department performing duties under the direction of an official analyst.
(2) For the purposes of this Part, a sample of therapeutic goods is appropriately fastened and sealed if the sample is fastened and sealed:
(a) in a container or package that is marked with a unique identification number or with the name and address of:
(i) the person from whom the sample was taken; or
(ii) for a sample delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act—the sponsor of the goods; and
(b) so as to prevent the opening of the container or package, and the removal of the unique identification number or the name and address, without breaking the seal.
24 Authorised officer—powers and duties
(1) An authorised officer may, during normal business hours:
(a) for the purpose of exercising the powers and performing the duties of an authorised officer under this regulation, enter the premises of a licence holder, manufacturer in respect of whom a conformity assessment certificate has been issued, or wholesaler on which therapeutic goods are kept for supply; and
(b) inspect the place at which those goods are kept; and
(c) take samples of those goods; and
(d) ask the owner of therapeutic goods, or the person apparently in charge of those goods, for information relevant to the manufacture and testing of those goods.
(2) If the entry of goods in the Register is subject to the condition that the sponsor of the goods comply with this regulation, the powers of an authorised officer referred to in subregulation (1) extend to the sponsor as if the sponsor were a licence holder or a manufacturer in respect of whom a conformity assessment certificate has been issued.
25 Appointment of analysts and official analysts and powers of official analysts
(1) The Secretary may, in writing, appoint a person who has appropriate qualifications and experience to be an analyst or an official analyst for the purposes of these Regulations.
(3) In addition to the other powers and functions of an official analyst, an official analyst may:
(a) ask an authorised officer to take samples of therapeutic goods; and
(b) determine the tests that are to be performed on a sample taken under paragraph (a) or delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act; and
(c) nominate an analyst or official analyst to be the responsible analyst for a sample taken under paragraph (a) or delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act.
(4) The tests determined under paragraph (3)(b), by an official analyst, for the following matters must be tests covered by regulation 28:
(a) determining whether particular therapeutic goods (other than medical devices) are goods that conform with a standard applicable to the goods;
(b) determining whether a particular kind of medical device complies with the applicable provisions of the essential principles.
(5) The tests determined under paragraph (3)(b), by an official analyst, for a matter not covered by subregulation (4), are the tests that the official analyst considers appropriate.
26 Taking of samples for testing
(1) When an authorised officer takes a sample of therapeutic goods (other than a further sample taken under the circumstances described in subregulation 30(6)), the authorised officer:
(a) must notify the person from whom the sample was taken that the authorised officer is going to send the sample to a laboratory operated by the Department for analysis; and
(b) must give the person from whom the sample was taken a notice setting out details of the goods taken and, if the person from whom the sample was taken was not the sponsor of the goods, send a copy of that notice to the sponsor of the goods; and
(c) must forward the whole or part of the sample to the relevant laboratory.
(2) An authorised officer must ensure that any sample of goods taken (including further samples taken under the circumstances described in subregulation 30(6)) is:
(a) appropriately fastened and sealed; and
(b) stored and transported in accordance with the instructions (if any) specified on the label of the goods.
26A Receiving samples for testing
(1) When a sample of therapeutic goods is delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act, the Secretary must as soon as practicable:
(a) determine whether the sample is appropriately fastened and sealed; and
(b) do either of the following:
(i) if the sample is appropriately fastened and sealed—send the sample, in the form in which it was received, to the relevant laboratory operated by the Department for analysis;
(ii) if the sample is not appropriately fastened and sealed—return the sample to the sponsor of the goods, with a statement explaining in what way the sample is not appropriately fastened or sealed.
(2) In complying with subregulation (1), the Secretary must ensure that the sample is stored and transported in accordance with the instructions (if any) specified on the label of the goods.
27 Examination and testing of sample
(1) A samples officer must, as soon as practicable after receiving a sample of goods at a laboratory operated by the Department:
(a) determine whether the sample is appropriately fastened and sealed; and
(b) if the sample is appropriately fastened and sealed—store the sample under the officer’s control and under secure conditions that are appropriate to the kind of goods.
(2) The responsible analyst must, as soon as practicable, collect the sample from the samples officer and arrange for:
(a) an analysis of the sample by performing the tests determined under paragraph 25(3)(b) in relation to the sample to establish:
(i) the quantity and quality of the goods comprising the sample; and
(ii) any other matter relevant to determining whether:
(A) for goods other than medical devices—the goods from which the sample was taken conform with any standard applicable to the goods and any conditions relating to matters mentioned in paragraph 28(2)(d) of the Act; and
(B) for medical devices—the goods from which the sample was taken comply with the applicable provisions of the essential principles and any conditions relating to matters mentioned in paragraph 41FO(2)(d) of the Act; and
(iii) for a sample of medicine listed under section 26A or 26AE of the Act—whether the medicine contains an ingredient that is not specified in a determination under paragraph 26BB(1)(a) of the Act or whether any of the requirements determined under paragraph 26BB(1)(b) of the Act have been contravened; and
(b) an examination of the goods, the label (if any) relating to the goods and the packaging of the goods, to determine whether the goods comply with the labelling, packaging and other requirements (including requirements relating to advertising) applicable to the goods.
28 Tests for determining conformity with a standard or compliance with essential principles
(1) Each of the following is a test for determining whether particular therapeutic goods (other than medical devices) are goods that conform with a standard applicable to the goods:
(a) a test specified by the Minister in an order under section 10 of the Act for those goods in relation to that standard; and
(b) a test specified in a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary in relation to that standard if:
(i) those goods are for use in humans; and
(ii) the Minister has not specified a test in an order under section 10 of the Act for those goods in relation to that standard; and
(d) a test accepted for the purposes of registration of the goods under Part 3‑2 of the Act; and
(e) any other suitable test that the Secretary requires to be carried out in respect of those goods in relation to that standard.
(2) Each of the following is a test for determining whether a particular kind of medical device complies with the applicable provisions of the essential principles:
(a) a test specified in a medical device standard or conformity assessment standard for the kind of device;
(b) a test accepted for the purpose of issuing a conformity assessment certificate in respect of the kind of device;
(c) a test required under paragraph 41FO(2)(d) of the Act as a condition of inclusion of the kind of device in the Register;
(d) any other suitable test that the Secretary requires to be carried out in respect of the kind of device for the purpose of demonstrating compliance with the applicable provisions of the essential principles.
29 Certificate of responsible analyst
(1) The responsible analyst must issue a certificate setting out the results of the examination and analysis.
(2) Within a reasonable time of the completion of the analysis, the responsible analyst must send a copy of the certificate to:
(a) the sponsor of the goods; and
(b) if the sample was taken under paragraph 25(3)(a) and the person from whom the sample was taken is not the sponsor of the goods—the person from whom the sample was taken.
(4) If the certificate referred to in subregulation (1) states:
(a) for relevant goods other than medical devices—that the goods do not conform with a specified standard or comply with a requirement that is applicable to the goods under regulation 27; or
(b) for medical devices—that the goods do not comply with the applicable provisions of the essential principles or a requirement that is applicable to the goods under regulation 27;
a copy of the certificate sent under subregulation (2) must be accompanied by a notice that complies with subregulation (4A).
(4A) For subregulation (4), the notice must:
(a) state that the person to whom the copy is sent may ask for the results of the analysis referred to in the copy to be reviewed in accordance with regulation 30; and
(b) specify the time within which a request for a review of the results may be made; and
(c) state that the person may ask for an extension of that time if it is not reasonable to expect the person to comply with regulation 30 within the specified time.
(5) In proceedings under the Act or these Regulations, a certificate issued under subregulation (1), or a copy of that certificate, is, in the absence of evidence to the contrary, conclusive proof of the matters set out or stated in it.
(6) A document purporting to be:
(a) a certificate issued under subregulation (1); or
(b) a copy of that certificate;
is, in the absence of evidence to the contrary, to be taken to be the certificate or a copy of the certificate.
30 Review of results of examination and analysis
(1) A person:
(a) to whom a copy of a certificate, setting out the results of the examination and analysis of goods, is sent under subregulation 29(2); and
(b) who sends to the Secretary evidence in writing establishing that the goods do conform with the specified standard or comply with an applicable requirement, or, for medical devices, do comply with the applicable provisions of the essential principles or an applicable requirement;
may ask for the results of the analysis to be reviewed.
(2) A request for review of the results of the analysis is to be made not later than 21 days after the person receives the copy of the certificate.
(3) The Secretary must extend the period of 21 days if it is not reasonable to expect the person to provide the evidence within the period referred to in subregulation (2).
(4) A person is not to be regarded as having sent the Secretary evidence establishing that goods conform with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, unless that person has sent to the Secretary a certificate of a person (the third party) who has appropriate qualifications and experience setting out:
(a) a statement that the third party has analysed a part of the same sample, or a similar sample from the same batch (if any), of those goods; and
(b) the results of that analysis; and
(c) details of the tests used in the analysis.
(5) If the certificate referred to in subregulation (4) shows that an analysis of goods for the purpose of establishing that the goods conform with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, was carried out in accordance with the tests determined by an official analyst under paragraph 25(3)(b) on the basis of which the certificate referred to in paragraph (1)(a) of this regulation was issued, subregulation (6) applies to those goods.
(6) Unless the results of the analysis of a sample of goods to which this subregulation applies, or other information available to the Secretary in relation to those goods, shows lack of homogeneity in the sample, the Secretary must direct:
(a) if part of the sample remains unimpaired—an official analyst to send so much of the sample as remains unimpaired; or
(b) if no part of the sample remains unimpaired—that a further sample be taken by an authorised officer from the same batch as the original sample and that that further sample be sent;
to a person agreed (who may be an analyst or official analyst) upon by the person who requested the review and the official analyst referred to in subregulation (5), or, in the absence of agreement, to a person nominated (who may be an analyst or official analyst) by the Secretary.
(7) If a sample is sent to a person as mentioned in subregulation (6), the person is to:
(a) analyse the sample of the goods in accordance with the tests determined by an official analyst under paragraph 25(3)(b) on the basis of which the certificate referred to in paragraph (1)(a) of this regulation was issued;
(b) send to the Secretary a certificate, signed by the person, setting out the results of the analysis; and
(c) send a copy of that certificate, signed by the person to the person who requested the review.
(8) A certificate under regulation 29 setting out the results of the analysis of a sample of goods ceases to have effect when the Secretary receives the certificate in relation to those goods under subregulation (7).
(9) If the findings of the responsible analyst are upheld, the sponsor must pay any charges payable to the person to whom a sample is sent as mentioned in subregulation (6) in respect of the analysis of the sample.
(10) In proceedings under the Act or these Regulations, a certificate issued under subregulation (7) or a copy of that certificate is, in the absence of evidence to the contrary, conclusive proof of the matters stated in it.
(11) A document purporting to be:
(a) a certificate of a person issued under subregulation (7); or
(b) a copy of that certificate, and purporting to be signed by the person;
is, in the absence of evidence to the contrary, to be regarded as the certificate or a copy of the certificate.
31 Payment for samples
(1) If a sample of therapeutic goods is taken by an authorised officer, the Commonwealth is liable to pay the owner of the goods from which the sample was taken an amount equal to the value of any part of the sample removed by the authorised officer.
(1A) If a sample of therapeutic goods delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act is sent to a laboratory for analysis, the Commonwealth is liable to pay to the person in relation to whom the goods are entered on the Register an amount equal to the value of the sample.
(2) The amount the Commonwealth is liable to pay is to be worked out on the basis of the market value of the sample when the sample was taken by the authorised officer or delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act.
32 Offences relating to analysis etc
(1) A person must not:
(a) molest, obstruct or try to intimidate or influence an authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or
(b) on being asked by an authorised officer, fail:
(i) to show the authorised officer the place where any therapeutic goods are kept; or
(ii) to admit the authorised officer to a place where therapeutic goods are kept; or
(iii) to show the authorised officer, or let the authorised officer inspect, therapeutic goods kept by the person; or
(iv) to allow a sample of therapeutic goods to be taken in accordance with these Regulations; or
(v) to give an authorised officer information required by the authorised officer, being information relevant to the manufacture and testing of therapeutic goods that the person is able to provide; or
(vi) to assist the authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or
(c) on being asked by an official analyst, fail to give any information required by the official analyst, being information relevant to the testing of therapeutic goods, that that person is able to provide.
Penalty: 10 penalty units.
(1A) For the purposes of an offence under paragraph (1)(a), strict liability applies to the physical element that the duties mentioned in that paragraph are duties under these Regulations.
Note: For strict liability, see section 6.1 of the Criminal Code.
(1B) An offence under paragraph (1)(b) or (c) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(1C) It is a defence to a prosecution under paragraph (1)(b) or (c) if the person has a reasonable excuse.
Note: A defendant bears an evidential burden in relation to the matter mentioned in subregulation (1C) (see section 13.3 of the Criminal Code).
(2) It is a reasonable excuse for a person to fail to comply with a request for information under paragraph (1)(b) or (c) if compliance with that request would tend to incriminate that person.
33 Identity cards
(1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.
(2) Where the authorised officer enters premises in the course of his or her duties under this Part, the authorised officer must, if requested to do so by any person at those premises, produce his or her identity card for inspection by that person.
(3) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.
Penalty: 1 penalty unit.
(4) An offence under subregulation (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
Part 5A—Exceptional release
33A Prescribed circumstances under which biologicals may be imported, exported or supplied
For paragraphs 14(5A)(b), (9A)(b), (13A)(b), 14A(1A)(b), (2A)(b) and (3A)(b) of the Act, the circumstances are:
(a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and
(b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and
(c) a nonconforming biological that is included in the Register under Part 3‑2A of the Act is available; and
(d) no other treatment option is suitable for the patient; and
(e) the nonconforming biological is assessed as the most suitable treatment for the patient; and
(f) the nonconforming biological is to be used only for the treatment of one patient.
33B Conditions for supply of biologicals
(1) For subsection 15AB(1) of the Act, the conditions are that:
(a) all the circumstances mentioned in regulation 33A have occurred; and
(b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:
(i) the proposal to use the nonconforming biological;
(ii) that the patient or guardian has been told about the likely risks and benefits from the use of the biological;
(iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and
(c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and
(d) before the biological is used:
(i) the patient or the patient’s guardian must give written informed consent; or
(ii) the treating medical practitioner must give written statement of the reasons that consent cannot be given; and
(e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.
(2) Within 28 days after the release of the nonconforming biological, the sponsor must give to the Secretary:
(a) a notification of use of the nonconforming biological, on a form approved by the Secretary; and
(b) a copy of the documents mentioned in paragraphs (1)(b) to (d); and
(c) any other information requested by the Secretary, including any information requested after submission of the notification.
(3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.
33C Report on release of nonconforming biological
For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:
(a) within 6 months after the release—a report that includes the following information:
(i) date of release;
(ii) product identification details;
(iii) name and address of transplant centre or medical practitioner to whom the nonconforming biological was released;
(iv) initials, gender and date of birth of patient;
(v) any adverse events relating to the use of the nonconforming biological; and
(b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances sur