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Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010

Authoritative Version
  • - C2010A00054
  • In force - Latest Version
Act No. 54 of 2010 as made
An Act to amend the Therapeutic Goods Act 1989, and for related purposes
Administered by: Health and Aged Care
Originating Bill: Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009
Registered 07 Jun 2010
Date of Assent 31 May 2010
Table of contents.

 

 

 

 

 

 

Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010

 

No. 54, 2010

 

 

 

 

 

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

  

  


Contents

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 2

3............ Schedule(s)......................................................................................... 2

Schedule 1—Biologicals                                                                                                      4

Therapeutic Goods Act 1989                                                                                     4

Schedule 2—Immunity from civil actions                                                            103

Therapeutic Goods Act 1989                                                                                 103

Schedule 3—Recall of therapeutic goods                                                             106

Therapeutic Goods Act 1989                                                                                 106

Schedule 4—Information gathering                                                                       107

Therapeutic Goods Act 1989                                                                                 107

Schedule 5—Unpaid annual charges                                                                     109

Therapeutic Goods Act 1989                                                                                 109

Schedule 6—Other amendments                                                                               110

Therapeutic Goods Act 1989                                                                                 110

 


 

 

Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010

No. 54, 2010

 

 

 

An Act to amend the Therapeutic Goods Act 1989, and for related purposes

[Assented to 31 May 2010]

The Parliament of Australia enacts:

1  Short title

                   This Act may be cited as the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010.

2  Commencement

             (1)  Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1.  Sections 1 to 3 and anything in this Act not elsewhere covered by this table

The day this Act receives the Royal Assent.

31 May 2010

2.  Schedule 1

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not commence within the period of 12 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period.

However, if the Therapeutic Goods (Charges) Amendment Act 2010 does not receive the Royal Assent before the end of that period, the provision(s) do not commence at all.

31 May 2011

3.  Schedules 2 to 6

The day after this Act receives the Royal Assent.

1 June 2010

Note:          This table relates only to the provisions of this Act as originally passed by both Houses of the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.

             (2)  Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act.

3  Schedule(s)

                   Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.


 

Schedule 1Biologicals

  

Therapeutic Goods Act 1989

1  Subsection 3(1)

Insert:

biological has the meaning given by section 32A.

2  Subsection 3(1)

Insert:

biological number of a biological means:

                     (a)  the number assigned to the biological under subsection 32DB(2), 32DF(2) or 32DN(5); or

                     (b)  if, in accordance with regulations made for the purposes of paragraph 9A(4)(ca), a different number is assigned to the biological—that different number.

3  Subsection 3(1)

Insert:

Class 1 biological means a biological included in a class of biologicals that is:

                     (a)  a class prescribed by the regulations for the purposes of section 32AA; and

                     (b)  a class referred to in those regulations as Class 1 biologicals.

4  Subsection 3(1) (definition of included in the Register)

Repeal the definition, substitute:

included in the Register:

                     (a)  in relation to a biological—means included in the Register under Part 3‑2A; and

                     (b)  in relation to a medical device to which Chapter 4 applies—means included in the Register under Chapter 4.

Note:          Section 41BJ deals with the application of Chapter 4 to medical devices.

5  Subsection 3(1) (paragraph (a) of the definition of medicine)

After “goods”, insert “(other than biologicals)”.

6  Subsection 3(1) (definition of therapeutic device)

After “means therapeutic goods”, insert “(other than biologicals)”.

7  Subsection 3(1) (definition of therapeutic goods)

After “and includes”, insert “biologicals,”.

8  After paragraph 6AAE(6)(b)

Insert:

                   (ba)  in the part of the Register for biologicals included under Part 3‑2A; or

9  Paragraph 7B(1)(b)

Omit “or are exempt goods in relation to Part 3‑2”, substitute “, are exempt goods in relation to Part 3‑2, are included in the Register under Part 3‑2A or are exempt under subsection 32CA(2) or section 32CB”.

10  After paragraph 9(1)(a)

Insert:

                    (aa)  the evaluation of a biological, other than a Class 1 biological, for inclusion in the Register under Part 3‑2A; or

11  Subsection 9A(3)

Omit “3 parts”, substitute “4 parts”.

12  After paragraph 9A(3)(b)

Insert:

                   (ba)  a part for biologicals included in the Register under Part 3‑2A; and

13  Paragraph 9A(4)(b)

Repeal the paragraph, substitute:

                     (b)  the ways in which goods that are included in one part of the Register may be transferred, or may be required to be transferred, to another part of the Register; and

14  After paragraph 9A(4)(c)

Insert:

                    (ca)  the ways in which a biological that has been assigned a number under subsection 32DB(2), 32DF(2) or 32DN(5) may be assigned a different number (which may be any combination of numbers and either or both of letters and symbols); and

15  After subsection 9D(3)

Insert:

          (3A)  If:

                     (a)  the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and

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

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

          (3B)  If:

                     (a)  a particular biological ceases to be a biological because of a determination under subsection 32A(3); and

                     (b)  the biological is included in the Register under Part 3‑2A;

the Secretary must move the entry relating to the biological from the part of the Register for biologicals to whichever other part of the Register is applicable.

16  Subsection 9D(4)

Omit “the part for goods to be known as registered goods or to the part for goods to be known as listed goods (whichever is applicable)”, substitute “whichever other part of the Register is applicable”.

17  After subsection 14(5)

Insert:

          (5A)  Subsection (1), (2) or (4) does not apply if:

                     (a)  the therapeutic goods are a biological; and

                     (b)  the person imports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (5A): see subsection 13.3(3) of the Criminal Code.

Note:       The heading to subsection 14(5) is replaced by the heading “Exceptions”.

18  After subsection 14(9)

Insert:

Exception

          (9A)  Subsection (6), (7) or (9) does not apply if:

                     (a)  the therapeutic goods are a biological; and

                     (b)  the person supplies the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (9A): see subsection 13.3(3) of the Criminal Code.

19  After subsection 14(13)

Insert:

Exception

        (13A)  Subsection (10), (11) or (13) does not apply if:

                     (a)  the therapeutic goods are a biological; and

                     (b)  the person exports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

Note:          A defendant bears an evidential burden in relation to the matter in subsection (13A): see subsection 13.3(3) of the Criminal Code.

20  After subsection 14A(1)

Insert:

Exception

          (1A)  Subsection (1) does not apply if:

                     (a)  the therapeutic goods are a biological; and

                     (b)  the person imports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

21  After subsection 14A(2)

Insert:

Exception

          (2A)  Subsection (2) does not apply if:

                     (a)  the therapeutic goods are a biological; and

                     (b)  the person supplies the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

22  After subsection 14A(3)

Insert:

Exception

          (3A)  Subsection (3) does not apply if:

                     (a)  the therapeutic goods are a biological; and

                     (b)  the person exports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred.

23  At the end of Part 3‑1

Add:

15AB  Conditions relating to exceptional release of biologicals

             (1)  Regulations made for the purposes of paragraphs 14(9A)(b) and 14A(2A)(b) may also prescribe conditions that apply in relation to the supply of a biological that occurs after the circumstances prescribed for the purposes of those paragraphs have occurred.

             (2)  The conditions prescribed by those regulations must apply only to the person supplying the biological.

             (3)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission results in the breach of any of the conditions referred to in subsection (1).

Penalty for contravention of this subsection:        60 penalty units.

24  After section 15A

Insert:

15B  Application of this Part to a biological

             (1)  Subject to this section, this Part does not apply to a biological on and after the commencement of this section.

Biologicals currently included in the Register

             (2)  If, immediately before the commencement of this section, therapeutic goods that are a biological were registered goods or listed goods, this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3‑2A.

Note:          Section 32DN deals with including the biological under Part 3‑2A.

Pending applications

             (3)  If:

                     (a)  before the commencement of this section, an application was made under this Part for the registration or listing of therapeutic goods that are a biological; and

                     (b)  immediately before that commencement, the application was not finally determined; and

                     (c)  the application had not been withdrawn before that commencement;

this Part continues to apply to the biological on and after that commencement until the earliest of the following:

                     (d)  the time the biological is included in the Register under Part 3‑2A;

                     (e)  if the application is unsuccessful when it is finally determined—the time the application is finally determined;

                      (f)  the time the application is withdrawn;

                     (g)  the time the application lapses.

Note:          Section 32DN deals with including the biological under Part 3‑2A.

             (4)  For the purposes of this section, 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.

Transitional

             (5)  This Part applies to a biological on and after the commencement of this section in relation to things done, or omitted to be done, in relation to the biological before the commencement of this section.

             (6)  If this Part continues to apply to a biological during a period described in subsection (2) or (3), then this Part also applies to the biological after the end of that period in relation to things done, or omitted to be done, in relation to the biological during that period.

25  After Part 3‑2

Insert:

Part 3‑2ABiologicals

Division 1Preliminary

32  What this Part is about

This Part regulates biologicals. It does this by providing a process for including biologicals in the Register and providing for enforcement through criminal offences and civil penalties.

This Part provides for the following administrative processes:

               (a)     exempting biologicals from the requirement to be included in the Register;

              (b)     making the inclusion of biologicals in the Register subject to conditions;

               (c)     suspending or cancelling entries of biologicals from the Register;

              (d)     requiring public notification of problems with biologicals, and recovery of biologicals;

               (e)     obtaining information or documents about biologicals.

32A  Meaning of biological

             (1)  Subject to subsection (3), a biological is a thing that:

                     (a)  either:

                              (i)  comprises, contains or is derived from human cells or human tissues; or

                             (ii)  is specified under subsection (2); and

                     (b)  is represented in any way to be, or is, whether because of the way in which it is presented or for any other reason, likely to be taken to be:

                              (i)  for use in the treatment or prevention of a disease, ailment, defect or injury affecting persons; or

                             (ii)  for use in making a medical diagnosis of the condition of a person; or

                            (iii)  for use in influencing, inhibiting or modifying a physiological process in persons; or

                            (iv)  for use in testing the susceptibility of persons to a disease or ailment; or

                             (v)  for use in the replacement or modification of parts of the anatomy in persons.

             (2)  The Secretary may, by legislative instrument, specify things for the purposes of subparagraph (1)(a)(ii).

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

             (3)  The Secretary may, by legislative instrument, determine that a specified thing is not a biological for the purposes of this Act.

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

32AA  Biological classes

                   The regulations may prescribe different classes of biologicals.

Note 1:       The regulations may prescribe the circumstances in which a biological included in a class of biologicals is separate and distinct from other biologicals: see section 32AB.

Note 2:       The Secretary may approve different application forms for different classes of biologicals: see section 32DD.

32AB  When biologicals are separate and distinct from other biologicals

             (1)  The regulations may prescribe the circumstances in which a biological included in a specified class of biologicals is separate and distinct from other biologicals.

             (2)  The regulations may make different provision in relation to different classes of biologicals that are prescribed by the regulations for the purposes of section 32AA.

Note:          The Secretary may cancel the entry of a biological from the Register if the biological has changed so that it has become separate and distinct from the biological as so included: see subsection 32GC(1).

Division 2Main criminal offences and civil penalties

32B  What this Division is about

This Division contains criminal offences and civil penalties relating to the import, export, manufacture, supply and use of biologicals.

32BA  Criminal offences for importing a biological

             (1)  A person commits an offence if:

                     (a)  the person imports into Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological;

                             (v)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person; and

                     (c)  either:

                              (i)  the use of the biological has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the biological, if the biological were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person imports into Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological;

                             (v)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person; and

                     (c)  the use of the biological, if the biological were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the person imports into Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological;

                             (v)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Defences

             (5)  Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the importation.

Note:          A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

             (6)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, or will not, directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological; or

                     (b)  harm or injury would not directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

32BB  Criminal offences for exporting a biological

             (1)  A person commits an offence if:

                     (a)  the person exports from Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological; and

                     (c)  either:

                              (i)  the use of the biological has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the biological, if the biological were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person exports from Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological; and

                     (c)  the use of the biological, if the biological were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the person exports from Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Defences

             (5)  Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the exportation.

Note:          A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

             (6)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, or will not, directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological; or

                     (b)  harm or injury would not directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

32BC  Criminal offences for manufacturing a biological

             (1)  A person commits an offence if:

                     (a)  the person manufactures in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB; and

                     (c)  either:

                              (i)  the use of the biological has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the biological, if the biological were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person manufactures in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB; and

                     (c)  the use of the biological, if the biological were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the person manufactures in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Defences

             (5)  Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the manufacture.

Note:          A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

             (6)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, or will not, directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological; or

                     (b)  harm or injury would not directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

32BD  Criminal offences for supplying a biological

             (1)  A person commits an offence if:

                     (a)  the person supplies in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;

                             (v)  the biological is the subject of an authority under subsection 32CM(1) that is held by the person;

                            (vi)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological; and

                     (c)  either:

                              (i)  the use of the biological has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the biological, if the biological were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person supplies in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;

                             (v)  the biological is the subject of an authority under subsection 32CM(1) that is held by the person;

                            (vi)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological; and

                     (c)  the use of the biological, if the biological were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the person supplies in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;

                             (v)  the biological is the subject of an authority under subsection 32CM(1) that is held by the person;

                            (vi)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Defences

             (5)  Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the supply.

Note:          A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

             (6)  Subsection (1) does not apply if:

                     (a)  harm or injury did not, or will not, directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological; or

                     (b)  harm or injury would not directly result from:

                              (i)  the quality, safety or efficacy of the biological; or

                             (ii)  a matter relating to the labelling or packaging of the biological; or

                            (iii)  the improper use of the biological.

Note:          A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

32BE  Notice required to adduce evidence in support of exception to offences

             (1)  If:

                     (a)  a defendant is committed for trial for an offence against subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(1); or

                     (b)  an offence against subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(1) is to be heard and determined by a court of summary jurisdiction;

the committing magistrate or the court must:

                     (c)  inform the defendant of the requirements of this section; and

                     (d)  cause a copy of this section to be given to the defendant.

             (2)  A defendant must not, without leave of the court, adduce evidence in support of the exception under subsection 32BA(6), 32BB(6), 32BC(6) or 32BD(6) unless the defendant gives notice of particulars of the exception:

                     (a)  if paragraph (1)(a) applies—more than 21 days before the trial begins; or

                     (b)  if paragraph (1)(b) applies—more than 21 days before the hearing of the offence begins.

             (3)  A defendant must not, without leave of the court, call any other person to give evidence in support of the exception unless:

                     (a)  the notice under subsection (2) includes the name and address of the person or, if the name and address is not known to the defendant at the time the defendant gives the notice, any information in the defendant’s possession that might be of material assistance in finding the person; and

                     (b)  if the name or the address is not included in the notice—the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address; and

                     (c)  if the name or address is not included in the notice, but the defendant subsequently ascertains the name or address or receives information that might be of material assistance in finding the person—the defendant immediately gives notice of the name, address or other information, as the case may be; and

                     (d)  if the defendant is told by or on behalf of the prosecutor that the person has not been found by the name, or at the address, given by the defendant:

                              (i)  the defendant immediately gives notice of any information in the defendant’s possession that might be of material assistance in finding the person; and

                             (ii)  if the defendant later receives any such information—the defendant immediately gives notice of the information.

             (4)  A notice purporting to be given under this section on behalf of the defendant by the defendant’s legal practitioner is, unless the contrary is proved, taken as having been given with the authority of the defendant.

             (5)  Any evidence tendered to disprove that the exception applies may, subject to direction by the court, be given before or after evidence is given in support of the exception.

             (6)  A notice under this section must be given in writing to the Director of Public Prosecutions. A notice is taken as having been given if it is:

                     (a)  delivered to or left at an office of the Office of the Director of Public Prosecutions; or

                     (b)  sent by certified mail addressed to the Director of Public Prosecutions at an office of the Office of the Director of Public Prosecutions.

             (7)  In this section:

Director of Public Prosecutions means a person holding office as, or acting as, the Director of Public Prosecutions under the Director of Public Prosecutions Act 1983.

32BF  Civil penalties for importing, exporting, manufacturing or supplying a biological

Importing a biological for use in humans

             (1)  A person contravenes this subsection if:

                     (a)  the person imports into Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological;

                             (v)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Exporting a biological for use in humans

             (2)  A person contravenes this subsection if:

                     (a)  the person exports from Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Manufacturing a biological for use in humans

             (3)  A person contravenes this subsection if:

                     (a)  the person manufactures in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Supplying a biological for use in humans

             (4)  A person contravenes this subsection if:

                     (a)  the person supplies in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;

                             (v)  the biological is the subject of an authority under subsection 32CM(1) that is held by the person;

                            (vi)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Exception if person was not the sponsor of the biological

             (5)  Subsection (1), (2), (3) or (4) does not apply if the person proves that he or she was not the sponsor of the biological at the time of the importation, exportation, manufacture or supply, as the case may be.

Civil penalty relating to the supply of biologicals included in the Register

             (6)  A person contravenes this subsection if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the biological is of a kind prescribed by the regulations for the purposes of this paragraph; and

                     (c)  the person supplies the biological in Australia; and

                     (d)  the biological number of the biological is not set out on the label of the biological in the prescribed manner.

Maximum civil penalty:

                     (a)  for an individual—200 penalty units; and

                     (b)  for a body corporate—2,000 penalty units.

32BG  Criminal offence and civil penalty relating to a failure to notify the Secretary about manufacturing

Criminal offence

             (1)  A person commits an offence if:

                     (a)  the person:

                              (i)  imports a biological into Australia for use in humans; or

                             (ii)  exports a biological from Australia for use in humans; or

                            (iii)  manufactures a biological in Australia for use in humans; or

                            (iv)  supplies a biological in Australia for use in humans; and

                     (b)  the person is the sponsor of the biological; and

                     (c)  the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and

                     (d)  the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:

                              (i)  the manufacturer of the biological;

                             (ii)  the premises used in the manufacture of the biological.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Civil penalty

             (2)  A person contravenes this subsection if:

                     (a)  the person:

                              (i)  imports a biological into Australia for use in humans; or

                             (ii)  exports a biological from Australia for use in humans; or

                            (iii)  manufactures a biological in Australia for use in humans; or

                            (iv)  supplies a biological in Australia for use in humans; and

                     (b)  the person is the sponsor of the biological; and

                     (c)  the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and

                     (d)  the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:

                              (i)  the manufacturer of the biological;

                             (ii)  the premises used in the manufacture of the biological.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Definition

             (3)  For the purposes of this section:

                     (a)  a manufacturer is properly notified to the Secretary if:

                              (i)  the manufacturer was nominated, as a manufacturer of the biological, in an application for inclusion of the biological in the Register; or

                             (ii)  the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the biological; and

                     (b)  premises are properly notified to the Secretary if:

                              (i)  the premises were nominated, as premises used in the manufacture of the biological, in an application for inclusion of the biological in the Register; or

                             (ii)  the Secretary was subsequently informed in writing that the premises are used in the manufacture of the biological.

32BH  Criminal offence relating to wholesale supply

                   A person commits an offence if:

                     (a)  the person supplies a biological in Australia for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;

                             (v)  the biological is the subject of an authority under subsection 32CM(1) that is held by the person;

                            (vi)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological; and

                     (c)  the person to whom the biological is supplied is not the ultimate consumer of the biological.

Penalty:  120 penalty units.

32BI  Criminal offence for using a biological not included in the Register

             (1)  A person commits an offence if:

                     (a)  the person uses a biological; and

                     (b)  the biological is used:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans; and

                     (c)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CO(1) or (2);

                             (v)  the person uses the biological in accordance with an approval under subsection 32CK(1);

                            (vi)  the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL;

                           (vii)  the person uses the biological in accordance with an authority under subsection 32CM(1); and

                     (d)  either:

                              (i)  if the person used the biological in the treatment of that other person—the use of the biological has resulted in, or will result in, harm or injury to that other person; or

                             (ii)  if the person used the biological solely for experimental purposes in humans—the use of the biological has resulted in, or will result in, harm or injury to any of those humans.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person uses a biological; and

                     (b)  the biological is used:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans; and

                     (c)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CO(1) or (2);

                             (v)  the person uses the biological in accordance with an approval under subsection 32CK(1);

                            (vi)  the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL;

                           (vii)  the person uses the biological in accordance with an authority under subsection 32CM(1); and

                     (d)  either:

                              (i)  if the person used the biological in the treatment of another person—the use of the biological is likely to result in harm or injury to that other person; or

                             (ii)  if the person used the biological solely for experimental purposes in humans—the use of the biological is likely to result in harm or injury to any of those humans.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the person uses a biological; and

                     (b)  the biological is used:

                              (i)  in the treatment of another person; or

                             (ii)  solely for experimental purposes in humans; and

                     (c)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CO(1) or (2);

                             (v)  the person uses the biological in accordance with an approval under subsection 32CK(1);

                            (vi)  the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL;

                           (vii)  the person uses the biological in accordance with an authority under subsection 32CM(1).

Penalty for contravention of this subsection:        500 penalty units.

32BJ  General criminal offences relating to this Part

Including incorrect biological number on containers etc.

             (1)  A person commits an offence if:

                     (a)  the person sets out or causes to be set out, on a container or package that contains a biological or on a label of a biological, a number that purports to be the biological number of the biological; and

                     (b)  the number is not that biological number.

Penalty:  60 penalty units.

             (2)  For the purposes of subsection (1), number includes any combination of one or more of the following:

                     (a)  numbers;

                     (b)  letters;

                     (c)  symbols.

Advertising biological for an indication

             (3)  A person commits an offence if:

                     (a)  the person, by any means, advertises a biological for an indication; and

                     (b)  the biological is included in the Register; and

                     (c)  the indication is not an indication accepted in relation to that inclusion.

Penalty:  60 penalty units.

Arranging supply of biological not included in Register

             (4)  A person commits an offence if:

                     (a)  the person claims, by any means, that the person or another person can arrange the supply of a biological; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;

                             (v)  the biological is the subject of an authority under subsection 32CM(1) that is held by the person;

                            (vi)  the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological.

Penalty for contravention of this subsection:        60 penalty units.

32BK  Civil penalty for making misrepresentations about biologicals

             (1)  A person contravenes this section if:

                     (a)  the person makes a representation of a kind referred to in subsection (2); and

                     (b)  the representation is false or misleading.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

             (2)  Subsection (1) applies to the following representations:

                     (a)  representations that a biological is included in the Register;

                     (b)  representations that a person is exempt under subsection 32CA(1) in relation to a biological or that a biological is exempt under subsection 32CA(2);

                     (c)  representations that a biological is exempt under section 32CB;

                     (d)  representations that a biological is the subject of an approval under subsection 32CK(1);

                     (e)  representations that a biological is the subject of an authority under subsection 32CM(1);

                      (f)  representations that a biological is the subject of an approval under subsection 32CO(1) or (2).

Division 3Exemptions

Subdivision APreliminary

32C  What this Division is about

There are 4 kinds of exemptions in relation to biologicals:

               (a)     exemptions of biologicals under the regulations; and

              (b)     exemptions of biologicals to deal with emergencies; and

               (c)     exemptions of biologicals for special and experimental uses; and

              (d)     exemptions of biologicals where substitutes are unavailable.

Subdivision BExempting biologicals under the regulations

32CA  Exempt biologicals

             (1)  The regulations may exempt specified persons from the operation of Division 4 in relation to specified biologicals.

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

             (2)  The regulations may exempt specified biologicals from the operation of Division 4.

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

             (3)  An exemption under this section may be subject to conditions that are prescribed in the regulations.

             (4)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission results in the breach of a condition of an exemption under this section.

Penalty:  60 penalty units.

             (5)  If the regulations revoke an exemption, the revocation takes effect on the day specified in the regulations. The day must not be earlier than 28 days after the day on which the regulations revoking the exemption take effect.

Subdivision CExempting biologicals to deal with emergencies

32CB  Minister may make exemptions

             (1)  The Minister may, by writing, exempt specified biologicals from the operation of Division 4.

Note 1:       For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901.

Note 2:       There are criminal offences and a civil penalty relating to biologicals exempt under this section not conforming to standards etc.: see section 32CJ.

             (2)  The Minister may make an exemption under subsection (1) only if the Minister is satisfied that, in the national interest, the exemption should be made so that:

                     (a)  the biologicals may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or

                     (b)  the biologicals can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.

Period of exemption

             (3)  An exemption under subsection (1) comes into force:

                     (a)  on the day the exemption is made; or

                     (b)  on a later day specified in the exemption.

             (4)  An exemption under subsection (1) remains in force for the period specified in the exemption, unless revoked earlier.

Note:          Section 32CD deals with variation and revocation of the exemption.

Effect of inclusion of biological in the Register

             (5)  An exemption under subsection (1) ceases to have effect in relation to a particular biological when that biological becomes included in the Register under Division 4.

Exemption not a legislative instrument

             (6)  An exemption under subsection (1) is not a legislative instrument.

32CC  Conditions of exemptions

                   An exemption under section 32CB is subject to conditions specified in the exemption about any of the following:

                     (a)  the quantity of biologicals that are exempt;

                     (b)  the source of those biologicals;

                     (c)  the persons or class of persons who may import, export, manufacture or supply those biologicals;

                     (d)  the supply of those biologicals (including the persons or class of persons to whom biologicals may be supplied for use and the circumstances under which a stockpile of biologicals may be supplied for use);

                     (e)  the storage and security of those biologicals;

                      (f)  the keeping and disclosure of, and access to, records about those biologicals;

                     (g)  the disposal of those biologicals;

                     (h)  the manner in which any of those biologicals is to be dealt with if a condition of the exemption is breached;

                      (i)  any other matters that the Minister thinks appropriate.

Whether or not biologicals are exempt under section 32CB is not affected by whether or not there is a breach of a condition under this section in relation to those biologicals.

Note 1:       There are criminal offences and civil penalties related to the breach of a condition of an exemption: see sections 32CH and 32CI.

Note 2:       Section 32CD deals with variation and revocation of the conditions.

32CD  Variation or revocation of exemption

Variation of exemption

             (1)  The Minister may, by writing, vary an exemption made under section 32CB by removing specified biologicals from the exemption.

Note:          For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901.

Revocation of exemption

             (2)  The Minister may, by writing, revoke an exemption made under section 32CB.

Variation or revocation of conditions

             (3)  The Minister may, by writing:

                     (a)  vary the conditions of an exemption made under section 32CB (including by imposing new conditions); or

                     (b)  revoke the conditions of an exemption made under section 32CB.

When variation or revocation takes effect

             (4)  A variation or revocation under this section takes effect:

                     (a)  if the Minister states in the variation or revocation that the variation or revocation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day the variation or revocation is made; or

                     (b)  in any other case—on a later day specified in the variation or revocation (which must not be earlier than 28 days after the day the variation or revocation is made).

32CE  Informing persons of exemption etc.

                   If the Minister makes an exemption under section 32CB, the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph 32CC(c):

                     (a)  the exemption;

                     (b)  any variation or revocation of the exemption under section 32CD.

32CF  Notification and tabling

Notification

             (1)  The Secretary must cause a notice setting out particulars of the following:

                     (a)  an exemption made under section 32CB because of paragraph 32CB(2)(b);

                     (b)  a variation or revocation under section 32CD, to the extent that the variation or revocation relates to an exemption made under section 32CB because of paragraph 32CB(2)(b);

to be published in the Gazette within 7 days after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.

Tabling

             (2)  The Minister must cause a document setting out particulars of the following:

                     (a)  an exemption made under section 32CB because of paragraph 32CB(2)(b);

                     (b)  a variation or revocation under section 32CD, to the extent that the variation or revocation relates to an exemption made under section 32CB because of paragraph 32CB(2)(b);

to be tabled in each House of the Parliament within 5 sitting days of that House after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection.

32CG  Disposal of unused biologicals

             (1)  This section applies to a biological if:

                     (a)  an exemption under section 32CB in relation to that biological ceases to have effect otherwise than because that biological becomes included in the Register under Division 4; and

                     (b)  that biological has not been used before the exemption so ceases to have effect.

             (2)  The Secretary may arrange for the disposal of the biological in accordance with the regulations.

             (3)  Regulations made for the purposes of subsection (2) may set out the methods by which the biological is to be stored, supplied, destroyed, exported or otherwise disposed of.

             (4)  A method set out in the regulations under subsection (3) must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the biological.

32CH  Criminal offences for breaching a condition of an exemption

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a biological; and

                     (b)  the biological is covered by an exemption in force under section 32CB; and

                     (c)  the act or omission results in the breach of a condition of the exemption; and

                     (d)  the act or omission is likely to cause a serious risk to public health.

Penalty:  Imprisonment for 5 years or 2,000 penalty units, or both.

             (2)  Strict liability applies to paragraph (1)(b).

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

             (3)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a biological; and

                     (b)  the biological is covered by an exemption in force under section 32CB; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  Imprisonment for 4 years or 240 penalty units, or both.

             (4)  Strict liability applies to paragraph (3)(b).

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

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a biological; and

                     (b)  the biological is covered by an exemption in force under section 32CB; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  60 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

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

32CI  Civil penalty for breaching a condition of an exemption

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act in relation to a biological; and

                     (b)  the biological is covered by an exemption in force under section 32CB; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

32CJ  Criminal offences and civil penalty for biologicals not conforming to standards etc.

             (1)  This section applies if:

                     (a)  a biological is exempt under section 32CB; and

                     (b)  a person supplies a batch of the biologicals; and

                     (c)  the Secretary is satisfied that the biologicals included in that batch:

                              (i)  do not conform to a standard applicable to the biologicals; or

                             (ii)  are otherwise not fit to be used for their intended purposes.

             (2)  The Secretary may, by written notice given to the person, require the person to take steps to recover the biologicals included in that batch (except any of those biologicals that cannot be recovered because they have been administered to, or applied in the treatment of, a person).

             (3)  The notice may specify one or more of the following requirements:

                     (a)  the steps to be taken to recover the biologicals;

                     (b)  the manner in which the steps are to be taken;

                     (c)  a reasonable period within which the steps are to be taken.

             (4)  The Secretary must, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette.

Notice is not a legislative instrument

             (5)  A notice given under subsection (2) is not a legislative instrument.

Offences

             (6)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement; and

                     (d)  either:

                              (i)  the use of any of the biologicals has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of any of the biologicals, if any of the biologicals were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the person failed to comply with that requirement.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

             (7)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement; and

                     (d)  the use of any of the biologicals, if any of the biologicals were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the person failed to comply with that requirement.

Penalty:  2,000 penalty units.

             (8)  An offence against subsection (7) is an offence of strict liability.

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

             (9)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person fails to comply with that requirement.

Penalty:  60 penalty units.

           (10)  An offence against subsection (9) is an offence of strict liability.

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

Civil penalty

           (11)  A person contravenes this subsection if:

                     (a)  the Secretary gives a notice to the person under subsection (2); and

                     (b)  the notice specifies a particular requirement mentioned in subsection (3); and

                     (c)  the person does not comply with the requirement.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Subdivision DExempting biologicals for special and experimental uses

32CK  Approvals for importing, exporting or supplying a biological for special and experimental uses

             (1)  The Secretary may, by notice in writing, grant an approval to a person for one or more of the following:

                     (a)  the importation into Australia of a specified biological;

                     (b)  the exportation from Australia of a specified biological;

                     (c)  the supply in Australia of a specified biological;

that is:

                     (d)  for use in the treatment of another person; or

                     (e)  for use solely for experimental purposes in humans.

             (2)  Subsection (1) does not apply if the biological is included in the Register, the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2).

Application for approval

             (3)  An application for an approval for use of the kind referred to in paragraph (1)(d) must:

                     (a)  be made to the Secretary; and

                     (b)  be accompanied by such information relating to the biological the subject of the application as is required by the Secretary.

             (4)  An application for an approval for use of the kind referred to in paragraph (1)(e) must:

                     (a)  be made to the Secretary; and

                     (b)  be made in writing; and

                     (c)  be accompanied by such information relating to the biological the subject of the application as is required by the Secretary; and

                     (d)  be accompanied by the prescribed evaluation fee.

Secretary’s decision

             (5)  If an application for an approval is made, the Secretary must:

                     (a)  after having considered the application; and

                     (b)  in the case of an application for an approval for use of the kind referred to in paragraph (1)(e)—after having evaluated the information submitted with the application;

notify the applicant of the decision on the application as soon as practicable after making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

Conditions

             (6)  The Secretary may grant an approval under subsection (1) subject to any conditions that are specified in the notice of approval.

             (7)  Those conditions may include a condition relating to the charges that may be made for the biological to which the approval relates. This subsection does not limit subsection (6).

             (8)  An approval under subsection (1) for use of the kind referred to in paragraph (1)(e) is subject to the conditions (if any) specified in the regulations. Those conditions (if any) are in addition to any conditions imposed under subsection (6).

             (9)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission results in the breach of a condition of an approval under subsection (1).

Penalty:  60 penalty units.

Approval not a legislative instrument

           (10)  An approval under subsection (1) is not a legislative instrument.

32CL  Conditions of use of biological for experimental purposes in humans

             (1)  The use by a person (the experimenter) for experimental purposes in humans of a biological that is the subject of an approval:

                     (a)  that is held by another person under subsection 32CK(1); and

                     (b)  that covers the importation into Australia, or the supply in Australia, of the biological for use solely for experimental purposes in humans;

is subject to the conditions (if any) specified in the regulations relating to one or more of the following:

                     (c)  the preconditions on the use of the biological for those purposes;

                     (d)  the principles to be followed in the use of the biological for those purposes;

                     (e)  the monitoring of the use, and the results of the use, of the biological for those purposes;

                      (f)  the circumstances in which the experimenter must cease the use of the biological for those purposes.

             (2)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission results in the breach of a condition applicable under regulations made for the purposes of this section.

Penalty for contravention of this subsection:        60 penalty units.

32CM  Exemptions for medical practitioners

             (1)  The Secretary may, in writing, authorise a specified medical practitioner to supply a specified biological, for use in the treatment of humans, to the class or classes of recipients specified in the authority.

Note:          Section 32CN contains criminal offences relating to the giving an authority to a medical practitioner.

             (2)  The Secretary may give an authority under subsection (1) subject to any conditions that are specified in the authority.

             (3)  The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (1) by giving to the person written notice of the conditions (or further conditions).

             (4)  An authority under subsection (1) may only be given:

                     (a)  to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; or

                     (b)  to a medical practitioner who has the approval of an ethics committee to supply the specified biological.

Paragraph (b) does not apply in the exceptional circumstances (if any) prescribed by the regulations for the purposes of this subsection.

             (5)  An authority under subsection (1) may only be given in relation to a class or classes of recipients prescribed by the regulations for the purposes of this subsection.

             (6)  The regulations may prescribe the circumstances in which a biological may be supplied under an authority under subsection (1).

             (7)  An authority under subsection (1) is not a legislative instrument.

             (8)  In this section:

medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.

32CN  Criminal offences relating to the giving of an authority to a medical practitioner

             (1)  A person commits an offence if:

                     (a)  the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and

                     (b)  the person supplies the biological; and

                     (c)  any of the following applies:

                              (i)  the supply is not in accordance with the authority;

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject;

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 32CM(6); and

                     (d)  either:

                              (i)  the use of the biological has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the biological, if the biological were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 32CM(6).

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and

                     (b)  the person supplies the biological; and

                     (c)  any of the following applies:

                              (i)  the supply is not in accordance with the authority;

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject;

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 32CM(6); and

                     (d)  the use of the biological, if the biological were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because:

                              (i)  the supply is not in accordance with the authority; or

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject; or

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 32CM(6).

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the Secretary has authorised, under subsection 32CM(1), the person to supply a biological; and

                     (b)  the person supplies the biological; and

                     (c)  any of the following applies:

                              (i)  the supply is not in accordance with the authority;

                             (ii)  the supply is not in accordance with the conditions to which the authority is subject;

                            (iii)  the supply is not in accordance with regulations made for the purpose of subsection 32CM(6).

Penalty for contravention of this subsection:        500 penalty units.

Subdivision EExempting biologicals where substitutes are unavailable etc.

32CO  Approvals where substitutes for biologicals are unavailable etc.

             (1)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified biological; or

                     (b)  the importation into Australia of a specified biological and the supply in Australia of that biological;

if the Secretary is satisfied that:

                     (c)  therapeutic goods included in the Register that could act as a substitute for the biological are unavailable or are in short supply; and

                     (d)  either:

                              (i)  the biological that is the subject of the application for approval is registered or approved for general marketing in at least one foreign country specified by the Secretary under subsection (5); or

                             (ii)  an application that complies with section 32DA or 32DD has been made for inclusion of the biological in the Register; and

                     (e)  the biological is of a kind specified by the Secretary in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

             (2)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified biological; or

                     (b)  the importation into Australia of a specified biological and the supply in Australia of that biological;

if the Secretary is satisfied that:

                     (c)  there are no therapeutic goods that are included in the Register that could act as a substitute for the biological; and

                     (d)  an application that complies with section 32DA or 32DD has been made for inclusion of the biological in the Register; and

                     (e)  the biological is of a kind specified by the Secretary in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

Application for approval

             (3)  An application for an approval must:

                     (a)  be made to the Secretary; and

                     (b)  be accompanied by such information relating to the biological as is required by the Secretary.

Secretary’s decision

             (4)  If an application for an approval is made, the Secretary must, after having considered the application, notify the applicant of the decision on the application as soon as practicable after making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

Determinations

             (5)  The Secretary may, by legislative instrument, make a determination specifying foreign countries for the purposes of subparagraph (1)(d)(i).

             (6)  The Secretary may, by legislative instrument, make a determination specifying the kinds of biologicals that can be the subject of an approval under this section.

Conditions

             (7)  The Secretary may grant an approval subject to any conditions that are specified in the notice of approval.

             (8)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission results in the breach of a condition of an approval under subsection (1) or (2).

Penalty:  60 penalty units.

Period of approval

             (9)  The Secretary may grant an approval for such period as is specified in the notice of approval.

When approval lapses

           (10)  The approval lapses if:

                     (a)  the period specified in the notice of approval expires; or

                     (b)  a decision has been made on an application that has been made for inclusion of the biological in the Register.

           (11)  The approval lapses if:

                     (a)  the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f), or paragraph (2)(c), (d), (e) or (f), as the case requires, no longer applies in relation to the biological, or that a condition of the approval has been contravened; and

                     (b)  the Secretary has given to the person to whom the approval was granted a notice stating that the Secretary is so satisfied.

           (12)  The lapsing of the approval on the expiry of the period specified in the notice of approval does not prevent another approval being granted under this section in relation to the biological before that lapsing. The other approval may be expressed to take effect on the expiry of that period.

Approval not a legislative instrument

           (13)  An approval under subsection (1) or (2) is not a legislative instrument.

Division 4Including biologicals in the Register

Subdivision APreliminary

32D  What this Division is about

A Class 1 biological can be included in the Register if a proper application is made and the applicant certifies various matters.

A biological other than a Class 1 biological can be included in the Register if a proper application is made and the Secretary is satisfied the biological is suitable for inclusion following an evaluation of the biological.

Subdivision BClass 1 biologicals

32DA  Application for inclusion in the Register

             (1)  A person may make an application to the Secretary to include a Class 1 biological in the Register.

             (2)  An application must:

                     (a)  be made in accordance with a form that is approved, in writing, by the Secretary; and

                     (b)  be accompanied by a statement certifying the matters mentioned in subsection (3); and

                     (c)  be delivered to an office of the Department specified in the form; and

                     (d)  be accompanied by the prescribed application fee.

             (3)  The applicant must certify that:

                     (a)  the biological is a Class 1 biological; and

                     (b)  the biological is safe for the purposes for which it is to be used; and

                     (c)  the biological conforms to every standard (if any) applicable to it; and

                     (d)  the biological complies with every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and

                     (e)  the biological complies with all prescribed quality or safety criteria that are applicable to it; and

                      (f)  the biological does not contain substances that are prohibited imports for the purposes of the Customs Act 1901.

             (4)  An approval of a form may require or permit an application 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.

32DB  Inclusion of Class 1 biological in the Register

             (1)  If an application is made in accordance with section 32DA for a Class 1 biological to be included in the Register in relation to a person, the Secretary must include the biological in the Register in relation to the person.

Biological number

             (2)  If the Secretary includes the biological in the Register, the Secretary must assign a unique number to the biological. The number assigned may be any combination of numbers and either or both of letters and symbols.

Note:          The number assigned is the biological number of the biological.

Certificate

             (3)  As soon as practicable after the biological has been included in the Register, the Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.

             (4)  The certificate must:

                     (a)  specify the biological number of the biological; and

                     (b)  specify the day on which the inclusion of the biological in the Register commences.

Duration of inclusion in the Register

             (5)  The biological remains included in the Register in relation to the person until the Secretary cancels the entry of the biological from the Register under this Part.

Note:          The biological is taken not to be included in the Register while it is suspended: see section 32FD.

32DC  Refusal to include Class 1 biological in the Register

                   If:

                     (a)  an application is made under subsection 32DA(1) to include a Class 1 biological in the Register; and

                     (b)  the Secretary refuses the application;

the Secretary must, as soon as practicable after the refusal, give the person notice of the refusal and of the reasons for the refusal.

Subdivision CBiologicals other than Class 1 biologicals

32DD  Application for inclusion in the Register

             (1)  A person may make an application to the Secretary to include a biological, other than a Class 1 biological, in the Register.

             (2)  An application is not effective unless:

                     (a)  the application is made in accordance with a form that is approved, in writing, by the Secretary and that relates to that biological; and

                     (b)  the application is accompanied by any documents that the form requires; and

                     (c)  the application is delivered to an office of the Department specified in the form; and

                     (d)  if the Secretary so requires—the applicant has delivered to that office a reasonable number of samples of the biological; and

                     (e)  the application is accompanied by the prescribed application fee.

Note:          An evaluation fee is also payable: see sections 32DI to 32DM.

             (3)  The Secretary may approve different forms for different classes of biologicals that are prescribed by the regulations for the purposes of section 32AA.

             (4)  An approval of a form may require or permit an application 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.

32DE  Evaluation of biologicals

             (1)  If an application is made in accordance with section 32DD for a biological to be included in the Register in relation to a person, the Secretary must evaluate the biological for inclusion in the Register, having regard to:

                     (a)  whether the quality, safety and efficacy of the biological for the purposes for which it is to be used have been satisfactorily established; and

                     (b)  whether the presentation of the biological is acceptable; and

                     (c)  whether the biological conforms to any standard applicable to it; and

                     (d)  whether the biological complies with every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and

                     (e)  if a step in the manufacture of the biological has been carried out outside Australia and the biological is not exempt from the operation of Part 3‑3—whether the manufacturing and quality control procedures used in the step are acceptable; and

                      (f)  if a step in the manufacture of the biological has been carried out in Australia, the biological is not exempt from the operation of Part 3‑3 and the person is not exempt from the operation of that Part in relation to that step—whether that step has been carried out in accordance with that Part; and

                     (g)  whether the biological contains substances that are prohibited imports for the purposes of the Customs Act 1901; and

                     (h)  whether all of the manufacturers of the biological are nominated as manufacturers of the biological in the application; and

                      (i)  such other matters (if any) as the Secretary considers relevant.

             (2)  For the purposes of paragraph (1)(e), subsections 25(2), (2E), (2F) and (2G) apply in a way corresponding to the way in which they apply for the purposes of paragraph 25(1)(g).

32DF  Inclusion of biological in the Register

             (1)  If:

                     (a)  an application is made in accordance with section 32DD for a biological to be included in the Register in relation to a person; and

                     (b)  the Secretary decides that it is appropriate to include the biological in the Register after an evaluation under section 32DE; and

                     (c)  no part of an evaluation fee under section 32DI that is due and payable by the person remains unpaid;

the Secretary must include the biological in the Register in relation to the person.

Biological number

             (2)  If the Secretary includes the biological in the Register, the Secretary must assign a unique number to the biological. The number assigned may be any combination of numbers and either or both of letters and symbols.

Note:          The number assigned is the biological number of the biological.

Certificate

             (3)  As soon as practicable after the biological has been included in the Register, the Secretary must give to the applicant a certificate of the inclusion of the biological in the Register.

             (4)  The certificate must:

                     (a)  specify the biological number of the biological; and

                     (b)  specify the day on which the inclusion of the biological in the Register commences.

Duration of inclusion in the Register

             (5)  The biological remains included in the Register in relation to the person until the Secretary cancels the entry of the biological from the Register under this Part.

Note:          The biological is taken not to be included in the Register while it is suspended: see section 32FD.

32DG  Refusal to include biological in the Register

                   If:

                     (a)  an application is made under subsection 32DD(1) to include a biological in the Register; and

                     (b)  the Secretary refuses the application;

the Secretary must, as soon as practicable after the refusal, give the person notice of the refusal and of the reasons for the refusal.

32DH  Lapsing of application

             (1)  An application under subsection 32DD(1) for inclusion of a biological in the Register lapses if:

                     (a)  any part of the evaluation fee payable in respect of the biological remains unpaid at the end of the period of 42 days after the day on which the part became due and payable; or

                     (b)  information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purpose of a requirement under section 32JA, is false or misleading in a material particular; or

                     (c)  the applicant fails to comply with a requirement under section 32JA to give information consisting of patient data in relation to the biological.

             (2)  In this section:

patient data, in relation to a biological, means information, derived from clinical trials, relating to individuals before, during and after the administration of the biological to those individuals, including, but not limited to, demographic, biochemical and haematological information.

32DI  Evaluation fee

             (1)  If an application is made in accordance with section 32DD for a biological to be included in the Register, an evaluation fee specified in, or determined in accordance with, the regulations is payable by the applicant in respect of the evaluation of the biological for inclusion in the Register.

             (2)  The Secretary must notify the applicant in writing of the amount of the evaluation fee.

32DJ  When evaluation fee due for payment

             (1)  Subject to sections 32DK and 32DM, an evaluation fee payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

             (2)  The evaluation fee is payable in the manner prescribed by the regulations.

32DK  Payment of evaluation fee by instalments

             (1)  The regulations may provide for the payment of an evaluation fee to be made by such instalments and at such times as are ascertained in accordance with the regulations, and the evaluation fee is due and payable accordingly.

             (2)  Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee by instalments if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment.

             (3)  If:

                     (a)  the regulations make provision as mentioned in subsection (2); and

                     (b)  an instalment of an evaluation fee under section 32DI was unpaid immediately after the time when it became due for payment;

the balance of the evaluation fee becomes due and payable immediately.

             (4)  Subsection (2) does not limit subsection (1).

32DL  Recovery of evaluation fee

                   An evaluation fee may be recovered by the Commonwealth as a debt due to the Commonwealth.

32DM  Reduction of evaluation fee where evaluation not completed within prescribed period

             (1)  Nothing in section 32DI, 32DJ or 32DK requires the applicant to pay more than 3/4 of the evaluation fee before the completion of the evaluation if a period is prescribed under paragraph 63(2)(daa) for completing the evaluation.

             (2)  The Secretary must notify the applicant in writing of the day the evaluation is completed.

             (3)  If the evaluation is not completed within that period, the evaluation fee is 3/4 of the fee that, apart from this subsection, would have been the evaluation fee.

             (4)  If:

                     (a)  the evaluation is completed within that period; and

                     (b)  part of the evaluation fee under section 32DI is unpaid when the evaluation is completed;

that part becomes due and payable on the completion of the evaluation.

             (5)  For the purposes of this section, if a copy of the evaluation report, or a summary of that report, is given to either or both of the following:

                     (a)  the applicant;

                     (b)  a committee established under the regulations to advise the Secretary on applications to include biologicals in the Register where a period for evaluating the biologicals is prescribed under paragraph 63(2)(daa);

then the evaluation is taken to be completed immediately before the first copy or summary is so given.

Note:          This subsection has the effect that if the applicant withdraws the application after being given a copy of the evaluation report, or a summary of that report, before the end of that period, the full evaluation fee is due and payable by the applicant.

             (6)  A notification under subsection (2) is not a legislative instrument.

Subdivision DTransitional provisions for existing biologicals

32DN  Transitional provisions for existing biologicals

Biologicals currently included in the Register

             (1)  If, immediately before the commencement of this section, therapeutic goods that are a biological were included in relation to a person:

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

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

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

then, as soon as practicable after the commencement of this section, the Secretary must:

                     (d)  by writing, cancel the inclusion of the goods in that part; and

                     (e)  include the biological in the Register under this Part in relation to the person; and

                      (f)  vary the Register as a result of that cancellation and inclusion.

Pending applications

             (2)  If:

                     (a)  before the commencement of this section, an application was made for the registration or listing of therapeutic goods that are a biological or for the inclusion of such goods in the Register under Chapter 4; and

                     (b)  immediately before that commencement, the application was not finally determined; and

                     (c)  the application has not been, and is not, withdrawn either before or after that commencement; and

                     (d)  the application is successful when it is finally determined; and

                     (e)  the goods are included:

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

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

                            (iii)  in the part of the Register for medical devices included in the Register under Chapter 4;

then, as soon as practicable after that inclusion, the Secretary must:

                      (f)  by writing, cancel the inclusion of the goods in that part; and

                     (g)  include the biological in the Register under this Part in relation to the person; and

                     (h)  vary the Register as a result of that cancellation and inclusion.

             (3)  For the purposes of this section, 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.

Notice of decisions

             (4)  The Secretary must give the person written notice of the cancellation and inclusion under subsection (1) or (2).

Biological number

             (5)  If the Secretary includes the biological in the Register under subsection (1) or (2), the Secretary must assign a unique number to the biological. The number assigned may be any combination of numbers and either or both of letters and symbols.

Note:          The number assigned is the biological number of the biological.

Certificate

             (6)  As soon as practicable after the biological has been included in the Register under this Part, the Secretary must give to the person a certificate of the inclusion of the biological in the Register.

             (7)  The certificate must:

                     (a)  specify the biological number of the biological; and

                     (b)  specify the day on which the inclusion of the biological in the Register under this Part commences.

Duration of inclusion in the Register

             (8)  The biological remains included in the Register in relation to the person until the Secretary cancels the entry of the biological from the Register under this Part.

Note:          The biological is taken not to be included in the Register while it is suspended: see section 32FD.

Annual charge

             (9)  If, during a financial year, the Secretary includes a biological in the Register under subsection (1) or (2), subsection 4(1AA) of the Therapeutic Goods (Charges) Act 1989 does not apply in relation to the biological for that financial year.

No review of decisions

           (10)  A decision under this section is taken not to be an initial decision for the purposes of section 60.

Subdivision ECriminal offences and civil penalties

32DO  Criminal offences for false statements in applications for including biologicals in the Register

             (1)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in, or in connection with, an application for inclusion of a biological in the Register; and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the biological has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the biological, if the biological were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in, or in connection with, an application for inclusion of a biological in the Register; and

                     (c)  the statement is false or misleading in a material particular; and

                     (d)  the use of the biological, if the biological were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the person makes a statement; and

                     (b)  the statement is made in, or in connection with, an application for inclusion of a biological in the Register; and

                     (c)  the statement is false or misleading in a material particular.

Penalty for contravention of this subsection:        Imprisonment for 12 months or 1,000 penalty units, or both.

32DP  Civil penalty for false statements in applications for including biologicals in the Register

                   A person contravenes this section if the person in, or in connection with, an application for inclusion of a biological in the Register, makes a statement that is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

32DQ  Criminal offence and civil penalty for failing to notify adverse effects etc. of biological while it is included in the Register

Criminal offence

             (1)  A person commits an offence if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person knows that particular information is information of a kind to which subsection (3) applies; and

                     (c)  the person fails to give that information to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Civil penalty

             (2)  A person contravenes this subsection if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person knows that particular information is information of a kind to which subsection (3) applies; and

                     (c)  the person fails to give that information to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

Relevant information

             (3)  This subsection applies to information of the following kinds:

                     (a)  information that contradicts information already given by the person under this Act in relation to the biological (including information given about the quality, safety or efficacy of the biological);

                     (b)  information that indicates that the use of the biological in accordance with the recommendations for its use may have an unintended harmful effect;

                     (c)  information that indicates that the biological, when used in accordance with the recommendations for its use, may not be as effective as the application for inclusion of the biological in the Register or information already given by the person under this Act suggests.

32DR  Criminal offences and civil penalties for failing to notify adverse effects etc. of biological where application withdrawn or lapses

             (1)  If an application for inclusion of a biological in the Register is withdrawn or lapses, the Secretary may, within 14 days after the application is withdrawn or lapses, give the applicant written notice requiring the applicant:

                     (a)  to inform the Secretary in writing whether the applicant is aware of any information of a kind to which subsection (2) applies; and

                     (b)  if the applicant is aware of such information, to give the information to the Secretary in writing.

             (2)  This subsection applies to information of the following kinds:

                     (a)  information that contradicts information already given by the person under this Act in relation to the biological (including information given about the quality, safety or efficacy of the biological);

                     (b)  information that indicates that the use of the biological in accordance with the recommendations for its use may have an unintended harmful effect;

                     (c)  information that indicates that the biological, when used in accordance with the recommendations for its use, may not be as effective as the application for inclusion of the biological in the Register or information already given by the person under this Act suggests.

Offences

             (3)  A person commits an offence if:

                     (a)  the Secretary gives a notice to the person under subsection (1); and

                     (b)  the person fails to comply with the notice within 30 days after the notice is given to the person.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

             (4)  A person commits an offence if:

                     (a)  the person gives information in purported compliance with a notice under subsection (1); and

                     (b)  the information is false or misleading in a material particular.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Civil penalties

             (5)  A person contravenes this subsection if:

                     (a)  the Secretary gives a notice to the person under subsection (1); and

                     (b)  the person fails to comply with the notice within 30 days after the notice is given to the person.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

             (6)  A person contravenes this subsection if:

                     (a)  the person gives information in purported compliance with a notice under subsection (1); and

                     (b)  the information is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—3,000 penalty units; and

                     (b)  for a body corporate—30,000 penalty units.

Subdivision FAdvice from Gene Technology Regulator

32DS  Consultation with Gene Technology Regulator

             (1)  This section applies to an application for inclusion of a biological in the Register if the biological is, or contains, a GM product or a genetically modified organism.

             (2)  Subject to subsection (5), the Secretary must give written notice to the Gene Technology Regulator:

                     (a)  stating that the application has been made; and

                     (b)  requesting the Gene Technology Regulator to give advice about the application.

             (3)  If the Secretary gives the Gene Technology Regulator a notice under subsection (2), the Gene Technology Regulator may give written advice to the Secretary about the application.

             (4)  The advice is to be given within the period specified in the notice.

             (5)  If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

             (6)  A notice under subsection (2) is not a legislative instrument.

32DT  Secretary may seek advice about classes of GM products or genetically modified organisms

             (1)  The Secretary may request advice from the Gene Technology Regulator in relation to:

                     (a)  biologicals that consist of, or that contain, a GM product belonging to a class of GM products specified in the request; or

                     (b)  biologicals that consist of, or that contain, genetically modified organisms belonging to a class of genetically modified organisms specified in the request.

             (2)  A request for advice under subsection (1) must specify the matters to which the advice is to relate.

             (3)  If the Secretary requests advice from the Gene Technology Regulator under subsection (1), the Gene Technology Regulator may provide written advice in relation to the matters specified in the request.

             (4)  If the Gene Technology Regulator gives advice to the Secretary under subsection (3), the advice remains in force until it is withdrawn by the Gene Technology Regulator by written notice given to the Secretary.

32DU  Secretary to take advice into account

                   If the Secretary receives advice from the Gene Technology Regulator:

                     (a)  in response to a notice under section 32DS within the period specified in the notice; or

                     (b)  under section 32DT;

the Secretary must:

                     (c)  ensure that the advice is taken into account in making a decision on the application to which the notice relates, or on an application to which the advice under section 32DT relates, as the case requires; and

                     (d)  inform the Gene Technology Regulator of the decision on the application.

Division 5Conditions

32E  What this Division is about

Inclusions of biologicals in the Register are subject to certain automatic conditions. The Minister and the Secretary may impose further conditions.

32EA  Conditions applying automatically

Entry and inspection powers

             (1)  The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will:

                     (a)  allow an authorised person:

                              (i)  to enter, at any reasonable time, any premises (including premises outside Australia) at which that person or any other person deals with the biological; and

                             (ii)  while on those premises, to inspect those premises and any biological on those premises and to examine, take measurements of, conduct tests on or take samples of any biological on those premises or any thing on those premises that relates to any biological; and

                            (iii)  while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and

                     (b)  if requested to do so by an authorised person, produce to the person such documents relating to the biological included in the Register as the person requires and allow the person to copy the documents.

             (2)  An authorised person is not authorised to enter premises as mentioned in subsection (1) unless the person has shown his or her identity card issued under section 52 if required by the occupier of the premises. For the purposes of this subsection, occupier, in relation to premises, includes a person present at the premises who is in apparent control of the premises.

Delivery of samples

             (3)  The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will deliver a reasonable number of samples of the biological if the Secretary so requests:

                     (a)  within the period, of not less than 14 days after the day the request is made, specified in the request; and

                     (b)  in accordance with any other requirements specified in the request.

Manufacturing

             (4)  The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will:

                     (a)  if a manufacturer who was not nominated as a manufacturer of the biological in the application for inclusion of the biological in the Register is to become a manufacturer of a step in the manufacture of the biological—inform the Secretary in writing of that fact and of the name and address of that manufacturer before that manufacturer begins to carry out that step; and

                     (b)  if premises that were not nominated in the application as premises to be used in the manufacture of the biological are to become premises used in a step in the manufacture of the biological—inform the Secretary in writing of that fact and of the name and address of the new premises before the premises are first so used.

             (5)  The inclusion of a biological, other than a Class 1 biological, in the Register is subject to a condition that:

                     (a)  each step in the manufacture of the biological that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3‑3 in relation to that step; and

                     (b)  each step in the manufacture of the biological that is carried out outside Australia is the subject of a certification in force under subsection 32EB(2).

             (6)  Subsection (5) does not apply if the biological is exempt from the operation of Part 3‑3.

             (7)  Paragraph (5)(b) does not apply in relation to a step that was the subject of the evaluation under section 32DE. This subsection ceases to apply in relation to that step if either or both of the following occur:

                     (a)  that step begins to be carried out at premises that are different from the premises in respect of which that evaluation was conducted;

                     (b)  that step begins to be carried out by a manufacturer that is different from the manufacturer in respect of which that evaluation was conducted.

Expiry date

             (8)  The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will not supply a batch of the biological in Australia, or export a batch of the biological from Australia, after the expiry date for the biological.

Advertising

             (9)  The inclusion of a biological in the Register is subject to a condition that the person in relation to whom the biological is included in the Register will not, by any means, advertise the biological for an indication other than an indication accepted in relation to that inclusion.

32EB  Certification of manufacturing steps outside Australia

             (1)  The person in relation to whom a biological, other than a Class 1 biological, is included in the Register may apply to the Secretary for a certification under this section of a step in the manufacture of the biological that is to be carried out outside Australia.

             (2)  If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable. The Secretary must give the person written notice of the certification.

             (3)  In deciding whether to give the certification, subsections 25(2), (2E), (2F) and (2G) apply in a way corresponding to the way in which they apply for the purposes of paragraph 25(1)(g).

32EC  Imposition of conditions by legislative instrument

             (1)  The inclusion of a biological in the Register is subject to the conditions set out in a determination under subsection (2).

             (2)  The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1), being conditions that relate to:

                     (a)  the manufacture of the biological; or

                     (b)  the custody, use, supply, disposal or destruction of the biological; or

                     (c)  the keeping of records relating to the biological; or

                     (d)  matters dealt with in, or matters additional to matters dealt with in, standards applicable to the biological; or

                     (e)  such other matters relating to the biological as the Minister thinks appropriate.

             (3)  Without limiting subsection (2), different conditions may be specified for different classes of biologicals.

32ED  Imposition of conditions at time biological included in the Register

             (1)  If the Secretary includes a biological in the Register in relation to a person, the Secretary may, by notice in writing given to the person, impose conditions on the inclusion of the biological in the Register.

             (2)  A notice under subsection (1) is not a legislative instrument.

32EE  Imposition or variation or removal of conditions after biological included in the Register

             (1)  The Secretary may, by notice in writing given to the person in relation to whom a biological is included in the Register, impose new conditions on the inclusion or vary or remove conditions imposed under section 32ED or this subsection.

             (2)  The Secretary’s power under subsection (1) may be exercised at the request of the person concerned or on the Secretary’s own initiative. A request must be accompanied by the prescribed fee.

             (3)  The imposition or variation or removal of a condition under subsection (1) takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on a later day specified in the notice, being a day not earlier than 28 days after the notice is given to the person.

             (4)  A notice under subsection (1) is not a legislative instrument.

32EF  Criminal offences for breach of condition

             (1)  A person commits an offence if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the biological in the Register; and

                     (d)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the biological in the Register; and

                     (d)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the biological in the Register.

Penalty for contravention of this subsection:        Imprisonment for 12 months or 1,000 penalty units, or both.

32EG  Civil penalty for breach of condition

                   A person contravenes this section if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the person does an act or omits to do an act; and

                     (c)  the act or omission breaches a condition of the inclusion of the biological in the Register.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

Division 6Suspension from the Register

32F  What this Division is about

The Secretary may suspend biologicals from the Register in certain circumstances. A biological that is suspended is taken not to be included in the Register for most purposes.

32FA  Suspension of biological from the Register

             (1)  The Secretary may, by written notice given to a person in relation to whom a biological is included in the Register, suspend the biological from the Register if:

                     (a)  the Secretary is satisfied that:

                              (i)  there is a potential risk of death, serious illness or serious injury if the biological continues to be included in the Register; and

                             (ii)  it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the biological would not cause a potential risk of death, serious illness or serious injury if the biological were to continue to be included in the Register; or

                     (b)  the Secretary is satisfied that it is likely that there are grounds for cancelling the entry of the biological from the Register under Division 7 (other than because of paragraph 32GA(1)(a) or (d)).

Notice of proposed suspension in some cases

             (2)  However, before suspending a biological from the Register because it is likely that there are grounds for cancelling the entry of the biological from the Register under section 32GC, the Secretary must:

                     (a)  inform the person by written notice that the Secretary proposes the suspension and set out the reasons for it; and

                     (b)  invite the person to make written submissions to the Secretary in relation to the proposed suspension within the period specified in the notice (being not less than 28 days after the day the notice is given).

             (3)  The Secretary must not make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

Period of suspension

             (4)  A notice under subsection (1) must specify the period of the suspension (which must not exceed 6 months).

Note:          Section 32FB deals with when the suspension takes effect and extensions of the suspension.

Publication in Gazette

             (5)  As soon as practicable after giving a notice under subsection (1), the Secretary must cause to be published in the Gazette a notice setting out particulars of the suspension.

Notice not a legislative instrument

             (6)  A notice under subsection (1) is not a legislative instrument.

32FB  When suspension takes effect etc.

             (1)  A suspension under section 32FA takes effect:

                     (a)  if the notice under subsection 32FA(1) states that the suspension is necessary to prevent a potential risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or

                     (b)  in any other case—on a later day specified in the notice, being a day not earlier than 28 days after the notice is given to the person.

             (2)  The suspension has effect until:

                     (a)  the Secretary revokes it under section 32FC; or

                     (b)  the end of:

                              (i)  the period specified under subsection 32FA(4); or

                             (ii)  if the period is extended under subsection (3) of this section—the period as so extended.

Extension of suspension

             (3)  The Secretary may, by written notice given to the person, extend the period specified under subsection 32FA(4) by a further specified period not exceeding 6 months.

Publication in Gazette

             (4)  As soon as practicable after giving a notice under subsection (3), the Secretary must cause to be published in the Gazette a notice setting out particulars of the extension.

Notice not a legislative instrument

             (5)  A notice under subsection (3) is not a legislative instrument.

32FC  Revocation of suspension

             (1)  The Secretary must revoke a suspension under section 32FA, by written notice given to the person in relation to whom the biological is included in the Register, if the Secretary is satisfied that:

                     (a)  the ground on which the biological was suspended from the Register no longer applies; and

                     (b)  there are no other grounds for suspending the biological from the Register.

             (2)  The Secretary’s power to revoke the suspension may be exercised:

                     (a)  if the person in relation to whom the biological is included in the Register applies in writing to the Secretary; or

                     (b)  on the Secretary’s own initiative.

Publication in Gazette

             (3)  As soon as practicable after giving a notice under subsection (1), the Secretary must cause to be published in the Gazette a notice setting out particulars of the revocation.

Notice of refusal to revoke suspension

             (4)  If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:

                     (a)  notify the applicant in writing of his or her decision; and

                     (b)  state in the notice the reasons for the decision.

Notice not a legislative instrument

             (5)  A notice under subsection (1) is not a legislative instrument.

32FD  Effect of suspension

             (1)  If a biological is suspended from the Register under section 32FA, the biological is taken, for the purposes of this Act (other than section 32DQ, Division 5, sections 32FB and 32FC and Divisions 7 and 9), not to be included in the Register while the suspension has effect.

Note:          Dealing in a biological that is not included in the Register may be a criminal offence or may contravene a civil penalty provision: see Division 2.

             (2)  While the suspension has effect, the Secretary’s power under Division 7 to cancel the entry of the biological from the Register is not affected.

Division 7Cancellation from the Register

32G  What this Division is about

The Secretary may cancel inclusions of biologicals in the Register in certain circumstances.

32GA  Immediate cancellation of biological from the Register in various circumstances

             (1)  The Secretary may, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if:

                     (a)  the Secretary is satisfied that there would be an imminent risk of death, serious illness or serious injury if the biological continued to be included in the Register; or

                     (b)  the biological ceases to be a biological or the biological becomes covered by an order under section 7 declaring goods not to be therapeutic goods; or

                     (c)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); or

                     (d)  the person requests in writing the cancellation of the entry of the biological from the Register; or

                     (e)  the biological contains substances that are prohibited imports for the purposes of the Customs Act 1901; or

                      (f)  the Secretary is satisfied that a statement made in, or in connection with, the application for including the biological in the Register was false or misleading in a material particular; or

                     (g)  the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the biological in the Register is not paid within 28 days after it becomes payable; or

                     (h)  the person has failed to comply with a condition mentioned in subsection 32EA(1) or (3); or

                      (i)  both of the following apply:

                              (i)  under the regulations, an authority constituted by or under the regulations gives a direction to, or makes a requirement of, the person in relation to an advertisement of the biological to ensure that advertising complies with the Therapeutic Goods Advertising Code;

                             (ii)  the person does not comply with the direction or requirement; or

                      (j)  there is a breach, involving the biological, of the requirements relating to advertising applicable under Part 5‑1 or under the regulations.

             (2)  A notice under subsection (1) is not a legislative instrument.

32GB  Immediate cancellation of biological from the Register after failure to comply with information gathering notice

             (1)  The Secretary may, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if:

                     (a)  the Secretary gives to the person a notice under section 32JA requiring the person to give to the Secretary information, or to produce to the Secretary documents, relating to the biological; and

                     (b)  the notice under section 32JA is given for the purposes of ascertaining whether the biological should have been included in the Register; and

                     (c)  the person fails to comply with the notice under section 32JA within a further 14 days after the end of the period specified in that notice.

             (2)  The Secretary may, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if:

                     (a)  the Secretary gives to the person a notice under section 32JA requiring the person to give to the Secretary information, or to produce to the Secretary documents, relating to whether the biological is being:

                              (i)  supplied in Australia; or

                             (ii)  imported into Australia; or

                            (iii)  exported from Australia; and

                     (b)  either:

                              (i)  the information or documents given are to the effect that the biological is not being supplied in Australia, imported into Australia or exported from Australia; or

                             (ii)  the person fails to comply with the notice under section 32JA within a further 14 days after the end of the period specified in that notice.

             (3)  A notice under subsection (1) or (2) is not a legislative instrument.

32GC  Cancellation of biological from the Register after notice of proposed cancellation

             (1)  The Secretary may, by written notice given to the person in relation to whom a biological is included in the Register, cancel the entry of the biological from the Register if:

                     (a)  it appears to the Secretary that the quality, safety or efficacy of the biological is unacceptable or that the presentation of the biological is unacceptable; or

                     (b)  the biological has changed so that it has become separate and distinct from the biological as so included; or

Note:       Section 32AB deals with when a biological is separate and distinct from other biologicals.

                     (c)  the person has failed to comply with a condition to which the inclusion of the biological is subject (except a condition mentioned in subsection 32EA(1) or (3)); or

                     (d)  the Secretary gives to the person a notice under section 32JA:

                              (i)  that requires the person to give to the Secretary information, or to produce to the Secretary documents, relating to the biological; and

                             (ii)  in respect of which section 32GB does not apply;

                            and the person fails to comply with that notice within a further 14 days after the end of the period specified in that notice; or

                     (e)  the person contravenes subsection 32DQ(1) or (2) in relation to the biological; or

                      (f)  the biological does not conform to a standard applicable to it; or

                     (g)  the biological does not comply with a requirement relating to advertising applicable to it under Part 5‑1 or under the regulations.

             (2)  However, before cancelling the entry of the biological from the Register, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the cancellation and set out the reasons for it; and

                     (b)  invite the person to make written submissions to the Secretary in relation to the proposed cancellation within the period specified in the notice (being not less than 28 days after the day the notice is given).

             (3)  The Secretary must not make a decision relating to the proposed cancellation until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

             (4)  A notice under subsection (1) is not a legislative instrument.

32GD  Revocation of cancellation of biological upon request

             (1)  If:

                     (a)  the Secretary cancels the entry of a biological from the Register because of the request of a person made under paragraph 32GA(1)(d); and

                     (b)  before the end of the period of 90 days beginning on the day the biological ceased to be included in the Register, the person requests, in writing, the Secretary to revoke the cancellation; and

                     (c)  the request is accompanied by the prescribed application fee;

the Secretary may, by notice in writing given to the person, revoke the cancellation.

             (2)  If the cancellation is revoked, the cancellation is taken never to have occurred.

32GE  Publication of cancellation of entry from Register

                   The Secretary must cause to be published in the Gazette, as soon as practicable after cancelling an entry of a biological from the Register, a notice setting out particulars of the cancellation.

32GF  Date of effect of cancellation of entries from Register

                   If the Secretary cancels an entry of a biological from the Register, the cancellation has effect on the day on which the notice of cancellation is given to the person in relation to whom the biological was included in the Register.

Division 8Public notification and recovery of biologicals

32H  What this Division is about

The Secretary may require a person to recover biologicals, or to inform the public about biologicals, that do not comply with requirements or cannot lawfully be supplied. There are criminal offences and a civil penalty for breaching such a requirement.

32HA  Public notification and recovery of biologicals

             (1)  The Secretary may, by notice in writing, impose requirements, relating to a biological, on a person if:

                     (a)  any of the circumstances referred to in the 2nd column of an item in the following table occur in relation to the biological; and

                     (b)  the person is referred to in the 3rd column of that item.

 

Circumstances in which requirements may be imposed

Item

Circumstance relating to biological

Person subject to requirements

1

It is supplied while it is included in the Register, but it does not conform with a standard applicable to it

The person in relation to whom it is included in the Register

2

It is a biological, other than a Class 1 biological, and it is supplied while it is included in the Register, but the manufacturing principles have not been observed in its manufacture

The person in relation to whom it is included in the Register

3

It is supplied while:

(a) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); or

(b) it is exempt under section 32CB; or

(c) it is the subject of an approval under subsection 32CK(1); or

(d) it is the subject of an authority under subsection 32CM(1); or

(e) it is the subject of an approval under subsection 32CO(1) or (2);

but it does not conform with a standard applicable to it

The person supplying it

4

It is a biological, other than a Class 1 biological, and it is supplied while:

(a) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); or

(b) it is exempt under section 32CB; or

(c) it is the subject of an approval under subsection 32CK(1); or

(d) it is the subject of an authority under subsection 32CM(1); or

(e) it is the subject of an approval under subsection 32CO(1) or (2);

but the manufacturing principles have not been observed in its manufacture

The person supplying it

5

It is supplied while:

(a) it is not included in the Register; and

(b) the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and

(c) it is not exempt under section 32CB; and

(d) it is not the subject of an approval under subsection 32CK(1); and

(e) it is not the subject of an authority under subsection 32CM(1); and

(f) it is not the subject of an approval under subsection 32CO(1) or (2)

The person supplying it

6

It is supplied while it is exempt under section 32CB, and the Secretary is satisfied that it is not fit to be used for its intended purpose

The person supplying it

7

It is supplied in contravention of subsection 42E(1) or section 42EA

The person supplying it

8

It is a biological, other than a Class 1 biological, and it is supplied while it is included in the Register, but there is a breach of the condition set out in subsection 32EA(5)

The person in relation to whom it is included in the Register

9

It appears to the Secretary that the quality, safety or efficacy of the biological is unacceptable or that the presentation of the biological is unacceptable

The person in relation to whom the biological is included in the Register

10

It has been suspended from the Register

The person in relation to whom it is included in the Register

11

Its entry has been cancelled from the Register

The person in relation to whom it is included in the Register

             (2)  The requirements may be one or more of the following:

                     (a)  to take specified steps, in the specified manner and within such reasonable period as is specified, to recover the biological that has been supplied;

                     (b)  to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, that the circumstances referred to in paragraph (1)(a) have occurred in relation to the biological;

                     (c)  to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or supply of the biological.

             (3)  If the circumstances referred to in paragraph (1)(a) apply only to a batch of the biological, the Secretary may limit the imposition of the requirements to that batch.

             (4)  A requirement to recover a biological under this section does not apply to a biological that cannot be recovered because it has been administered to, or applied in the treatment of, a person.

             (5)  A notice under subsection (1) is not a legislative instrument.

32HB  Publication of requirements

                   The Secretary must cause to be published in the Gazette, as soon as practicable after imposing a requirement under section 32HA, a notice setting out particulars of the requirement.

32HC  Criminal offences for non‑compliance with requirements

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 32HA; and

                     (c)  the act or omission has resulted in, or will result in, harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 32HA; and

                     (c)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  An offence against subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 32HA.

Penalty for contravention of this subsection:        Imprisonment for 12 months or 1,000 penalty units, or both.

32HD  Civil penalty for non‑compliance with requirements

                   A person contravenes this section if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission breaches a requirement imposed on the person under section 32HA.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

32HE  Powers of suspension and cancellation unaffected

                   Imposition of a requirement under section 32HA does not affect the Secretary’s power to suspend a biological, or cancel the entry of a biological, from the Register under this Part.

Division 9Obtaining information or documents

Subdivision APreliminary

32J  What this Division is about

The Secretary may by written notice seek information or documents relating to:

•      applications for inclusion of biologicals in the Register; or

•      biologicals included in the Register; or

•      the supply of, and other matters relating to, biologicals covered by exemptions under Division 3.

There are criminal offences for failing to comply with a notice and for giving false or misleading information or documents and civil penalties for giving false or misleading information or documents.

Subdivision BObtaining information or documents for biologicals included or proposed to be included in the Register

32JA  Secretary may require information or documents

             (1)  The Secretary may, by written notice given to a person:

                     (a)  who is an applicant for the inclusion of a biological in the Register; or

                     (b)  in relation to whom a biological is included in the Register; or

                     (c)  in relation to whom a biological was, at any time during the previous 5 years, included in the Register;

require the person to give to the Secretary information, or to produce to the Secretary documents, that are relevant to one or more of the following:

                     (d)  the formulation of the biological;

                     (e)  the composition of the biological;

                      (f)  the design specifications of the biological;

                     (g)  the quality of the biological;

                     (h)  the method and place of manufacture or preparation of the biological and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the biological;

                      (i)  the presentation of the biological;

                      (j)  the safety and efficacy of the biological for the purposes for which it is to be used;

                     (k)  whether the biological conforms with a standard applicable to it;

                      (l)  whether the biological complies with conditions (if any) on the inclusion of the biological in the Register;

                    (m)  whether the biological complies with every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations;

                     (n)  if the biological is included in the Register in relation to the person—whether the biological is being:

                              (i)  supplied in Australia; or

                             (ii)  imported into Australia; or

                            (iii)  exported from Australia;

                     (o)  the regulatory history of the biological in another country;

                     (p)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

             (2)  The person must give the information, or produce the documents, to the Secretary:

                     (a)  within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

                     (b)  in the form specified in the notice.

Note:          Section 32JB contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JC contains a civil penalty for giving false or misleading information or documents.

             (3)  The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements:

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

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

             (4)  If a notice is given under subsection (1) to a person covered by paragraph (1)(c), then paragraphs (1)(d) to (p) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the biological was included in the Register.

32JB  Criminal offences for failing to comply with a notice etc.

             (1)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA; and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

Note:          Failure to comply with the notice might also lead to suspension or cancellation of the entry of a biological in the Register (see Divisions 6 and 7).

             (2)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA in relation to a biological; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular; and

                     (d)  either:

                              (i)  the use of the biological has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the biological, if the biological were used, would result in harm or injury to any person.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

             (3)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA in relation to a biological; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular; and

                     (d)  the use of the biological, if the biological were used, would be likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (4)  An offence against subsection (3) is an offence of strict liability.

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

             (5)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JA; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular.

Penalty for contravention of this subsection:        Imprisonment for 12 months or 1,000 penalty units, or both.

32JC  Civil penalty for giving false or misleading information or document in compliance with a notice

                   A person contravenes this section if:

                     (a)  the person is given a notice under section 32JA; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

32JD  Self‑incrimination

             (1)  A person is not excused from giving information or producing a document under section 32JA on the ground that the information or the production of the document might tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given or the document produced; and

                     (b)  giving the information or producing the document; and

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document;

are not admissible in evidence against the individual:

                     (d)  in criminal proceedings, except proceedings for an offence against subsection 32JB(1), (2), (3) or (5); or

                     (e)  in civil proceedings, except proceedings under section 42Y for a contravention of section 32JC.

Subdivision CObtaining information or documents for biologicals covered by exemptions

32JE  Secretary may require information etc. about biologicals exempt under the regulations

             (1)  If a person is exempt under subsection 32CA(1) in relation to a biological, the Secretary may give the person a written notice requiring the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:

                     (a)  the supply of the biological;

                     (b)  the handling of the biological;

                     (c)  the monitoring of the supply of the biological;

                     (d)  the results of the supply of the biological;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

             (2)  If a biological is exempt under subsection 32CA(2), the Secretary may give the sponsor of the biological a written notice requiring the sponsor to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:

                     (a)  the supply of the biological;

                     (b)  the handling of the biological;

                     (c)  the monitoring of the supply of the biological;

                     (d)  the results of the supply of the biological;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Compliance

             (3)  A person given a notice under subsection (1) or (2) must give the information, or produce the documents, to the Secretary:

                     (a)  within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

                     (b)  in the form specified in the notice.

Note:          Section 32JI contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JJ contains a civil penalty for giving false or misleading information or documents.

             (4)  The form may require or permit the information to be given, or the documents to be produced, 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.

32JF  Secretary may require information etc. about biologicals exempt to deal with emergencies

             (1)  This section applies to a person who is required to comply with a condition of an exemption of a biological under section 32CB.

             (2)  The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:

                     (a)  the supply of the biological;

                     (b)  the handling of the biological;

                     (c)  the monitoring of the supply of the biological;

                     (d)  the results of the supply of the biological;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

             (3)  The person must give the information, or produce the documents, to the Secretary:

                     (a)  within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

                     (b)  in the form specified in the notice.

Note:          Section 32JI contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JJ contains a civil penalty for giving false or misleading information or documents.

             (4)  The form may require or permit the information to be given, or the documents to be produced, 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.

32JG  Secretary may require information etc. about biologicals exempt for special and experimental uses

Approval under subsection 32CK(1)

             (1)  The Secretary may give to a person who is granted an approval under subsection 32CK(1) in relation to a biological a written notice requiring the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:

                     (a)  the supply of the biological;

                     (b)  the handling of the biological;

                     (c)  the monitoring of the supply of the biological;

                     (d)  the results of the supply of the biological;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Approval under subsection 32CK(1)—use by another person

             (2)  The Secretary may give to a person (the experimenter) using a biological that is the subject of an approval:

                     (a)  that is held by another person under subsection 32CK(1); and

                     (b)  that covers the importation into Australia, or the supply in Australia, of the biological for use solely for experimental purposes in humans;

a written notice requiring the experimenter to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to either or both of the following:

                     (c)  the use of the biological;

                     (d)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Authority under subsection 32CM(1)

             (3)  The Secretary may give to a person who is granted an authority under subsection 32CM(1) in relation to a biological a written notice requiring the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:

                     (a)  the supply of the biological;

                     (b)  the handling of the biological;

                     (c)  the monitoring of the supply of the biological;

                     (d)  the results of the supply of the biological;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Compliance

             (4)  A person given a notice under subsection (1), (2) or (3) must give the information, or produce the documents, to the Secretary:

                     (a)  within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

                     (b)  in the form specified in the notice.

Note:          Section 32JI contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JJ contains a civil penalty for giving false or misleading information or documents.

             (5)  The form may require or permit the information to be given, or the documents to be produced, 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.

32JH  Secretary may require information etc. about biologicals exempt where substitutes are unavailable etc.

             (1)  The Secretary may give to a person who is granted an approval under subsection 32CO(1) or (2) in relation to a biological a written notice requiring the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to one or more of the following:

                     (a)  the supply of the biological;

                     (b)  the handling of the biological;

                     (c)  the monitoring of the supply of the biological;

                     (d)  the results of the supply of the biological;

                     (e)  any other matter prescribed by the regulations for the purposes of this paragraph in relation to a biological of that kind.

Compliance

             (2)  A person given a notice under subsection (1) must give the information, or produce the documents, to the Secretary:

                     (a)  within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

                     (b)  in the form specified in the notice.

Note:          Section 32JI contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JJ contains a civil penalty for giving false or misleading information or documents.

             (3)  The form may require or permit the information to be given, or the documents to be produced, 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.

32JI  Criminal offences for failing to comply with a notice etc.

             (1)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

             (2)  A person commits an offence if:

                     (a)  the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular.

Penalty for contravention of this subsection:        Imprisonment for 12 months or 1,000 penalty units, or both.

32JJ  Civil penalty for giving false or misleading information or document in compliance with a notice

                   A person contravenes this section if:

                     (a)  the person is given a notice under section 32JE, 32JF, 32JG or 32JH; and

                     (b)  the person gives information or produces a document in compliance or purported compliance with the notice; and

                     (c)  the information or document is false or misleading in a material particular.

Maximum civil penalty:

                     (a)  for an individual—5,000 penalty units; and

                     (b)  for a body corporate—50,000 penalty units.

32JK  Self‑incrimination

             (1)  A person is not excused from giving information or producing a document under section 32JE, 32JF, 32JG or 32JH on the ground that the information or the production of the document might tend to incriminate the person or expose the person to a penalty.

             (2)  However, in the case of an individual:

                     (a)  the information given or the document produced; and

                     (b)  giving the information or producing the document; and

                     (c)  any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document;

are not admissible in evidence against the individual:

                     (d)  in criminal proceedings, except proceedings for an offence against subsection 32JI(1) or (2); or

                     (e)  in civil proceedings, except proceedings under section 42Y for a contravention of section 32JJ.

Subdivision DInspecting, copying and retaining documents

32JL  Secretary may inspect and copy documents

                   The Secretary may inspect a document produced under section 32JA, 32JE, 32JF, 32JG or 32JH and may make and retain copies of the whole or a part of the document.

32JM  Secretary may retain documents

             (1)  The Secretary may take possession of a document produced under section 32JA, 32JE, 32JF, 32JG or 32JH, and retain it for as long as is reasonably necessary.

             (2)  The person otherwise entitled to possession of the document is entitled to be supplied, as soon as practicable, with a copy certified by the Secretary to be a true copy.

             (3)  The certified copy must be received in all courts and tribunals as evidence as if it were the original.

             (4)  Until a certified copy is supplied, the Secretary must provide the person otherwise entitled to possession of the document, or a person authorised by that person, reasonable access to the document for the purposes of inspecting and making copies of the whole or a part of the document.

26  After section 33A

Insert:

33B  Application of this Part to biologicals

                   This Part does not apply to a Class 1 biological.

27  Paragraphs 35(1)(a), (2)(a) and (4)(a)

After “section 18A”, insert “or 32CB”.

28  Paragraphs 35(5)(c), (7)(c) and (9)(c)

After “section 18A”, insert “or 32CB”.

29  Paragraphs 35A(1)(c) and (2)(c)

After “section 18A”, insert “or 32CB”.

30  At the end of section 39

Add:

             (3)  If:

                     (a)  the licence covers a biological that is exempt under section 32CB; and

                     (b)  the biological ceases to be exempt under that section before the licence is revoked;

the licence ceases to be in force in relation to the biological when the biological ceases to be exempt under that section.

Note:          An exemption under section 32CB may cease to have effect only in relation to some of the biologicals covered by the exemption: see subsections 32CB(5) and 32CD(1).

31  Paragraph 40(4)(a)

Repeal the paragraph, substitute:

                     (a)  ensure that:

                              (i)  the goods conform to any standard applicable to the goods; and

                             (ii)  the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence;

                            unless:

                            (iii)  the goods are a biological and are for supply after the circumstances prescribed by the regulations for the purposes of paragraphs 14(9A)(b) and 14A(2A)(b) have occurred; or

                            (iv)  the goods are a biological and are for export after the circumstances prescribed by the regulations for the purposes of paragraphs 14(13A)(b) and 14A(3A)(b) have occurred; and

32  After paragraph 41(1)(g)

Insert:

                    (ga)  the licence covers a biological that is exempt under section 32CB and the holder has breached a condition of the exemption in relation to the biological; or

33  After section 41BJ

Insert:

41BJA  Application of this Chapter to a biological

             (1)  Subject to this section, this Chapter does not apply to a biological on and after the commencement of this section.

Biologicals currently included in the Register

             (2)  If, immediately before the commencement of this section, therapeutic goods that are a biological were included in the Register under this Chapter, this Chapter continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3‑2A.

Note:          Section 32DN deals with including the biological under Part 3‑2A.

Pending applications

             (3)  If:

                     (a)  before the commencement of this section, an application was made under this Chapter for the inclusion in the Register of therapeutic goods that are a biological; and

                     (b)  immediately before that commencement, the application was not finally determined; and

                     (c)  the application had not been withdrawn before that commencement;

this Chapter continues to apply to the biological on and after that commencement until the earliest of the following:

                     (d)  the time the biological is included in the Register under Part 3‑2A;

                     (e)  if the application is unsuccessful when it is finally determined—the time the application is finally determined;

                      (f)  the time the application is withdrawn;

                     (g)  the time the application lapses.

Note:          Section 32DN deals with including the biological under Part 3‑2A.

             (4)  For the purposes of this section, 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.

Transitional

             (5)  This Chapter applies to a biological on and after the commencement of this section in relation to things done, or omitted to be done, in relation to the biological before the commencement of this section.

             (6)  If this Chapter continues to apply to a biological during a period described in subsection (2) or (3), then this Chapter also applies to the biological after the end of that period in relation to things done, or omitted to be done, in relation to the biological during that period.

34  After paragraph 42DL(1)(f)

Insert:

                    (fa)  that contains a statement referring to a biological, other than a statement authorised or required by a government or government authority (including a foreign government or foreign government authority); or

35  Subsection 42V(7)

Omit “section 30”, substitute “section 29D or 30, Division 6 or 7 of Part 3‑2A”.

36  After subparagraph 46A(4)(a)(ii)

Insert:

                       (iiaaa)  who is required to comply with a condition of an exemption of biologicals under section 32CB; or

                       (iiaab)  who has been granted an approval under subsection 32CK(1) or an authority under subsection 32CM(1); or

                       (iiaac)  who has been granted an approval under subsection 32CO(1) or (2); or

37  After paragraph 53(b)

Insert:

                   (ba)  inclusion of a biological in the Register; or

38  Section 53A (after table item 13)

Insert:

 

13A

subsection 32BA(1)

subsection 32BA(4)

13B

subsection 32BB(1)

subsection 32BB(4)

13C

subsection 32BC(1)

subsection 32BC(4)

13D

subsection 32BD(1)

subsection 32BD(4)

13E

subsection 32BI(1)

subsection 32BI(4)

13F

subsection 32CN(1)

subsection 32CN(4)

13G

subsection 32DO(1)

subsection 32DO(4)

13H

subsection 32EF(1)

subsection 32EF(4)

13J

subsection 32HC(1)

subsection 32HC(4)

13K

subsection 32JB(2)

subsection 32JB(5)

39  After paragraph 56A(1)(a)

Insert:

                (aaaa)  a person was not exempt under subsection 32CA(1) in relation to a particular biological or there was no exemption under subsection 32CA(2) in relation to a particular biological; or

                (aaab)  there was no exemption in effect under section 32CB in relation to a particular biological; or

40  After paragraph 56A(1)(b)

Insert:

                  (baa)  there was no approval under subsection 32CK(1) or authority under subsection 32CM(1) granted to a particular person in relation to a particular biological; or

41  After paragraph 56A(1)(c)

Insert:

                    (ca)  there was no approval under subsection 32CO(1) or (2) granted to a particular person in relation to a particular biological; or

42  After paragraph 56A(1)(e)

Insert:

                  (eaa)  a particular biological was or was not included in the Register; or

43  Subsections 57(2) and (3)

After “paragraph 19(1)(a)”, insert “, 32CK(1)(d)”.

44  Paragraph 57(5)(b)

After “paragraph 19(1)(a)”, insert “, 32CK(1)(d)”.

45  Subsections 57(6) and (7)

After “subsection 19(5)”, insert “, 32CM(1)”.

46  Subsection 57(8)

After “section 19A”, insert “or 32CO”.

47  After subsection 57(10)

Insert:

        (10A)  The power of the Minister under subsection 32CB(1) may be delegated only to the Secretary.

48  Subsection 59(3)

Repeal the subsection.

49  Subsection 60(1) (after paragraph (c) of the definition of initial decision)

Insert:

                    (ca)  under Part 3‑2A (Biologicals); or

50  Subsection 60A(1)

After “section 25”, insert “, 32DF, 32DG”.

51  After subsection 60A(6)

Insert:

       (6AA)  If:

                     (a)  the matter relates to a decision under section 32DF or 32DG; and

                     (b)  the Minister or the Tribunal remits the matter; and

                     (c)  the appellant has paid, as a further evaluation fee, the evaluation fee that the appellant would have to pay under section 32DI on making a new application for inclusion of the biological in the Register;

the authorised delegate must make a decision whether or not to include the biological in the Register, taking into account the initial new information or later new information (or both), as the case may be, as if a fresh application for inclusion of the biological in the Register had been made.

52  Subsection 60A(7)

After “Part 3‑2”, insert “, 3‑2A”.

53  Subsection 60A(8) (after paragraph (a) of the definition of authorised delegate)

Insert:

                    (aa)  exercising a power to decide whether to include a biological in the Register; or

54  Subsection 61(3A)

After “31B,”, insert “32JE, 32JF, 32JG, 32JH,”.

55  After paragraph 61(4)(b)

Insert:

                  (baa)  decisions on the inclusion of biologicals in the Register, or the suspension or cancellation of the inclusion of biologicals in the Register; or

56  Subsection 61(10)

After “subsection 25(2E)”, insert “(including as that subsection applies because of subsection 32DE(2) or 32EB(3))”.

57  After paragraph 63(2)(da)

Insert:

                  (daa)  provide for the periods within which evaluations under section 32DE in relation to specified biologicals or specified classes of biologicals are to be completed; and

58  Application—licences

The amendment made by item 31 applies in relation to licences granted before, on or after the commencement of that item.

59  Transitional—exempt biologicals

(1)       This item applies in relation to a class of biologicals that, immediately before the commencement of this item, was covered by an exemption of the kind referred to in paragraph 18(1)(c) of the Therapeutic Goods Act 1989.

(2)       At the commencement of this item, there is taken to be an exemption (the transitional exemption) in force under subsection 32CA(2) of that Act covering that class of biologicals.

(3)       Subject to this item, the transitional exemption ceases to be in force at the end of the period (the transitional period) of 3 years beginning on the day this item commences.

(4)       If:

                     (a)  before the end of the period of 18 months beginning on the day this item commences, a person makes an application in accordance with section 32DA or 32DD of that Act to include in the Register a biological included in that class; and

                     (b)  before the end of the transitional period, the person has not been notified of the Secretary’s decision on the application;

the transitional exemption, in relation to that biological, continues in force past the end of the transitional period until the person is notified of the Secretary’s decision on the application.

(5)       If:

                     (a)  before the end of the transitional period, a person makes an application in accordance with section 32DA or 32DD of that Act to include in the Register a biological included in that class; and

                     (b)  before the end of that period, the person is notified of the Secretary’s decision on the application;

the transitional exemption, in relation to that biological, ceases to be in force immediately after that notification.

60  Transitional regulations

The Governor‑General may make regulations prescribing matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments made by this Schedule.


 

Schedule 2Immunity from civil actions

  

Therapeutic Goods Act 1989

1  Subsection 18A(12)

Repeal the subsection (not including the note).

2  Subsection 19(8)

Repeal the subsection.

3  Subsection 25(1)

Omit “the goods are to be evaluated for registration”, substitute “the Secretary must evaluate the goods for registration”.

4  Subsection 25(4A)

Repeal the subsection.

5  Subsection 25(6)

Repeal the subsection.

6  Subsection 25A(4)

Repeal the subsection.

7  Subsection 26(1B)

Repeal the subsection.

8  Subsection 26A(1B)

Repeal the subsection.

9  Subsection 41ED(1)

Omit “(1)”.

10  Subsection 41ED(2)

Repeal the subsection.

11  Section 41GX

Repeal the section.

12  Subsection 41HC(6)

Repeal the subsection.

13  Subsection 61(9)

Repeal the subsection.

14  After section 61

Insert:

61A  Immunity from civil actions

             (1)  No civil action, suit or proceeding lies against:

                     (a)  the Commonwealth; or

                     (b)  a protected person;

in respect of loss, damage or injury of any kind suffered by another person as a result of anything done, or omitted to be done, by a protected person in relation to the performance or purported performance, or in relation to the exercise or purported exercise, of a protected person’s functions, duties or powers under this Act or the regulations.

             (2)  Subsection (1) does not apply to an act or omission in bad faith.

             (3)  A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.

             (4)  In this section:

protected person means any of the following:

                     (a)  the Minister;

                     (b)  the Secretary;

                     (c)  a person to whom powers or functions are delegated under subsection 57(1);

                     (d)  a member of a committee established under this Act or the regulations;

                     (e)  an authorised person in relation to a provision of this Act (other than this section);

                      (f)  an authorised officer (within the meaning of the regulations);

                     (g)  an authorised person (within the meaning of the regulations);

                     (h)  a person assisting a person (a primary person) referred to in paragraph (a), (b), (c), (d), (e), (f) or (g) in relation to the performance or purported performance, or in relation to the exercise or purported exercise, of a primary person’s functions, duties or powers under this Act or the regulations.

15  Application

The amendment made by item 14 applies in relation to anything done or omitted to be done on or after the commencement of that item.

16  Saving

Despite the repeal of provisions of the Therapeutic Goods Act 1989 made by items 1, 2, 4 to 8 and 10 to 13, those provisions (as in force immediately before the commencement of those items) continue to apply on and after that commencement in relation to anything done or omitted to be done before that commencement.


 

Schedule 3Recall of therapeutic goods

  

Therapeutic Goods Act 1989

1  Subsection 30EA(1) (after table item 5)

Insert:

 

5A.

The goods are supplied while they are registered goods or listed goods, but it appears to the Secretary that the quality, safety or efficacy of the goods is unacceptable or that the presentation of the goods is unacceptable

The person in relation to whom the goods are included in the Register

2  Subsection 41KA(1) (after table item 5A)

Insert:

 

5B.

It is supplied while it is included in the Register, but it appears to the Secretary that the quality, safety or performance of medical devices of that kind is unacceptable

The person in relation to whom the kind of medical device is included in the Register

3  Application

The amendments made by items 1 and 2 apply in relation to therapeutic goods, and kinds of medical devices, included in the Register before, on or after the commencement of those items.


 

Schedule 4Information gathering

  

Therapeutic Goods Act 1989

1  Subsection 31(1)

Omit “person who is an applicant for the registration of therapeutic goods or in relation to whom therapeutic goods are registered, require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:”, substitute:

                   person:

                    (aa)  who is an applicant for the registration of therapeutic goods; or

                   (ab)  in relation to whom therapeutic goods are registered; or

                    (ac)  in relation to whom therapeutic goods were, at any time during the previous 5 years, registered;

require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:

2  After subsection 31(1)

Insert:

          (1A)  If a notice is given under subsection (1) to a person covered by paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were registered.

3  Subsection 31(2)

Omit “person who is an applicant for the listing of therapeutic goods or in relation to whom therapeutic goods are listed, require the person to give to the Secretary, within such reasonable time as is specified in the notice, information or documents relating to one or more of the following:”, substitute:

                   person:

                    (aa)  who is an applicant for the listing of therapeutic goods; or

                   (ab)  in relation to whom therapeutic goods are listed; or

                    (ac)  in relation to whom therapeutic goods were, at any time during the previous 5 years, listed;

require the person to give to the Secretary, within such reasonable time as is specified in the notice and in such form as is specified in the notice, information or documents relating to one or more of the following:

4  After subsection 31(2)

Insert:

          (2A)  If a notice is given under subsection (2) to a person covered by paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were listed.

5  Subsection 31(4)

Repeal the subsection, substitute:

             (4)  A person commits an offence if:

                     (a)  the person is given a notice under this section; and

                     (b)  the person fails to comply with the notice.

Penalty:  500 penalty units.

6  Application

(1)       The amendments made by items 1 to 5 apply in relation to notices given on or after the commencement of those items.

(2)       Paragraphs 31(1)(ac) and (2)(ac) of the Therapeutic Goods Act 1989, as inserted by this Act, apply in relation to the registration or listing of therapeutic goods occurring before, on or after the commencement of this item.


 

Schedule 5Unpaid annual charges

  

Therapeutic Goods Act 1989

1  After section 44A

Insert:

44B  Recovery of unpaid charges

                   An amount of an annual registration charge, an annual listing charge, an annual charge for inclusion in the Register or an annual licensing charge that remains unpaid at the end of the period of 28 days after the day on which the charge becomes payable may be recovered by the Commonwealth as a debt due to the Commonwealth.

Note:          Section 44 sets out the day on which a charge becomes payable.

2  Application

The amendment made by item 1 applies in relation to an annual registration charge, an annual listing charge, an annual charge for inclusion in the Register or an annual licensing charge that becomes payable on or after the day on which that item commences.


 

Schedule 6Other amendments

  

Therapeutic Goods Act 1989

1  Subsection 3(1) (paragraph (e) of the definition of therapeutic goods)

Omit “prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australia New Zealand Food Authority Act 1991”, substitute “standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991)”.

2  Subsection 3(1) (paragraph (f) of the definition of therapeutic goods)

After “goods”, insert “(other than goods declared to be therapeutic goods under an order in force under section 7)”.

3  At the end of subsection 28(3A)

Add “A request must be accompanied by the prescribed fee.”.

4  Paragraph 42DL(1)(f)

Omit “refers”, substitute “contains a statement referring”.

5  Paragraph 42DL(1)(f)

Omit “Poisons Standard”, substitute “current Poisons Standard, other than a statement authorised or required by a government or government authority (including a foreign government or foreign government authority)”.

6  Paragraphs 42DL(2)(c) and (3)(b)

Omit “Poisons Standard”, substitute “current Poisons Standard”.

7  After paragraph 57(1)(c)

Insert:

                 or (d)  a person seconded to the Department from:

                              (i)  an authority of a State or a Territory that has functions relating to therapeutic goods, health or law enforcement; or

                             (ii)  a national regulatory authority of a foreign country that has national responsibility relating to therapeutic goods, health or law enforcement; or

                            (iii)  an international organisation that has a function relating to therapeutic goods, health or law enforcement;

8  Subsection 60A(2)

Omit “new information”, substitute “initial new information”.

9  Subsection 60A(3)

Omit “new information”, substitute “initial new information or later new information (or both)”.

10  Subsection 60A(4)

Repeal the subsection, substitute:

             (4)  If:

                     (a)  the appellant applies to the Administrative Appeals Tribunal for review of the decision on reconsideration and lodges initial new information in support of that application; and

                     (b)  the appellant does not lodge later new information in support of that application;

the Tribunal must not remit the matter under subsection (3) if all of the initial new information is information that the Minister took into account under paragraph (2)(a) in making the decision on reconsideration.

11  Paragraph 60A(5)(a)

Omit “new information”, substitute “initial new information or later new information (or both)”.

12  Paragraph 60A(5)(c)

Omit “new information”, substitute “initial new information”.

13  Paragraph 60A(5)(d)

Omit “new information” (wherever occurring), substitute “initial new information”.

14  At the end of subsection 60A(5)

Add:

             ; and (e)  must not consider any later new information, except later new information that indicates that the quality, safety or efficacy of the therapeutic goods is unacceptable.

15  Subsections 60A(6) and (6A)

Omit “new information”, substitute “initial new information or later new information (or both), as the case may be”.

16  Subsection 60A(8) (definition of authorised delegate)

Repeal the definition, substitute:

authorised delegate means a delegate of the Secretary:

                     (a)  exercising a power to decide whether to register therapeutic goods; or

                     (b)  exercising a power to decide whether to issue a conformity assessment certificate.

17  Subsection 60A(8)

Insert:

initial new information means information that:

                     (a)  was in existence at the time the decision referred to in subsection (1) was made; and

                     (b)  was not made available to the Secretary or authorised delegate for the purpose of making that decision; and

                     (c)  is relevant to that decision;

and includes any opinions that are wholly or substantially based on such information (whether the opinions were formed before or after that decision was made).

18  Subsection 60A(8)

Insert:

later new information means information that:

                     (a)  was in existence at the time the decision on reconsideration was made; and

                     (b)  was not made available to the Minister or delegate of the Minister for the purpose of making that decision; and

                     (c)  is relevant to that decision;

and includes any opinions that are wholly or substantially based on such information (whether the opinions were formed before or after that decision was made).

19  Subsection 60A(8) (definition of new information)

Repeal the definition.

20  Application

(1)       The amendment made by item 3 applies in relation to requests made on or after the commencement of that item.

(2)       The amendments made by items 4 and 5 apply in relation to advertisements published or broadcast on or after the commencement of those items.

(3)       The amendments made by items 8 to 15 and 17 to 19 apply in relation to requests made to the Minister to reconsider decisions, where the requests are made on or after the commencement of those items (regardless of whether the decisions were made before, on or after that commencement).

 

 

 

 

 

[Minister’s second reading speech made in—

House of Representatives on 25 November 2009

Senate on 18 March 2010]

(249/09)