Therapeutic Goods Amendment Act (No. 1) 2003 (Cth)

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Therapeutic Goods Amendment Act (No. 1) 2003

No. 39, 2003

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

Contents

Therapeutic Goods Amendment Act (No. 1) 2003

No. 39, 2003

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

[Assented to 27 May 2003]

The Parliament of Australia enacts:

1Short title

This Act may be cited as the Therapeutic Goods Amendment Act (No. 1) 2003.

2Commencement
  1. (1)

    Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.

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 on which this Act receives the Royal Assent

27 May 2003

2.

Schedule 1, Parts 1 and 2

A single day to be fixed by Proclamation, subject to subsection (3)

27 November 2003

3.

Schedule 1, items 20 to 78

The day on which this Act receives the Royal Assent

27 May 2003

4.

Schedule 1, item 79

Immediately after the commencement of the Health and Aged Care Legislation Amendment (Application of Criminal Code) Act 2001

17 September 2001

5.

Schedule 1, item 80

The day on which this Act receives the Royal Assent

27 May 2003

6.

Schedule 2

At the same time as the provisions covered by item 2 of this table

27 November 2003

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

  1. (2)

    Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.

  2. (3)

    If a provision covered by item 2 of the table does not commence within the period of 6 months beginning on the later of:

    1. (a)

      the day on which this Act receives the Royal Assent; and

    2. (b)

      the day on which Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences;

it commences on the first day after the end of that period.

3Schedule(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Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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 1—Amendment of the Therapeutic Goods Act 1989

Part 1Definition of therapeutic goods
  1. 1

    Subsection 3(1) (paragraph (1)(e) of the definition of therapeutic goods)

    Repeal the paragraph, substitute:

    1. (e)

      goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a 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; or

Part 2Advertising of therapeutic goods
  1. 2

    Subsection 3(1) (definition of Therapeutic Goods Advertising Code)

    Repeal the definition, substitute:

    Therapeutic Goods Advertising Code means the Code known as the Therapeutic Goods Advertising Code notified in the Gazette with effect from the date of commencement of Schedule 1 to the Therapeutic Goods Amendment Act (No. 1) 2003 together with any amendments of the Code published by the Minister in the Gazette from time to time.

  2. 3

    Paragraphs 25(1)(f), 26(1)(f), 26A(2)(d), 30(1A)(c), 30(2)(e), 31(1)(h), 31(2)(g), 41FD(h), 41GL(h) and 41JA(1)(h)

    Before “under the regulations”, insert “under Part 5‑1 or”.

4

Part 5‑1 of Chapter 5 (heading)

Repeal the heading, substitute:

Part 5‑1—Advertising and generic information

Division 1—Preliminary

42AAThis Part not to apply to advertisements directed at health professionals etc.

  1. (1)

    This Part does not apply to advertisements directed exclusively to:

    1. (a)

      medical practitioners, psychologists, dentists, veterinary surgeons, pharmacists, physiotherapists, dietitians, scientists working in medical laboratories or nurses; or

    2. (b)

      persons who are:

      1. (i)

        engaged in the business of wholesaling therapeutic goods; or

      2. (ii)

        purchasing officers in hospitals; or

    3. (c)

      herbalists, homoeopathic practitioners, chiropractors, naturopaths, nutritionists, practitioners of traditional Chinese medicine, podiatrists or osteopaths registered under a law of a State or Territory.

  2. (2)

    This Part does not apply to advertisements directed exclusively to persons who are members of an Australian branch (however described) of one of the bodies prescribed for the purposes of this subsection.

  3. (3)

    For the purposes of subsection (2), a person is taken to be a member of an Australian branch of one of those bodies if, and only if, the person has the qualifications and training that are necessary or appropriate for membership of the relevant body.

  4. (4)

    This Part does not apply to advice or information given directly to a patient by a person referred to in paragraph (1)(a) or (c) or subsection (2) in the course of treatment of that patient.

42ABThis Part not to apply to advertisements for goods not for human use

This Part does not apply to advertisements in respect of goods that are not for use in humans.

42ACThis Part not to apply to advertisements for exported goods

  1. (1)

    Subject to subsection (2), this Part does not apply to advertisements solely for therapeutic goods that have been exported or are intended exclusively for export.

  2. (2)

    Section 42DC applies to advertisements of that kind.

5

Section 42A

Repeal the section.

6

Section 42B

Insert:

broadcaster, in relation to an advertisement for therapeutic goods, means a person (other than a person who is required to enter those goods on the Register) who undertakes, as a business activity in its own right:

  1. (a)

    the broadcasting of the advertisement in broadcast media; or

  2. (b)

    the placement of the advertisement for such broadcasting.

7

Section 42B

Insert:

broadcast media, in relation to an advertisement or generic information, means any means (other than a means declared in the regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms.

8

Section 42B

Insert:

generic information, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:

  1. (a)

    an advertisement about the goods; or

  2. (b)

    generic information included in an advertisement about the goods; or

  3. (c)

    bona fide news.

9

Section 42B

Insert:

prohibited representation means a representation referred to in subsection 42DJ(1).

10

Section 42B (definition of publisher)

Repeal the definition, substitute:

publisher, in relation to an advertisement for therapeutic goods, means a person (other than a person who is required to enter those goods on the Register) who undertakes, as a business activity in its own right:

  1. (a)

    the publishing of the advertisement in specified media other than broadcast media; or

  2. (b)

    the placement of the advertisement for such publication.

11

Section 42B

Insert:

publishing, in relation to an advertisement, includes inserting material within the pages of an item of mainstream media.

12

Section 42B

Insert:

required representation means a representation referred to in subsection 42DJ(2).

13

Section 42B

Insert:

restricted representation means a representation referred to in subsection 42DD(1).

14

Section 42B

Insert:

specified media, in relation to an advertisement or generic information, means:

  1. (a)

    mainstream media; or

  2. (b)

    broadcast media; or

  3. (c)

    cinematograph films; or

  4. (d)

    displays about goods, including posters:

    1. (i)

      in shopping malls (except inside an individual shop); and

    2. (ii)

      in or on public transport; and

    3. (iii)

      on billboards.

15

Section 42B

Insert:

visual broadcast media means broadcast media that is intended to be viewed by its audience.

16

After section 42B

Insert:

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

42BAApplication of Division

This Division applies only to advertisements to which Part 2 of the Therapeutic Goods Regulations applies.

17

Sections 42C and 42D

Repeal the sections, substitute:

42COffences relating to publication of advertisements

  1. (1)

    A person is guilty of an offence if:

    1. (a)

      the person:

      1. (i)

        publishes or broadcasts; or

      2. (ii)

        causes to be published or broadcast;

    in specified media, an advertisement that is required by the Therapeutic Goods Regulations to be an approved advertisement; and

    1. (b)

      the advertisement is not an approved advertisement.

    Penalty: 60 penalty units.

  2. (2)

    A person is guilty of an offence if:

    1. (a)

      the person:

      1. (i)

        publishes or broadcasts; or

      2. (ii)

        causes to be published or broadcast;

    an advertisement in specified media; and

    1. (b)

      the advertisement is not an approved advertisement in that it differs, in any respect, from the advertisement that was approved.

    Penalty: 60 penalty units.

  3. (3)

    It is a defence to a prosecution under subsection (2) if:

    1. (a)

      the person prosecuted is a publisher or broadcaster who received the advertisement to which the prosecution relates for publication or broadcasting in specified media in the ordinary course of business; or

    2. (b)

      the particular advertisement to which the prosecution relates differs only in respect of a matter mentioned in paragraph 5C(2)(b), (e) or (f) of the Therapeutic Goods Regulations.

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

  4. (4)

    A person is guilty of an offence if:

    1. (a)

      the person:

      1. (i)

        publishes or broadcasts; or

      2. (ii)

        causes to be published or broadcast;

    in specified media referred to in paragraph (a), (c) or (d) of the definition of specified media, or in visual broadcast media, a particular advertisement; and

    1. (b)

      the advertisement:

      1. (i)

        does not display its approval number; or

      2. (ii)

        displays a number purporting to be its approval number but that is not its approval number; or

      3. (iii)

        displays an approval number that has expired.

    Penalty: 30 penalty units.

  5. (5)

    It is a defence to a prosecution under subsection (4) if the person prosecuted:

    1. (a)

      is a publisher who received the advertisement to which the prosecution relates for publication in specified media referred to in paragraph (a), (c) or (d) of the definition of specified media; or

    2. (b)

      is a broadcaster who received the advertisement to which the prosecution relates for broadcasting in visual broadcast media;

in the ordinary course of business.

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

  1. (6)

    A person is guilty of an offence if:

    1. (a)

      the person:

      1. (i)

        publishes or broadcasts; or

      2. (ii)

        causes to be published or broadcast;

    in specified media, an approved advertisement; and

    1. (b)

      the person’s action is in contravention of a condition to which the approval of the advertisement is subject.

    Penalty: 60 penalty units.

  2. (7)

    It is a defence to a prosecution under subsection (6) if the person prosecuted is a publisher or broadcaster who received the advertisement to which the prosecution relates for publication or broadcasting in specified media in the ordinary course of business.

    Note: A defendant bears an evidential burden in relation to the matters in subsection (7) (see subsection 13.3 of the Criminal Code).

  3. (8)

    An offence against this section is an offence of strict liability.

18

At the end of Part 5‑1 of Chapter 5

Add:

Division 3—General provisions about advertising therapeutic goods

42DAApplication of Division

This Division applies to advertisements about therapeutic goods other than advertisements for which an approval is required under Part 2 of the Therapeutic Goods Regulations.

42DBDefinitions

In this Division:

applicant means an applicant for approval of the use of a restricted representation in an advertisement about therapeutic goods.

approval holder, in relation to a restricted representation, means the person to whom notice of approval of the use of the restricted representation was given.

42DCCertain representations not to be published or broadcast

If a representation in an advertisement about therapeutic goods is false or misleading, the Secretary may, by notice given to the person apparently responsible for publishing or broadcasting the advertisement, prevent that person from publishing or broadcasting, or causing to be published or broadcast, an advertisement containing that representation (whether express or implied) about those goods.

42DDRestricted representations

  1. (1)

    For the purposes of this Part, a representation in an advertisement about therapeutic goods that refers to a serious form of a disease, condition, ailment or defect specified in a part of the Therapeutic Goods Advertising Code that is prescribed by the regulations for the purposes of this subsection is a restricted representation about therapeutic goods.

  2. (2)

    A person must not use a restricted representation in an advertisement about therapeutic goods unless the Secretary:

    1. (a)

      has approved its use under subsection 42DF(1); or

    2. (b)

      has permitted its use under subsection 42DK(1).

42DEApplications for approval of use of restricted representation

An application for approval of the use of a restricted representation must be:

  1. (a)

    made to the Secretary in writing, in a form approved by the Secretary; and

  2. (b)

    signed by or on behalf of the applicant.

42DFApproval of use of restricted representation

  1. (1)

    If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the restricted representation if the Secretary is satisfied that:

    1. (a)

      the representation is accurate and balanced; and

    2. (b)

      the representation is not misleading or likely to be misleading.

  2. (2)

    Otherwise, the Secretary must refuse to approve the use of the restricted representation.

  3. (3)

    An approval may be subject to conditions imposed by the Secretary.

  4. (4)

    In deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration:

    1. (a)

      any recommendation of the Therapeutic Goods Advertising Code Council; and

    2. (b)

      any advice of the Complementary Medicines Evaluation Committee or the Medicines Evaluation Committee; and

    3. (c)

      the public interest criteria mentioned in a part of the Therapeutic Goods Advertising Code that is prescribed by the regulations made for the purposes of this paragraph.

42DGNotice of approval or refusal

  1. (1)

    The Secretary must give written notice to the applicant of the approval of, or of the refusal to approve, the use of a restricted representation.

  2. (2)

    If written notice is not given to the applicant within the period of 60 days after the day on which the application was made (or within such longer period as the Secretary specifies by written notice to the applicant before the end of that period), the Secretary is taken to have approved the use of the restricted representation at the end of the period.

  3. (3)

    If an approval is subject to conditions, the conditions must be set out in the notice.

  4. (4)

    A notice of refusal to approve the use of a restricted representation must:

    1. (a)

      give the Secretary’s reasons for the refusal; and

    2. (b)

      inform the applicant of the applicant’s right to have the Secretary’s decision reviewed by the Minister under section 60.

42DHVariation of conditions of approval

  1. (1)

    The Secretary, by written notice to an approval holder, may vary any condition of approval of the use of a restricted representation.

  2. (2)

    The notice must:

    1. (a)

      give the Secretary’s reasons for the variation; and

    2. (b)

      inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under section 60.

42DIWithdrawal of approval

  1. (1)

    The Secretary, by written notice, may withdraw the approval of the use of a restricted representation if:

    1. (a)

      the Secretary is satisfied that:

      1. (i)

        information given by the applicant in the application was false or incorrect and the Secretary, or the Minister on review of a decision of the Secretary under section 42DF or 42DH, relied on the information in deciding to approve the use of the representation; or

      2. (ii)

        the restricted representation has become a prohibited representation; or

      3. (iii)

        there has been a breach of a condition of approval; or

    2. (b)

      both:

      1. (i)

        additional information about the safety of the therapeutic goods becomes available; and

      2. (ii)

        the Secretary is satisfied that, if that information had been available at the time of the approval, the Secretary would not have approved the use of the restricted representation.

  2. (2)

    The notice must:

    1. (a)

      give the Secretary’s reasons for the withdrawal; and

    2. (b)

      inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under section 60.

42DJProhibited and required representations

  1. (1)

    For the purposes of this Part, representations of a kind specified in regulations made for the purposes of this subsection are prohibited representations about therapeutic goods of a kind specified in those regulations.

  2. (2)

    For the purposes of this Part, representations of a kind specified in regulations made for the purposes of this subsection are required representations about the therapeutic goods of a kind specified in those regulations.

42DKUse of restricted or prohibited representations

  1. (1)

    The Secretary may, by notice in writing published in the Gazette or on the Department’s web site on the Internet, permit, in relation to therapeutic goods, the use of a restricted representation (including its use on the label of the goods or in information included in the package in which the goods are contained).

  2. (2)

    The Secretary may, by notice in writing published in the Gazette or on the Department’s web site on the Internet, permit a prohibited representation to be included on the label of therapeutic goods, or in information included in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.

42DLAdvertising offences

  1. (1)

    A person must not publish or broadcast an advertisement about therapeutic goods:

    1. (a)

      that contains a prohibited representation (whether in express terms or by necessary implication) about those goods; or

    2. (b)

      that does not contain a required representation about those goods; or

    3. (c)

      that contains a restricted representation, about those goods, the use of which has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1); or

    4. (d)

      that is in contravention:

      1. (i)

        of a notice referred to in section 42DC that was served on the person; or

      2. (ii)

        of a notice referred to in section 42DK of which the person was aware when the advertisement was published; or

    5. (e)

      that contains:

      1. (i)

        a reference to the Act other than in a statement of the registration number, listing number or device number of the goods; or

      2. (ii)

        a statement suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority (including a foreign government or foreign government authority), other than a statement of their availability as a pharmaceutical benefit or a statement authorised or required by a government or government authority (including a foreign government or foreign government authority); or

    6. (f)

      that refers to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 to the Poisons Standard; or

    7. (g)

      that are not entered in the Register; or

    8. (h)

      if the goods are therapeutic goods, or come within a class of therapeutic goods, that:

      1. (i)

        are exempt goods or exempt devices prescribed in the regulations for the purposes of this provision; or

      2. (ii)

        have been approved under subsection 19(1) or section 41HB of this Act for importation into, exportation from, or supply within, Australia.

    Penalty: 60 penalty units.

  2. (2)

    For the purposes of an offence against subsection (1), strict liability applies to the following physical elements:

    1. (a)

      that the use of a restricted representation, as referred to in paragraph (1)(c), has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1);

    2. (b)

      that the notice referred to in paragraph (1)(d):

      1. (i)

        in a case to which subparagraph (1)(d)(i) applies—is a notice referred to in section 42DC; and

      2. (ii)

        in a case to which subparagraph (1)(d)(ii) applies—is a notice referred to in section 42DK;

    1. (c)

      that goods, substances or preparations referred to in paragraph (1)(f) are included in Schedule 3, 4 or 8 to the Poisons Standard;

    2. (d)

      that the therapeutic goods, or class of therapeutic goods, referred to in paragraph (1)(h):

      1. (i)

        are exempt goods or exempt devices prescribed in the regulations made for the purposes of subparagraph (1)(h)(i); or

      2. (ii)

        have been approved under subsection 19(1) or section 41HB of the Act for importation into, exportation from or supply within, Australia.

  2. (3)

    It is a defence to a prosecution under subsection (1) if:

    1. (a)

      in relation to an advertisement mentioned in paragraph (1)(a) or (f)—the advertisement is made by, or on behalf of, the Commonwealth; and

    2. (b)

      in relation to an advertisement mentioned in paragraph (1)(f)—the goods, substances or preparations are mentioned in Appendix H of the Poisons Standard; and

    3. (c)

      in relation to goods mentioned in paragraph (1)(g)—the goods are exempt goods or exempt devices other than goods of a kind mentioned in paragraph (1)(h).

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

42DMCompliance with Code

  1. (1)

    A person is guilty of an offence if:

    1. (a)

      the person publishes or broadcasts an advertisement about therapeutic goods; and

    2. (b)

      the advertisement does not comply with the Therapeutic Goods Advertising Code.

    Penalty: 60 penalty units.

  2. (2)

    An offence against this section is an offence of strict liability.

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

42DNApplication of Division

This Division applies to generic information about goods that:

  1. (a)

    may be used as an ingredient or component in the manufacture of therapeutic goods; and

  2. (b)

    although not presented for supply as therapeutic goods, come within the meaning of therapeutic goods because they are represented to be:

    1. (i)

      for therapeutic use; or

    2. (ii)

      for use as an ingredient or component in the manufacture of other therapeutic goods.

42DOCompliance with the Code

Generic information to which this Division applies must comply with principles of the Therapeutic Goods Advertising Code specified in regulations made for the purposes of this section as if those principles applied to generic information in the same way as they apply to advertisements.

42DPOffences—publication of generic information

  1. (1)

    A person is guilty of an offence if:

    1. (a)

      the person publishes or broadcasts generic information about therapeutic goods; and

    2. (b)

      the publication or broadcasting of that generic information does not comply with principles contained in the part of the Therapeutic Goods Advertising Code that are specified in Regulations.

    Penalty: 60 penalty units.

  2. (2)

    An offence against this section is an offence of strict liability.

19

Subsection 60(1) (at the end of the definition of initial decision)

Add:

  1. ; or (l)

    under section 42DF, 42DH or 42DI.

Part 3Other amendments
  1. 20

    Subsection 3(1) (at the end of paragraph (b) of the definition of authorised person)

    Add “, or a Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the Customs Act 1901)”.

21

Subsection 3(1)

Insert:

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

22

Subsection 3(5)

After “proper use”, insert “or identification”.

23

Subsection 14(1) (penalty)

Repeal the penalty, substitute:

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

24

Subsection 14(3) (penalty)

Repeal the penalty, substitute:

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

25

Subsection 20(1AA)

Omit “a fine not more than 240 penalty units”, substitute “imprisonment for 12 months or a fine not more than 1,000 penalty units, or both”.

26

After subsection 20(1A)

Insert:

  1. (1B)

    A person is guilty of an offence if:

    1. (a)

      the person is the sponsor of therapeutic goods for use in humans; and

    2. (b)

      the person:

      1. (i)

        imports the goods into Australia; or

      2. (ii)

        exports the goods from Australia; or

      3. (iii)

        manufactures the goods in Australia; or

      4. (iv)

        supplies the goods in Australia; and

    3. (c)

      the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:

      1. (i)

        the manufacturer of the goods;

      2. (ii)

        premises used in the manufacture of the goods.

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

  2. (1C)

    For the purposes of paragraph (1B)(c):

    1. (a)

      a manufacturer is properly notified to the Secretary if:

      1. (i)

        the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or

      2. (ii)

        the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and

    2. (b)

      premises are properly notified to the Secretary if:

      1. (i)

        the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or

      2. (ii)

        the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods.

27

Subsection 22(2A) (penalty)

Repeal the penalty, substitute:

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

28

Section 22A (penalty)

Repeal the penalty, substitute:

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

29

After paragraph 25(1)(j)

Insert:

  1. (ja)

    whether all of the manufacturers of the goods are nominated as manufacturers of the goods in the application; and

30

At the end of subsection 26(1)

Add:

  1. ; or (n)

    one or more of the manufacturers of the goods are not nominated as manufacturers of the goods in the application.

31

After paragraph 26A(1)(d)

Insert:

  1. ; and (e)

    the medicine is not one that has previously had its registration or listing cancelled;

32

At the end of subsection 28(5)

Add:

  1. ; and (c)

    in relation to each batch of the goods—keep a record, at least until the end of the period of 12 months after the expiry date for the goods, of all of the manufacturers involved in the manufacture of that batch; and

  2. (d)

    if requested to do so by an authorised person, make any such record available to the authorised person for inspection:

    1. (i)

      at or before the time the authorised person requests, or (if the authorised person requests) immediately; and

    2. (ii)

      either in electronic form or in paper form, as the authorised person requests; and

  3. (e)

    comply, in relation to the goods, with any reporting requirements that are prescribed; and

  4. (f)

    if a manufacturer who was not nominated as a manufacturer of the goods in the application for the registration or listing of the goods becomes a manufacturer of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the manufacturer becomes a manufacturer of the goods; and

  5. (g)

    if premises that were not nominated as premises to be used in the manufacture of the goods in the application become premises used in the manufacture of the goods—inform the Secretary in writing of that fact, no later than 10 working days after the premises are first used for that purpose.

33

Subsection 29A(1)

After “registered”, insert “or listed”.

34

Paragraph 29A(2)(c)

After “registration”, insert “or listing”.

35

At the end of subsection 29A(2)

Add:

  1. ; (d)

    information that indicates that the quality, safety or efficacy of the goods is unacceptable.

36

Subsection 29B(1)

After “registration”, insert “or listing”.

37

After paragraph 30(1)(d)

Insert:

  1. (da)

    the person has refused or failed to comply with the condition to which the inclusion of the goods is subject under paragraph 28(5)(d):

    1. (i)

      if the person was requested under that paragraph to make the record in question available at or before a requested time—before the end of the period of 24 hours after that time; or

    2. (ii)

      if the person was requested under that paragraph to make the record in question available immediately—within 24 hours after the request was made; or

38

Paragraph 30(2)(c)

After “subject”, insert “(other than the condition under paragraph 28(5)(d))”.

39

Subsections 30(6) and (7)

Repeal the subsections.

40

Sections 30A and 30B

Repeal the sections.

41

Saving provisions

(1) The repeal of subsections 30(6) and (7) of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of paragraph 30(6)(b) and subsection 30(7) of that Act in relation to a requirement imposed under paragraph 30(6)(a) of that Act before that commencement.

(2) The repeal of section 30A of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of subsections 30A(3) and (4) of that Act in relation to a requirement imposed under subsection 30A(2) of that Act before that commencement.

(3) The repeal of section 30B of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of subsections 30B(3), (4) and (5) of that Act in relation to a requirement imposed under subsection 30B(2) of that Act before that commencement.

42

After Division 2 of Part 3‑2

Insert:

Division 2A—Public notification and recovery of therapeutic goods

30EAPublic notification and recovery of therapeutic goods

  1. (1)

    The Secretary may, in writing, impose requirements, relating to therapeutic goods, on a person if:

    1. (a)

      any of the circumstances referred to in the second column of an item in the following table occur in relation to the goods; and

    2. (b)

      the person is referred to in the third column of that item.

Circumstances in which requirements may be imposed

Item

Circumstance relating to therapeutic goods

Person subject to requirements

1.

The goods are supplied while they are registered goods or listed goods, but they do not conform with a standard applicable to the goods

The person in relation to whom the goods are included in the Register

2.

The goods are supplied while they are registered goods or listed goods, but the manufacturing principles have not been observed in the manufacture of the goods

The person in relation to whom the goods are included in the Register

3.

The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

(c) they are the subject of an approval or authority under section 19; or

(d) they are the subject of an approval under section 19A;

but they do not conform with a standard applicable to the goods

The person supplying the goods

4.

The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

(c) they are the subject of an approval or authority under section 19; or

(d) they are the subject of an approval under section 19A;

but the manufacturing principles have not been observed in the manufacture of the goods

The person supplying the goods

5.

The goods are supplied in contravention of subsection 20(1) or 42E(1)

The person supplying the goods

6.

The goods are supplied while they are registered goods or listed goods, but one or more steps in the manufacture of the goods has been carried out by a manufacturer while the manufacturer did not hold a licence that was in force

The person in relation to whom the goods are included in the Register

7.

The registration or listing of the goods has been cancelled under this Part

The person in relation to whom the goods were included in the Register

  1. (2)

    The requirements may be one or more of the following:

    1. (a)

      to take specified steps, in the specified manner and within such reasonable period as is specified, to recover therapeutic goods that have been distributed;

    2. (b)

      to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, to the effect that the circumstances referred to in paragraph (1)(a) have occurred in relation to therapeutic goods;

    3. (c)

      to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of therapeutic goods.

  2. (3)

    If the circumstances referred to in paragraph (1)(a) apply only to a batch of therapeutic goods, the Secretary may limit the imposition of the requirements to the therapeutic goods included in that batch.

  3. (4)

    A requirement to recover therapeutic goods under this section does not apply to therapeutic goods that cannot be recovered because they have been administered to, or applied in the treatment of, a person.

30EBPublication of requirements

The Secretary must cause to be published in the Gazette, as soon as practicable after imposing a requirement under section 30EA, a notice setting out particulars of the requirement.

30ECNon‑compliance with requirements

A person is guilty of an offence if:

  1. (a)

    the person does an act, or omits to do an act; and

  2. (b)

    the act or omission constitutes a contravention of a requirement imposed on the person under section 30EA.

Maximum penalty: 60 penalty units.

30EDPower of cancellation unaffected

Imposition of a requirement under section 30EA does not affect the Secretary’s power to cancel the registration or listing of therapeutic goods under this Part.

43

Subsection 35(1) (penalty)

Repeal the penalty, substitute:

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

44

Subsection 35(2) (penalty)

Repeal the penalty, substitute:

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

45

Subsection 35(4) (penalty)

Repeal the penalty, substitute:

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

46

Paragraph 38(1)(d)

Omit “person”, substitute “applicant”.

47

Subsection 38(1)

Omit all the words after “Secretary must grant”, substitute:

the applicant a licence to carry out those steps at those premises unless the Secretary is satisfied that:

  1. (e)

    the applicant will be unable to comply with the manufacturing principles; or

  2. (f)

    the premises are not satisfactory for the manufacture of the goods; or

  3. (g)

    the applicant is not a fit and proper person to hold a licence; or

  4. (h)

    a person who is participating in, or is likely to participate in, managing the applicant’s affairs is not a fit and proper person to participate in the management of the affairs of a holder of a licence; or

  5. (i)

    a person who has, or is likely to have, effective control over the applicant is not a fit and proper person to have effective control over a holder of a licence.

48

After subsection 38(1)

Insert:

  1. (1A)

    Without limiting the matters to which the Secretary may have regard in considering whether the applicant or person is not a fit and proper person for the purposes of paragraph (1)(g), (h) or (i), the Secretary must have regard to:

    1. (a)

      any suspension or revocation of a manufacturing licence granted to:

      1. (i)

        the applicant or person; or

      2. (ii)

        another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

      3. (iii)

        another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the suspension or revocation; or

    2. (b)

      any conviction, for an offence against a law of the Commonwealth or a law of a State or Territory, against:

      1. (i)

        the applicant or person; or

      2. (ii)

        another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

      3. (iii)

        another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time the offence was committed or the time of the conviction; or

    3. (c)

      any failure to comply with a condition of a manufacturing licence by:

      1. (i)

        the applicant or person; or

      2. (ii)

        another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

      3. (iii)

        another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the failure.

  2. (1B)

    In subsection (1A):

manufacturing licence means:

  1. (a)

    a licence granted under this Part; or

  2. (b)

    a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods.

49

Subsection 38(2)

Omit “paragraph (1)(f)”, substitute “paragraphs (1)(g), (h) and (i)”.

50

Subsection 38(2)

Omit “a person”, substitute “an applicant”.

51

Subsection 38(2)

Omit “that paragraph”, substitute “one or more of those paragraphs”.

52

Subsection 38(3)

Omit “a person”, substitute “an applicant”.

53

Paragraph 38(3)(a)

Omit “person”, substitute “applicant”.

54

Subsection 40(1)

Repeal the subsection, substitute:

  1. (1)

    A licence may be granted subject to such conditions relating to the manufacture of the goods as the Secretary thinks appropriate.

55

Saving provision

The repeal and substitution of subsection 40(1) of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of any condition that:

  1. (a)

    was imposed on a licence under that subsection; and

  2. (b)

    was in force immediately before that commencement.

56

Paragraph 40(4)(a)

Repeal the paragraph, substitute:

  1. (a)

    ensure that:

    1. (i)

      the goods conform to any standard applicable to the goods; and

    2. (ii)

      the holder of the licence observes the manufacturing principles in carrying out any steps in the manufacture of the goods under the licence; and

57

After paragraph 40(4)(aa)

Insert:

  1. (ab)

    as soon as the holder of the licence becomes aware of information of a kind mentioned in subsection (5), give the information to the Secretary in writing; and

58

Subparagraph 40(4)(b)(ii)

Omit “, with the agreement of the holder,”.

59

At the end of section 40

Add:

  1. (5)

    The information with which paragraph (4)(ab) is concerned is information of the following kinds:

    1. (a)

      information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect;

    2. (b)

      information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as was suggested by:

      1. (i)

        the application for registration or listing of the goods; or

      2. (ii)

        information already furnished by the holder of the licence under this Act; or

      3. (iii)

        if the holder of the licence is not the sponsor of the goods—information already furnished by the sponsor of the goods under this Act;

    3. (c)

      information that indicates that the quality, safety or efficacy of the goods is unacceptable.

60

Application provision

Subsection 40(4) of the Therapeutic Goods Act 1989 as amended by this Act, and subsection 40(5) of that Act, apply to any licence in force after the commencement of this item, whether or not the licence was granted after that commencement.

61

Paragraphs 41(1)(aa) and (ab)

Omit “a body corporate”, substitute “another person”.

62

Paragraph 41(1)(ab)

Omit “the body” (wherever occurring), substitute “the other person”.

63

Paragraph 41(1)(c)

Repeal the paragraph, substitute:

  1. (c)

    the holder is controlled by another person (whether directly, or indirectly through one or more interposed entities) and that other person has breached a condition of a licence; or

  2. (ca)

    the holder controls another person (whether directly, or indirectly through one or more interposed entities) and that other person has, while controlled by the holder, breached a condition of a licence; or

  3. (cb)

    the holder is not a fit and proper person to hold a licence; or

  4. (cc)

    a person who is participating in managing the holder’s affairs is not a fit and proper person to participate in the management of the affairs of a holder of a licence; or

  5. (cd)

    a person who has effective control over the holder is not a fit and proper person to have effective control over a holder of a licence; or

64

After subsection 41(1)

Insert:

  1. (1A)

    Without limiting the matters to which the Secretary may have regard in considering whether the holder or another person is not a fit and proper person for the purposes of paragraph (1)(cb), (cc) or (cd), the Secretary must have regard to the matters set out in paragraphs 38(1A)(a), (b) and (c).

65

At the end of section 41EC

Add:

  1. (3)

    In deciding whether to issue the certificate, the Secretary must also consider:

    1. (a)

      whether the applicant is a fit and proper person to hold a conformity assessment certificate; and

    2. (b)

      whether the persons who participate in, or who are likely to participate in, managing the applicant’s affairs are fit and proper persons to participate in managing the affairs of a manufacturer in respect of whom a conformity assessment certificate is issued; and

    1. (c)

      whether the persons who have, or are likely to have, effective control over the applicant are fit and proper persons to have effective control over a manufacturer in respect of whom a conformity assessment certificate is issued.

  2. (4)

    Without limiting the matters to which the Secretary may have regard in considering whether the applicant or person is a fit and proper person for the purposes of paragraph (3)(a), (b) or (c), the Secretary must have regard to:

    1. (a)

      any suspension or revocation of a conformity assessment certificate issued to:

      1. (i)

        the applicant or person; or

      2. (ii)

        another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

      3. (iii)

        another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the suspension or revocation; or

    2. (b)

      any conviction, for an offence against a law of the Commonwealth or a law of a State or Territory, against:

      1. (i)

        the applicant or person; or

      2. (ii)

        another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

      3. (iii)

        another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time the offence was committed or the time of the conviction; or

    3. (c)

      any failure to comply with a condition of a conformity assessment certificate by:

      1. (i)

        the applicant or person; or

      2. (ii)

        another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); or

      3. (iii)

        another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time of the failure.

66

At the end of subsection 41ET(1)

Add:

  1. ; or (e)

    the manufacturer is not a fit and proper person to be a manufacturer in respect of whom a conformity assessment certificate is issued; or

  2. (f)

    a person who is participating in managing the manufacturer’s affairs is not a fit and proper person to participate in managing the affairs of a manufacturer in respect of whom a conformity assessment certificate is issued; or

  3. (g)

    a person who has effective control over the manufacturer is not a fit and proper person to have effective control over a manufacturer in respect of whom a conformity assessment certificate is issued.

67

After subsection 41ET(1)

Insert:

  1. (1A)

    Without limiting the matters to which the Secretary may have regard in considering whether the holder or another person is not a fit and proper person for the purposes of paragraph (1)(e), (f) or (g), the Secretary must have regard to the matters set out in paragraphs 41EC(4)(a), (b) and (c).

68

Section 41FE (penalty)

Repeal the penalty, substitute:

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

69

Subsection 41MA(1) (penalty)

Repeal the penalty, substitute:

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

70

Subsection 41MA(2) (penalty)

Repeal the penalty, substitute:

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

71

Subsection 41MA(3) (penalty)

Repeal the penalty, substitute:

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

72

Subsection 41ME(1) (penalty)

Repeal the penalty, substitute:

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

73

Subsection 41ME(2) (penalty)

Repeal the penalty, substitute:

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

74

Subsection 41MF(1) (penalty)

Repeal the penalty, substitute:

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

75

Subsection 41MF(2) (penalty)

Repeal the penalty, substitute:

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

76

Section 41MH (penalty)

Repeal the penalty, substitute:

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

77

Subsection 41MI(1) (penalty)

Repeal the penalty, substitute:

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

78

Subsection 42E(4)

Omit “500 penalty units”, substitute “2,000 penalty units”.

79

Subsection 54AA(1)

After “whichever of n or (3) applies”, insert “whichever of subsection (2) or (3) applies”.

80

After section 54AA

Insert:

54ABDamage etc. to documents

  1. (1)

    A person is guilty of an offence if:

    1. (a)

      the person damages, destroys, alters, conceals or falsifies a document; and

    2. (b)

      the document is created, retained or issued for the purposes of this Act, or for purposes that include the purposes of this Act.

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

  2. (2)

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

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

Schedule 2—Amendment of the Broadcasting Services Act 1992

1

Clause 1 of Schedule 2 (definition of medicine)

Repeal the definition.

2

Subclauses 6(2) to (8) of Schedule 2

Repeal the subclauses, substitute:

  1. (2)

    A broadcaster must not broadcast an advertisement relating to therapeutic goods that is required to be approved under the Therapeutic Goods Act 1989 unless the text of the advertisement has been so approved.

3

Saving and transitional provisions

(1) If, before the date of commencement of items 1 and 2 of this Schedule:

  1. (a)

    a person has applied, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992, to the Secretary (the Health Secretary) of the Department whose Minister (the Health Minister) is responsible for the administration of the Therapeutic Goods Act 1989 for approval of an advertisement proposed for broadcasting; and

  2. (b)

    a decision has not been made by the Health Secretary before that date;

that application is to be treated, on and after that date, for all purposes as if it were an application for approval under the Therapeutic Goods Regulations 1990.

(2) If, before the date of commencement of items 1 and 2 of this Schedule:

  1. (a)

    the Health Secretary has made a decision in relation to an application, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992, for approval of an advertisement proposed for broadcasting; and

  2. (b)

    an appeal from that decision has not been made to the Minister responsible for the administration of the Broadcasting Services Act 1992;

the person who sought that approval has the same right to appeal to the Health Minister under the Therapeutic Goods Regulations 1990, on and after that date, as if that decision had been made under those regulations.

(3) If, before the date of commencement of items 1 and 2 of this Schedule:

  1. (a)

    the Health Secretary has made a decision in relation to an application, under clause 6 of Schedule 2 to the Broadcasting Services Act 1992, for approval of an advertisement proposed for broadcasting; and

  2. (b)

    an appeal from that decision has been made to the Minister responsible for the administration of the Broadcasting Services Act 1992; and

  3. (c)

    the appeal has not been finally determined before that date;

that appeal is to continue to be dealt with under the Broadcasting Services Act 1992, on and after that date, as if the amendments made by items 1 and 2 had not been made.

[Minister’s second reading speech made in—

House of Representatives on 27 June 2002

Senate on 15 May 2003]

(143/02)

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