Therapeutic Goods Amendment Regulations 2003 (No. 5) (Cth)

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Therapeutic Goods Amendment Regulations 2003 (No. 5)1

Statutory Rules 2003 No. 3012

I, PHILIP MICHAEL JEFFERY, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 4 December 2003

P. M. JEFFERY

Governor-General

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

1Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2003 (No. 5).

2Commencement

These Regulations commence on gazettal.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(regulation 3)

  

[1]Regulation 2, definitions of generic information, prohibited representation, required representation, restricted representation and specified media

omit

[2]After regulation 3

insert in Part 1

3AUnacceptable presentations

For paragraph 3 (5) (e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.

[3]Part 2, Division 1

substitute

Division 1Application of Part

4Application of Part 2

  1. (1)

    This Part applies to advertisements to which Part 5-1 of the Act applies.

  2. (2)

    For subsection 42AA (2) of the Act, the bodies mentioned in Schedule 1 are prescribed.

4AInterpretation

A term used in this Part and in Part 5-1 of the Act has the same meaning in this Part as it has in Part 5-1 of the Act.

Note See section 42B of the Act for definitions of terms used in Part 5-1 of the Act.

[4]Regulation 5B, definition of approved advertisement

omit

[5]After regulation 5B

insert

5BAMeans that are not broadcast media

For the definition of broadcast media in section 42B of the Act, in relation to an advertisement to which this Division applies, each of the following means is declared to be an exempted means:

  1. (a)

    the Internet;

  2. (b)

    electronic mail;

  3. (c)

    narrowcast transmission, being a system the reception of which is limited:

    1. (i)

      by being targeted to special interest groups; or

    2. (ii)

      by being intended only for limited locations (for example, arenas or business premises); or

    3. (iii)

      by being provided during a limited period or to cover a special event; or

    4. (iv)

      because it provides programs of limited appeal; or

    5. (v)

      for any other reason;

  4. (d)

    short message service (SMS), being a system enabling the transmission of short text messages from a digital mobile telephone to another digital mobile telephone;

  5. (e)

    multimedia messaging service (MMS), being a system enabling the transmission of visual communication, voice communication or electronic mail from a digital mobile telephone to:

    1. (i)

      another digital mobile telephone; or

    2. (ii)

      an electronic mail address.

[6]Paragraph 5G (1) (d)

omit

regulation 6A;

insert

regulation 3A;

[7]Paragraph 5G (1) (e)

substitute

  1. (e)

    does not contain a restricted representation about the goods the use of which has not been approved under section 42DF of the Act or permitted under subsection 42DK (1) of the Act.

[8]Subregulations 5Q (3) and (4)

substitute

  1. (3)

    The Secretary may delegate to the CHCA the Secretary’s power under regulation 5G to approve or refuse to approve an advertisement about designated therapeutic goods that are complementary medicines if the advertisement is to be published or used in specified media of the kind mentioned in paragraph (a), (c) or (d) of the definition of specified media in section 42B of the Act.

  2. (4)

    The Secretary may delegate to the ASMI the following powers of the Secretary under regulation 5G:

    1. (a)

      the power to approve or refuse to approve an advertisement about designated therapeutic goods that are complementary medicines if the advertisement is to be broadcast in broadcast media;

    2. (b)

      the power to approve or refuse to approve an advertisement about designated therapeutic goods that are not complementary medicines if the advertisement is to be published or broadcast in specified media.

[9]Part 2, Divisions 3 and 4

substitute

Division 3General provisions about advertising therapeutic goods

6Restricted representations

For subsection 42DD (1) of the Act, Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code is prescribed.

6AApproval of use of restricted representation — public interest criteria

For paragraph 42DF (4) (c) of the Act, Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code is prescribed.

6BProhibited and required representations

  1. (1)

    For subsection 42DJ (1) of the Act, the following representations are prohibited representations:

    1. (a)

      the representations in column 2 of an item in Part 1 of Schedule 2 about therapeutic goods in column 3 of that item;

    2. (b)

      the representations in Part 1 of Appendix 6 to the Therapeutic Goods Advertising Code.

  2. (2)

    For subsection 42DJ (2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.

7Exempt goods and exempt devices

  1. (1)

    For subparagraph 42DL (1) (h) (i) of the Act, the following exempt goods are prescribed:

    1. (a)

      goods that are exempt from the operation of Part 3-2 of the Act under subregulation 12 (1A) or regulation 12A;

    2. (b)

      goods specified in item 1 of Schedule 5.

  2. (2)

    For subparagraph 42DL (1) (h) (i) of the Act, the following exempt devices are prescribed:

    1. (a)

      devices that are exempt from the operation of Division 3 of Part 4-11 of the Act under subregulation 7.1 (2) or regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;

    2. (b)

      devices of a kind mentioned in item 1.1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

      Division 4Generic information about ingredients or components of therapeutic goods

8Compliance with the Code

For section 42DO of the Act, the principles stated in clauses 4.1, 4.2, 4.3 and 4.4 of Part 4 of the Therapeutic Goods Advertising Code are specified.

8APublication of generic information

For paragraph 42DP (1) (b) of the Act, the principles contained in clauses 4.1, 4.2, 4.3 and 4.4 of Part 4 of the Therapeutic Goods Advertising Code are specified.

Division 5General

9Orders about advertisements or generic information

  1. (1)

    On the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI (3) in relation to an advertisement or generic information about therapeutic goods, the Secretary, by written notice, may order a person to do one or more of the following:

    1. (a)

      withdraw the advertisement or generic information;

    2. (b)

      publish a retraction;

    3. (c)

      publish a correction;

    4. (d)

      recover any advertisement or generic information that is still in circulation;

    5. (e)

      destroy the advertisement or generic information;

    6. (f)

      withdraw a particular claim or representation made by the advertisement or generic information, and not use that claim or representation in any other advertisement or generic information unless the person satisfies the Secretary that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.

  2. (2)

    An order under subregulation (1) may be subject to conditions imposed by the Secretary.

  3. (3)

    The Secretary may delegate all or any of the Secretary’s powers under subregulation (1) to the chairperson of the Complaints Resolution Panel.

[10]Part 2B

omit

[11]Paragraph 42B (1) (d)

omit

observers

insert

Council members or observers

[12]Regulation 42Y

substitute

42YQuorum

  1. (1)

    Subject to subregulations (2) and (3), at a meeting of the Panel, a quorum exists if the chairperson and 4 other persons, being members of the Panel or observers to the Panel, are present.

Note See regulation 42T in relation to the nomination of members of the Panel and regulation 42X in relation to the nomination of observers to the Panel.

  1. (2)

    If a complaint about a medical device or other therapeutic goods is to be considered at a meeting of the Panel, the quorum must include the member nominated under subregulation 42T (1A) for that meeting.

  2. (3)

    A quorum for a meeting convened to consider a complaint does not include a member of the Panel if the complaint was made by:

    1. (a)

      the member; or

    2. (b)

      the body that nominated the member.

[13]Subregulation 42ZCAB (2)

substitute

  1. (2)

    A person may complain in writing to the Complaints Resolution Panel that generic information, to which Division 4 of Part 5-1 of the Act applies, that is published or inserted in specified media or broadcast media contravenes that Division.

[14]Paragraph 42ZCAI (1) (c)

omit

correction.

insert

correction;

[15]After paragraph 42ZCAI (1) (c)

insert

  1. (d)

    withdraw a particular claim or representation made by the advertisement, and not use that claim or representation in any other advertisement unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.

[16]Paragraph 42ZCAI (2) (c)

omit

correction.

insert

correction;

[17]After paragraph 42ZCAI (2) (c)

insert

  1. (d)

    withdraw a particular claim or representation made by the generic information, and not use that claim or representation in any other generic information unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.

[18]Paragraph 42ZCAI (4) (h)

omit

Act.

insert

Act;

[19]After paragraph 42ZCAI (4) (h)

insert

  1. (i)

    order that a particular claim or representation made by the advertisement or generic information be withdrawn, and not be used in any other advertisement or generic information unless the person apparently responsible satisfies the Panel that the use of the claim or representation would not result in a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.

[20]Subregulation 48 (1), definition of initial decision, paragraphs (a), (b), (ba) and (bb)

substitute

  1. (a)

    subregulation 9 (1);

[21]Schedule 2, heading

substitute

Schedule 2Prohibited and required representations

(regulation 6B)

Notes

1. These Regulations amend Statutory Rules 1990 No. 394, as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84, 114, 143, 234, 315 and 345; 2003 Nos. 111, 151, 257 and 258.

2. Notified in the Commonwealth of Australia Gazette

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