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Therapeutic Goods Amendment Regulations 2006 (No. 1)

Authoritative Version
  • - F2006L01615
  • No longer in force
SLI 2006 No. 122 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to change some of the administrative arrangements for the Therapeutic Goods Advertising Code Council and the Complaints Resolution Panel.
Administered by: Health
Registered 02 Jun 2006
Tabling HistoryDate
Tabled HR13-Jun-2006
Tabled Senate13-Jun-2006
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2006 (No. 1)1

Select Legislative Instrument 2006 No. 122

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 1 June 2006

P. M. JEFFERY

Governor‑General

By His Excellency’s Command

CHRISTOPHER PYNE


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2006 (No. 1).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.


Schedule 1        Amendments

(regulation 3)

  

[1]           Regulations 8 and 8A

omit

clauses 4.1, 4.2, 4.3 and 4.4 of Part 4

insert

subsections 4 (1), (2), (3), (4), (5) and (6)

[2]           Subregulation 42C (1)

omit

13 members

insert

15 members

[3]           Paragraph 42C (1) (a)

omit

4 manufacturer/supplier members,

insert

5 manufacturer/supplier members,

[4]           After subparagraph 42C (1) (a) (iv)

insert

                         (v)    the Medical Industry Association of Australia;

[5]           Paragraph 42C (1) (e)

substitute

                (e)    2 members nominated by the Therapeutic Goods Administration;

                (f)    1 member jointly nominated by the Australian Publishers Bureau and the Outdoor Advertising Association of Australia.

[6]           Paragraph 42J (2) (c)

omit

[7]           Subregulations 42J (2A) and (2B)

substitute

      (2A)   Free TV Australia and Commercial Radio Australia Limited may jointly nominate a person to attend meetings of the Council as an observer.

[8]           After regulation 42ZCAG

insert

42ZCAGA      Panel may refer complaint to another authority

         (1)   If the Panel is satisfied that:

                (a)    the subject matter of a complaint, or the advertisement or generic information to which a complaint relates, involves a matter that could more effectively or conveniently be dealt with by another authority; and

               (b)    a complaint relating to the matter could have been made by the complainant to the authority;

the Panel may, in writing, refer the matter, and any material before the Panel relating to the matter, to the authority.

         (2)   If the Panel refers a matter to another authority, the Panel must give written notice of its decision to the complainant (if known) and the person apparently responsible.

         (3)   The referral of a matter under subregulation (1) does not prevent the Panel from dealing with other matters to which the complaint relates in accordance with this Subdivision.

         (4)   This regulation applies despite the withdrawal of the complaint.

[9]           Paragraph 42ZCAI (1) (d)

substitute

               (d)    withdraw a particular claim or representation made by the advertisement, and give the Panel a written undertaking not to 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.

[10]         Paragraph 42ZCAI (2) (d)

substitute

               (d)    withdraw a particular claim or representation made by the generic information, and give the Panel a written undertaking not to 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.

[11]         Subregulation 42ZCAI (3)

substitute

         (3)   If the person apparently responsible:

                (a)    does not comply with a request under subregulation (1) or (2) within 14 days after the request is made; or

               (b)    breaches an undertaking given under paragraph (1) (d) or (2) (d);

                the Panel may make a recommendation to the Secretary about the advertisement or generic information.

[12]         Schedule 1, item 3

omit

[13]         Schedule 2, Part 1, item 4, column 2

omit

paragraph 7.1.3 (a) or (b)

insert

subparagraph 7 (1) (e) (i) or (ii)

[14]         Schedule 2, Part 1, item 8, column 2

omit

paragraph 7.2 (a) or (b)

insert

paragraph 7 (2) (a) or (b)


Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.frli.gov.au.