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Guide to the Advertising of Non-prescription Medicines to Consumers

Amendments

Restricted Representations

Guidelines for the Levels and Kinds of Evidence to Support Claims for Therapeutic Goods

Industry Codes

Amendments to the Code

03/05/03
Therapeutic Goods Amendment Regulations 2002 (No. 5)

Therapeutic Goods Amendment Regulations 2002 (No. 5)1

Statutory Rules 2002 No. 3152

I, PETER JOHN HOLLINGWORTH, 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 12 December 2002

PETER HOLLINGWORTH

Governor-General

By His ExcellencyÕs Command

TRISH WORTH


Contents

                        1     Name of Regulations                                                        2

                        2     Commencement                                                              2

                        3     Amendment of Therapeutic Goods Regulations 1990          2

Schedule 1           Amendments commencing on gazettal                           3

Schedule 2           Amendment commencing on 1 January 2003                  6


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2002 (No. 5) .

2              Commencement

                These Regulations commence as follows:

                (a)    on gazettal Ñ regulations 1 to 3 and Schedule 1;

                (b)    on 1 January 2003 Ñ Schedule 2.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedules 1 and 2 amend the Therapeutic Goods Regulations 1990.


Schedule 1                       Amendments commencing on gazettal

(regulation 3)

[1]            Before paragraph 9AA (1) (a)

insert

              (aa)    withdraw the advertisement;

[2]            Before paragraph 9S (1) (a)

insert

              (aa)    withdraw the generic information;

[3]            After subregulation 42J (2)

insert

       (2A)   Each pair of bodies mentioned in subregulation (2B) may jointly nominate a person to attend meetings of the Council as an observer.

       (2B)   For subregulation (2A), the pairs of bodies are:

                (a)    the Federation of Australian Commercial Television Stations and the Federation of Australian Radio Broadcasters; and

                (b)    the Australian Publishers Bureau and the Outdoor Advertising Association of Australia.

[4]            Regulation 42Y

omit

At

insert

          (1)   Subject to subregulation (2), at

[5]            Regulation 42Y

insert

          (2)   If a meeting of the Panel is convened to consider a complaint from:

                (a)    a member of the Panel mentioned in subregulation (1); or

                (b)    an organisation, or a member of an organisation, represented by a member of the Panel mentioned in subregulation (1);

the quorum for that meeting does not include that member of the Panel.

[6]            After subregulation 42ZCAD (2)

insert

          (3)   If the complaint is received from:

                (a)    a member of the Panel; or

                (b)    an organisation, or a member of an organisation, that is represented by a member of the Panel;

that member of the Panel must not participate in the PanelÕs consideration of the complaint.

[7]            After paragraph 42ZCAI (4) (b)

insert

              (ba)    order the withdrawal of the advertisement or generic information;

[8]            After regulation 42ZCAK

insert

42ZCAL    Register of complaints

          (1)   The Panel may publish, including on the Internet, a register of complaints and related information.

          (2)   The register may include copies of, and information about, the following:

                (a)    complaints received by the Panel;

                (b)    decisions made by the Panel under regulation 42ZCAD in relation to complaints;

                (c)    action taken by the Panel under regulation 42ZCAI in relation to complaints;

                (d)    statements of reasons given for decisions or action mentioned in paragraph (b) or (c);

                (e)    any other information that the Panel considers appropriate.

[9]            Schedule 3, Part 1, paragraph 2B (a)

substitute

                (a)    are not mentioned in item 1, 1A, 3, 4, 5, 7 or 8 in Schedule 5A; and

[10]           Schedule 4, Part 1, after item 10

insert

    10A       medicines containing L-arginine singly or in combination with other substances and intended for application to the skin for a localised effect, if a warning label is attached to the medicine stating that the medicine is to be applied only to the skin, and not to the mucosa, vagina or rectum, unless:

                (a)    the medicine also contains an amino acid, other than L‑arginine, mentioned in paragraph (a) of item 10; or

                (b)    the other substances are included in Schedule 3; or

                (c)    the goods are included in a Schedule to the Poisons Standard; or

                (d)    the goods are in a form required to be sterile; or

                (e)    the indications proposed by the sponsor of the goods are in the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code

Schedule 2                       Amendment commencing on 1 January 2003

(regulation 3)

[1]            Subregulations 9A (1) and (1AAA)

substitute

          (1)   The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a patient information document set out in Schedule 12.

Penalty:   10 penalty units.

   (1AAA)   For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.

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

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 and 234.

2.       Notified in the Commonwealth of Australia Gazette on 19 December 2002.


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