Commonwealth Numbered Regulations

THERAPEUTIC GOODS AMENDMENT REGULATIONS 2002 (NO. 5) 2002 NO. 315 - SCHEDULE 1

(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 Panel's 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