Statutory Rules 1987 No. 641

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Therapeutic Goods Regulations2 (Amendment)

I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the Therapeutic Goods Act 1966.

Dated 13 April 1987.

N. M. STEPHEN

Governor-General

By His Excellency's Command,

NEAL BLEWETT

Minister of State for Health

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Principal Regulations

1. In these Regulations, "Principal Regulations" means the Therapeutic Goods Regulations.

2. Regulations 17 and 18 of the Principal Regulations are repealed and the following regulation is substituted:

Therapeutic Goods Committee

"17. (1) There shall be a committee to be known as the Therapeutic Goods Committee.

"(2) Subject to subregulation (3), the functions of the Committee are:

(a) to consider any matters referred to it by the Minister relating to the administration of the Act; and

(b) to consider and inquire into:

(i) the standards applicable to any goods for therapeutic use, and any matter relating to those standards; and

(ii) the requirements with respect to labelling and packaging applicable to any such goods;

and to advise the Minister in relation to those matters, standards and requirements.

"(3) The Committee is not empowered to consider any matters relating to, or arising out of the operation of, section 29 of the Act.

"(4) Subject to this regulation, the Committee shall consist of the following persons:

(a) persons having expertise in one or more of the following fields:

(i) pharmaceutics;

(ii) pharmaceutical chemistry;

(iii) pharmacology;

(iv) microbiology;

(v) virology;

(vi) medical devices;

(vii) veterinary science;

being persons so appointed that expertise in each of those fields is available among the members of the Committee;

(b) a person or persons having the following kinds of experience and expertise:

(i) scientific experience in the manufacture of pharmaceutical therapeutic goods;

(ii) scientific experience in the manufacture of therapeutic devices; and

(iii) consumer affairs expertise in respect of therapeutic goods; being a person or persons so appointed that each of those kinds of experience and expertise is available among the members of the Committee; and

(c) a person nominated by the Secretary of the Department of Primary Industry.

"(5) The Minister shall designate, in writing, one of the members of the Committee to be the chairperson.

"(6) The Committee shall consist of not fewer than 8 persons and not more than 11 persons, who shall be appointed in writing by the Minister.

"(7) The Committee may appoint a sub-committee consisting of such members of the Committee and such other persons, if any, as the Committee thinks fit for the purpose of inquiring into, and reporting to the Committee on, any matter that is within the functions of the Committee."

Repeal of regulation 19a

3. Regulation 19a of the Principal Regulations is repealed.

Repeal of regulation 21

4. Regulation 21 of the Principal Regulations is repealed.

Meetings of committees

5. Regulation 23 of the Principal Regulations is amended by omitting subregulation (2) and substituting the following subregulation:

"(2) At a meeting of a committee established under this Part:

(a) in the case of the Therapeutic Goods Committee—5 members constitute a quorum; and

(b) in the case of the Australian Drug Evaluation Committee:

(i) if fewer than 7 members of the Committee are in Australia when a meeting is held—3 members constitute a quorum; or

(ii) in any other case—4 members constitute a quorum.".

Minor amendments

6. The Principal Regulations are amended as set out in the Schedule to these Regulations.

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SCHEDULE Regulation 6

MINOR AMENDMENTS

NOTES

1. Notified in the Commonwealth of Australia Gazette on 1 May 1987.

2. Statutory Rules 1970 No. 165 as amended by 1973 Nos. 76 and 225; 1974 No. 166; 1975 No. 36; 1979 No. 135; 1984 Nos. 53 and 158; 1985 Nos. 297 and 312.