Statutory Rules 1985 No. 2971

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Therapeutic Goods Regulations (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 7 November 1985.

N. M. STEPHEN

Governor-General

By His Excellency’s Command,

NEAL BLEWETT

Minister of State for Health

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1. After regulation 19 of the Therapeutic Goods Regulations the following regulation is inserted:

Monoclonal Antibody Committee

“19a. (1) There shall be a Committee to be known as the Monoclonal Antibody Committee.

“(2) The Monoclonal Antibody Committee shall consist of—

(a) the Chairman of the Australian Drug Evaluation Committee or a person authorised by that Chairman to attend a meeting or meetings of the Monoclonal Antibody Committee on behalf of that Chairman;

(b) an officer of the Department appointed by the Minister, or another officer of the Department authorised by that officer to attend a meeting or meetings of the Monoclonal Antibody Committee on behalf of that officer;

(c) one person, appointed by the Minister, who has scientific experience in the manufacture of monoclonal antibodies; and

(d) 4 other persons appointed by the Minister from persons expert in one or more of the fields of biochemistry, molecular biology, immunology, protein chemistry or clinical medicine.

“(3) The Minister shall appoint one of the members of the Monoclonal Antibody Committee to be chairman of that Committee.

“(4) The functions of the Monoclonal Antibody Committee are to advise the Minister on matters affecting the quality, efficacy and safety of monoclonal antibodies and related products for therapeutic use.”.

Meetings of Committees

2. Regulation 23 of the Therapeutic Goods Regulations is amended—

(a) by omitting from paragraph (2) (b) “and”;

(b) by adding after paragraph (c) the following word and paragraph:

“; and (d) in the case of the Monoclonal Antibody Committee— 4 members constitute a quorum”.

NOTES

1. Notified in the Commonwealth of Australia Gazette on 14 November 1985.

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