Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1996 NO. 25

STATUTORY RULES 1996 No. 25

Issued by the authority of the Minister for Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

Section 63 of the Act enables the Governor-General to make regulations prescribing matters necessary or convenient to be prescribed for carrying out or giving effect to the Act.

The Australian Drug Evaluation Committee advises the Minister or the Secretary on medical and scientific evaluations of drugs and on the timely availability of new therapeutic advances in Australia. As decisions made in relation to therapeutic goods directly affect consumers, it is appropriate that their views are considered and that they participate in the decision making process. The current core membership of the Committee consists of 6 or 7 members.

The proposed amendment to regulation 36(3)(a) increases the number of core members of the Australian Drug Evaluation Committee by two to provide for consumer representation.

Regulation 36 (4) (a) is amended to insert a new paragraph (iii) to provide for 2 further persons as core members, both of whom must have experience in consumer health issues and one of whom must have technical expertise.

The Regulations commence on the date of Gazettal.