EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 158
THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 30 of the Therapeutic Goods Act 1966 (‘the Act’) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act, and in particular, inter alia, for making provisions for or in relation to the establishment of committees to advise the Minister on matters relating to the importation into Australia of therapeutic substances and on such other matters as are prescribed, and the functions and powers of those committees.
Regulation 17 of the Therapeutic Goods Regulations (‘the Regulations’) establishes the Therapeutic Goods Advisory Committee and prescribes its functions and membership. The functions of the Committee are to consider:
• any matter (except any matter relating to substances classified as dangerous under section 29 of the Act) referred to it by the Minister relating to the administration of the Act; and
• the standards applicable to any goods for therapeutic use, and the requirements with respect to labelling and packaging applicable to any such goods, insofar as those standards or requirements relate to the manufacture, distribution or use of goods for therapeutic use,
and to advise the Minister in relation to that matter or those standards.
The membership of the Committee has been extended to allow for a number of additional organizations to be represented.
Regulation 1 amended existing regulation 17 to provide for persons appointed by the Minister for Health on the nomination of the following organizations to be represented on the Committee:
• Agricultural and Veterinary Chemicals Association of Australia;
• The Australian Medical Devices and
Diagnostics Association;
• Australian Physiotherapy Association;
• Australian Resuscitation Council; and
• The Institution of Biomedical Engineering (Australia) Incorporated.
The Regulations also provide for representation on the Committee of two persons appointed by the Minister for Health on the nomination of the National Council of Chemical and Pharmaceutical Industries instead of three persons as was formerly prescribed. The amendment was required because an organization previously represented on the National Council of Chemical and Pharmaceutical Industries, the Agricultural and Veterinary Chemicals Association of Australia, now seeks representation in its own right.
Regulation 1 also made a minor drafting change to existing sub-regulation 17(5), in consequence of the changes to the membership.
Regulation 2 amended existing sub-regulation 23(2) which provides for the numbers of members that constitute a quorum at meetings of the various committees established under the Regulations.
Sub-regulation 23(2) was omitted and a new sub-regulation 23(2) substituted which provides that at the meeting of a Committee:
• in the case of the Therapeutic Goods Advisory Committee, 7 members constitutes a quorum;
• in the case of the Therapeutic Goods Standards Committee, 5 members constitutes a quorum; and
• in the case of the Australian Drug Evaluation Committee, if less than 7 members of the committee are in Australia when a meeting is held - 3 members constitutes a quorum, or in any other case - 4 members constitutes a quorum.