EXPLANATORY STATEMENT
STATUTORY RULES 1987 No 64
ISSUED BY AUTHORITY OF THE MINISTER FOR HEALTH
THERAPEUTIC GOODS ACT 1966
THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
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 for carrying out or giving effect to the Act.
The Therapeutic Goods Advisory Committee (“TGAC”) and the Therapeutic Goods Standards Committee (“TGSC”) were established under the former Regulations. The TGAC and the TGSC are abolished by repealing former Regulations 17 and 18 and a new committee has been established to perform the combined functions of those committees. The purpose of the Therapeutic Goods Regulations (Amendment) is, in the main, to combine the functions of the TGAC and the TGSC under a newly established committee, that is, the Therapeutic Goods Committee (“TGC”). The functions of the TGC are defined in subregulation 17(2) of the Regulations, and are as follows -
• to consider any matter referred to it by the Minister relating to the administration of the Act; and
• to consider and inquire into the standards and matters relating to the standards applicable to any goods for therapeutic use, and the requirements with respect to labelling and packaging applicable to any such goods; and to furnish advice to the Minister in relation to those standards or requirements.
The new Committee (the TGC) consists of persons who have expertise in the fields detailed at subregulation 17(4) of the Regulations as follows -
• pharmaceutics;
• pharmaceutical chemistry;
• pharmacology;
• microbiology;
• virology;
• medical devices;
• veterinary science;
• manufacture of pharmaceutical therapeutic goods;
• manufacture of therapeutic devices;
• consumer affairs in respect of therapeutic goods.
and include a person nominated by the Secretary of the Department of Primary Industry.
The Regulations also effect the following -
• the abolition of the Monoclonal Antibody Committee (“MAC”) by repealing former Regulation 19A [The MAC is to become a subcommittee of the Australian Drug Evaluation Committee (ADEC) rather than a separate committee];
• the repealing of former Regulation 21 - “Chairman of Committees” - consequential upon the abolition of the TGAC, the TGSC and the MAC as the Secretary of the Department of Health will not be a member, ex officio, of the TGC or ADEC;
• consequential amendment to existing Regulation 23 concerning a quorum for the TGC;
• minor amendments to existing Regulations 19, 20, 22, 23 and 25 to remove sexist expressions.
The Regulations are expressed to come into operation on the date of gazettal.