THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1987 NO. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1987 NO. 64 - TABLE OF PROVISIONS 1. Principal Regulations 2. 3. Repeal of regulation 19A 4. Repeal of regulation 21 5. Meetings of committees 6. Minor amendments SCHEDULE 1987 No. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 1 Principal Regulations 1. In these Regulations, "Principal Regulations" means the Therapeutic Goods Regulations. 1987 No. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 2 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 Regulations 17 and 18 of the Principal Regulations are repealed and the following regulation is substituted: Therapeutic Goods Committee "17.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.". 1987 No. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 3 Repeal of regulation 19A 3. Regulation 19A of the Principal Regulations is repealed. 1987 No. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 4 Repeal of regulation 21 4. Regulation 21 of the Principal Regulations is repealed. 1987 No. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 5 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.". 1987 No. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 6 Minor amendments 6. The Principal Regulations are amended as set out in the Schedule to these Regulations. 1987 No. 64 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - SCHEDULE SCHEDULE Regulation 6 MINOR AMENDMENTS ------------------------------------------------------------------------------ -- Provision Omit: Substitute: ------------------------------------------------------------------------------ -- Subregulation 19 (4) chairman chairperson Regulation 20 he he or she Subregulation 22 (1) (a) three years unless he 3 years unless the (b) (3) of this regulation member (3) Subregulation 22 (3) writing under his hand instrument in writing Regulation 23 chairman (wherever chairperson occurring) Regulation 25 (a) Chairman (wherever chairperson occurring) (b) he (wherever occurring) the member Subregulation 25 (3) his attendance attendance Subregulation 25 (4) (a) chairman chairperson (b) his home his or her home (c) connexion connection (d) his attendance attendance (e) during which he is so of that absence absent (wherever occurring) ------------------------------------------------------------------------------ - - NOTES 1987 No. 64*1* THERAPEUTIC GOODS REGULATIONS*2* (AMENDMENT) *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.