Statutory Rules 1987 No. 2611
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Therapeutic Goods Regulations2 (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 5 November 1987.
N. M. STEPHEN
Governor-General
By His Excellency's Command,
NEAL BLEWETT
Minister of State for Community Services and Health
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Principal Regulations
1. In these Regulations, "Principal Regulations" means the Therapeutic Goods Regulations.
Interpretation
2. Regulation 4 of the Principal Regulations is amended by inserting after the definition of "the Act" the following definition:
"'therapeutic devices' means goods for therapeutic use, other than goods that are represented to achieve, or are likely to be taken to achieve, one or more of the principal purposes of their use as a result of chemical action within or upon the human body.".
3. After regulation 17 of the Principal Regulations the following regulation is inserted:
Therapeutic Device Evaluation Committee
"18. (1) There shall be a Committee to be known as the Therapeutic Device Evaluation Committee.
"(2) The Committee shall consist of not less than 6 and not more than 8 persons appointed by the Minister from persons expert in one or more of the fields of anaesthetics, bioengineering, biomaterials, dentistry, epidemiology, intensive care, medicine, microbiology, ophthalmology, pharmaceutics and surgery.
"(3) The Minister shall appoint one of the members of the Committee to be chairperson of the Committee.
"(4) The functions of the Committee are:
(a) to make medical and scientific evaluations of such therapeutic devices as the Minister refers to it for evaluation;
(b) to make medical and scientific evaluations of other therapeutic devices if, in the opinion of the Committee, it is desirable that it should do so;
(c) to make medical and scientific evaluations of such goods for therapeutic use (not being therapeutic devices) as the Minister refers to it for evaluation;
(d) to make medical and scientific evaluations of other goods for therapeutic use (not being therapeutic devices) if, in the opinion of the Committee, it is desirable that it should do so and the Committee has informed the Minister of its opinion;
(e) to furnish such advice to the Minister as the Committee considers necessary relating to the importation into, the production within, and the distribution within, Australia of therapeutic devices that have been the subject of evaluations made by the Committee;
(f) to furnish such advice to the Minister as the Committee considers necessary relating to the importation into, the production within, and the distribution within, Australia of goods for therapeutic use (not being therapeutic devices) that have been the subject of evaluations made by the Committee; and
(g) to furnish advice that has been furnished to the Minister pursuant to paragraph (f) to such persons or bodies as the Minister may direct.
"(5) 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.".
Australian Drug Evaluation Committee
4. Regulation 19 of the Principal Regulations is amended:
(a) by inserting in subregulation (5) "(other than therapeutic devices)" after "therapeutic use" (wherever occurring);
(b) by omitting from paragraph (5) (b) "and" (last occurring);
(c) by inserting after paragraph (5) (b) the following paragraphs:
"(ba) to make medical and scientific evaluations of such therapeutic devices as the Minister refers to it for evaluation;
(bb) to make medical and scientific evaluations of other therapeutic devices if, in the opinion of the Committee, it is desirable that it should do so and the Committee has informed the Minister of its opinion;"; and
(d) by adding at the end of subregulation (5) the following paragraphs:
"(d) to furnish such advice to the Minister as the Committee considers necessary relating to the importation into, the production within, and the distribution within, Australia of therapeutic devices that have been the subject of evaluations made by the Committee; and
(e) to furnish advice that has been furnished to the Minister pursuant to paragraph (d) to such persons or bodies as the Minister may direct.".
Meetings of Committee
5. Regulation 23 of the Principal Regulations is amended:
(a) by omitting from paragraph (2) (a) "and"; and
(b) by adding at the end of subregulation (2) the following word and paragraph:
";and(c) in the case of the Therapeutic Device Evaluation Committee—4 members constitute a quorum.".
Repeal of regulation 25
6. Regulation 25 of the Principal Regulations is repealed.
NOTES
1. Notified in the Commonwealth of Australia Gazette on 12 November 1987.
2. Statutory Rules 1970 No. 165 as amended to date. For previous amendments see Note 2 to Statutory Rules 1987 No. 64 and see also Statutory Rules 1987 No. 64.