Statutory Rules 1985 No. 3121

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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 21 November 1985.

N.M. STEPHEN

Governor-General

By His Excellency's Command,

NEAL BLEWETT

Minister of State for Health

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Interpretation

1. Regulation 4 of the Therapeutic Goods Regulations is amended—

(a) by inserting after the definition of "official analyst" the following definition:

"'Secretary' means Secretary of the Department;"; and

(b) by omitting the definition of "the Director-General".

Goods for therapeutic use to which the Act applies

2. Regulation 4a of the Therapeutic Goods Regulations is amended by adding at the end the following paragraphs:

"(c) goods for use in, or in connection with, prosthetics;

(d) goods for use in, or in connection with, orthotics.".

Further amendments

3. The Therapeutic Goods Regulations are amended as set out in the Schedule.

SCHEDULE Regulation 3

FURTHER AMENDMENTS OF THE THERAPEUTIC GOODS REGULATIONS

The following provisions of the Therapeutic Goods Regulations are amended by omitting "Director-General" (wherever occurring) and substituting "Secretary":

Regulations 5 and 6, sub-regulation 9 (2), paragraph 12 (1) (c), sub-regulations 13 (1) and (3), paragraphs 13 (4) (a) and (b), sub-regulation 13 (5), sub-paragraphs 13 (6) (c) (i) and (ii), paragraphs 17 (2) (a) and 18 (2) (a) and sub-regulations 21 (1) and (2).

NOTES

1. Notified in the Commonwealth of Australia Gazette on 28 November 1985.

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 No. 297.