Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1992

No. 370 1

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Therapeutic Goods

Regulations 2(Amendment)

I, The Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act1989.

 Dated 23 November 1992.

 BILL HAYDEN

 Governor-General

 By His Excellency’s Command,

 PETER STAPLES

Minister of State for Aged, Family

 and Health Services

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1.   Amendment

1.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

[NOTE:

 These Regulations commence on gazettal: see Acts Interpretation Act 1901, s.48.]

2.   Schedule 3 (Therapeutic goods required to be included in the part of the Register for registered goods)

2.1   Part 1, item 3, paragraph (f):

Omit the paragraph, substitute:

 “(f) powered drug infusion systems, including their accessories, that regulate the flow of infusate; or”.

2.2   Part 1, item 3, paragraph (g):

Omit all the words before subparagraph (i), substitute “devices of human or animal origin for use in or on the body of a person, other than devices for that use that:”.

2.3   Part 1, item 3, paragraph (g):

Add at the end:

 “; or (vii) incorporate gelatine that conforms to generally accepted pharmacopoeial standards; or”.

 

2.4   Part 1, paragraph (h):

Omit the paragraph, substitute:

 “(h) implantable breast prostheses consisting of, or containing, material of fluid consistency that is not only:

• (i)

  water; or

• (ii)

  a saline solution;

 if unintentional migration of that material to a part of the body away from the site of implantation could occur.”.

2.5   Part 2:

Add at end:

“3 implantable breast prostheses, except:

• (a)

  those referred to in Part 1; and

• (b)

  tissue expanders that are:

  • (i)

    filled only with water or a saline solution; and

  • (ii)

    not intended by the manufacturer to be left permanently in place

4 devices that are barriers indicated for contraception or for prevention of the transmission of disease in the course of penile penetration during sexual intercourse, other than rubber diaphragms and condoms that conform to a standard under Part 2 of the Act”.

3.   Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)

3.1   Item 7, paragraph (n):

Omit the paragraph, substitute:

 “(n) non-sterile, non-powered therapeutic devices that are:

 (i) medicine droppers, measures or spoons; or

• (ii)

  non-absorbent applicators; or

• (iii)

  absorbent applicators designed for use with inhalations; or”.

3.2   Item 7:

Add at the end:

 “; or (q) human tissue for implantation in the human body that is obtained, stored and supplied without any deliberate alteration to its biological or mechanical properties by institutions the procedures of which conform with principles determined under subsection 36 (1) of the Act”.

4.   Schedule 6 (Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act)

4.1   Item 3, paragraph (b):

Omit the paragraph, substitute:

 “(b) materials for restoration of teeth; or”.

4.2 Item 3:

Add at the end:

 “(g) implantable therapeutic devices”.

5.   Schedule 7 (Therapeutic goods exempt from the operation of Part 4 of the Act unless supplied as pharmaceutical benefits)

5.1   Item 4, paragraph (b):

Omit the paragraph, substitute:

 “(b) materials for restoration of teeth; or”.

5.2   Item 4:

Add at the end:

 “(h) implantable therapeutic devices”.

6.   Schedule 10 (Prescription drugs)

6.1   Omit the heading, substitute:

 “SCHEDULE 10 Subregulations 16C (1), 16D (1) and 16F (1)

 

DRUGS EVALUATED BY THE DRUG EVALUATION BRANCH OF THE DEPARTMENT”.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 November 1992.

2. Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos.19, 89, 109 and 332.