Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1996

No. 9 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 Act 1989.

Dated 24 January 1996.

 BILL HAYDEN

 Governor-General

By His Excellency’s Command,

ROSEMARY CROWLEY

Minister for Family 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.   Regulation 6 (Advertising offences)

2.1   Paragraph (1) (g):

After subparagraph (ii), insert:

• “; or (iii)

  are specified in item 1 of Schedule 5.”.

3.   Regulation 12 (Exempt goods)

3.1   Subregulation (1B):

Omit “29 February 1996.”, substitute “31 August 1996.”.

4.   Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods)

4.1   Part 1, paragraph 3 (a):

Omit the paragraph, substitute:

• “(a)

  the preparation:

  • (i)

    is not included in a Schedule to the Poisons Standard; and

  • (ii)

    is not of a kind required to be sterile; and”.

4.2   Part 3:

After “ferrous gluconate”, insert “ferrous lactate”.

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

5.1   Item 3:

Omit “samples of therapeutic goods supplied for:”, substitute “samples of therapeutic goods imported, exported, manufactured, or supplied for:”.

5.2   Add at the end:

“13

radiopharmaceutical cold kits that are: (a) containers of sterile reagents to which radioisotope is added immediately before injection into patients; and (b) manufactured by a radiochemist or a pharmacist in a public or private hospital for subsequent extemporaneous compounding and dispensing for use by, or in connection with: (i) a patient of that hospital; or (ii) a patient of another public or private hospital in the same State or Territory”.

6.   Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to exemptions)

6.1   Item 2:

Omit the item.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 31 January 1996.

2. Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328.