Therapeutic Goods Amendment Regulations 2004 (No. 2) (Cth)

Therapeutic Goods Amendment Regulations 2004 (No. 2)1

Statutory Rules 2004 No. 1272

I, PHILIP MICHAEL JEFFERY, 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 10 June 2004

P. M. JEFFERY

Governor-General

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

1Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2004 (No. 2).

2Commencement

These Regulations commence on 1 July 2004.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

4Transitional

Despite the amendments made by these Regulations, the Therapeutic Goods Regulations 1990, as in force immediately before the commencement of these Regulations (the commencement time), continue to apply for a period of 12 months after the commencement time in relation to therapeutic goods that, immediately before the commencement time, were registered goods or listed goods.

Schedule 1Amendments

(regulation 3)

[1]Regulation 2, after definition of rare disease

insert

Required Advisory Statements for Medicine Labels means the document of that name published by the Therapeutic Goods Administration on 1 July 2004, as in force from time to time.

[2]Subparagraph 11 (2) (b) (v)

substitute

1. (v)

   the Required Advisory Statements for Medicine Labels;

2. (vi)

   any other provision in these Regulations or in the Act that deals with eligibility of medicines for listing.

[3]Schedule 4, Part 1, item 3, column 2, subparagraphs (g) (i) and (ii)

substitute

(i)

in accordance with the qualification (if any) mentioned in relation to the substance in that Division; and

(ii)

with a label that complies with the requirements of the Required Advisory Statements for Medicine Labels for that substance;

[4]Schedule 4, Part 4, Division 2, item 5A, column 3, paragraph (c)

substitute

(c)

if the preparation contains more than 1% of the herbal substance:

1. (i)

   the preparation is provided in a container fitted with a child-resistant closure; and

2. (ii)

   label on the goods complies with the requirements of the Required Advisory Statements for Medicine Labels

[5]Schedule 4, Part 4, Division 2, item 6, column 3, paragraph (d)

substitute

(d)

the label on the goods complies with the requirements of the Required Advisory Statements for Medicine Labels

[6]Schedule 4, Part 4, Division 2, item 20

substitute

20 Hypericum perforatum if the preparation is not a homoeopathic preparation and the proposed route of administration of the preparation is oral — the label on the goods complies with the requirements of the Required Advisory Statements for Medicine Labels

[7]Schedule 4, Part 4, Division 2, item 21, column 3, paragraph (d)

substitute

(d)

the label on the goods complies with the requirements of the Required Advisory Statements for Medicine Labels

[8]Schedule 4, Part 4, Division 2, item 32

substitute

32 Paullinia cupana the label on the goods complies with the requirements of the Required Advisory Statements for Medicine Labels

[9]Schedule 4, Part 4, Division 2, item 35, column 3, subparagraph (a) (v)

substitute

(v)

if the preparation contains more than 25mg of kavalactones per dose — the label on the goods complies with the requirements of the Required Advisory Statements for Medicine Labels;

[10]Schedule 4, Part 5, Division 3

substitute

Division 3Substances requiring a label with an advisory statement

1. 1.

   Activated charcoal.

2. 2.

   Ademetionine in the form of sulphate salts, tosylate salts or mixed sulphate and tosylate salts.

3. 3.

   Bovine colostrum powder.

4. 4.

   Bovine lactoferrin.

5. 5.

   Calcium sodium caseinate.

6. 6.

   Creatine.

7. 7.

   Creatine monohydrate.

8. 8.

   Creatine phosphate.

9. 9.

   Honey (for oral administration).

10. 10.

    (S)-S-Adenosylmethionine in the form of sulphate salts, tosylate salts or mixed sulphate and tosylate salts.

11. 11.

    Selenium yeast — high.

12. 12.

    Selenocysteine.

13. 13.

    Selenomethionine.

14. 14.

    Sodium selenate.

15. 15.

    Sodium selenite.

16. 16.

    Sodium sulfate, other than sodium sulfate intended for laxative use.

17. 17.

    Sugar cane wax alcohols.

18. 18.

    Ubidecarenone.

Notes

1. These Regulations amend 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; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84, 114, 143, 234, 315 and 345; 2003 Nos. 111, 151, 257, 258, 301 and 361; 2004 No. 78.

2. Notified in the Commonwealth of Australia Gazette