Therapeutic Goods Amendment Regulations 1998 (No. 3) (Cth)

Therapeutic Goods Amendment Regulations 1998 (No. 3)

Statutory Rules 1998No. 369

I, WILLIAM PATRICK DEANE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations under theTherapeutic Goods Act 1989.

Dated 17 December 1998.

WILLIAM DEANE

Governor-General

By His Excellency’s Command,

grant tambling

Parliamentary Secretary to the Minister for Health

and Aged Care

for the Minister for Health and Aged Care

Therapeutic Goods Amendment Regulations 1998 (No. 3)1

Statutory Rules 1998No. 3692

made under the

Therapeutic Goods Act 1989

   

Contents

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1Name of regulations

 These regulations are the Therapeutic Goods Amendment Regulations 1998 (No. 3).

2Commencement

 These regulations commence on 1 January 1999.

3Amendment of Therapeutic Goods Regulations

 Schedule 1 amends the Therapeutic Goods Regulations.

Schedule 1Amendment of Therapeutic Goods Regulations

(regulation 3)

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[1]Regulation 1

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1Name of regulations

 These regulations are the Therapeutic Goods Regulations 1990.

[2]Regulation 2

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CHCA means the Complementary Healthcare Council of Australia.

NFAA means the Nutritional Foods Association of Australia.

[3]Regulation 5B, definition of complementary use

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 National Medical and Research Council

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 National Health and Medical Research Council

[4]Regulation 5B, definition of NFAA

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[5]Regulation 5B

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withdraw, in relation to an approved advertisement, includes withdrawal by any delegate under subregulation 5Q (2) or (3), whether or not that delegate gave the approval and, in the case of an approval given by the NFAA, includes a withdrawal by the CHCA.

[6]Subregulation 5Q (3)

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 NFAA

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 CHCA

[7]Paragraph 9A (1) (a)

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 Schedule 10

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 Part 1 of Schedule 10

[8]Regulation 42C

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 The Council

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• (1)

  The Council

[9]Subparagraph 42C (a) (i)

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• (i)

  the CHCA;

[10]Regulation 42C

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• (2)

  A member of the Council who, before 1 January 1999, was nominated under paragraph (1) (a) by the NFAA is taken to have been nominated by the CHCA.

[11]Subregulation 42E (2)

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 NFAA

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 CHCA

[12]Paragraph 42K (a)

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 NFAA

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 CHCA

[13]Subparagraph 42T (1) (b) (i)

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• (i)

  the CHCA;

[14]Subregulation 42T (3)

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 NFAA

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 CHCA

[15]After subregulation 42T (3)

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• (4)

  A member of the Panel who, before 1 January 1999, was nominated under paragraph (1) (b) by the NFAA is taken to have been nominated by the CHCA.

[16]Paragraph 42Y (b)

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 NFAA;

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 CHCA;

[17]Schedule 4, Part 1, paragraph 3 (f)

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(f) if a substance mentioned in Division 2 of Part 5 is an ingredient — the preparation is not sold or otherwise distributed:

(i) in a form that exceeds the maximum amount per dosage form mentioned in column 2 of the table in that Division for that substance; and

(ii) without the information about daily dosage mentioned in column 3 of the table for that substance;

[18]Schedule 4, Part 5

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Part 5Substances specified for item 3 of Part 1

Division 1

Bacterial strains of the genera Lactobacillus and Bifidobacterium (other than Bifidobacterium dentium) present in registered goods on 31 July 1998

Bioflavonoids (except quercetin)

Chitosan

Chlorophyll

Choline bitartrate

Dolomite

Fish oils used as a source of omega-3 marine triglycerides — if accompanied by information that the recommended daily intake of omega-3 marine triglycerides is less than 1 g

Fish oils used as a source of vitamins

Fructose

Glucosamine hydrochloride

Glucosamine sulphate

Glucose

Hydroxyapatite

Inositol

Inulin

Lecithin

Methylcellulose

Oligofructose

Oyster shell

Pectin

Propolis

Rice — hydrolysed

Royal jelly

Shark cartilage

Starch — maize — high amylose

Division 2

Subdivision 1 Interpretation

1. A reference in column 2 of the table to a maximum amount per dosage form of a substance is a reference to the maximum amount of the substance that can be present in the particular form of preparation mentioned in that column in relation to the substance.

2. A reference in column 3 of the table to a maximum daily dose of a substance is a reference to the daily maximum intake of the substance, in all forms in which it is present in preparations containing the substance.

Subdivision 2 Maximum amounts and daily doses of specified substances

Substance	Maximum amount per dosage form	Maximum daily dose (all forms)
chromium nicotinate	50 mg of chromium
chromium picolinate	50 mg of chromium
high chromium yeast	50 mg of chromium
creatine	3 g
creatine monohydrate	3 g of creatine
creatine phosphate	3 g of creatine
cupric citrate	750 mg of copper
high molybdenum yeast	62.5 mg of molybdenum
Piper methysticum	if in a tablet or capsule — 125 mg of kavalactones per tablet or capsule	250 mg of kavalactones
if in a tea bag — 3 g of dried rhizome per tea bag

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 and 247.

2. Made by the Governor-General on 17 December 1998, and notified in the Commonwealth of Australia Gazette