Therapeutic Goods Amendment Regulations 2003 (No. 4) (Cth)

Therapeutic Goods Amendment Regulations 2003 (No. 4)1

Statutory Rules 2003 No. 2582

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 9 October 2003

P. M. JEFFERY

Governor-General

By His Excellency’s Command

TRISH WORTH

Parliamentary Secretary to the Minister for Health and Ageing

Contents

1Name of Regulations

These Regulations are the Therapeutic Goods Amendment Regulations 2003 (No. 4).

2Commencement

These Regulations commence as follows:

1. (a)

   on gazettal — regulations 1 to 3 and Schedule 1;

2. (b)

   on 1 October 2004 — Schedule 2.

3Amendment of Therapeutic Goods Regulations 1990

Schedules 1 and 2 amend the Therapeutic Goods Regulations 1990.

Schedule 1Amendments commencing on gazettal

(regulation 3)

  

[1]Subregulation 12 (1)

omit

(except section 31A and sections 31C to 31F).

insert

(except sections 30EA, 31A and 31C to 31F).

[2]Subregulation 12 (1A)

omit

(except section 31A and sections 31C to 31F)

insert

(except sections 30EA, 31A and 31C to 31F)

[3]Subregulation 12AB (1)

omit

, exportation

[4]Subregulation 12B (1)

substitute

1. (1)

   For the purposes of paragraph 19 (6) (a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.

2. (1A)

   For the purposes of subsection 19 (6) of the Act, in relation to medicines, paragraph 19 (6) (aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:

   1. (a)

      has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and

   2. (b)

      has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.

[5]After regulation 15

insert

15AConditions of registration of therapeutic goods

1. (1)

   For the purposes of paragraph 28 (5) (e) of the Act, a person to whom the registration of a therapeutic good specified in Part 1 of Schedule 10 relates must comply with the reporting requirements set out in the document entitled ‘Australian Guideline For Pharmacovigilance Responsibilities Of Sponsors Of Registered Medicines Regulated By Drug Safety And Evaluation Branch’ published by the Therapeutic Goods Administration, as in force from time to time.

2. (2)

   For the purposes of subregulation (1), a reference to a registered medicine or a registered medicinal product in the document mentioned in that subregulation is taken to be a reference to a therapeutic good.

[6]Subparagraph 42C (1) (a) (iv)

substitute

1. (iv)

   the Direct Selling Association of Australia Inc;

[7]Paragraph 42J (2) (a)

omit

[8]After paragraph 42J (2) (c)

insert

1. (ca)

   Medicines Australia; and

[9]Paragraph 42J (2B) (a)

omit

the Federation of Australian Radio Broadcasters;

insert

Commercial Radio Australia Limited;

[10]Subregulation 42X (2)

omit

The Australia New Zealand Food Authority

insert

Food Standards Australia New Zealand

[11]Paragraph 42ZZJ (i)

substitute

1. (i)

   government regulation;

2. (j)

   consumer representation.

[12]Schedule 1, after item 6

insert

6A Australian College of Acupuncturists Ltd

[13]Schedule 1, after item 26A

insert

26AA The Australian Association of Homotoxicology Incorporated

[14]Schedule 1, after item 26B

insert

26BA The Homeopathic Medicine Association Inc.

[15]Schedule 4, Part 3

after

Ammonium iron (III) citrate

insert

Borax

Borax pentahydrate

Boric acid

[16]Schedule 4, Part 3

after

Magnesium phosphate

insert

Magnesium phosphate dibasic trihydrate

[17]Schedule 4, Part 3

after

Manganese (II) sulfate

insert

Molybdenum trioxide

[18]Schedule 4, Part 3

after

Sodium glycerophosphate

insert

Sodium perborate

[19]Schedule 4, Part 4, Division 2, after item 5

insert

5A

Azadirachta indica (Neem)

(a) the herbal substance is derived from the seed in the form of cold pressed oil; and (b) the proposed route of administration of the preparation containing the herbal substance is topical; and (c) the herbal substance does not make up more than 1% of the preparation, unless provided in a container fitted with child-resistant closure and labelled with the following warnings (or words to the same effect): · Not to be taken · Keep out of the reach of children · Do not use if pregnant or likely to become pregnant

[20]Schedule 4, Part 4, Division 2, after item 51

insert

52 Trametes versicolor the preparation only contains aqueous extracts of the hyphae, dried to powder form

[21]Schedule 4, Part 5, Division 1

omit

Bioflavonoids (except quercetin)

[22]Schedule 4, Part 5, Division 1

after

Calcium hydroxycitrate

insert

Calcium sodium caseinate

[23]Schedule 4, Part 5, Division 1

after

Chondroitin sulfate — shark

insert

Citrus bioflavonoids extract

[24]Schedule 4, Part 5, Division 1

after

Propolis

insert

Quercetin

[25]Schedule 4, Part 5, Division 2, Subdivision 2, before item 1

insert

1A	Borax	3 mg of boron
1B	Borax pentahydrate	3 mg of boron
1C	Boric acid	3 mg of boron

[26]Schedule 4, Part 5, Division 2, Subdivision 2, after item 4

insert

4A Molybdenum trioxide 125 mg of molybdenum

[27]Schedule 4, Part 5, Division 2, Subdivision 2, after item 5

insert

6 Sodium perborate 3 mg of boron

[28]Schedule 4, Part 5, Division 3, after item 1B

insert

1C Calcium sodium caseinate Derived from cows milk

[29]Schedule 5, item 9, paragraph (b)

omit

the Australian Red Cross Blood Service

insert

the holder of a licence to manufacture blood and blood components

Schedule 2Amendments commencing on 1 October 2004

(regulation 3)

  

[1]Regulation 6A

omit

For the purposes

insert

1. (1)

   For the purposes

[2]Regulation 6A

insert

1. (2)

   For the purposes of paragraph 3 (5) (e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recovery.

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 and 257.

2. Notified in the Commonwealth of Australia Gazette on 16 October 2003.