Therapeutic Goods Amendment Regulations 2003 (No. 6) (Cth)

Therapeutic Goods Amendment Regulations 2003 (No. 6)1

Statutory Rules 2003 No. 3612

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 18 December 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. 6).

2Commencement

These Regulations commence on gazettal.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

4Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 2 amends the Therapeutic Goods (Medical Devices) Regulations 2002.

Schedule 1Amendments of Therapeutic Goods Regulations 1990

(regulation 3)

  

[1]Regulation 2, definition of authorised person

substitute

authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.

Note Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.

[2]Regulation 3

substitute

2AAuthorised officers

The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:

1. (a)

   an officer of the Department, of another Department or of an authority of the Commonwealth;

2. (b)

   an officer of:

   1. (i)

      a Department of State of a State; or

   2. (ii)

      a Department or administrative unit of the Public Service of a Territory; or

   3. (iii)

      an authority of a State or of a Territory;

being a Department, unit or authority that has functions relating to health matters.

3Corresponding State law

1. (1)

   In this regulation:

the Regulations means:

1. (a)

   the Therapeutic Goods Regulations 1990; and

2. (b)

   the Therapeutic Goods (Medical Devices) Regulations 2002.

1. (2)

   For the definition of corresponding State law in subsection 3 (1) of the Act, the Therapeutic Goods (Victoria) Act 1994 is declared to correspond to the Act.

2. (3)

   For the definition of corresponding State law in subsection 3 (1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:

   1. (a)

      the Poisons and Therapeutic Goods Act 1966 (NSW);

   2. (b)

      the Poisons and Therapeutic Goods Regulation 2002 (NSW);

   3. (c)

      the Therapeutic Goods Act 2001 (Tas);

   4. (d)

      the Therapeutic Goods Regulations 2002 (Tas).

[3]Regulation 12AC, heading

substitute

12ACPowers of authorised officers in relation to goods imported etc for experimental uses

[4]Paragraph 12B (4) (b)

omit

authorised person

insert

medical practitioner

[5]Subregulation 23 (1), definition of authorised officer

omit

[6]Subregulation 42D (2)

omit

3 consecutive terms.

insert

4 consecutive terms.

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

substitute

1. (a)

   Commercial Television Australia and Commercial Radio Australia Limited; and

[8]Subregulation 42U (2)

omit

3 consecutive terms.

insert

4 consecutive terms.

[9]Subregulation 45 (1)

after

therapeutic goods

insert

(other than goods of a kind mentioned in Part 1 of Schedule 10)

[10]Regulation 47AA

omit

[11]Schedule 4, Part 4, Division 2, item 35

substitute

35	Piper methysticum	(a) if the herbal substance is for oral use: (i) it is any of the following: (A) aqueous dispersion of whole or peeled rhizome; (B) aqueous extract of whole or peeled rhizome; (C) dried whole or peeled rhizome; and (ii) the preparation does not contain, for its recommended daily dose, more than 250mg of kavalactones; and (iii) if the preparation is in the form of a tablet or capsule — the amount of kavalactones does not exceed 125mg for each tablet or capsule; and (iv) if the preparation is in the form of a tea bag — the amount of dried whole or peeled rhizome does not exceed 3g for each tea bag; and
(v) if the preparation contains more than 25mg of kavalactones per dose — the label on the goods includes the following warnings (or words to the same effect): · Not for prolonged use. If symptoms persist, seek advice from a health care practitioner · Not recommended for use by pregnant or lactating women · May harm the liver
(b) if the herbal substance is for topical application to the rectum or vagina or by spray to the throat — it is any of the following: (i) aqueous dispersion of whole or peeled rhizome; (ii) aqueous extract of whole or peeled rhizome; (iii) dried whole or peeled rhizome;
(c) if the herbal substance is not a substance to which paragraph (a) or (b) applies, the herbal substance may be: (i) used in homeopathic preparations more dilute than a 1 000-fold dilution of a mother tincture; or (ii) used in a preparation for topical application to the skin if the preparation does not contain, for its daily dose, more than 250mg of kavalactones

[12]Further amendments — authorised officer

Provision	omit	insert
Subparagraph 12AB (2) (b) (i)	authorised person,	authorised officer,
Subparagraph 12AB (2) (b) (ii)	authorised person	authorised officer
Subregulation 12AC (1)	authorised person	authorised officer
Subparagraph 12AC (1) (f) (i)	authorised person;	authorised officer;
Subparagraph 12AC (1) (f) (ii)	authorised person.	authorised officer.
Subregulation 12AC (2)	authorised person	authorised officer
Paragraphs 12AC (2) (a) and (b) and 30 (6) (b)	authorised person	authorised officer

[13]Further amendments — Schedule 4

Schedule 4 is amended in accordance with the following table:

Provision	omit	insert
Part 1, item 3, subparagraph (d) (ii)	column 2	column 3
Part 1, item 3, sub-subparagraph (d) (ii) (B)	column 1	column 3
Part 1, item 3, subparagraph (f) (i)	column 2	column 3
Part 1, item 3, subparagraph (f) (ii)	column 3	column 4
Part 5, Division 2, Subdivision 1, item 1	column 2	column 3
Part 5, Division 2, Subdivision 1, item 1	column 1	column 2
Part 5, Division 2, Subdivision 1, item 1	column 2	column 3
Part 5, Division 2, Subdivision 1, item 2	column 3	column 4
Part 5, Division 2, Subdivision 1, item 2	column 1	column 2
Part 5, Division 2, Subdivision 1, item 3	column 1	column 2
Part 5, Division 2, Subdivision 1, item 3, paragraph (b)	column 3	column 2
Part 5, Division 2, Subdivision 1, item 3, example	column 1	column 2

Schedule 2Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

(regulation 4)

  

[1]Regulation 10.1

substitute

10.1Authorised persons

The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:

1. (a)

   an officer of the Department, of another Department or of an authority of the Commonwealth;

2. (b)

   an officer of:

   1. (i)

      a Department of State of a State; or

   2. (ii)

      a Department or administrative unit of the Public Service of a Territory; or

   3. (iii)

      an authority of a State or of a Territory;

being a Department, unit or authority that has functions relating to health matters.

Notes

1. These Regulations amend (in Schedule 1) 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 and 301.

These Regulations also amend (in Schedule 2) Statutory Rules 2002 No. 236, as amended by 2003 Nos. 153 and 259.

2. Notified in the Commonwealth of Australia Gazette on 23 December 2003.