Therapeutic Goods Amendment Regulations 2001 (No. 4) (Cth)

Therapeutic Goods Amendment Regulations 2001 (No. 4)1

Statutory Rules 2001 No. 3432

I, PETER JOHN HOLLINGWORTH, 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 20 December 2001

PETER HOLLINGWORTH

Governor-General

By His Excellency’s Command

KAY PATTERSON

Minister for Health and Ageing

Contents

• •
• •

1Name of Regulations

 These Regulations are the Therapeutic Goods Amendment Regulations 2001 (No. 4).

2Commencement

 These Regulations commence, or are taken to have commenced, as follows:

• (a)

  on 30 September 2001 — regulations 1 to 3 and Schedule 1;

• (b)

  on gazettal — Schedule 2.

3Amendment of Therapeutic Goods Regulations 1990

 Schedules 1 and 2 amend the Therapeutic Goods Regulations 1990.

 

Schedule 1Amendment taken to have commenced on 30 September 2001

(regulation 3)

  

[1]Schedule 5A, after item 8

insert

9	Combopen Autoinjector Atropen Autoinjector	(a) the goods must be imported from Meridian Medical Technologies in the United States of America; and (b) the supply of the goods must be approved in writing by the Secretary; and
(c) the goods must be stored, supplied or used in accordance with any conditions specified in the approval; and (d) the goods must be consumed, destroyed or returned to the consignor by the end of 31 December 2002

   

Schedule 2Amendments commencing on gazettal

(regulation 3)

  

[1]After subregulation 12 (1B)

insert

• (1C)

  Items 9 and 10 in Schedule 5A cease to apply at the end of 31 December 2002.

• (1D)

  Item 11 in Schedule 5A ceases to apply at the end of 30 June 2002.

[2]After subregulation 47 (1)

insert

• (1A)

  The Secretary may delegate the power to approve the supply of goods under item 9 or 11 in Schedule 5A to the chief executive officer or chief health officer (however described), or a senior medical officer, of the Department of each State or Territory that has responsibility for health matters.

[3]Schedule 5A, after item 9

insert

10	Smallpox vaccine	(a) the goods must be imported by or on behalf of the Department from a source that is approved in writing by the Secretary; and (b) the supply of the goods must be approved in writing by the Secretary; and
(c) the goods must be stored, supplied or used in accordance with any conditions specified in the approval; and (d) the goods must be consumed, destroyed or returned to the consignor by the end of 31 December 2002
11	Therapeutic goods that are: (a) manufactured or imported by or on behalf of the Department; and (b) certified in writing by the Secretary to be emergency supplies that are essential to the protection of public health	(a) the supply of the goods must be approved in writing by the Secretary; and (b) the goods must be stored, supplied or used in accordance with any conditions specified in the approval; and (c) the goods must be consumed, destroyed or returned to the consignor by the end of 30 June 2002

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 and 252.

2. Notified in the Commonwealth of Australia Gazette on 21 December 2001.