Therapeutic Goods Amendment Regulations 2002 (No. 2) (Cth)

Therapeutic Goods Amendment Regulations 2002 (No. 2)1

Statutory Rules 2002 No. 1142

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 6 June 2002

PETER HOLLINGWORTH

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 2002 (No. 2).

2Commencement

 These Regulations commence on gazettal.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(regulation 3)

  

[1]Schedule 3, Part 1, item 4

omit

active implantable medical devices,

insert

active implantable therapeutic devices,

[2]Schedule 3, Part 1, after item 4

insert

5	implantable therapeutic devices that: (a) incorporate an ancillary medicinal substance; or (b) are designed to incorporate an ancillary medicinal substance; if the purpose of the incorporation is to enhance the function of the device

[3]Schedule 4, Part 1, item 2, paragraph (a)

omit

item 3 or 4 of Part 1

insert

item 3, 4 or 5 of Part 1

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 and 84.

2. Notified in the Commonwealth of Australia Gazette