Therapeutic Goods Amendment Regulations 2002 (No. 2)1
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
1 Name of Regulations
These Regulations are the Therapeutic Goods Amendment Regulations 2002 (No. 2).
2 Commencement
These Regulations commence on gazettal.
3 Amendment of Therapeutic Goods Regulations 1990
Schedule 1 amends the Therapeutic Goods Regulations 1990.
Schedule 1 Amendments
(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 on 7 June 2002.