Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1995

No. 33 1

__________________

Therapeutic Goods Regulations 2(Amendment)

I, The 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 7 March 1995.

 BILL HAYDEN

 Governor-General

By His Excellency’s Command,

ROSEMARY CROWLEY

Minister for Family Services

____________

1.   Amendment

1.1   The Therapeutic Goods Regulations are amended as set out in these Regulations.

[NOTE: These Regulations commence on gazettal: see Acts Interpretation Act 1901, s. 48.]

2.   Regulation 12 (Exempt goods)

2.1   After subregulation (1A), insert:

“(1B)

Item 6 in Schedule 5A ceases to apply at the end of 29 February 1996.”.

3.   Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)

3.1   Add at the end:

“6	Anti-D immunoglobulin		(a)	the product must be imported  by Commonwealth Serum Laboratories Limited (“CSL”) from Orthodiagnostic Systems Inc. (“OSI”) in the United States of America; and
(b)	supply of the product in Australia must be by, or on behalf of, CSL; and
(c)	when supplied to the patient, the product must have with it:
(i)	a copy of the Patient Information that includes an explanation  of the conditions under which its importation was permitted; and
(ii)		a copy of the Product Information, applicable to the product, that is published by OSI and approved by the United States Food and Drug Administration; and
(d)		the patient must give to the treating medical practitioner, in writing, adequately informed consent to the administration of the product; and
(e)		the treating medical practitioner must retain the written consent of the patient”.

____________________________________________________________

NOTES

1. Notified in the Commonwealth of Australia Gazette on 8 March 1995.

2. 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.