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Therapeutic Goods Regulations (Amendment)

Authoritative Version
  • - F1996B00419
  • No longer in force
SR 1995 No. 33 Regulations as made
These Regulations amend the Therapeutic Goods Regulations.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled Senate21-Mar-1995
Tabled HR27-Mar-1995
Gazetted 08 Mar 1995
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Statutory Rules 1995   No. 331


Therapeutic Goods Regulations2 (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


By His Excellency’s Command,




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:



Anti-D immunoglobulin


the product must be imported  by Commonwealth Serum  Laboratories Limited (“CSL”)  from Orthodiagnostic Systems  Inc. (“OSI”) in the United  States of America; and





supply of the product in Australia must be by, or on behalf of, CSL; and





when supplied to the patient, the product must have with it:




a copy of the Patient Information that includes an explanation  of the conditions under which its importation was permitted; and




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



the patient must give to the treating medical practitioner, in writing, adequately informed consent to the administration of the product; and




the treating medical practitioner must retain the written consent of the patient”.




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.