Federal Register of Legislation - Australian Government

Primary content

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  • No longer in force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Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014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

                                                                                   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.