THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1995 NO. 33 

THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1995 NO. 33 
- TABLE OF PROVISIONS

1.  Amendment  
2.  Regulation 12 (Exempt goods)  
3.  Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to conditions)  


1995 No. 33 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 1
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.)


1995 No. 33 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 2
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.".


1995 No. 33 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 3
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


1995 No. 33*1* THERAPEUTIC GOODS REGULATIONS*2* (AMENDMENT)



*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.