THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1996 NO. 9 

THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1996 NO. 9 
- TABLE OF PROVISIONS

1.  Amendment  
2.  Regulation 6 (Advertising offences)  
3.  Regulation 12 (Exempt goods)  
4.  Schedule 4 (Therapeutic goods required to be included in the part of the Register for listed goods)  
5.  Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the Act)  
6.  Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of the Act subject to exemptions)  


1996 No. 9 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.)


1996 No. 9 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 2
2. Regulation 6 (Advertising offences)


  2.1 Paragraph (1) (g):
After subparagraph (ii), insert:
  "; or (iii) are specified in item 1 of Schedule 5.".


1996 No. 9 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 3
3. Regulation 12 (Exempt goods)


  3.1 Subregulation (1B):
Omit "29 February 1996.", substitute "31 August 1996.".


1996 No. 9 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 4
4. Schedule 4 (Therapeutic goods required to be included in the part of
the Register for listed goods)


  4.1 Part 1, paragraph 3 (a):
Omit the paragraph, substitute:
  "(a) the preparation:
    (i) is not included in a Schedule to the Poisons Standard; and
    (ii) is not of a kind required to be sterile; and".

  4.2 Part 3:
After "ferrous gluconate", insert "ferrous lactate".


1996 No. 9 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 5
5. Schedule 5 (Therapeutic goods exempt from the operation of Part 3 of the
Act)


  5.1 Item 3:
Omit "samples of therapeutic goods supplied for:", substitute "samples of
therapeutic goods imported, exported, manufactured, or supplied for:".

5.2 Add at the end:
  "13 radiopharmaceutical cold kits that are:
  (a) containers of sterile reagents to which radioisotope is added
immediately before injection into patients; and
  (b) manufactured by a radiochemist or a pharmacist in a public or private
hospital for subsequent extemporaneous compounding and dispensing for use by,
or in connection with:
    (i) a patient of that hospital; or
    (ii) a patient of another public or private hospital in the same
State or Territory".


1996 No. 9 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 6
6. Schedule 5A (Therapeutic goods exempt from the operation of Part 3 of
the Act subject to exemptions)


  6.1 Item 2:
Omit the item.


- NOTES


1996 No. 9*1* THERAPEUTIC GOODS REGULATIONS*2* (AMENDMENT)

- Dated 24 January 1996.


*1* Notified in the Commonwealth of Australia Gazette on 31 January 1996.

*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; 1995
Nos. 33, 111, 192, 208, 253, 320 and 328.