THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1984 NO. 53 

THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1984 NO. 53 
- TABLE OF PROVISIONS

1. Principal Regulations  
2. Repeal of regulation 3  
3.  


1984 No. 53 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 1
Principal Regulations


  1. In these Regulations, "Principal Regulations" means the Therapeutic Goods
Regulations.


1984 No. 53 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 2
Repeal of regulation 3


  2. Regulation 3 of the Principal Regulations is repealed.


1984 No. 53 THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
- REG 3


  3. After regulation 4 of the Principal Regulations the following regulation
and Part are inserted:
Goods for therapeutic use to which the Act applies
  "4A. For the purposes of sub-section 5 (8) of the Act, goods included in
each of the following classes of goods are declared to be goods for
therapeutic use to which the Act applies:

  (a)  goods for use in, or in connection with, testing for pregnancy;
  (b)  goods for use in, or in connection with, contraception.

             "PART  1A-NATIONAL  REGISTER  OF  THERAPEUTIC  GOODS
Goods to which section 23M of the Act applies
  "4B. Goods for therapeutic use that consist of a substance, being goods
other than-
  (a)  homoeopathic goods;
  (b)  diagnostic goods for in vitro use other than for diagnosing pregnancy;
  (c)  goods for use as an ingredient or component in the preparation or
manufacture of a substance or article for therapeutic use; or
  (d)  goods in the process of being prepared or manufactured for therapeutic
use,
are declared to be goods to which section 23M of the Act applies.
Prescribed matters for the purposes of paragraph 23M (2) (b) of the Act
  "4C. For the purposes of paragraph 23M (2) (b) of the Act, each of the
following matters is prescribed:

  (a)  the proprietary name of the goods;
  (b)  the name and address of the manufacturer of the goods;
  (c)  the identity and address of the person responsible for the quality and
safety of the goods in Australia;
  (d)  the non-proprietary name of each substance in the goods;
  (e)  the content of each of the active substances in a dosage unit of the
goods;
  (f)  the dosage form of the goods;
  (g)  the route of administration of the goods;
  (h)  the labelling of the goods and the labelling of the packaging used in
relation to the goods;
  (j)  the explanatory printed material accompanying the goods.".



- NOTES


1984 No. 53*1* THERAPEUTIC GOODS REGULATIONS*2* (AMENDMENT)



*1* Notified in the Commonwealth of Australia Gazette on 5 April 1984.
*2* Statutory Rules 1970 No. 165 as amended by Statutory Rules 1973 Nos. 76
and 225; 1974 No. 166; 1975 No. 36; 1979 No. 135.