Commonwealth Numbered Regulations

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.".