Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:3:p2
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 3 (pt 2/5)
Character Range: 19862–22670

be sterile; or
 (b) an immunobiological product;
whether or not the licence also authorises the carrying out of steps in the manufacture of other chemical products.
category 2 licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product, other than a veterinary chemical product mentioned in the definition of:
 (a) category 1 licence; or
 (b) category 3 licence; or
 (c) category 4 licence; or
 (d) category 6 licence.
category 3 licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product that is an externally applied ectoparasiticide.
category 4 licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product that is a premix or stockfood supplement.
category 6 licence means a licence issued under Part 8 of the Code to carry out only one or more of the following steps in the manufacture of a veterinary chemical product:
 (a) processing;
 (b) assembling;
 (c) packaging;
 (d) labelling;
 (e) storage;
 (f) sterilising;
 (g) testing;
 (h) releasing for supply.
chemical product number, for a chemical product for which registration is sought in an application under section 10 of the Code, means the number that the APVMA gives to the chemical product after the application is lodged.
Code has the same meaning as this Code in section 3 of the Schedule to the Act.
collecting agency has the meaning given by subsection 3(1) of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.
CSIRO means the Commonwealth Scientific and Industrial Research Organisation established by the Science and Industry Research Act 1949.
current Poisons Standard has the meaning given by subsection 52A(1) of the Therapeutic Goods Act 1989.
EDTA means ethylenediaminetetraacetic acid.
emergency use, in relation to a chemical product or an active constituent, means a use of the product or constituent in the genuine belief that the use is required because of an emergency or impending emergency.
European Pharmacopoeia means the book of that name published for the European Pharmacopoeia Commission.
extended assessment period, for an application: see subregulation 76A(4).
FAO and WHO Specifications for Pesticides means specifications for pesticides or plant protection products published by the Food and Agriculture Organization of the United Nations or the World Health Organization of the United Nations.
formulation change, in relation to a chemical product, means:
 (a) a change in the source of any active constituent of the product; or
 (b) a variation in the amount or concentration of one or more of the active constituents, or other constituents, of the product; or
 (c) the addition to