Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:3:p3
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 3 (pt 3/5)
Character Range: 22449–25333

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 the product, or removal from the product of one or more of the active constituents, or other constituents, of the product.
formulation type means:
 (a) for an agricultural chemical product—the formulation code and description that:
 (i) are set out in guidelines made under section 6A of the Code as in force from time to time; and
 (ii) apply to the product; and
 (b) for a veterinary chemical product—the form of the product.
Examples: A capsule, emulsifiable concentrate, injectable solution, implant, intramammary treatment, oral drench or tablet.
GMP audit: see subregulation 61(8).
hormonal growth promotant means a veterinary chemical product containing a substance that is, or a mixture of substances that are, responsible for oestrogenic, androgenic or gestagenic activity to enhance growth or production in bovines or bubalines.
identifying information, for a person, means the following information:
 (a) if the person is an individual—the person's name;
 (b) the person's ABN or ACN (if any);
 (c) the person's trading name (if any);
 (d) whether the person is an individual or a body corporate;
 (e) the person's street address;
 (f) if the person's postal address is different from the person's street address—the person's postal address.
immunobiological product means a chemical product which, when administered to a vertebrate or invertebrate living creature, provides, induces or changes an immune response to a particular chemical or biological entity in that creature.
interchangeable constituent determination means a determination under regulation 19AEA.
labelling standard means a standard made by the APVMA under paragraph 6E(1)(c) of the Code.
legal practitioner means a person who is admitted, and entitled to practise, as a barrister or solicitor in a State or Territory.
lodged: see regulation 5A.
medical practitioner means a person registered or licensed as a medical practitioner under a law of a State or Territory.
minor use: see regulation 3AA.
modular assessment fee has the meaning given by subregulation 70A(4).
modular assessment period has the meaning given by regulation 77.
multi‑category licence means a licence issued under Part 8 of the Code to carry out steps in the manufacture of a veterinary chemical product mentioned in the definition of one of the following terms:
 (a) category 2 licence;
 (b) category 3 licence;
 (c) category 4 licence;
at the same premises as are used to carry out steps in the manufacture of veterinary chemical products mentioned in the definition of at least one other of those terms.
NATA means the National Association of Testing Authorities, Australia, a company having the Australian