Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) In these Regulations, unless the contrary intention appears:
"Act" means the Agricultural and Veterinary Chemicals Code Act 1994 .
"active constituent number" , for an active constituent for a proposed or existing chemical product for which approval is sought in an application under section 10 of the Code, means the number that the APVMA gives to the active constituent after the application is lodged.
"application information details" , for an item of information contained in or accompanying an application, means the following details:
(a) the title shown on the item of information;
(b) the name of the author, or each of the authors, of the information;
(c) the date shown on the item of information (if any);
(d) if no date is shown on the item of information--the date when the preparation of the information was completed;
(e) if the information was published:
(i) the date when it was published; and
(ii) the name of the publication in which it was published;
(f) a unique identifier for the item of information that indicates the location of the item in the application;
(g) the name and address of the authorising party for the information.
Example: An example for paragraph (f) is the volume and page number where the item of information is located in the application.
"application number" , for an application under section 10 or 27 of the Code, means the number that the APVMA gives to the application after the application is lodged.
"APVMA CEO" means the Chief Executive Officer of the APVMA.
"assessment period" , in relation to an application, means the period specified in column 2 of the table in clause 2.1 of Schedule 6 for an application of that kind.
Note: See also Division 9.3 (notification, assessment periods and review).
"Australian GMP Code" means the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products , published by the APVMA.
"block" or lick means a blend or mixture of one or more stockfood ingredients compressed or poured into a solid block form for voluntary consumption by livestock.
"British Pharmacopoeia" means the book of that name published for the British Pharmacopoeia Commission.
"British Pharmacopoeia (Veterinary)" means the book of that name published on the recommendation of the Medicines Commission of the United Kingdom.
"category 1 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) registered as being, represented to be, or required to 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 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 Company Number 004379748.
"notification number" , means a notification number assigned to a person under regulation 47.
"nutritional ingredient" includes, but is not limited to, the following:
(a) protein meals (as a protein source);
(b) fermentation products from human foods, (including brewer's grains, yeasts and yeast extracts);
(c) hay, including lucerne hay and peanut hay;
(d) chaff;
(e) straw;
(f) grains, other similar seeds and the products of those grains or seeds;
(g) vitamins, minerals and amino acids at normal nutritional levels;
(h) salt, limestone and inorganic phosphorus sources;
(i) fats and oils;
(j) milk by - products;
(k) non - protein nitrogen sources;
(l) molasses.
"poison schedule classification" , in relation to a chemical product, means classification of the product or any of its constituents in the current Poisons Standard.
"premix" means a mixture that:
(a) contains vitamins, minerals, amino acids or other substances; and
(b) is intended to be added to stockfood to form a finished feed for feeding to a group of animals.
"purchaser declaration number" means a distinguishing number issued in respect of premises by a State or Territory or by an authority of a State or Territory, for the purpose of identifying those premises as premises where animals to be treated with a hormonal growth promotant are, or are to be, kept.
"reference active constituent" has the meaning given by regulation 3A.
"reference chemical product" has the meaning given by regulation 3B.
"stockfood" means a basic food or food mixture that:
(a) contains one or more nutritional ingredients; and
(b) is intended to be fed to animals for the maintenance of life, normal growth, production, work, reproduction or performance.
"stockfood supplement" means any substance or mixture of substances in the form of tablets, sachets or measures added to stockfood for administration to animals individually in order to supplement or balance that stockfood, but does not include a substance or mixture of substances in an injectable dose form, an intraruminal bolus, a block or a lick.
"supply" , in relation to any product or thing, includes cause or permit the supply of the product or thing.
Note: Section 3 of the Code provides that supply includes do, or cause or permit the doing of, any of the following:
(a) sell;
(b) expose for sale;
(c) send or deliver for sale or on sale;
(d) dispose of under a hire purchase agreement;
(e) exchange;
(f) give;
(g) offer to do an act that would be a supply (including an act referred to in any of the above paragraphs).
"timeshift application" : see regulation 3BA.
"United States Pharmacopeia" means the book of that name published by the United States Pharmacopeia Convention.
Note: Several other words and expressions used in these Regulations have the meaning given by section 3 of the Code in the Schedule to the Act. For example:
ï‚· active constituent
ï‚· agricultural chemical product
ï‚· approved label
ï‚· holder
ï‚· label
ï‚· relevant particulars
ï‚· veterinary chemical product.
(1A) Unless the contrary intention appears, an expression used in both these Regulations and the Code has the same meaning in these Regulations as in the Code.
(2) Unless the contrary intention appears, a reference in these Regulations to a book or other publication is a reference to the latest edition of that book or publication as modified or amended from time to time, and includes any addendum or other addition to the book or publication.