1Name of Regulations
These Regulations are the Agricultural and Veterinary Chemicals Code Regulations 1995.
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These Regulations are the Agricultural and Veterinary Chemicals Code Regulations 1995.
For the purposes of paragraph 7(1)(b) of the Act, the matters covered by subsections 6(1), (2) and (3) of the Act (other than paragraph 6(2)(i)) are declared to be matters to which section 7 of the Act applies.
The Minister may make orders under section 7 of the Act in relation to these matters.
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:
the title shown on the item of information;
the name of the author, or each of the authors, of the information;
the date shown on the item of information (if any);
if no date is shown on the item of information—the date when the preparation of the information was completed;
if the information was published:
the date when it was published; and
the name of the publication in which it was published;
a unique identifier for the item of information that indicates the location of the item in the application;
the name and address of the authorising party for the information.
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.
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:
registered as being, represented to be, or required to be sterile; or
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:
category 1 licence; or
category 3 licence; or
category 4 licence; or
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:
processing;
assembling;
packaging;
labelling;
storage;
sterilising;
testing;
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 change in the source of any active constituent of the product; or
a variation in the amount or concentration of one or more of the active constituents, or other constituents, of the product; or
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:
for an agricultural chemical product—the formulation code and description that:
are set out in guidelines made under section 6A of the Code as in force from time to time; and
apply to the product; and
for a veterinary chemical product—the form of the product.
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:
if the person is an individual—the person’s name;
the person’s ABN or ACN (if any);
the person’s trading name (if any);
whether the person is an individual or a body corporate;
the person’s street address;
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:
category 2 licence;
category 3 licence;
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:
protein meals (as a protein source);
fermentation products from human foods, (including brewer’s grains, yeasts and yeast extracts);
hay, including lucerne hay and peanut hay;
chaff;
straw;
grains, other similar seeds and the products of those grains or seeds;
vitamins, minerals and amino acids at normal nutritional levels;
salt, limestone and inorganic phosphorus sources;
fats and oils;
milk by‑products;
non‑protein nitrogen sources;
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:
contains vitamins, minerals, amino acids or other substances; and
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:
contains one or more nutritional ingredients; and
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.
Section 3 of the Code provides that supply includes do, or cause or permit the doing of, any of the following:
sell;
expose for sale;
send or deliver for sale or on sale;
dispose of under a hire purchase agreement;
exchange;
give;
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.
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:
• active constituent
• agricultural chemical product
• approved label
• holder
• label
• relevant particulars
• veterinary chemical product.
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.
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.
A minor use, in relation to a chemical product or an active constituent, is a use of the product or constituent that would not produce sufficient economic return to an applicant for registration of the product to meet the cost of registration of the product, or the cost of registration of the product for that use, as the case requires (including, in particular, the cost of providing the data required for that purpose).
A minor use, in relation to a chemical product, is a use of the product where the following apply:
instructions for that use are in the Register in relation to one or more registered chemical products;
none of those registered chemical products is available for sale anywhere in Australia.
For these Regulations, reference active constituent, for an application under section 10 or 27 of the Code (the primary application), means an active constituent that:
is or was the subject of another application, being an application under section 10 or 27 of the Code that was lodged before the primary application; and
is referred to in the primary application because information that is relevant to the active constituent is also relevant to the primary application.
For these Regulations, reference chemical product, for an application under section 10 or 27 of the Code (the primary application), means a chemical product that:
is or was the subject of another application, being an application under section 10 or 27 of the Code that was lodged before the primary application; and
is referred to in the primary application because information that is relevant to the chemical product is also relevant to the primary application.
An application is a timeshift application if:
it is covered by subregulation (2); and
the applicant and the APVMA have agreed that it will be assessed in accordance with assessment periods set out in a project plan for the application agreed to by the applicant and the APVMA.
An application is covered by this subregulation if:
the application is of a kind described in column 1 of item 1, 2, 3, 4, 5, 10, 11, 14 or 15 of the table in clause 2.1 of Schedule 6; and
if the application is of a kind described in column 1 of item 10 or 14—the APVMA has determined that at least 2 of the modules at items 2 to 10 of the table in Schedule 7 are necessary for the application.
The table in clause 2.1 of Schedule 6 sets out the assessment periods and fees applicable to applications. For timeshift applications, see item 27 of the table.
For paragraph (e) of the definition of confidential commercial information in section 3 of the Code, the following information is prescribed:
the name of the applicant;
the application number;
the chemical product number;
the name of each of the active constituents of the chemical product;
a short description of the application and its purpose, including a description of the way in which the chemical product is intended to be used.
For the purposes of the definition of date‑controlled chemical product in section 3 of the Code, the following are declared to be date‑controlled chemical products:
each veterinary chemical product;
an agricultural chemical product specified in Schedule 1.
Division 3 of Part 4 of the Code dealing with date‑controlled chemical products does not apply to listed chemical products or reserved chemical products: see regulation 43A.
For the definition of lodged in subsection 3(1) of the Code, an application is lodged when the applicant gives:
the information in the approved form for the application; and
any other information specified for the application under section 8B of the Code;
to the APVMA, in the manner (if any) required by regulation 65.
However, if the applicant does not give the information mentioned in paragraph (1)(b) to the APVMA within 7 days of giving the information mentioned in paragraph (1)(a) to the APVMA, the applicant is taken to have lodged the application 7 days after giving the APVMA the information mentioned in paragraph (1)(a).
For subsection 4(3) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Part 2 of Schedule 3 is declared to be an agricultural chemical product.
For paragraph 4(4)(b) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Part 3 of Schedule 3 is declared not to be an agricultural chemical product.
For paragraph 5(3)(b) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Part 2 of Schedule 3AA is declared to be a veterinary chemical product.
For paragraph 5(4)(b) of the Code, a substance or mixture of substances included in a class of substances or mixtures of substances listed in Division 3.1 of Part 3 of Schedule 3AA is declared not to be a veterinary chemical product.
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