Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth)

Agricultural and Veterinary Chemicals Code Regulations 1995

Statutory Rules No. 27, 1995

made under the

Agricultural and Veterinary Chemicals Code Act 1994

Compilation No. 49

Compilation date:1 October 2025

Includes amendments:F2025L00478

About this compilation

This compilation

This is a compilation of the Agricultural and Veterinary Chemicals Code Regulations 1995 that shows the text of the law as amended and in force on 1 October 2025 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register ( saving and transitional provisions

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Presentational changes

The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. Any modifications affecting the law are accessible on the Register.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1PreliminaryDivision 1.1AName and commencement1Name of Regulations

These Regulations are the Agricultural and Veterinary Chemicals Code Regulations 1995.

Division 1.1BOrders2Orders

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.
Note: The Minister may make orders under section 7 of the Act in relation to these matters.

Division 1.1Definitions3Interpretation

(1)In these Regulations, unless the contrary intention appears:
Actmeans 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.
blockor lickmeans a blend or mixture of one or more stockfood ingredients compressed or poured into a solid block form for voluntary consumption by livestock.
British Pharmacopoeiameans 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.
CSIROmeans 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 Pharmacopoeiameans 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 promotantmeans 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 productmeans 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 practitionermeans a person who is admitted, and entitled to practise, as a barrister or solicitor in a State or Territory.
lodged: see regulation 5A.
medical practitionermeans a person registered or licensed as a medical practitioner under a law of a State or Territory.
minor use: see regulation 3AA.
modular assessment feehas the meaning given by subregulation 70A(4).
modular assessment periodhas 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.
NATAmeans 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.
premixmeans 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 numbermeans 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.
stockfoodmeans 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 supplementmeans 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:
· active constituent
· agricultural chemical product
· approved label
· holder
· label
· relevant particulars
· 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.

3AADefinition of minor use

(1)
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).
(2)
A minor use, in relation to a chemical product, is a use of the product where the following apply:
(a)
instructions for that use are in the Register in relation to one or more registered chemical products;
(b)
none of those registered chemical products is available for sale anywhere in Australia.

3AMeaning of reference active constituent

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:
(a)
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
(b)
is referred to in the primary application because information that is relevant to the active constituent is also relevant to the primary application.

3BMeaning of reference chemical product

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:
(a)
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
(b)
is referred to in the primary application because information that is relevant to the chemical product is also relevant to the primary application.

3BADefinition of timeshift application

(1)
An application is a timeshift application if:
(a)
it is covered by subregulation (2); and
(b)
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.
(2)
An application is covered by this subregulation if:
(a)
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
(b)
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.
Note: 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.

3CDefinition of confidential commercial information – section 3 of the Code

For paragraph (e) of the definition of confidential commercial information in section 3 of the Code, the following information is prescribed:
(a)
the name of the applicant;
(b)
the application number;
(c)
the chemical product number;
(d)
the name of each of the active constituents of the chemical product;
(e)
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.

4Definition of date‑controlled chemical product – section 3 of the Code

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:
(a)
each veterinary chemical product;
(b)
an agricultural chemical product specified in Schedule 1.
Note: 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.

5AMeaning of lodged

(1)
For the definition of lodged in subsection 3(1) of the Code, an application is lodged when the applicant gives:
(a)
the information in the approved form for the application; and
(b)
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.
(2)
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).

7Definition of agricultural chemical product – section 4 of the Code

(1)
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.
(2)
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.

8Definition of veterinary chemical product – section 5 of the Code

(1)
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.
(2)
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.

8AASafety criteria – active constituents

For subparagraph 5A(2)(a)(vii) of the Code, the method of analysis (if any) of the chemical composition of the active constituent concerned is a prescribed matter.

8ABSafety criteria – chemical products

(1)
For subparagraph 5A(3)(a)(vii) of the Code, the following are prescribed matters for a chemical product:
(a)
for all chemical products—the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product;
(b)
for a product manufactured in Australia—whether each step in the manufacture of the product complies, or will comply, with the manufacturing principles and the Australian GMP Code;
(c)
for a product manufactured outside Australia—whether each step in the manufacture of the product complies, or will comply, with a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code;

(d)
for a molluscicide in the form of a bait and of which the active constituent is metaldehyde:
(i)
whether the product contains sufficient green pigment or dye to colour the bait a distinctive green colour; and
(ii)
whether the product contains, in the bait, any bone meal or other product of animal origin;
(e)for a molluscicide in the form of a bait and of which the active constituent is methiocarb:
(i)
whether the product contains sufficient blue pigment or dye to colour the bait a distinctive blue colour; and
(ii)
whether the product contains, in the bait, any bone meal or other product of animal origin;
(f)for an agricultural chemical product to be applied to seeds to be stored before planting or sowing—whether the product contains sufficient pigment or dye to colour the seed to enable the seed to be readily distinguished from seed to which the product has not been applied.
(2)
However, paragraphs (1)(b) and (c) do not apply if the product is prescribed under subregulation 59(1) for the purposes of section 120A of the Code.

8ADTrade criteria

(1)
For subsection 5C(3) of the Code, this regulation sets out the extent to which the APVMA is required to have regard to the matters set out in subsections 5C(1) and (2) of the Code in determining whether a chemical product meets the trade criteria.
(2)
If it can be reasonably expected that the chemical product will be used in relation to:
(a)
a crop or animal, a product of which might be provided to a place outside Australia; or
(b)
a crop that will be fed to an animal mentioned in paragraph (a);
the APVMA must have full regard to all of the matters set out in subsections 5C(1) and (2) of the Code.
(3)
In any other case, the APVMA is to have regard to the matters set out in subsections 5C(1) and (2) of the Code to the extent that the APVMA thinks is relevant.

8AELabelling criteria

(1)
For paragraph 5D(1)(j) of the Code, the following are prescribed matters:
(a)
for a chemical product that is a veterinary chemical product—the duration of any treatment using the product;
(b)
the prevention of undue prejudice to trade or commerce between Australia and places outside of Australia;
(c)
the appropriate signal words (if any) required by the current Poisons Standard;
(d)
for a chemical product that is a date‑controlled chemical product—the storage of containers for the product;
(e)
any other matter determined by the APVMA CEO under subregulation (2).
(2)
For paragraph 6(2)(c) of the Act, the APVMA CEO may determine matters in relation to which a label must contain adequate instructions.

8AFStandards made by APVMA

(1)
Before making or varying a standard under section 6E of the Code, the APVMA must:
(a)
consider whether it is necessary to make the standard or variation, having regard to any relevant standards specified in any of the following:
(i)
the British Pharmacopoeia;
(ii)
the British Pharmacopoeia (Veterinary);
(iii)
the European Pharmacopoeia;
(iv)
the United States Pharmacopeia;
(v)
the FAO and WHO Specifications for Pesticides; and
(b)
publish a notice in the Gazette and on the APVMA’s website stating:
(i)
that it proposes to make or vary the standard; and
(ii)
the reasons that the APVMA considers it is necessary to make the standard or variation; and
(iii)
how to obtain more information about the proposed standard or variation; and
(c)
prepare a draft of the standard or variation the APVMA proposes to make; and
(d)
publish on the APVMA’s website:
(i)
the draft standard or variation; and
(ii)
if the APVMA determines that the standard or variation is necessary to prevent imminent risk to persons of death, serious injury or serious illness—a statement to that effect; and
(iii)
an invitation to the public to make a written submission on the draft standard or variation within the period stated in the invitation.
(2)
The period mentioned in subparagraph (1)(d)(iii) must be not less than 28 days after the publication of the invitation, unless the APVMA determines that the standard or variation is necessary to prevent imminent risk to persons of death, serious injury or serious illness.
(3)
In deciding whether to make the standard or variation, the APVMA must consider any submissions received in accordance with the invitation mentioned in subparagraph (1)(d)(iii).
(4)
If the APVMA makes or varies a standard under section 6E of the Code, the APVMA must publish a notice in the Gazette and on the APVMA’s website stating:
(a)
that it has made the standard or variation; and
(b)
its reasons for making or varying the standard; and
(c)
how to obtain more information about the standard or variation.
(4A)
For the purposes of subparagraph 6(2)(a)(iii) of the Act, a labelling standard must include requirements relating to one or more of the following:
(a)
the presentation of the label, including the size, colour, legibility, dimensions, layout and format of the label;
(b)
the display of the label;
(c)
the information contained on the label.
Note: A label can contain information in addition to the information required by legislation.
(5)
If the APVMA decides, after taking into account the matters mentioned in subregulation (3), not to make the standard or variation, the APVMA must publish a notice in the Gazette stating:
(a)
that it has abandoned the development of the standard or variation; and
(b)
the reasons for abandoning the development of the standard or variation; and
(c)
how to obtain more information about the decision to abandon the development of the standard or variation.

Division 1.2General provisions about applications8AFAApplication requirements – chemical product registration renewal applications

For subparagraph 8A(a)(v) of the Code, an application for the renewal of the registration of a chemical product must nominate whether the application is for a 5 year or 12 month renewal period.

8AGApplication requirements – timeshift applications

(1)
For paragraph 8A(d) of the Code, a timeshift application must include a project plan agreed to by the applicant and the APVMA that includes:
(a)
timeframes for the applicant to provide information; and
(b)
assessment periods for assessing the application.
(2)
The applicant and the APVMA may, at any time, agree to vary a timeframe or assessment period set out in the project plan.

8AHApplication requirements – copies of applications

For paragraph 8A(d) of the Code, if the APVMA gives an applicant a notice under subsection 11(2), 28(2) or 110A(2) of the Code, or subregulation 8AP(1) or 8AQ(2) of these Regulations, asking the applicant to provide copies of the application, the applicant must provide the requested number of copies, in the form requested, to the APVMA within 28 days of the date of the notice.

8AHAAWhen other information may be taken into account in determining applications

(1)
For the purposes of subsection 8C(2A) of the Code, the information is information that clarifies or updates information referred to in subparagraph 8C(1)(a)(i) or (ii) of the Code.
(2)
For the purposes of subsection 8C(2A) of the Code, the circumstances are that the information is provided by, or on behalf of, the applicant on the request of the APVMA and is provided before the end of the period of 14 days beginning on the day the request is made.

Division 1.3General provisions about notices8AHAPublished notice of approvals of labels and variations of relevant particulars or conditions of approvals

(1)
If the APVMA approves a label for a container for a chemical product, or varies the relevant particulars or conditions of the approval, it must, unless it thinks that in the circumstances it is unnecessary to do so, publish notice of the approval or variation.
(2)
The notice must:
(a)
be published in the Gazette, as soon as practicable, and in any other manner that the APVMA thinks appropriate; and
(b)
for an approval—state that the label has been approved, and the date of the approval as provided by section 22 of the Code; and
(c)
for a variation—state that the relevant particulars or conditions of the approval have been varied and the day on which the variation took place; and
(d)
include any information set out under regulation 8AN.

8AKInformation to be given in notice to holder

For paragraph 8F(2)(e) of the Code, the following information is prescribed for a notice given to a holder under subsection 8F(1) of the Code:
(a)
for the approval of an active constituent:
(i)
the information required by section 8H of the Code in relation to the approval; and
(ii)
the date of the approval under section 22 of the Code; and
(iii)
the date on which the notice is given to the holder; and
(iv)
any other details entered in the Record about the active constituent that the APVMA thinks appropriate;
(b)
for the registration of a chemical product:
(i)
the information required by section 8H of the Code in relation to the registration; and
(ii)
the date of the registration under section 22 of the Code; and
(iii)
the distinguishing name of the chemical product; and
(iv)
the date on which the notice is given to the holder; and
(v)
any other details about the chemical product, entered in the Register, that the APVMA thinks appropriate;
(c)
for the approval of a label:
(i)
the date of the approval under section 22 of the Code; and
(ii)
the distinguishing number of the label; and
(iii)
the date on which the notice is given to the holder; and
(iv)
any other details about the label, entered in the relevant APVMA file, that the APVMA thinks appropriate;
(d)
for the variation of a relevant particular or condition:
(i)
the information required by section 8J of the Code in relation to the variation; and
(ii)
the date of the variation under section 22 of the Code; and
(iii)
the date on which the notice is given to the holder; and
(iv)
for a variation of a relevant particular or condition of an approval of an active constituent—any other details entered in the Record about the active constituent that the APVMA thinks appropriate; and
(v)
for a variation of a relevant particular or condition of a registration of a chemical product—any other details about the chemical product, entered in the Register, that the APVMA thinks appropriate; and
(vi)
for a variation of a relevant particular or condition of an approval of a label—any other details about the label, entered in the relevant APVMA file, that the APVMA thinks appropriate.

8ALInformation to be given on refusal of application to vary prescribed relevant particular

For paragraph 8G(2)(c) of the Code, a notice of refusal of an application to vary a prescribed relevant particular of an approval or registration, made under Division 2A of Part 2 of the Code, must inform the holder of the approval or registration that the holder may apply to have the particular varied under Division 3 of Part 2 of the Code.

8AMPublication requirements – approvals and variations of approvals of active constituents

(1)
For paragraphs 8H(2)(e) and 8J(2)(d) of the Code, this regulation sets out the information that must be included in a notice published in the Gazette under those sections in relation to:
(a)
the approval of an active constituent; or
(b)
the variation of the relevant particulars or conditions of the approval of an active constituent.
(2)
The information is:
(a)
the name of the applicant for the approval or variation; and
(b)
the application number for the application for approval or variation; and
(c)
the name of the active constituent; and
(d)
the distinguishing number given to the active constituent by the APVMA when the APVMA approved the active constituent; and
(e)
a short description of the application and its purpose, including the way in which the active constituent is intended to be used.
(3)
The following information must also be published by the APVMA on the APVMA website:
(a)
the information mentioned in paragraphs (2)(a) to (e);
(b)
brief details about the APVMA’s decision.
(4)
For each item of information relied on by the APVMA in making its decision, the following details must also be published by the APVMA on the APVMA website:
(a)
the details for the information mentioned in paragraphs (a) to (e) of the definition of application information details in subregulation 3(1);
(b)
if the item of information was given to the APVMA in connection with the application by the applicant or a person on behalf of the applicant:
(i)
the data number given to the item of information by the APVMA; and
(ii)
unless the information is publicly available—the name and address of the authorising party for the item of information.

8ANPublication requirements – registrations, variations of registrations and approval of labels

(1)
For the purposes of paragraphs 8H(2)(e) and 8J(2)(d) of the Code and paragraph 8AHA(2)(d) of these Regulations, this regulation sets out the information that must be included in the Gazette in relation to:
(a)
the registration of a chemical product; or
(b)
the approval of a label for containers for a chemical product; or
(c)
the variation of the relevant particulars or conditions of:
(i)
the registration of a chemical product; or
(ii)
the approval of a label for a container for a chemical product.
(2)
The information is:
(a)
the name of the applicant for the registration, approval or variation; and
(b)
the application number for the application for registration, approval or variation; and
(c)
the name of the chemical product; and
(d)
for a registration of a chemical product or variation of the relevant particulars or conditions of the registration of a chemical product—the distinguishing number given to the product by the APVMA when the APVMA registered the product; and
(e)
for approval of a label or variation of the relevant particulars or conditions of the approval of a label—the distinguishing number given to the label by the APVMA when the APVMA approved the label; and
(f)
the name of the active constituents of the chemical product; and
(g)
a short description of the application and its purpose, including the way in which the chemical product is intended to be used.
(3)
The following information must also be published by the APVMA on the APVMA website:
(a)
the information mentioned in paragraphs (2)(a) to (e);
(b)
brief details about the APVMA’s decision.
(4)
For each item of information relied on by the APVMA in making its decision, the following details must also be published by the APVMA on the APVMA website:
(a)
the details for the information mentioned in paragraphs (a) to (e) of the definition of application information details in subregulation 3(1);
(b)
if the item of information was given to the APVMA in connection with the application by the applicant or a person on behalf of the applicant:
(i)
the data number given to the item of information by the APVMA; and
(ii)
unless the information is publicly available—the name and address of the authorising party for the item of information.

8AOMatters for notice following preliminary assessment

(1)
For subparagraphs 11(2)(a)(ii) and 28(2)(a)(ii) and paragraph 110A(2)(b) of the Code, this regulation prescribes the matters that must be set out in a notice under subsection 11(2), 28(2) or 110A(2) of the Code.
(2)
The matters are the following:
(a)
that the application to which the notice relates has passed preliminary assessment;
(b)
the section of the Code under which the application will be determined;
(c)
the date on which the assessment of the application will commence;
(d)
if an amount of application fee payable in relation to the application under subregulation 70(2) is unpaid:
(i)
the balance of the application fee that is payable; and
(ii)
that the balance must be paid within 28 days of the date of the notice;
(e)
that the APVMA may determine that:
(i)
the application is more correctly categorised as an application mentioned in a different item of the table in clause 2.1 of Schedule 6 to the item in relation to which any fee has been paid; or
(ii)
different modules, levels and types mentioned in Schedule 7 are necessary for the application;
and that if it does so, a further amount of application fee may be payable and the assessment period may change;
(f)
the number of copies (if any) of the application that must be given to the APVMA and the form in which those copies must be given;
(g)
that if copies of the application are required, the copies must be given to the APVMA within 28 days of the date of the notice;
(h)
the assessment period for the application and the expected date by which the application will be determined;
(i)
if the modular assessment period applies to the application—the modules to be completed in relation to the application;
(j)
that if the APVMA or another prescribed authority makes a request under section 159 of the Code, the assessment period will be extended;
(k)
for an applicant who is a nominated agent for an approval or registration—the applicant’s obligations under subsection 152(2) of the Code;
(l)
that if the applicant becomes aware of any information (new information) that contradicts any information given to the APVMA or shows that the constituent or product to which the application relates may not meet the safety criteria, the trade criteria or the efficacy criteria, the applicant must give the new information to the APVMA in accordance with sections 160A and 161 of the Code;
(m)
that if the APVMA does not determine the application within the assessment period for the application (or the extended application period, if applicable), the applicant may:
(i)
notify the APVMA under subsection 165(3) of the Code that the applicant wishes to treat the application as having been refused; and
(ii)
apply under subsection 167(1) of the Code for a review of the decision;
(n)
that the applicant may withdraw the application in accordance with section 8D of the Code.

8APMatters for notice – applications for technical assessments etc.

(1)
The APVMA must give a person a notice if:
(a)
the person lodges an application for the APVMA to provide an assessment of a technical nature, and the APVMA decides to provide that assessment (see regulation 8AS); or
(b)
the person lodges an application for the APVMA to:
(i)
make an interchangeable constituent determination (see regulation 19AEB); or
(ii)
make or vary an ingredient determination (see clause 10 of Schedule 3AA).
(2)
The notice must set out the following:
(a)
the date on which the assessment or the determination will commence;
(b)
if an amount of application fee payable for the application under subregulation 70(2) is unpaid:
(i)
the balance of the application fee that is payable; and
(ii)
that the balance must be paid within 28 days of the date of the notice;
(c)
if the applicant must give copies of the application to the APVMA:
(i)
the number of copies that must be given; and
(ii)
the form in which those copies must be given; and
(iii)
that the copies must be given to the APVMA within 28 days of the date of the notice;
(d)
the assessment period for the application and the expected date by which the application will be determined;
(e)
the modules to be completed in relation to the application;
(f)
that the assessment periodwill be extended if the APVMA or another prescribed authority makes a request under section 159 of the Code;
(g)
that if the APVMA does not determine the application within the assessment period for the application (or the extended application period, if applicable), the applicant may:
(i)
notify the APVMA under subsection 165(3) of the Code that the applicant wishes to treat the application as having been refused; and
(ii)
apply under subsection 167(1) of the Code for review of the decision;
(h)
that the applicant may withdraw the application in accordance with section 8D of the Code.
(3)
The notice must be given to the person within 1 month of the day on which the person lodges the application.
(4)
If a person lodges an application under regulation 8AS for the APVMA to provide an assessment of a technical nature, and the APVMA decides not to provide that assessment, the APVMA must notify the person of that decision within 1 month of the day on which the person lodges the application.

8AQMatters for notice in relation to extension of permit

(1)
This regulation applies to an application for an extension or extensions of a permit under subsection 115(3) of the Code.
(2)
Within 1 month of the application being lodged, the APVMA must give the applicant a notice setting out the following:

(a)
that the application will be determined under section 115 of the Code;
(b)
the date on which the assessment of the application will commence;
(c)
if an amount of application fee payable in relation to the application under subregulation 70(2) is unpaid:
(i)
the balance of the application fee that is payable; and
(ii)
that the balance must be paid within 28 days of the date of the notice;
(d)
the number of copies (if any) of the application that must be given to the APVMA and the form in which those copies must be given;
(e)
that any copies must be given to the APVMA within 28 days of the date of the notice;
(f)
the assessment period for the application and the expected date by which the application will be determined;
(fa)
that the assessment period will be extended if the APVMA or another prescribed authority makes a request under section 159 of the Code;
(g)
if the modular assessment period applies to the application—the modules to be completed in relation to the application;
(h)
that if the applicant becomes aware of any information (new information) that contradicts any information given to the APVMA or shows that the constituent or product to which the application relates may not meet the safety criteria, the trade criteria or the efficacy criteria, the applicant must give the new information to the APVMA in accordance with sections 160A and 161 of the Code;
(i)
that if the APVMA does not determine the application within the assessment period for the application (or the extended application period, if applicable), the applicant may:
(i)
notify the APVMA under subsection 165(3) of the Code that the applicant wishes to treat the application as having been refused; and
(ii)
apply under subsection 167(1) of the Code for review of the decision;
(j)
that the applicant may withdraw the application in accordance with section 8D of the Code.

Division 1.6Listed chemical products8ARListed chemical products

For subsection 8T(1) of the Code, the chemical products, or classes of chemical products, specified in Schedule 3B are listed chemical products for the purposes of the Code.

Part 2Approvals and registrationDivision 2.1APre‑application assessments and assistance8ASAPVMA may provide technical assessments

If a person applies to the APVMA for an assessment of a technical nature (a technical assessment) before making an application, the APVMA may provide the technical assessment.
Example: Assessment of data an applicant is considering submitting to the APVMA as part of a proposed application for registration of a chemical product or approval of an active constituent.
Note: Regulation 70 provides for fees for making an application for a technical assessment.

8ATAPVMA may provide pre‑application assistance

(1)
A person may apply to the APVMA for assistance (pre‑application assistance) in preparing or making an application to the APVMA under the Code or these Regulations.
(2)
If a person makes an application for pre‑application assistance in accordance with subregulation (1), the APVMA may provide the pre‑application assistance.
Note: Regulation 69B prescribes the fees payable for pre‑application assistance.

Division 2.1Granting or refusing approvals and registrationsSubdivision 2.1.1—Preliminary applicationssummaries of applications8BSummaries of applications for active constituents for chemical products

(1)
This regulation applies to an application for the approval of an active constituent for a proposed or existing chemical product.
(2)
For paragraph 11(2)(b) of the Code, the details are:
(a)
the name of the applicant; and
(b)
the application number; and
(c)
the name of the active constituent; and
(d)
the active constituent number; and
(e)
a short description of the application and its purpose, including the way in which the active constituent is intended to be used; and
(f)
for any reference active constituent mentioned in the application:
(i)
the name of the reference active constituent; and
(ii)
if the active constituent is an approved active constituent—the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and
(g)
a short description of each item of information contained in, or accompanying, the application in compliance with subparagraph 8A(a)(v) of the Code, including the application information details for the item of information; and
(h)
any other information that the APVMA considers to be relevant to its decision on the application.

8DSummaries of applications for chemical products that are not the same as a registered chemical product

(1)
This regulation applies to an application for:
(a)
registration of a chemical product that is not a chemical product mentioned in paragraph 8E(1)(a); or
(b)
approval of a label for a container for a chemical product mentioned in paragraph (a).
(2)
For paragraph 11(2)(b) of the Code, the details are:
(a)
the name of the applicant; and
(b)
the application number; and
(c)
the name of the chemical product; and
(d)
the chemical product number; and
(e)
the name of each of the active constituents of the chemical product; and
(f)
a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and
(g)
for any reference active constituent mentioned in the application:
(i)
the name of the reference active constituent; and
(ii)
if the active constituent is an approved active constituent—the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and
(h)
for any reference chemical product mentioned in the application:
(i)
the name of the reference chemical product; and
(ii)
if the chemical product has been registered—the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and
(i)
a short description of each item of information contained in, or accompanying, the application in compliance with subparagraph 8A(a)(v) of the Code, including the application information details for the item of information; and
(j)
any other information that the APVMA considers to be relevant to its decision on the application.

8ESummaries of applications for chemical products that are the same as a registered chemical product

(1)
This regulation applies to an application for:
(a)
registration of any kind of chemical product that is:
(i)
the same as a registered chemical product; and
(ii)
intended to be marketed under a brand name that is different from the brand name used for the registered chemical product; or
(b)
approval of a label for a container for a chemical product mentioned in paragraph (a).
(2)
For paragraph 11(2)(b) of the Code, the details prescribed are:
(a)
the name of the applicant; and
(b)
the application number; and
(c)
the chemical product number; and
(d)
the name of each of the active constituents of the chemical product; and
(e)
a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

Subdivision 2.1.3Particulars for approvals, registrations and labelling15Particulars of approved active constituents to be recorded

(1)
For paragraph 19(c) of the Code, the following particulars are prescribed:
(a)
if a name is given to the active constituent by the International Union of Pure and Applied Chemistry—that name;
(b)
if no name is given to the active constituent by the International Union of Pure and Applied Chemistry—the name given to the active constituent in the standard prescribed in respect of the active constituent for the purposes of paragraph 87(1)(a) of the Code;
(c)
the name of the active constituent;
(d)
the composition and purity of the active constituent;
(e)
the name of the manufacturer of the active constituent;
(f)
the address of each site at which the active constituent is manufactured by the manufacturer;
(g)
identifying information for the holder of the approval of the active constituent;
(h)
the date of entry of these particulars in the Record of Approved Active Constituents;
(j)
identifying information for any nominated agent for the approval.
(2)
A particular mentioned in paragraphs (1)(c) to (j) is only prescribed for an active constituent approved in accordance with section 14A of the Code if the particular is readily available to the APVMA.

16Particulars of registered chemical products to be recorded

For paragraph 20(1)(c) of the Code, the following particulars are prescribed:
(a)
the distinguishing name of the chemical product;
(b)
the constituents of the chemical product;
(c)
the concentration of each constituent of the chemical product;
(d)
if possible, the composition and purity of each active constituent of the chemical product;
(da)
the formulation type for the chemical product;
(db)
the net contents for the chemical product;
(e)
identifying information for the holder of the registration of the chemical product;
(g)
the name of each manufacturer of the chemical product;
(h)
the address of each site at which the chemical product is manufactured by the manufacturer;
(j)
the date of entry of these particulars in the Register of Chemical Products;
(k)
identifying information for any nominated agent for the registration.

17Particulars for label

(1)
For paragraph 21(a) of the Code, the following particulars are prescribed:
(a)
the appropriate signal words required by the current Poisons Standard;
(b)
the name of the chemical product that is to appear on a label for containers of the chemical product;
(c)
the name of each active constituent of the product;
(d)
the proportion of each active constituent of the product;
(e)
the name of each constituent for the product that is:
(i)
not an active constituent; and
(ii)
classified as a poison in the current Poisons Standard;
(f)
the proportion of each constituent referred to in paragraph (e);
(h)
the net contents of the product;
(j)
particulars determined by the APVMA CEO under subregulation (2).
(2)
For paragraph 6(2)(c) of the Act, the APVMA CEO may determine additional particulars to be placed on a label for a product.
(3)
For subparagraph 21(c)(iva) of the Code, the following information is prescribed in relation to the approval of a label for a chemical product, unless the information has already been recorded for the approval of the label as part of the registration of the chemical product:
(a)
identifying information for the holder of the approval;
(b)
identifying information for any nominated agent for the approval;
(c)
the distinguishing name of the chemical product that is prescribed under paragraph 16(a) and entered in the Register;
(d)
the distinguishing number of the chemical product that is entered in the Register.

Subdivision 2.1.4—Conditions of approvalactive constituents and chemical products17CConditions of approval or registration – active constituents and chemical products

(1)
For paragraph 23(1)(a) of the Code, the table sets out conditions to which the approval of an active constituent for a proposed or existing chemical product is subject.

Conditions for approval of active constituent
Item	Condition
1	The active constituent must be manufactured in accordance with the composition and purity entered for the active constituent in the Record in accordance with paragraph 15(1)(d)
2	The active constituent must be manufactured by the manufacturer whose name is entered for the active constituent in the Record in accordance with paragraph 15(1)(e)
3	The active constituent must be manufactured at a site of manufacture entered for the active constituent in the Record in accordance with paragraph 15(1)(f)
4	The identifying information for the holder of the approval, and the nominated agent (if any), of the active constituent must be the identifying information for the holder and nominated agent (if any) entered for the active constituent in the Record

(2)
For paragraph 23(1)(a) of the Code, the table sets out conditions to which the registration of a chemical product is subject.

Conditions for registration of chemical product
Item	Condition
1	The chemical product must contain each of the constituents entered for the chemical product in the Register in accordance with paragraph 16(b)
2	The chemical product must be manufactured: (a) in accordance with the particulars entered for the chemical product in the Register in accordance with paragraphs 16(b), (c), (d) and (da); and (b) by a manufacturer whose name is entered for the chemical product in the Register in accordance with paragraph 16(g); and (c) at a site of manufacture entered for the chemical product in the Register in accordance with paragraph 16(h)
3	A chemical product manufactured in Australia must not be supplied unless the APVMA has determined it is satisfied that each holder of a licence to carry out steps in the manufacture of the product is complying with the following conditions of the licence: (a) any conditions imposed on the licence under subsections 126(1) and (2) of the Code; (b) the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition; (c) any of the conditions mentioned in subregulations 61(3) to (7A) to which the licence is subject
4	A chemical product manufactured outside Australia must not be supplied unless: (a) the holder of the registration of the product has, on request by the APVMA, given the APVMA, or arranged for the manufacturer of the product to give the APVMA, evidence that each step in the manufacture of the product complies with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code (an overseas GMP compliance assessment); and (b) the APVMA has assessed the overseas GMP compliance assessment and is satisfied that each step in the manufacture of the product complies with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code
5	The formulation type of the chemical product as supplied must be the formulation type entered for the chemical product in the Register in accordance with paragraph 16(da)
6	The net contents for the chemical product as supplied must be the net contents entered for the chemical product in the Register in accordance with paragraph 16(db)
7	The identifying information for the holder of the registration, and the nominated agent (if any), for the chemical product as supplied must be the identifying information for the holder and nominated agent (if any) entered for the chemical product in the Register

(3)
Items 3 and 4 of the table in subregulation (2) do not apply in relation to a chemical product if:
(a)
the chemical product is prescribed under subregulation 59(1) for the purposes of section 120A of the Code; or
(b)
the holder of the registration of the product is an exempt person within the meaning given by regulation 59A, 59B, 59C or 59D.

18Conditions of registration of chemical products – containers

(1)
For paragraph 23(1)(a) of the Code, the registration of a chemical product is subject to the condition that the product is supplied only in a container that meets the requirements mentioned in subregulation (2).
(2)
The container must:
(a)
be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service; and
(b)
have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions; and
(c)
if it is intended to be opened more than once—be able to be securely and readily closed and reclosed; and
(d)
have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage; and
(e)
enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot:
(i)
harm a person; or
(ii)
have an unintended effect that is harmful to the environment.
(3)
Nothing in subregulation (2) is intended to affect the operation of any other law that applies in relation to containers for chemical products.

Subdivision 2.1.6—Conditions of approvallabels18BPrescribed conditions for approval of labels

For paragraph 23(1)(a) of the Code, the approval of a label for containers for a chemical product is subject to the conditions prescribed by this Subdivision.

18CLabel must be attached to containers for chemical products

The label must be attached to the container for the chemical product to which it relates before the supply of the product.
Note: For supply, see section 3 of the Code.

18DInformation on label

(1)
Unless authorised by a permit, the label must state the following information:
(a)
the information recorded for the label in the relevant APVMA file under subparagraphs 21(c)(iii) and (iv) of the Code;
(b)
the batch number of the chemical product;
(c)
the expiry date of the chemical product (if applicable);
(d)
the date of manufacture of the chemical product (if applicable);
(e)
the name and address of the person primarily responsible for marketing the product.
Note: A label can contain information in addition to the information required by legislation.
(2)
The label must not contain information that is contrary to the information mentioned in subregulation (1).
(3)
The information mentioned in subregulation (1), on the label, must not be altered, defaced, obliterated, obscured or destroyed.

18ELabelling standards and requirements

The label must comply with the requirements of:
(a)
if a labelling standard has been made by the APVMA—the labelling standard; or
(b)
if a labelling standard has not been made by the APVMA—either:
(i)
if the product is a veterinary chemical product—the Veterinary Labelling Code made by the APVMA, as in force from time to time; or
(ii)
if the product is an agricultural chemical product—the Agricultural Labelling Code made by the APVMA, as in force from time to time.
Note: The Veterinary Labelling Code and the Agricultural Labelling Code are available at level="5">18FRequirements for information on labels
(1)
The label must not contain misleading or deceptive information about either:
(a)
the information required by subregulation 18D(1) to be stated on the label; or
(b)
the use, safety, environmental impact or efficacy of the chemical product to which the label relates.
(2)
If the label is, or is required to be, attached to a container, information must not accompany or be placed on the container, including in the form of another label, if the information expressly or impliedly:
(a)
negates or varies information required by subregulation 18D(1) to be stated on the label; or
(b)
qualifies or minimises the substance or effect of the information required by subregulation 18D(1) to be stated on the label.
(3)
To avoid doubt, the label must not contain instructions about the circumstances in which, or the purposes for which, the chemical product can be used, if those instructions are inconsistent with the instructions for use approved for the label by the APVMA.
18GRequirements about claims inconsistent with labels
(1)
The holder of the approval of the label in relation to the label must not make any claim, or cause or permit any claim to be made, about:
(a)
a registered chemical product; or
(b)
a chemical product that contains a registered chemical product;
that is inconsistent with an instruction on the label for a container for the chemical product.
(2)
Subregulation (1) does not apply to:
(a)
a claim exempted by the APVMA from the operation of section 84 of the Code; or
(b)
a claim made in a notice published under paragraph 45A(1)(b) of the Code; or
(c)
a claim permitted to be made under a law of the Commonwealth; or
(d)
a claim about conduct the person is authorised to engage in by a permit issued by the APVMA.
18HRetention of label and information about label
(1)
The holder of the approval of the label must:
(a)
retain a copy of each form of the label that is attached to a container, or a series of containers, released for supply; and
(b)
record either:
(i)
if the form of the label states a sequential batch number of the chemical product—the first batch number in the sequence for the form of label; or
(ii)
if the form of the label does not state a sequential batch number of the chemical product—each batch number for the form of label; and

(c)
record the day on which the series of containers on which the form of the label is attached is first released for supply.
(2)
The label and information mentioned in subregulation (1) must be retained:
(a)
in a secure manner; and
(b)
for a 5 year period commencing on the last day on which the chemical product is supplied in a container with the label attached.
(3)
For paragraphs (1)(a) and (c), a container is released for supply on the day when the container is sent from a manufacturing or packaging facility for the purposes of distribution or sale.

18IProviding label and information about label to APVMA

(1)
The holder of the approval of the label must, on a written request by the APVMA for:
(a)
a copy of a form of the label mentioned in paragraph 18H(1)(a); and
(b)
information about the label mentioned in paragraphs 18H(1)(b) and (c);
provide the label and information requested to the APVMA.
(2)
If the request is for a copy of a form of a label, the copy must be accompanied by a declaration that the copy is of a form of label that has been attached to a container to which it relates.
(3)
The label and information must be provided to the APVMA on the earlier of the following:
(a)
within 10 days of the day on which the request for the label and information is received;
(b)
on a day advised by the APVMA.
(4)
The APVMA must not advise a date for paragraph (3)(b) unless:
(a)
the APVMA believes it is necessary to receive the label or information before the end of the period mentioned in paragraph (3)(a) to prevent imminent risk to persons of death, serious illness or serious injury; and
(b)
the APVMA provides the reasons for the early date in the written request.

18JIdentifying information recorded for holder and nominated agent

The approval of a label for containers for a chemical product is subject to the condition that the identifying information for the holder of the approval, and the nominated agent (if any) for the holder, must be the identifying information for the holder, and the nominated agent (if any), recorded for the label in the relevant APVMA file.

Subdivision 2.1.6AIncorrect particulars and conditions18KIncorrect particulars and conditions APVMA must correct

For paragraph 26(1)(b) of the Code, the following kinds of relevant particulars or conditions are prescribed:
(a)
the signal words required by the current Poisons Standard in relation to an approved label;
(b)
the following information about the holder of an approval or registration or the nominated agent (if any) for the approval or registration:
(i)
the name of the holder or agent;
(ii)
the ABN (if any) of the holder or agent;
(iii)
the trading name (if any) of the holder or agent;
(iv)
the street address of the holder or agent;
(v)
the postal address of the holder or agent, if it is different from the street address.

Division 2.2Granting or refusing applications for variation of relevant particulars, or conditions, of approvals or registrationSubdivision 2.2.1—Variation applicationssummaries of applications19ADSummaries of applications for variation for chemical products

(1)
This regulation applies to an application for variation of the relevant particulars or conditions of:
(a)
the registration of a chemical product; or
(b)
the approval of a label for a container for a chemical product.
(2)
For paragraph 28(2)(b) of the Code, the details are:
(a)
the name of the applicant; and
(b)
the application number; and
(c)
the name of the chemical product; and
(d)
if the application is in relation to the registration of a chemical product—the distinguishing number that the APVMA gave to the product when it decided to register the product; and
(e)
the name of each of the active constituents of the chemical product; and
(f)
a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and
(g)
for any reference active constituent mentioned in the application:
(i)
the name of the reference active constituent; and
(ii)
if the active constituent is an approved active constituent—the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and
(h)
for any reference chemical product mentioned in the application:
(i)
the name of the reference chemical product; and
(ii)
if the chemical product has been registered—the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and
(i)
a short description of each item of information contained in, or accompanying, the application in compliance with subparagraph 8A(a)(v) of the Code, including the application information details for the item of information; and
(ia)
if the APVMA were to make a variation as a result of the application and this may result in:
(i)
an extension of a protection period in relation to protected information; or
(ii)
an extension of a limitation period for information covered by an item in the table in subsection 34M(1) of the Code;
a statement in relation to this matter; and
(j)
any other information that the APVMA considers to be relevant to its decision on the application.

Subdivision 2.2.2Interchangeable constituent determinations19AEAInterchangeable constituent determinations

APVMA may determine interchangeable constituents
(1)
The APVMA may, by legislative instrument, determine that one or more constituents of a chemical product or a class of chemical products may be interchanged with another constituent.
(2)
Without limiting subregulation (1), the interchangeable constituent determination may authorise a constituent being interchanged with another constituent if one or more requirements specified in the determination are met.
(3)
The power under subregulation (1) may be exercised on the APVMA’s own initiative or on application under regulation 19AEB.
(4)
If an interchangeable constituent determination can be made in relation to a class of chemical products, or varied so that it applies to a class of chemical products, the APVMA must make or, if varying a determination, vary the determination accordingly.
APVMA to be satisfied of certain matters
(5)
Before making or varying an interchangeable constituent determination, the APVMA must be satisfied that:
(a)
the constituent to be interchanged is not an active constituent of the product; and
(b)
the interchange of the constituents does not introduce material of human or animal origin into the product; and
(c)
the interchange of the constituents would not require variation to:
(i)
the signal words required by the current Poisons Standard to be contained on the label of the product; or
(ii)
the formulation type of the product entered in the Register; and
(d)
after the constituents are interchanged, the chemical product would continue to:
(i)
meet the safety criteria, the trade criteria and the efficacy criteria; and
(ii)
comply with any requirements prescribed for the purposes of paragraph 8A(b) or 41(1)(c) of the Code.
(6)
For the purposes of being satisfied of the matters mentioned in subregulation (5), the APVMA must have regard to any requirements to which the interchange of a constituent is, or could be, subject.
Variation or revocation of an interchangeable constituent determination
(7)
If the APVMA proposes to vary or revoke an interchangeable constituent determination, the APVMA must:
(a)
publish on its website a notice setting out the proposed variation or reasons for the proposed revocation; and
(b)
invite written submissions on the variation or revocation to be made on or before a specified date (the consultation period).
(8)
The notice must:
(a)
be published at least 28 days before the interchangeable constituent determination is so varied or revoked; and
(b)
remain on the APVMA’s website until the determination is so varied or revoked.
(9)
The APVMA must consider submissions made during the consultation period.
(10)
The APVMA may make a submission public, unless the person that made the submission has requested that the submission, or a part of it, be kept confidential.

19AEBApplying for an interchangeable constituent determination

(1)
A person may apply to the APVMA for the making of an interchangeable constituent determination in relation to a chemical product or a class of chemical products.
(2)
The application must specify the following for each constituent covered by the application:
(a)
the identity of the constituent, including:
(i)
the common name of the constituent; and
(ii)
if a name is given to the constituent by the International Union of Pure and Applied Chemistry—that name; and
(iii)
the chemical abstract service number for the constituent;
(b)
the purpose of the constituent in the chemical product;
(c)
any requirements (including, for example, minimum purity or other quality specifications) for the constituent.
(3)
The APVMA must make an interchangeable constituent determination if the APVMA is satisfied:
(a)
that the application meets the application requirements; and
(b)
of the matters mentioned in subregulation 19AEA(5).
(4)
The APVMA must, within 14 days of making an interchangeable constituent determination:
(a)
inform the applicant, in writing, of that fact; and
(b)
provide the applicant with a copy of the determination.
Note: For notification requirements if the APVMA refuses an application, see section 8G of the Code.
(5)
The following provisions of the Code apply in relation to an application under subregulation (1) as if the application were an application made under the Code in relation to an active constituent for a proposed or existing chemical product:
(a)
section 157 (samples to be given for analysis);
(b)
section 159 (requiring information to determine an application).
Note 1: A number of provisions in the Code apply automatically in relation to applications made under it (including applications made under these Regulations). See, for example, sections 8B to 8D, and sections 8G, 8S, 156A, 164 and 165, of the Code.
Note 2: Regulation 19AEC applies certain other provisions in relation to applications made under this regulation.

19AECLimits on information that may be used for interchangeable constituent determinations

Overseas trials and experiments, consultation and information, reports or samples
(1)
The following provisions apply in relation to the making, variation or revocation of an interchangeable constituent determination as if the constituent to which the determination relates were an active constituent for a proposed or existing chemical product:
(a)
section 159 of the Code (requiring information to determine an application);
(b)
subsections 160(2) and (3) of the Code (overseas trials and experiments);
(c)
section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (consultation).
Limits on use of information
(2)
The APVMA must not use information given to it in connection with an application under the Code:
(a)
to assess an application made under regulation 19AEB; or
(b)
to make any other decision in relation to the making, variation or revocation of an interchangeable constituent determination;
unless the information was given to it in connection with the application mentioned in paragraph (a) or the decision mentioned in paragraph (b).
(3)
A person or body consulted under section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as that section applies under subregulation (1), must not, for the purposes of providing information or advice in relation to the making, variation or revocation of an interchangeable constituent determination, use information that the APVMA must not, under subregulation (2), use in relation to the interchangeable constituent determination.
(4)
The following provisions of the Code apply in relation to subregulations (2) and (3) in the same way as they apply in relation to subsections 34G(1) and (3) of the Code:
(a)
subsections 34G(1B) and (2);
(b)
sections 34H to 34M.
(5)
For subregulation (4), the condition in subsection 34J(4) of the Code is taken to be replaced by the condition that:
(a)
the information relates to the making, variation or revocation of an interchangeable constituent determination in relation to a constituent; and
(b)
the information shows that a matter mentioned in subregulation 19AEA(5) may not be satisfied in relation to the constituent.
(6)
For subregulation (4), if the APVMA relies on information to make, vary or revoke an interchangeable constituent determination, a limitation period is taken to apply to the information under section 34M of the Code that ends 3 years after the day the determination is made, varied or revoked.

Division 2.3Reconsideration of approval or registration20Reconsideration work plan

(1)
For subsection 31(2) of the Code, a work plan for a proposed reconsideration must include the following:
(a)
the date of any relevant notice published under section 30 of the Code;
(b)
the date on which the APVMA will commence the reconsideration;
(c)
the proposed timeframe for the reconsideration and how the timeframe has been calculated for regulation 78B;
(d)
the matters the APVMA proposes dealing with in the reconsideration;
(e)
the expected date on which a notice will be given to the holder under subsection 32(1) of the Code;
(f)
both:
(i)
the expected date on which the APVMA proposes to inform persons about the reconsideration; and
(ii)
the persons proposed to be informed;
(g)
the expected date on which a notice (if any) will be given to the holder under subsection 33(1) of the Code, and a summary of the type of information, report, result or sample it is anticipated will be required by the notice;
(h)
the expected date on which a notice (if any) will be given under section 34AB of the Code, and the anticipated recipients of the notice;
(i)
the expected date on which a decision will be made in relation to the reconsideration under section 34 of the Code.
(2)
For paragraph 31(3)(a) of the Code:
(a)
the APVMA must review and update the work plan at least once a year; and
(b)
if the APVMA issues a notice or information mentioned in paragraph (1)(e), (f), (g) or (h), the APVMA must update the work plan to include the date the notice or information was issued; and
(c)
if the APVMA makes a decision in relation to the reconsideration under section 34 of the Code, the APVMA must include in the work plan details of the decision and the date of the decision; and
(d)
if the APVMA varies the instructions on a label for containers for a chemical product under section 34A of the Code in relation to the reconsideration—the APVMA must include in the work plan details of the variation; and
(e)
if the APVMA issues a permit in relation to the reconsideration—the APVMA must include in the work plan details of the permit; and
(f)
if the APVMA takes any suspension, cancellation or recall action, in relation to the reconsideration, under section 34AA, 41, 101, 102 or 103 of the Code, the APVMA must include in the work plan details of the action taken and the date of the action.

21Period for giving information, reports, results or samples

(1)
For subsection 33(1A) of the Code, the period stated in a notice issued under subsection 33(1) of the Code must not exceed the period that is half of the period in which the APVMA is required, under regulation 78B, to conclude the reconsideration to which the notice relates.
(2)
For subregulation (1), the period in which the APVMA is required, under regulation 78B, to conclude the reconsideration, is to be calculated as at the date of the notice.
(3)
For subsection 33(1B) of the Code, the APVMA may allow a further period if an extraordinary event or circumstance beyond the control of the holder prevents the holder from fulfilling the holder’s obligations in the notice.

22Notice of decision on reconsideration

For paragraph 34AC(2)(d) of the Code, the following information is prescribed:
(a)
particulars of the notice published under paragraph 34AC(1)(b) of the Code in relation to the affirmation;
(b)
the date on which the notice is given to the holder;
(c)
the date the APVMA affirmed the approval or registration;
(d)
for an affirmation of a registration of a chemical product—the distinguishing name of the chemical product;
(e)
for an affirmation of an approval of a label—the distinguishing number of the label;
(f)
any other details entered in the Record, Register or relevant APVMA file for the active constituent, chemical product or label that the APVMA thinks appropriate.

22AAReconsideration by APVMA of approval of label

For subsection 34AF(1) of the Code, the prescribed matters are either or both of the following:
(a)
the matters mentioned in paragraphs 5D(1)(g), (h) and (i) of the Code;
(b)
the matters mentioned in paragraphs 8AE(1)(a), (b), (c) and (d) of these Regulations.

Division 2.6Late applications23Late applications for renewal of registration of chemical product

(1)For the purposes of subsection 48(3) of the Code, the APVMA may accept a late application for the renewal of the registration of a chemical product:
(a)
if:
(i)
before the end of the period for making an application referred to in subsection 48(2) of the Code, the applicant requests in writing that the APVMA accept a late application; and
(ii)
the APVMA agrees to that request; or
(b)
if:
(i)
after the end of the period for making an application referred to in subsection 48(2) of the Code and before the registration of the product ends, the applicant requests in writing that the APVMA accept a late application; and
(ii)
the APVMA agrees to that request.
(2)
The fee payable for acceptance of a late application for the renewal of the registration of a chemical product (other than an application to which paragraph (1)(a) applies) is $50.

Division 2.7Renewal of registration23AWhen renewed registration ends

For paragraph 50(2)(b) of the Code, the method for working out the date the registration of a chemical product (as renewed) ends is:
(a)
if the holder applies for the registration of the product to be renewed, or further renewed, as the case may be, for a period of 5 years—add 5 years to the date on which the registration would otherwise end; or
(b)
if the holder applies for the registration of the product to be renewed, or further renewed, as the case may be, for a period of 12 months—add 12 months to the date on which the registration would otherwise end.

Part 2BReserved chemical products23GReserved Schedule

For subsection 56ZU(1) of the Code, Part 2 of Schedule 3C specifies chemical products or classes of chemical products that are reserved chemical products for the purposes of the Code.

23HConditions for dealing with reserved chemical product – containers for supply

(1)
For subsection 56ZU(3) of the Code, a container used for the supply of a chemical product mentioned in Part 2 of Schedule 3C must:
(a)
be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service; and
(b)
have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions; and
(c)
if it is intended to be opened more than once—be able to be securely and readily closed and reclosed; and
(d)
have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage; and
(e)
enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot:
(i)
harm a person; or
(ii)
have an unintended effect that is harmful to the environment.
(2)
Nothing in subregulation (1) is intended to affect the operation of any other law that applies in relation to containers for chemical products.

23IConditions for dealing with reserved chemical product – labels

(1)
For subsection 56ZU(3) of the Code, a label for a chemical product mentioned in Part 2 of Schedule 3C must not contain a claim about the product and its active constituents that is inconsistent with:
(a)
the definition of disinfectant in section 1 of Part 1 of Schedule 3C; and
(b)
the particulars of the product, and active constituents of the product, set out in Schedule 3C.
(2)
For the purposes of subsection 56ZU(3) of the Code, a label for a chemical product of the kind mentioned in Part 2 of Schedule 3C must include any first aid instructions and safety directions that apply to the product, based on its type and formulation, in accordance with the FAISD Handbook of the APVMA, as changed from time to time.

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r 48............................................

rs No 111, 1996; No 60, 2002

am No 353, 2004; F2019L00357

r 49............................................

rs No 111, 1996

am No 60, 2002; F2019L00357

r 50............................................

rs No 111, 1996

am No 60, 2002; F2019L00357

r 51............................................

rs No 111, 1996

am No 60, 2002; F2019L00357

r 52............................................

am No 179, 2013

r 53............................................

am No 60, 2002; No 353, 2004; F2019L00357

r 54............................................

am No 60, 2002; No 179, 2013; F2019L00357

Part 5

r 55............................................

am No 111, 1996; No 353, 2004; No 118, 2014; F2019L00357

r 55A.........................................

ad No 118, 2014

r. 56...........................................

am. 2004 No. 353; No 118, 2014

Part 5A

Part 5A......................................

ad F2021L01862

r 56A.........................................

ad F2021L01862

Part 6

r 57............................................

rs No 179, 2013

r 57A.........................................

ad No 179, 2013

r 57B.........................................

ad No 179, 2013

Part 7

r 58............................................

rep No 179, 2013

r. 59...........................................

am. 1996 No. 162; No 118, 2014

r. 59A........................................

ad. 1996 No. 162

r. 59B........................................

ad. 1996 No. 162

am. 2004 No. 353; No 118, 2014

r. 59C........................................

ad. 1996 No. 162

am. 1997 No. 264; 2004 No. 353; No 179, 2013

r. 59D........................................

ad. 1996 No. 162

am. 2004 No. 353; No 179, 2013

r. 59E.........................................

ad. No. 108, 2013

am No 179, 2013

r. 60...........................................

am. 2004 No. 353

r. 61...........................................

am. 1996 No. 162; 2004 No. 353; No. 108, 2013; F2016L01926

r. 61A........................................

ad. No. 108, 2013

r. 62...........................................

am. 2004 No. 353

Part 8

r 63............................................

rs No 179, 2013

r 64............................................

rs No 179, 2013

am F2025L01174

Part 9

Division 9.1

Division 9.1 heading....................

ad No 179, 2013

r. 65...........................................

am. 2004 No. 225

rs No 179, 2013

am No 67 and 118, 2014

r 65A.........................................

ad No 179, 2013

am No 67, 2014; No 118, 2014; F2019L00357

r 65B.........................................

ad No 67, 2014

r 66............................................

am No 353, 2004; No 179, 2013; F2019L00357

r. 69...........................................

am. 2002 No. 60; 2004 No. 353; No 179, 2013

Division 9.2

Division 9.2 heading....................

ad No 179, 2013

r 69A.........................................

ad No 67, 2014

r 69AA.......................................

ad No 118, 2014

rs F2019L00357

r 69AAA....................................

ad No 5, 2015

r 69B.........................................

ad No 179, 2013

am No 67, 2014

r 70............................................

am No 137, 1995; No 83, 1996; No 225, 2004; No 105, 2005; No 144, 2010; No 108, 2013; No 179, 2013; No 67, 2014; F2019L00357; F2021L01862

r. 70A........................................

ad. 1995 No. 54

am. 2004 No. 353

rs No 179, 2013

am No 219, 2015

r 70B.........................................

ad No 179, 2013

am F2019L00357

r. 71...........................................

rs. 2005 No. 105; No 144, 2010; No 16, 2011; No 108, 2013

rep No 179, 2013

r 71A.........................................

ad 1996 No. 83

am 1999 No. 247; 2004 No. 225

rs 2005 No. 105

am No 144, 2010; No 108, 2013; No 179, 2013; No 118, 2014; No 219, 2015; F2020L00581; F2025L00478

r. 71B........................................

ad. 1996 No. 83

rep. 2005 No. 105

ad. No. 108, 2013

am No 179, 2013; No 118, 2014

r 71C.........................................

ad No 179, 2013

r 72............................................

am No 353, 2004; No 105, 2005

rs No 179, 2013

am F2019L00357

r. 72A........................................

ad. 1996 No. 162

am. 2004 No. 353; 2005 No. 105; No 75, 2010; No 144, 2010

rs. No. 108, 2013

am No 179, 2013; No 118, 2014

r. 73...........................................

am. 2004 No. 353; 2005 No. 105; No 108 and 179, 2013; No 67 and 118, 2014

r 73A.........................................

ad No 67, 2014

r. 74...........................................

am. 2004 No. 353

rep No 67, 2014

Division 9.3

Division 9.3 heading....................

ad No 179, 2013

r. 75...........................................

am. 2004 No. 353

r 76............................................

am No 353, 2004; No 105, 2005; No 179, 2013; No 118, 2014; No 219, 2015; F2019L00357; F2021L01862

r 76A.........................................

ad No 179, 2013

am No 118, 2014; F2019L00357; F2021L01862

r 76B.........................................

ad No 179, 2013

r 77............................................

rs No 105, 2005

am No 179, 2013; No 219, 2015

rs F2019L00357

r 78............................................

am No 247, 1999; No 225, 2004; No 353, 2004

rs No 105, 2005

am No 144, 2010; No 108, 2013

rs No 179, 2013

am No 118, 2014; F2019L00357

r. 78A........................................

ad. 2005 No. 105

am. 2010 No. 144; No. 108, 2013

rep No 179, 2013

r 78AA.......................................

ad No 118, 2014

r 78B.........................................

ad No 179, 2013

am No 67, 2014; F2022L01617

r 78C.........................................

ad No 179, 2013

am No 5, 2015; F2015L02042; F2019L00357; F2024L01299

Division 9.4

Division 9.4 heading ...................

ad No 179, 2013

r. 79...........................................

ad. 2004 No. 224

Part 9A......................................

ad No 179, 2013

exp 30 June 2018 (r 80C)

rep F2019L00357

r 80A.........................................

ad No 179, 2013

exp 30 June 2018 (r 80C)

rep F2019L00357

r 80B.........................................

ad No 179, 2013

exp 30 June 2018 (r 80C)

rep F2019L00357

r 80C.........................................

ad No 179, 2013

exp 30 June 2018 (r 80C)

rep F2019L00357

r 80D.........................................

ad No 179, 2013

am No 67, 2014

rep F2017L00771

r 80E..........................................

ad No 179, 2013

am No 67, 2014

exp 30 June 2018 (r 80C)

rep F2019L00357

r 80F..........................................

ad No 179, 2013

rep No 67, 2014

Part 10

Part 10.......................................

ad No 179, 2013

Division 10.1

r 80............................................

ad No 179, 2013

am No 91, 2014

r 81............................................

ad No 179, 2013

am No 67, 2014

rs No 91, 2014

rep No 118, 2014

r 82............................................

ad No 179, 2013

r 83............................................

ad No 179, 2013

r 84............................................

ad No 179, 2013

r 85............................................

ad No 179, 2013

am No 67, 2014

Division 10.2

Division 10.2..............................

ad No 67, 2014

r 86............................................

ad No 67, 2014

Part 10

Part 10.......................................

ad No 118, 2014

r 87............................................

ad No 118, 2014

Division 10.4

Division 10.4..............................

ad No 5, 2015

rep 5 Mar 2016 (r 89)

ad F2019L00357

r 88............................................

ad No 5, 2015

rep 5 Mar 2016 (r 89)

ad F2019L00357

r 89............................................

ad No 5, 2015

rep 5 Mar 2016 (r 89)

ad F2019L00357

Division 10.5

Division 10.5..............................

ad No 219, 2015

rep 1 July 2017 (r 91)

ad F2020L00581

r 90............................................

ad No 219, 2015

rep 1 July 2017 (r 91)

ad F2019L00357

r 91............................................

ad No 219, 2015

rep 1 July 2017 (r 91)

ad F2020L00581

r 92............................................

ad F2020L00581

Division 10.6

Division 10.6..............................

ad F2021L01849

r 93............................................

ad F2021L01849

Division 10.7

Division 10.7..............................

ad F2021L01862

r 94............................................

ad F2021L01862

Division 10.8

Division 10.8..............................

ad F2022L01617

r 95............................................

ad F2022L01617

Division 10.9

Division 10.9 (first occurring).......

ad F2025L01174

r 96 (first occurring)....................

ad F2025L01174

Division 10.9

Division 10.9 (second occurring)..

ad F2025L00478

r 96 (second occurring)................

ad F2025L00478

Schedule 1

Schedule 1..................................

rs 1997 No. 264

am F2025L00478

Schedule 2

rep No 179, 2013

Schedule 3

Schedule 3..................................

rs No 75, 2010

am No 108, 2010; No 108, 2013; F2018L01086; F2019L00357; F2022L01617

Schedule 3AA

Schedule 3AA............................

ad No 75, 2010

am No 108, 2010; No 108, 2013; No 5, 2015; No 219, 2015; F2019L00357; F2021L01849

Schedule 3A...............................

ad. 2004 No. 251

am No 105, 2005

rep No 179, 2013

Schedule 3B

Schedule 3B heading...................

rs No 179, 2013

Schedule 3B...............................

ad. 2007 No. 278

am No 179, 2013; No 67, 2014

Schedule 4

Schedule 4..................................

am. 1995 No. 187

rs. 1997 No. 264

am. 1999 No. 215; 2002 No. 207; 2003 No. 8; 2006 No. 75; 2009 No. 341; 2012 No. 72; No 179, 2013; No 219, 2015

Schedule 5..................................

rep No 179, 2013

Schedule 5A

Schedule 5A...............................

ad No 179, 2013

am F2019L00357; F2021L01862; F2025L01174

Schedule 6

Schedule 6 heading......................

rs No 179, 2013

Schedule 6..................................

am No 137, 1995; No 216, 1996; No 247, 1999; No 225, 2004; No 353, 2004

rs No 105, 2005

am No 152, 2005; No 144, 2010; No 16, 2011; No 108, 2013; No 179, 2013; No 67, 2014; No 118, 2014; No 5, 2015; F2015L02042; F2019L00357; F2020L00581; F2021L01862; F2022L01617

Schedule 7

Schedule 7..................................

am. 1995 No. 137; 1996 No. 216; 2004 No. 353

rs. 2005 No. 105

am. 2010 No. 144; No. 108, 2013

rs No 179, 2013

am No 67, 2014; No 219, 2015; F2019L00357; F2020L00581; F2022L01617

Schedule 8

Schedule 8..................................

ad 2004 No 224