Agricultural and Veterinary Chemicals Code
Part 1—Preliminary
1 Object of Code
The object of this Code is to make provision for and in relation to:
(a) the evaluation, approval, and control of the supply, of active constituents for proposed or existing agricultural chemical products or veterinary chemical products; and
(b) the evaluation, registration, and control of the manufacture and supply, of agricultural chemical products and veterinary chemical products.
2 Relationship of Code to other laws
(1) This Code excludes the operation of any other laws of this jurisdiction that are inconsistent with this Code.
(2) A law of this jurisdiction is not taken to be inconsistent with this Code if it can operate concurrently with this Code.
(3) A law of this jurisdiction enacted, or an instrument made under a law of this jurisdiction, after the commencement of this Code is not to be interpreted as amending or repealing, or otherwise altering the effect of, this Code unless that law, or the law under which that instrument was made, as the case may be, so provides expressly.
3 Definitions
(1) In this Code, unless the contrary intention appears:
acknowledge an application made under section 10 or 27 has the meaning given in the table:
Acknowledgment of an application |
| If: | The application is acknowledged when: |
1 | The APVMA gives notice under subsection 11A(2) (applying of its own force or because of section 28A) that the application has passed a preliminary assessment and will be given a full evaluation in due course | The APVMA gives the notice |
2 | The APVMA is satisfied that defects in the application have been rectified as required by a notice given under paragraph 11A(3)(a) (applying of its own force or because of section 28A) | The APVMA becomes satisfied |
3 | The APVMA starts to consider the application after deferring the consideration under subparagraph 11A(3)(b)(i) (applying of its own force or because of section 28A) | The APVMA starts to consider the application |
active constituent, in relation to a proposed or existing agricultural chemical product or veterinary chemical product, means the substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the product as an agricultural chemical product or a veterinary chemical product, as the case may be.
adequate, in relation to instructions on a label for containers for a chemical product, means adequate to ensure, as far as reasonably practicable, that the use of the product in accordance with the instructions:
(a) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(b) would not be likely to have an effect that is harmful to human beings; and
(c) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(d) would not unduly prejudice trade or commerce between Australia and places outside Australia.
agricultural chemical product has the meaning given by section 4.
animal means any animal (other than a human being), whether vertebrate or not, and whether a food‑producing species or not, and includes:
(a) mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs; and
(b) the semen, ova or embryo of an animal (other than a human being) or any other substance or thing directly relevant to the reproduction of an animal (other than a human being); and
(c) any other prescribed form of animal life, whether prescribed by reference to a species or in any other way.
approval means:
(a) in relation to an active constituent for a proposed or existing chemical product—an approval of the constituent under Part 2 of the Agvet Code of this jurisdiction that is in force; or
(b) in relation to a label for containers for a chemical product—an approval of the label under Part 2 of the Agvet Code of this jurisdiction that is in force; or
(c) when the expression is used without reference to such a constituent or label—an approval referred to in either paragraph (a) or (b).
approved analyst means a person appointed under subsection 69G(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 to be an approved analyst for the purposes of this Code.
approved form means a form approved by the APVMA or prescribed by the regulations.
approved label, in relation to a container, means a label approved under Part 2 of the Agvet Code of this jurisdiction for the container.
approved person means:
(a) in relation to the making of an application or request, or the giving of a notice, consent, information, report, sample or any other thing, by a person:
(i) if that person is an individual residing, or a body corporate incorporated, in Australia—that person; or
(ii) in any case—an individual residing in Australia who, or a body corporate incorporated in Australia which, that person has authorised to make the application or request or to give the notice, consent, information, report, sample or other thing on that person’s behalf; or
(b) in relation to the giving of a notice by the APVMA that affects a person who is the interested person in relation to an approved active constituent for a chemical product, a registered chemical product, a registered listed chemical product or an approved label for containers for a chemical product or is the holder of a permit or a licence—an individual residing in Australia who, or a body corporate incorporated in Australia which, that person has authorised to receive the notice on that person’s behalf.
APVMA means the Australian Pesticides and Veterinary Medicines Authority continued in existence by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
Australia includes any external Territories that are participating Territories.
authorising party for information means a person who would be entitled to bring an action for breach of an obligation of confidence if the information were disclosed by someone else to the APVMA for the purposes of this Code without the person’s permission.
chemical product means an agricultural chemical product or a veterinary chemical product, or both.
Chief Executive Officer, in relation to the APVMA, includes a person acting as the Chief Executive Officer of the APVMA.
claim includes any statement.
companion animal product means a veterinary chemical product solely for administration or application to animals that:
(a) are not food‑producing species; and
(b) are not prescribed by the regulations.
confidential commercial information, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or a constituent of a chemical product, means:
(a) a trade secret relating to the constituent or product; or
(b) any other information relating to the constituent or product that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or
(c) information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that:
(i) concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and
(ii) relates to the manufacture, distribution or supply of the constituent or product; and
(iii) if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner;
but does not include:
(d) the making of an application for a permit for the use of an active constituent for a proposed or existing chemical product or for the use of a chemical product, if the use of the product proposed in the application is:
(i) a minor use; or
(ii) an emergency use; or
(e) any prescribed information relating to the making of an application for a permit, as mentioned in paragraph (d).
constituent, in relation to a chemical product, means any constituent of the product, whether an active constituent or not.
container includes anything by which or in which a chemical product is, or is to be, covered, enclosed, contained or packaged, but does not include a container (such as a shipping container) in which other containers of chemical products are, or are to be, placed for the purpose of being transported.
continued use of an active constituent for a proposed or existing chemical product, or of a chemical product, includes any dealing with the constituent or product.
co‑ordinator, in relation to a jurisdiction, means a person designated:
(a) if the jurisdiction is a State—by a Minister of the State; or
(b) if the jurisdiction is the participating Territories:
(i) if the Australian Capital Territory is the only participating Territory—by a Minister of the Australian Capital Territory; or
(ii) if there is more than one participating Territory—jointly by a Minister of the Commonwealth and a Minister of the Australian Capital Territory;
to perform the functions of a co‑ordinator under this Code.
corresponding previous law means a previous law of this jurisdiction that corresponds wholly or partly to this Code, to the extent that it so corresponds.
criteria includes standards.
date‑controlled chemical product means a chemical product declared by the regulations to be a date‑controlled chemical product.
date of manufacture, in relation to a chemical product, means the date on which formulation of the product was completed.
deal with, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, includes supply or otherwise dispose of the constituent or product.
director, in relation to a body corporate incorporated for a public purpose by a law of the Commonwealth, of a State or of a Territory, means:
(a) a constituent member of the body; or
(b) if the body does not have any members—a member of the board or other group of persons responsible for the administration or management of the affairs of the body.
distinguishing number includes a distinguishing number together with one or more letters or symbols, or both.
eligible law, in relation to a jurisdiction, means a law, or a provision of a law, of that jurisdiction that is declared by a law of that jurisdiction to be an eligible law for the purposes of this Code.
emergency use has the same meaning as in the regulations.
environment includes all aspects of the surroundings of human beings, whether affecting them as individuals or in their social groupings.
established standard for a listable chemical product means a standard established for the product under Division 3 of Part 2A.
excluded organism means an organism that is declared by the regulations to be an excluded organism.
expiry date, in relation to the contents of a container, means the month and year after which the contents should not be used.
fee includes a fee that is a tax.
file includes a file of information stored or recorded by means of a computer.
food‑producing species means an animal that produces food for human consumption or is used as food for human beings, and includes:
(a) any buffalo, cattle, deer, fish (other than ornamental fish), goat, kangaroo, pig, poultry, rabbit, sheep, bee, crustacean or mollusc; or
(b) any animal declared by the regulations to be a food‑producing species.
give information includes make a statement.
handling includes transportation, storage, processing, use or disposal.
holder, in relation to a permit or licence, means the person to whom the permit or licence was issued.
inspector means:
(a) a person appointed as an inspector for the purposes of this Code under subsection 69F(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992; or
(b) a person to whom an authorisation referred to in subsection 69F(2) of that Act applies for the purposes of this Code.
instruction includes direction, caution, warning or recommendation.
instructions for use of an active constituent for a proposed or existing chemical product, or of a chemical product, includes instructions for any dealing with the constituent or product.
interested person, in relation to an approved active constituent for a chemical product, a registered chemical product, a registered listed chemical product or an approved label for containers for a chemical product, means:
(a) subject to paragraphs (b), (c) and (d), the person (the original applicant) who applied for the approval, registration or listed registration or, in the case of a chemical product whose registration or listed registration has been renewed, applied for the renewal, or the last renewal, as the case may be; or
(b) subject to paragraphs (c) and (d), if:
(i) the original applicant has entered into a contract with another person in relation to the constituent or product under which, or as a result of which, the other person will or may apply to the APVMA to have the other person’s name entered in the relevant particulars in relation to the constituent or product, or to have a label approved in relation to containers for the product; and
(ii) the other person’s name is entered in those relevant particulars, or such a label is approved, on the application of the other person;
the other person; or
(c) if the person who, apart from this paragraph, would be the interested person because of paragraph (a) or (b) was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering the individual’s affairs, as the case may be; or
(d) if the person who, apart from this paragraph, would be the interested person because of paragraph (a) or (b) was a body corporate—a successor in law of the body corporate.
jurisdiction means:
(a) a State; or
(b) the participating Territories.
label includes tag, leaflet, brand, stamp, mark, stencil or written statement.
licence means a licence under Part 8.
listable chemical product means a chemical product that is, or is included in a class of chemical products that is, included in the Listing Schedule.
listed registration means listed registration of a listable chemical product that is in force under Part 2A of the Agvet Code of this jurisdiction.
Listing Schedule means the schedule contained in the regulations under section 56C.
manufacturing principles means principles that the APVMA has determined under section 23 of the Agricultural and Veterinary Chemicals Act 1994 to be principles to be observed in the manufacture of chemical products.
material safety data sheet, in relation to a chemical product, means a written statement:
(a) which:
(i) identifies the product; and
(ii) states the health hazards that could be caused by the product; and
(iii) states the manner of handling the product in a way that minimises hazards; and
(iv) states the procedures to be adopted in the event of an emergency involving the product; and
(v) contains information about the chemical and physical properties of the product other than confidential commercial information; and
(vi) contains information in relation to the product of a kind prescribed for the purposes of paragraph (f) of the definition of Material Safety Data Sheet in section 5 of the Industrial Chemicals (Notification and Assessment) Act 1989; and
(b) which, if there is a note known as a Guidance Note for Completion of a Material Safety Data Sheet published by the National Occupational Health and Safety Commission, is prepared in accordance with that note.
Maximum Residue Limits Standard means the Maximum Residue Limits Standard, made under the Food Standards Australia New Zealand Act 1991, as in force from time to time, or any standard in force in substitution for that standard.
member of the staff, in relation to the APVMA, has the same meaning as in the Agricultural and Veterinary Chemicals (Administration) Act 1992.
minor use has the same meaning as in the regulations.
occupier, in relation to any premises or a part of any premises, means the person in occupation, charge or control of the premises or of that part of the premises, as the case may be.
ordinary office hours means the hours when the office of the APVMA is open to members of the public.
participating Territory has the same meaning as in the Agricultural and Veterinary Chemicals Act 1994.
penalty unit has the same meaning as in section 4AA of the Crimes Act 1914.
permit means a permit under Part 7.
pest means:
(a) in relation to an animal, plant or thing—any animal, plant or other biological entity that injuriously affects the physical condition, worth or utility of the first‑mentioned animal or plant or of that thing; or
(b) in relation to a place—an animal, plant or other biological entity that injuriously affects the use or enjoyment of that place.
place of residence, in relation to a body corporate that is incorporated in Australia, means its registered office in Australia.
plant means any vegetation or fungus and includes a seed or cutting of a plant, or any other part or product of a plant.
premises includes any place (whether enclosed or built on or not), including a place situated under ground or under water, and, in particular, includes:
(a) a building, aircraft, vehicle or vessel; and
(b) any structure, whether a fixed structure, or a moveable structure such as a tent, and whether on land or the bed of any waters or floating on any waters; and
(c) a part of premises (including a part of premises of a kind referred to in paragraph (a) or (b)).
prescribed means prescribed by the Agvet Code of this jurisdiction or by the regulations.
previous registering authority means a registering authority under a corresponding previous law.
previously endorsed active constituent for a chemical product at a particular time means a substance that:
(a) before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as an active constituent for a chemical product; or
(b) was an active constituent for a chemical product that, before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as a chemical product;
whether or not the approval or registration was a result of an application by a particular person.
primary active constituent has the meaning given in section 59.
primary applicant means:
(a) in relation to a primary active constituent—the interested person by whom, or on whose behalf, protected information was given to the APVMA in respect of the constituent; or
(b) in relation to a primary chemical product—the interested person by whom, or on whose behalf, protected information was given to the APVMA in respect of the product.
primary chemical product has the meaning given in section 59.
prohibited chemical product means a chemical product that is declared by the regulations to be a prohibited chemical product.
protected active constituent means an approved active constituent for a proposed or existing chemical product, being an active constituent to which both of the following paragraphs apply:
(a) the constituent is or includes an invention in respect of which letters patent were granted under the Patents Act 1952 or the Patents Act 1990;
(b) the term of the letters patent (including any extension of that term) has ended, or will end, during the protection period that applies to protected information about that constituent.
protected chemical product means a registered chemical product to which both of the following paragraphs apply:
(a) the product is or includes an invention in respect of which letters patent were granted under the Patents Act 1952 or the Patents Act 1990;
(b) the term of the letters patent (including any extension of that term) has ended, or will end during the protection period that applies to protected information about that product;
but does not include a chemical product in respect of which the instructions on the approved label, or each of the approved labels, state that the product should be used only in relation to a particular class of animals that are not a food‑producing species.
protected commodity means:
(a) any substance or thing of a kind used, or capable of being used, as food or drink by human beings; or
(b) any substance or thing of a kind used, or capable of being used, as an ingredient or additive in, or any substance used in the preparation of, a substance or thing referred to in paragraph (a); or
(c) any plant or animal; or
(d) any soil, water or other environmental component; or
(e) any other agricultural commodity; or
(f) any animal feed; or
(g) any other prescribed substance or thing; or
(h) any substance or thing that is capable of being made into anything referred to in any of the above paragraphs;
but does not include a therapeutic good within the meaning of the Therapeutic Goods Act 1989.
protected information, in relation to an active constituent for a proposed or existing chemical product or in relation to a chemical product, means information that has been obtained because of trials or laboratory experiments and relates to the interaction between the constituent or product, as the case may be, and:
(a) the environment; or
(b) living organisms or naturally occurring populations in ecosystems, including human beings;
but does not include information obtained only for the purpose of assessing the performance of the constituent or product in respect of its proposed use.
protection period, in relation to protected information of a particular kind, means:
(a) if a period is stated in, or worked out in accordance with, the regulations in relation to information of that kind for the purposes of Part 3—the period so stated or worked out; or
(b) otherwise—7 years.
published literature, in relation to a particular matter, means all documents that relate to that matter and are accessible to the public.
recall notice means a notice issued under section 101, 102 or 103.
Record of Approved Active Constituents means the Record of Approved Active Constituents for Chemical Products kept under section 17.
Record of Permits means the Record of Permits kept under section 113.
re‑entry period, in relation to the use of a chemical product in a particular place (including a use of the product in relation to a crop or pasture in that place), means the period after that use during which it is unsafe for a person to enter the place without wearing appropriate protective clothing or equipment, or both.
Register of Chemical Products means the Register of Agricultural and Veterinary Chemical Products kept under section 18.
registered chemical product means a chemical product registered under Part 2 of the Agvet Code of this jurisdiction.
registered listed chemical product means a listable chemical product that has been granted listed registration.
registration means registration of a chemical product that is in force under Part 2 of the Agvet Code of this jurisdiction.
regulations means the Agvet Regulations of this jurisdiction.
relevant particulars means:
(a) in relation to the approval of an active constituent for a proposed or existing chemical product—the distinguishing number, instructions for use and other particulars that are required by paragraph 19(2)(a) to be entered in the Record of Approved Active Constituents; and
(b) in relation to the registration of a chemical product—the distinguishing number and other particulars that are required by paragraph 20(2)(a) to be entered in the Register of Chemical Products; and
(c) in relation to the listed registration of a chemical product—the notation, distinguishing number and other particulars that are required by paragraph 56M(2)(a) to be entered in the Register of Chemical Products; and
(d) in relation to the approval of a label for containers for a chemical product—the information required to be recorded in the relevant APVMA file by paragraph 21(2)(c);
and includes, in relation to the approval of an active constituent or of a label or in relation to the registration or listed registration of a chemical product, particulars of a variation of relevant particulars that is made under paragraph 26A(4)(a) or 29(1)(h), subsection 34(5), section 34A, paragraph 56U(1)(e) or subsection 56Z(5).
repealed Act means the Agricultural and Veterinary Chemicals Act 1988.
reserved means reserved by being a chemical product that is, or is included in a class of chemical products that is, specified in the Reserved Schedule.
reserved chemical product means a chemical product that is, or is included in a class of chemical products that is, specified in the Reserved Schedule.
Reserved Schedule means the schedule contained in the regulations under section 56ZU.
residues, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, means:
(a) subject to paragraph (b), any remains, persisting in or on a protected commodity, of:
(i) the active constituent, or the active constituents in the chemical product; or
(ii) any derivatives, metabolites, or degradation products, of the active constituent or of the active constituents in the chemical product; or
(b) if the APVMA has published a notice in the Gazette for the purposes of this paragraph that applies to the active constituent or chemical product—only such of the remains referred to in paragraph (a) as are specified in the notice to be remains that constitute residues of the active constituent or of the chemical product for the purposes of this Code.
restricted chemical product means a chemical product declared by regulations made for the purposes of section 93 to be a restricted chemical product.
sample includes specimen.
secondary active constituent has the meaning given in section 59.
secondary applicant, in relation to a secondary chemical product, means:
(a) if the APVMA is considering an application for the registration of that product—the person who made the application; or
(b) if the APVMA has reconsidered or is reconsidering the registration of that product:
(i) subject to subparagraphs (ii), (iii) and (iv), the person (the original applicant) who applied for the registration or, in the case of a product whose registration has been renewed, applied for the renewal, or the last renewal, as the case may be, of the registration; or
(ii) subject to subparagraphs (iii) and (iv), if the original applicant has entered into a contract with another person in relation to the product under which, or as a result of which, the other person will or may apply to the APVMA to have the other person’s name entered in the relevant particulars in relation to the product, or to have a label approved in relation to containers for the product, and the other person’s name is entered in those relevant particulars, or such a label is approved, on the application of the other person—the other person; or
(iii) if the person who, apart from this subparagraph, would be the secondary applicant because of subparagraph (i) or (ii) was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering his or her affairs, as the case may be; or
(iv) if the person who, apart from this subparagraph, would be the secondary applicant because of subparagraph (i) or (ii) was a body corporate—a successor in law of the body corporate.
secondary applicant, in relation to a secondary active constituent for a proposed or existing chemical product, means:
(a) if the APVMA is considering an application for the approval of that constituent—the person who made the application; or
(b) if the APVMA has reconsidered or is reconsidering the approval of that constituent:
(i) subject to subparagraphs (ii), (iii) and (iv), the person (the original applicant) who applied for the approval; or
(ii) subject to subparagraphs (iii) and (iv), if the original applicant has entered into a contract with another person in relation to the constituent under which, or as a result of which, the other person will or may apply to the APVMA to have the other person’s name entered in the relevant particulars in relation to the constituent and the other person’s name is entered in those particulars on the application of the other person—the other person; or
(iii) if the person who, apart from this subparagraph, would be the secondary applicant because of subparagraph (i) or (ii) was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering his or her affairs, as the case may be; or
(iv) if the person who, apart from this subparagraph, would be the secondary applicant because of subparagraph (i) or (ii) was a body corporate—a successor in law of the body corporate.
secondary chemical product has the meaning given in section 59.
State includes the Northern Territory.
substance includes:
(a) any gas, liquid, mixture or compound of gases, or mixture or compound of liquids; and
(b) an organism or part of an organism, including a genetically manipulated organism or part of a genetically manipulated organism; and
(c) material that is produced from an organism; and
(d) matter whose production involves the use of an organism;
but does not include an excluded organism or part of an excluded organism, or material that is produced from, or matter whose production involves the use of, an excluded organism.
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);
and, for example, includes supply under a contract for work or labour that also involves the supply of any thing.
Territory does not include the Northern Territory;
thing, except where used as an object of the verb “to do”, includes:
(a) an animal; and
(b) information; and
(c) a document; and
(d) a substance.
this Code means the Agvet Code of this jurisdiction and includes the Agvet Regulations of this jurisdiction.
variations includes additions, omissions, substitutions and modifications.
veterinary chemical product has the meaning given by section 5.
veterinary surgeon means a person who is registered as a veterinary surgeon under the law of a State or Territory.
withholding period, in relation to the use of a chemical product, means the minimum period that needs to elapse between:
(a) the last use of the product in relation to a crop, pasture or animal; and
(b) the harvesting or cutting of, or the grazing of animals on, the crop or pasture, the shearing or slaughtering of the animal, or the collection of milk or eggs from the animal for human consumption, as the case may be;
in order to ensure that the product’s residues fall to or below the maximum limit that the APVMA permits.
working day means a day other than a Saturday, a Sunday or a day that is a public holiday in the place where the office of the APVMA is situated.
(2) A regulation that prescribes information for the purposes of paragraph (e) of the definition of confidential commercial information is a legislative instrument.
4 Definition of agricultural chemical product
(1) This section defines what is meant by an agricultural chemical product for the purposes of this Code.
(2) Subject to subsections (3) and (4), an agricultural chemical product is a substance or mixture of substances that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:
(a) destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing; or
(b) destroying a plant; or
(c) modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity; or
(d) modifying an effect of another agricultural chemical product; or
(e) attracting a pest for the purpose of destroying it.
(3) An agricultural chemical product includes a substance or mixture of substances declared by the regulations to be an agricultural chemical product.
(4) An agricultural chemical product does not include:
(a) a veterinary chemical product; or
(b) a substance or mixture of substances declared by the regulations not to be an agricultural chemical product.
5 Definition of veterinary chemical product
(1) This section defines what is meant by an veterinary chemical product for the purposes of this Code.
(2) Subject to subsections (3) and (4), a veterinary chemical product is a substance or mixture of substances that is represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:
(a) preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or
(b) curing or alleviating an injury suffered by the animal; or
(c) modifying the physiology of the animal:
(i) so as to alter its natural development, productivity, quality or reproductive capacity; or
(ii) so as to make it more manageable; or
(d) modifying the effect of another veterinary chemical product.
(3) A veterinary chemical product includes:
(a) a vitamin, a mineral substance, or an additive, if, and only if, the vitamin, substance or additive is used for a purpose mentioned in paragraph (2)(a), (b), (c) or (d); and
(b) a substance or mixture of substances declared by the regulations to be a veterinary chemical product.
(4) A veterinary chemical product does not include:
(a) a substance or mixture of substances that is:
(i) prepared by a pharmacist in accordance with the instructions of a veterinary surgeon; or
(ii) prepared by a veterinary surgeon;
in the course of the practice, by the person preparing the substance or mixture of substances, of his or her profession as permitted by or under a law of this jurisdiction; or
(b) a substance or mixture of substances declared by the regulations not to be a veterinary chemical product.
6 Determinations, approvals, exemptions etc. by APVMA
(1) If a provision of this Code refers to a determination made, approval or exemption given or other thing done by the APVMA and there is no other provision of this Code expressly authorising the APVMA to make such a determination, give such an approval or exemption or do such a thing, the APVMA is authorised by this section to make such a determination, give such an approval or exemption or do such a thing either unconditionally or subject to conditions.
(2) The APVMA may at any time vary or revoke a determination made, approval or exemption given, or other thing done, by it under subsection (1).
7 Possession or custody of constituent or product
A reference in this Code to doing anything in respect of an active constituent for a proposed or existing chemical product, or in respect of a chemical product, includes a reference to having possession or custody of the constituent or product.
8 Labels attached to containers
(1) For the purposes of this Code, a label is attached to a container if the label is securely attached or affixed to, appears on, or is included with, the container.
(2) For the purposes of this Code but without limiting the generality of subsection (1):
(a) writing appearing on a container is taken to have been written on a label attached to the container; and
(b) a reference to a label attached to a container includes a reference to writing appearing on the container; and
(c) a reference to attaching a label to a container includes a reference to putting writing on the container.
8A Application of the Criminal Code
Chapter 2 (other than Part 2.5) of the Criminal Code applies to all offences against this Code.
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
Part 2—Approvals and registration
Division 1—Preliminary
9 Explanation of Part
(1) This Part contains provisions relating to:
(a) the approval of active constituents for proposed or existing chemical products; and
(b) the registration of chemical products; and
(c) the approval of labels for containers for chemical products.
(2) Division 2 deals with the giving of approvals and the granting of registrations.
(2A) Division 2A deals with applications to vary a relevant particular if the relevant particular is of a kind set out in a legislative instrument made by the APVMA for the purposes of section 26A.
(3) Division 3 deals with applications to vary approvals or registrations or to vary the conditions of any approvals or registrations.
(4) Division 4 provides for the APVMA to reconsider approvals and registrations for the purpose of deciding whether or not they should remain in force.
(5) Division 5 sets out the circumstances in which the APVMA may suspend or cancel approvals or registrations.
(6) Division 6 states how long approvals and registrations are to continue in force and makes provision for their renewal.
(7) Division 7 provides for the APVMA to publish notices telling the public of actions that it has taken under this Part.
Division 2—Granting or refusing approvals and registrations
10 Applications that may be made
A person may apply to the APVMA:
(a) for approval of an active constituent for a proposed or existing chemical product; or
(b) for registration of a chemical product; or
(c) for approval of a label for containers for a chemical product.
11 How application is to be made
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, any information that the APVMA requires; and
(ba) if the application is covered by paragraph 10(a) or (b)—contain proposed instructions for the use of or other dealing with the constituent or product; and
(c) be signed by an approved person; and
(d) be accompanied by:
(i) if only part of the prescribed fee is required to be paid at the time of making the application—the amount required to be paid; or
(ii) otherwise—the whole of the prescribed fee (if any); and
(e) be lodged with the APVMA.
(2) The APVMA may, with the written consent of an approved person, alter the application.
(3) At any time after an application has been made and before it has been determined, an approved person:
(a) may give to the APVMA information additional to or varying information previously given to the APVMA; and
(b) may withdraw the application by giving to the APVMA written notice of the withdrawal signed by an approved person.
11A Preliminary assessment of application
(1) The APVMA must, within one month after an application is lodged under section 11, make a preliminary assessment as to whether the application complies with subsection 11(1).
(2) If it appears to the APVMA from the preliminary assessment that the application complies with subsection 11(1), the APVMA must, as soon as practicable, give notice in writing to an approved person stating that the application has passed a preliminary assessment and will be given a full evaluation in due course.
(3) If it appears to the APVMA from the preliminary assessment that the application does not comply with subsection 11(1) but the defects in the application can reasonably be rectified:
(a) the APVMA must, as soon as practicable, give to an approved person notice in writing:
(i) stating that the application does not comply with subsection 11(1); and
(ii) giving particulars of the defects in the application; and
(iii) requiring the defects to be rectified within one month or within such further period as the APVMA allows; and
(b) if the defects are not rectified to the satisfaction of the APVMA within the period referred to in subparagraph (a)(iii), the APVMA may:
(i) defer consideration of the application; or
(ii) treat the application as having been withdrawn;
and, if it does either of those things, it must immediately give to the approved person notice in writing of its decision.
(4) If it appears to the APVMA from the preliminary assessment that the application does not comply with subsection 11(1) and that the defects in the application cannot reasonably be rectified, it may reject the application on the ground that the application has not been properly made and, if it does so, any fee paid in respect of the application (other than a component of the fee identified by the regulations as being in respect of the preliminary assessment) is repayable.
(5) If the APVMA rejects the application under subsection (4):
(a) it must, as soon as practicable, give notice in writing to an approved person:
(i) stating that the application has been rejected on the ground that it has not been properly made; and
(ii) setting out the defects in the application; and
(iii) giving brief particulars of the reasons why it considers that the application cannot reasonably be rectified; and
(iv) telling the approved person that any fee paid in respect of the application (other than a component of the fee identified by the regulations as being in respect of the preliminary assessment) is repayable; and
(b) it may return the application with the notice.
(6) Section 168 provides for additional matters to be included in a notice under paragraph (3)(b) or (5)(a).
(7) An application that is rejected by the APVMA on the ground that it was not properly made is taken for the purposes of this Code other than this section, and for the purposes of Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992, not to have been validly made.
11B APVMA to publish summary of application
(1) As soon as practicable after an application is acknowledged, the APVMA must cause to be published a summary of the application.
(2) The summary must include the details relating to the application that are prescribed by the regulations (if any).
12 APVMA to publish notice before deciding whether to approve new active constituent
(1) Before deciding whether to approve an active constituent not previously contained in a chemical product registered in this or another jurisdiction under the Agvet Code, or a corresponding previous law, of the jurisdiction concerned, the APVMA must cause to be published in the Gazette, and in any other manner that it thinks appropriate, a notice:
(a) stating that it has to decide whether to approve the constituent and setting out the following:
(i) the name of the constituent;
(ii) particulars of the constituent other than confidential commercial information;
(iii) a summary of the APVMA’s evaluation of the constituent with regard to the matters mentioned in paragraph 14(3)(e);
(iv) any other matters that the APVMA thinks appropriate; and
(b) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice is published in the Gazette, a written submission to the APVMA as to whether the constituent should be approved and stating the grounds on which the submission is based, which must be grounds that relate to matters that the APVMA is required to take into account in deciding whether to approve the constituent.
(2) The APVMA must take into account any submissions made in accordance with an invitation contained in the notice published under subsection (1).
13 APVMA to publish notice before deciding whether to register chemical product containing new active constituent
(1) Before deciding whether to register a chemical product containing an active constituent not previously contained in a chemical product registered in this or another jurisdiction under the Agvet Code, or a corresponding previous law, of the jurisdiction concerned, the APVMA must cause to be published in the Gazette, and in any other manner that it thinks appropriate, a notice:
(a) stating that it has to decide whether to register the product and setting out the following:
(i) the name that the applicant for registration intends to use to describe the product;
(ii) particulars of the product and its active constituents other than confidential commercial information;
(iii) a summary of the APVMA’s evaluation of the product with regard to the matters mentioned in paragraphs 14(3)(e) and (f);
(iv) any other matters that the APVMA thinks appropriate; and
(b) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice is published in the Gazette, a written submission to the APVMA as to whether the product should be registered and stating the grounds on which the submission is based, which must be grounds that relate to matters that the APVMA is required to take into account in deciding whether to register the product.
(2) The APVMA must take into account any submissions made in accordance with an invitation contained in the notice published under subsection (1).
13A Notifying Food Standards Australia New Zealand
(1) If:
(a) an application under section 10 or 27 is made in relation to a chemical product; and
(b) the application is acknowledged; and
(c) it is likely that, if the application were granted, a variation would be required to the Maximum Residue Limits Standard;
the APVMA must notify Food Standards Australia New Zealand of the application.
(1A) If:
(a) either:
(i) a variation under subsection 34(5) relates to the registration of a chemical product; or
(ii) a variation under subsection 34(5) or 34A(3) relates to the approval of a label for containers for a chemical product; and
(b) it is likely that, as a result of the variation, a variation will be required to the Maximum Residue Limits Standard;
the APVMA must notify Food Standards Australia New Zealand of the variation mentioned in paragraph (a).
(1B) If:
(a) an application under section 110 is made for a permit in respect of a chemical product and the application is in accordance with subsection 110(2); and
(b) it is likely that, if the application were granted, a variation would be required to the Maximum Residue Limits Standard;
the APVMA must notify Food Standards Australia New Zealand of the application.
(2) A notice under this section must:
(a) be in writing; and
(b) set out:
(i) particulars of the product and its active constituents other than confidential commercial information; and
(ii) any other matters that the APVMA thinks appropriate; and
(c) be given to Food Standards Australia New Zealand:
(i) if subsection (1) applies—as soon as practicable after the application is acknowledged; or
(ii) if subsection (1A) applies—as soon as practicable after the variation is made; or
(iii) if subsection (1B) applies—as soon as practicable after the application is made.
14 Grant or refusal of application
(1) The APVMA must grant an application made under section 10 if it is satisfied of all the matters referred to in subsection (3).
(2) If the APVMA is not satisfied as mentioned in subsection (1), it must refuse the application.
(3) The matters referred to in subsection (1) are the following:
(a) that the applicant has complied with subsection 11(1);
(b) that any requirement made under section 157 or 159 has been complied with;
(c) that, if necessary, section 158 has been complied with;
(ca) that, if necessary, paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with;
(d) that any requirements prescribed by the regulations in relation to the constituent, product or label, as the case may be, have been complied with;
(e) if the application is for approval of an active constituent or registration of a chemical product—that the use of the constituent or product in accordance with the instructions for its use that the APVMA has approved or approves:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia;
(f) if the application is for registration of a chemical product—that the use of the product in accordance with the instructions for its use that the APVMA has approved or approves would be effective according to criteria determined by the APVMA for the product;
(g) if the application is for approval of a label for containers for a chemical product—that the label will contain adequate instructions relating to such of the following as are appropriate:
(i) the circumstances in which the product should be used;
(ii) how the product should be used;
(iii) the times when the product should be used;
(iv) the frequency of the use of the product;
(v) the withholding period after the use of the product;
(vi) the re‑entry period after the use of the product;
(vii) the disposal of the product when it is no longer required;
(viii) the disposal of containers of the product;
(ix) the safe handling of the product and first aid in the event of an accident caused by the handling of the product;
(x) any other matters prescribed by the regulations;
(h) that the fee (if any) prescribed in respect of the approval or registration, and any other amount (including an amount in respect of a tax or penalty) that is payable (whether by the applicant or by any other person) to the APVMA in respect of the product under this Code or any other law in force in this or any other jurisdiction, have been paid.
(4) In satisfying itself for the purposes of subsection (1) whether the use of an active constituent in accordance with the instructions for its use that the APVMA has approved or approves would be an undue hazard as mentioned in subparagraph (3)(e)(i), or would be likely to have an effect that is harmful as mentioned in subparagraph (3)(e)(ii) or (iii), the APVMA may have regard to such matters as it thinks relevant but must have regard to the following:
(a) the toxicity of the constituent and its residues in relation to relevant organisms and ecosystems, including human beings;
(b) the method by which the constituent is, or is proposed to be, manufactured;
(c) the extent to which the constituent will contain impurities;
(d) whether an analysis of the chemical composition of the constituent has been carried out and, if so, the results of the analysis;
(e) any other matters prescribed by the regulations.
(5) In satisfying itself for the purposes of subsection (1) whether the use of a chemical product in accordance with the instructions for its use that the APVMA has approved or approves would be an undue hazard as mentioned in subparagraph (3)(e)(i), or would be likely to have an effect that is harmful as mentioned in subparagraph (3)(e)(ii) or (iii), the APVMA may have regard to such matters as it thinks relevant but must have regard to the following:
(a) the toxicity of the product and its residues in relation to relevant organisms and ecosystems, including human beings;
(b) the relevant poison classification of the product under the law in force in this jurisdiction;
(c) how the product is formulated;
(d) the composition and form of the constituents of the product;
(e) the acceptable daily intake of each active constituent contained in the product;
(ea) any dietary exposure assessment prepared under subsection 82(4) of the Food Standards Australia New Zealand Act 1991 as a result of any proposed variation notified under subsection 82(3) of that Act in relation to the product, and any comments on the assessment given to the APVMA under subsection 82(4) of that Act;
(f) whether any trials or laboratory experiments have been carried out to determine the residues of the product and, if so, the results of those trials or experiments and whether those results show that the residues of the product will not be greater than limits that the APVMA has approved or approves;
(g) the stability of the product;
(h) the specifications for containers for the product;
(i) any other matters prescribed by the regulations.
(6) In satisfying itself for the purposes of subsection (1) whether the use of a chemical product in accordance with the instructions for its use that the APVMA has approved or approves would be effective as mentioned in paragraph (3)(f), the APVMA must have regard to:
(a) whether any trials or laboratory experiments have been carried out to determine the efficacy of the product and, if so, the results of those trials or experiments; and
(b) any other matters prescribed by the regulations.
(7) This section has effect subject to sections 14A and 15.
14A Approval of active constituents for which information is not readily available
Despite section 14, if:
(a) either of the following applies in relation to an active constituent for a proposed or existing chemical product:
(i) the APVMA considers that the information referred to in paragraph 11(1)(b) is not readily available in respect of the constituent;
(ii) the constituent is, or is part of, a product in respect of which a standard is specified in the European Pharmacopoeia, the British Pharmacopoeia (Veterinary), the United States Pharmacopoeia or any other publication considered by the APVMA to be appropriate; and
(b) the APVMA is satisfied of all the matters mentioned in paragraph 14(3)(e) having regard to matters (relevant matters) mentioned in subsection 14(4) where information about the relevant matters is readily available;
the APVMA may decide to approve the constituent, whether or not an application has been made for the approval.
14B APVMA not to use information for registration of new agricultural chemical product to approve a similar product after disclosure
(1) This section applies if:
(a) information was given to the APVMA in connection with an application made after the commencement of this section for registration of an agricultural chemical product (the first product) containing an active constituent that was not a previously endorsed active constituent at the time of registration of the first product; and
(b) the information related to the first product or the active constituent and a matter that:
(i) is described in paragraph 14(3)(e) (except subparagraph 14(3)(e)(iv)) or paragraph 14(3)(f); or
(ii) is prescribed by the regulations; and
(c) the information was disclosed:
(i) by the Commonwealth, a State or a Territory; or
(ii) by an authority of the Commonwealth, a State or a Territory (including the APVMA); or
(iii) by anyone acting on behalf of the Commonwealth, a State, a Territory or an authority of the Commonwealth, a State or a Territory; and
(d) the information was not publicly available before the disclosure; and
(e) as a result of the disclosure, the interested person, or an approved person, for an application for registration of an agricultural chemical product (the second product) that is the same as, or similar to, the first product, seeks to have the APVMA use the information in granting the application.
(2) For 10 years after the first day on which the first product was registered, the APVMA must not use the information to grant the application for registration of the second product if:
(a) the registration of the second product would be commercially unfair; and
(b) the authorising party for the information does not consent to the use.
(3) The use of information in contravention of subsection (2) for granting the application for registration of the second product does not affect the validity of the grant or of the registration of the second product.
(4) An action or proceeding does not lie against any of the following for any loss directly or indirectly sustained because of the use of information in contravention of subsection (2):
(a) the Commonwealth;
(b) the APVMA;
(c) a person who is or has been:
(i) a director of the APVMA; or
(ii) the Chief Executive Officer of the APVMA; or
(iii) a delegate of the APVMA; or
(iv) a member of the staff of the APVMA.
(5) This section has effect in addition to Division 4A.
15 Restriction on power of APVMA to grant applications
(1) Subject to subsection (2), the APVMA must not:
(a) grant an application for registration of a chemical product unless:
(i) the APVMA also grants or has granted an application for approval of each active constituent for the product; and
(ii) the APVMA also grants an application for approval of a label for containers for the product; or
(b) grant an application for approval of a label for containers for a chemical product unless it also grants or has granted an application for registration of the product.
(2) Subparagraph (1)(a)(i) does not apply in relation to an active constituent that is exempted by the APVMA from the operation of that subparagraph.
16 Multiple approvals or registrations
(1) The approval of an active constituent for a proposed or existing chemical product does not preclude the approval of the same constituent on the application of another person.
(2) The registration of a chemical product on the application of a person does not preclude the registration on the application of another person of another chemical product that has the same or similar constituents.
(3) The approval of a label for containers for a chemical product does not preclude the approval of another label or other labels for containers for that product.
17 APVMA must keep a Record of Approved Active Constituents for Chemical Products
(1) For the purposes of this Code, the APVMA must keep a record to be known as the Record of Approved Active Constituents for Chemical Products.
(2) The Record may be kept at a place and in a form that the APVMA determines, and may be kept by electronic means.
(3) The Record is to be kept in 3 parts as follows:
(a) one part is to consist of confidential commercial information relating to constituents approved under section 14;
(b) one part is to consist of other information relating to constituents approved under section 14;
(c) one part is to consist of information relating to constituents approved under section 14A.
(4) The APVMA must permit any person to inspect any part of the Record that does not contain confidential commercial information at any time during ordinary office hours on a working day.
(5) If a person applies to the APVMA for a copy of, or extract from, a part of the Record that does not contain confidential commercial information and pays the prescribed fee (if any), the APVMA must give the copy or extract to that person.
18 APVMA must keep a Register of Agricultural and Veterinary Chemical Products
(1) For the purposes of this Code, the APVMA must keep a register to be known as the Register of Agricultural and Veterinary Chemical Products.
(2) The Register may be kept at a place and in a form that the APVMA determines, and may be kept by electronic means.
(3) The Register is to be kept in 2 parts, one containing confidential commercial information and the other containing other information.
(4) The APVMA must permit any person to inspect any part of the Register that does not contain confidential commercial information at any time during ordinary office hours on a working day.
(5) If a person applies to the APVMA for a copy of, or extract from, a part of the Register that does not contain confidential commercial information and pays the prescribed fee (if any), the APVMA must give the copy or extract to that person.
19 How approval of active constituent is effected
(1) If the APVMA decides to approve an active constituent for a proposed or existing chemical product, it must give a distinguishing number to, and approve, the constituent in accordance with subsection (2), either unconditionally or subject to conditions as mentioned in section 23.
(2) Approval of an active constituent takes place by entering in the Record of Approved Active Constituents:
(a) the relevant particulars, which are the distinguishing number, the instructions for the use of the constituent and any other particulars that are prescribed by the regulations; and
(b) any conditions of the approval.
20 How registration of chemical product is effected
(1) If the APVMA decides to register a chemical product, it must give a distinguishing number to, and register, the product in accordance with subsection (2), either unconditionally or subject to conditions as mentioned in section 23.
(2) Registration of a chemical product takes place by entering in the Register of Chemical Products:
(a) the relevant particulars, which are the distinguishing number and any other particulars that are prescribed by the regulations; and
(b) any conditions of the registration.
21 How approval of label is effected
(1) If the APVMA decides to approve a label for containers for a chemical product, the APVMA must give a distinguishing number to, and approve, the label in accordance with subsection (2), either unconditionally or subject to conditions as mentioned in section 23A.
(2) Approval of a label takes place by:
(a) determining the particulars, prescribed by the regulations, that are appropriate to be contained on the label; and
(b) giving a distinguishing number to the label; and
(c) recording the following information in the relevant APVMA file:
(i) the distinguishing number;
(ii) the adequate instructions and any particulars that are to be contained on the label; and
(d) recording any conditions imposed on the approval by the APVMA under subsection 23A(2) in the relevant APVMA file.
22 Date of approval or registration
(1) The date of approval of an active constituent for a proposed or existing chemical product, of registration of a chemical product or of approval of a label for containers for a chemical product is the date on which the relevant particulars are entered in the Record of Approved Active Constituents or in the Register of Chemical Products or are recorded in the relevant APVMA file, as the case may be.
(2) If:
(a) any of the relevant particulars of:
(i) an approval of an active constituent for a proposed or existing chemical product; or
(ii) a registration of a chemical product; or
(iii) an approval of a label for containers for a chemical product; or
(b) any of the conditions of such an approval or registration;
are varied pursuant to an application or request made under this Part, then, the date of the approval of the constituent, of the registration of the product, or of the approval of the label, as varied, or as subject to the varied conditions, is the date on which particulars of the variations are entered in the Record of Approved Active Constituents or in the Register of Chemical Products or are recorded in the relevant APVMA file, as the case may be.
23 Conditions of approval or registration—active constituents and chemical products
(1) The conditions of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product are the conditions that the APVMA thinks appropriate.
(2) Without limiting subsection (1), registration of a chemical product may be granted:
(a) on the condition that the product is supplied only in a container of a kind referred to in the condition or prescribed by the regulations; or
(b) on the condition that the product is not supplied in a container of a kind referred to in the condition or prescribed by the regulations.
(3) Approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product may be granted on the condition that the approval or registration remains in force only for a stated period that is not more than one year.
(4) If the approval or registration is subject to a condition referred to in subsection (3) and the conditions of approval or registration have not been varied before the end of the period referred to in the condition, or the end of that period as previously extended under this subsection, so as to remove the condition, the APVMA may vary the condition so as to extend the period for a further period of not more than one year or for further periods each of which is not more than one year.
23A Conditions of approval—labels
(1) The approval of a label for containers for a chemical product is subject to:
(a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the label is approved); and
(b) any conditions imposed on the approval by the APVMA under subsection (2).
(2) At the time of approving a label for containers for a chemical product, the APVMA may impose conditions, as the APVMA considers appropriate, on the approval.
(3) The conditions prescribed by the regulations may be expressed to apply in relation to:
(a) a label for containers for a particular chemical product; or
(b) a label for containers for a class of chemical products; or
(c) a label for containers for all chemical products.
(4) Approval of a label for containers for a chemical product may be granted on the condition that the approval remains in force for a particular period. The period may not be more than one year.
(5) If:
(a) the approval is subject to a condition referred to in subsection (4); and
(b) the conditions of approval have not been varied before the end of the period referred to in the condition, or the end of that period as previously extended under this subsection, so as to remove the condition;
the APVMA may vary the condition so as to extend the period for a further period of not more than one year or for further periods each of which is not more than one year.
24 Notice of approval or registration
(1) If an application for approval of an active constituent for a proposed or existing chemical product, for registration of a chemical product or for approval of a label for containers for a chemical product is granted:
(a) the APVMA must give to an approved person written notice of the approval or registration; and
(b) if the application related to registration of a chemical product—the APVMA may cause to be made publicly available, in an appropriate manner, a material safety data sheet in respect of the product.
(2) The notice referred to in paragraph (1)(a) must contain the information that is prescribed by the regulations.
(3) Section 168 provides for additional matters to be included in a notice approving a constituent, registering a product, or approving a label, subject to conditions.
25 Notice of refusal of application
(1) If an application for approval of an active constituent for a proposed or existing chemical product, registration of a chemical product or approval of a label for containers for a chemical product is refused, the APVMA must:
(a) give to an approved person written notice of the refusal; and
(b) include in the notice brief particulars of the reasons for the refusal.
(2) Section 168 provides for additional matters to be included in a notice under this section.
26 Notice of incorrectly recorded or registered particulars
(1) If a person:
(a) is the interested person in relation to an approved active constituent for a proposed or existing chemical product, a registered chemical product or an approved label for containers for a chemical product; and
(b) has reasonable cause to believe that, because of a change in circumstances, inaccurate recording or any other reason, a relevant particular or a condition entered in the Record of Approved Active Constituents or in the Register of Chemical Products or recorded in the relevant APVMA file in relation to the constituent, product or label is not correct in a material respect;
the person must, as soon as practicable, give to the APVMA a written notice, signed by an approved person, identifying the incorrect particular or condition and informing the APVMA of the correct particular or condition.
Penalty: 60 penalty units.
(1A) An offence under subsection (1) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(2) If the APVMA is satisfied that the particular or condition entered in the Record or Register, or recorded in the APVMA file, in relation to the constituent, product or label is not correct, the APVMA must change the entry or record accordingly.
Division 2A—Changes in certain relevant particulars
26A Applying for a change in certain relevant particulars
(1) An interested person in relation to:
(a) an approved active constituent for a proposed or existing chemical product; or
(b) a registered chemical product; or
(c) an approved label for containers;
may apply to the APVMA for variation of a relevant particular of the approval or registration if the relevant particular is of a kind set out in a legislative instrument made by the APVMA for the purposes of this section.
(2) An application must:
(a) be signed by an approved person; and
(b) be accompanied by the prescribed fee (if any); and
(c) be lodged with the APVMA.
(3) Subsection (4) applies if:
(a) in the case of an application that relates to an active constituent or registration of a chemical product—the APVMA is satisfied that, if those particulars were varied in accordance with the application, the continued use of, or any other dealing with, the constituent or product in accordance with the instructions for its use or for such a dealing:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia; or
(b) in the case of an application that relates to a label for containers for a chemical product—the APVMA is satisfied that, if those particulars were varied in accordance with the application, the use of the product in accordance with the instructions for its use would be effective according to criteria determined by the APVMA for the product.
(4) If the APVMA is satisfied, as mentioned in subsection (3), the APVMA must:
(a) both:
(i) vary the relevant particulars; and
(ii) record in the relevant APVMA file the relevant particulars as varied and the date on which the record is made; and
(b) give the interested person a written notice that states that the relevant particulars have been varied.
(5) If the APVMA is not satisfied, as mentioned in subsection (3), the APVMA must give the interested person a written notice that:
(a) states that the relevant particulars have not been varied; and
(b) sets out the reasons why the relevant particulars have not been varied; and
(c) states that the interested person may apply to have the relevant particulars varied under Division 3 of this Part.
Division 3—Application for variation of relevant particulars, or of conditions, of approval or registration
27 Who may apply
The interested person in relation to:
(a) an approved active constituent for a proposed or existing chemical product; or
(b) a registered chemical product; or
(c) an approved label for containers;
may apply to the APVMA for variation of the relevant particulars of the approval or registration, or variation of the conditions of the approval or registration.
28 How application is to be made
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the APVMA requires; and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the APVMA.
(1A) If an application is made under this Division and an application has previously been made for the same variation under Division 2A, the APVMA must set off the fee paid for the previous application against the fee payable (if any) under paragraph (1)(d).
(2) The APVMA may alter the application with the written consent of an approved person.
(3) At any time after an application has been made and before it has been determined, an approved person may withdraw the application by giving to the APVMA written notice of the withdrawal signed by an approved person.
28A Preliminary assessment of application
Section 11A applies to an application lodged under section 28 and compliance with subsection 28(1) in the same way as it applies to an application lodged under section 11 and compliance with subsection 11(1).
28B APVMA to publish summary of application
(1) As soon as practicable after an application is acknowledged, the APVMA must cause to be published a summary of the application, unless satisfied that the variation applied for does not relate to use of or dealing with a proposed or existing chemical product.
(2) The summary must include the details relating to the application that are prescribed by the regulations (if any).
29 Grant or refusal of application
(1) If the APVMA is satisfied of the following:
(a) that subsection 28(1) has been complied with;
(b) that any requirement made under section 157 or 159 has been complied with;
(c) that, if necessary, section 158 has been complied with;
(ca) that, if necessary, paragraph 8A(2)(b) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with;
(d) that any requirements prescribed by the regulations in relation to the variation of the relevant particulars of an approval or registration or of the conditions of an approval or registration have been complied with;
(e) if the application relates to a constituent or a product—that, if those particulars or conditions were varied in accordance with the application, the continued use of, or any other dealing with, the constituent or product in accordance with the instructions for its use or for such a dealing that the APVMA proposes to approve:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia;
(f) if the application relates to a product—that, if those particulars or conditions were varied in accordance with the application, the use of the product in accordance with the instructions for its use that the APVMA proposes to approve would be effective according to criteria determined by the APVMA for the product;
(g) if the application relates to a label—that the label would contain adequate instructions relating to the matters referred to in paragraph 14(3)(g);
it must:
(h) grant the application and vary those particulars or conditions:
(i) if the application was for a variation of the relevant particulars or the conditions of the approval of a constituent or the registration of a product—by entering in the relevant Record or Register particulars of the variation and the date on which the entry is made; or
(ii) if the application was for a variation of the relevant particulars of the approval of a label—by recording in the relevant APVMA file the relevant particulars as varied and the date on which the record is made; or
(iii) if the application was for a variation of the conditions of approval of a label—by recording in the file the conditions as varied; or
(i) give written notice to an approved person stating that the variation has been made and setting out particulars of the variation.
(2) In satisfying itself for the purposes of paragraph (1)(e) or (f), the APVMA must have regard to the matters referred to in subsection 14(4), (5) or (6), as the case requires.
(3) If the APVMA is not satisfied as mentioned in subsection (1), it must refuse the application.
(4) If the application is refused, the APVMA must:
(a) give to an approved person written notice of the refusal; and
(b) include in the notice brief particulars of the reasons for the refusal.
(5) Section 168 provides for additional matters to be included in a notice under subsection (4).
Division 4—Reconsideration of approval or registration
30 APVMA may invite the public to propose approved active constituents or registered chemical products for reconsideration
(1) The APVMA may cause to be published in the Gazette, and in any other manner it thinks appropriate, notices inviting persons to propose active constituents for proposed or existing chemical products, or to propose chemical products, whose approval or registration the APVMA might reconsider.
(2) A notice under subsection (1) must state the criteria that are to be taken into account by the APVMA in reconsidering the approval or registration.
(3) A proposal made by a person because of an invitation contained in a notice under subsection (1) must submit reasons, based on the criteria stated in the notice, in support of the proposal.
31 APVMA may reconsider approval or registration
(1) The APVMA may at any time, in accordance with this Division, reconsider:
(a) the approval of an active constituent for a proposed or existing chemical product; or
(b) the registration of a chemical product; or
(c) the approval of a label for containers for a chemical product.
32 APVMA may give notice of proposed reconsideration
(1) Before reconsidering the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product or the approval of a label for containers for a chemical product, the APVMA may, if it thinks it desirable to do so, cause to be published, in a manner that it thinks appropriate, a notice:
(a) stating that the APVMA proposes to reconsider the approval or registration and setting out the relevant particulars of the approval of the constituent or label or of the registration of the product; and
(aa) setting out the matters to be dealt with in the reconsideration and stating the requirement or requirements prescribed by the regulations for continued approval or registration that form the basis for the reconsideration; and
(b) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the publication of the notice, a written submission to the APVMA as to whether the approval or registration complies with the prescribed requirements for continued approval or registration.
(2) The APVMA must give written notice to the interested person in relation to the constituent, product or label or an approved person:
(a) telling the person the matter or matters that it proposes to reconsider and its reasons for so proposing; and
(b) requiring the person, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice is given, to give to the APVMA:
(i) any information of a kind stated in the notice of which either the interested person or the approved person is aware and which is relevant to the reconsideration; or
(ii) any information of which either the interested person or the approved person is aware that is relevant to the reconsideration; and
(c) inviting the person, within that period, to make a written submission to the APVMA about the matter or matters referred to in paragraph (a).
(3) A person must comply with a requirement made of the person under paragraph (2)(b).
Penalty: 120 penalty units.
(3A) An offence under subsection (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) Subsection (3) does not apply if, before the end of the period stated in the notice, the interested person or an approved person requests the APVMA under section 42 to cancel the approval of the constituent, the registration of the product or the approval of the label, as the case may be, and the APVMA complies with the request.
(5) The APVMA must take into account any submissions made in accordance with an invitation contained in a notice published under subsection (1) or in a notice given under subsection (2).
33 APVMA may require trials or laboratory experiments to be conducted
(1) The APVMA may, by written notice given to the interested person in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, or given to an approved person, require the interested person, within a reasonable period stated in the notice:
(a) to conduct, or cause to be conducted, trials or laboratory experiments in relation to the constituent or product, as the case may be, that the APVMA thinks necessary for the purposes of its reconsideration of the approval of the constituent or the registration of the product; and
(b) to give the results of the trials or experiments to the APVMA.
(2) A person must comply with a requirement made of the person under subsection (1).
Penalty: 120 penalty units.
(2A) An offence under subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) Subsection (2) does not apply if, before the end of the period stated in the notice, the interested person or an approved person requests the APVMA under section 42 to cancel the approval of the constituent or the registration of the product, as the case may be, and the APVMA complies with the request.
(4) This section does not affect the APVMA’s powers under section 159.
34 Reconsideration by APVMA of continued approval or registration
(1) If the APVMA is satisfied that, provided that the conditions to which an approval or registration is currently subject are complied with:
(a) if the reconsideration relates to an approval of a constituent or registration of a product—the continued use of, or any other dealing with, the constituent or product in accordance with the instructions for its use or for such a dealing that the APVMA has approved:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia; and
(b) if the reconsideration relates to registration of a product—the continued use of the product in accordance with the instructions for its use that the APVMA has approved would be effective according to criteria determined by the APVMA for the product; and
(c) if the reconsideration relates to an approval of a label:
(i) the label would comply with any prescribed requirements under paragraph 14(3)(d); and
(ii) the label would contain adequate instructions relating to the matters referred to in paragraph 14(3)(g); and
(d) any other prescribed requirements for continued approval or registration would be complied with; and
(da) that, if necessary, paragraph 8A(2)(c) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with;
the APVMA must as soon as practicable:
(e) give written notice to the interested person or to an approved person stating that it affirms the approval or registration on the conditions to which the approval or registration is currently subject and giving brief particulars of the reasons for its decision; and
(f) if it caused a notice to be published under subsection 32(1) in relation to its proposed reconsideration of the approval or registration—cause to be published, in the same way as the first‑mentioned notice, a notice stating that it has affirmed the approval or registration on the conditions to which the approval or registration is currently subject.
(2) In satisfying itself as mentioned in paragraph (1)(a) or (b), the APVMA must have regard to the matters referred to in subsection 14(4), (5) or (6), as the case requires.
(3) If the APVMA is not satisfied as mentioned in subsection (1), subsections (4) to (6) apply.
(4) The APVMA must give written notice to the interested person or to an approved person stating that the APVMA is not so satisfied.
(5) If the APVMA is satisfied that the relevant particulars or the conditions of the approval or registration can be varied in such a way that the requirements prescribed by the regulations for continued approval or registration will be complied with:
(a) the APVMA must vary the relevant particulars or conditions:
(i) if the variation relates to the relevant particulars or the conditions of the approval of a constituent or the registration of a product—by entering in the relevant Record or Register particulars of the variation and the date on which the entry is made; or
(ii) if the variation relates to the relevant particulars of the approval of a label—by recording in the relevant APVMA file the relevant particulars as varied and the date on which the record is made; or
(iii) if the variation relates to the conditions of the approval of a label—by recording in the relevant APVMA file particulars of the variation and the date on which the record is made; and
(b) the APVMA must:
(i) state in the notice referred to in subsection (4) that, although it is not satisfied as mentioned in subsection (1), it is satisfied that the relevant particulars or the conditions can be so varied and has varied them accordingly; and
(ii) set out in the notice details of the variation.
(5A) The APVMA may only vary a condition of the approval of a label that was imposed under subsection 23A(2).
(5B) If a variation of any relevant particulars or conditions under subsection (5) would affect any instructions for the use of an active constituent for an existing or proposed chemical product or for the use of a chemical product or any instructions on a label for containers for a chemical product, the APVMA must not make the variation until it has consulted each co‑ordinator designated for a jurisdiction and taken into account any recommendations made by the co‑ordinators.
(6) A notice given under subsection (4) must give brief particulars of the reasons for the APVMA’s decision and, if subsection (5) applies, also give brief particulars of the reasons for the variation of the conditions of the approval or registration.
(7) Section 168 provides for additional matters to be included in a notice to which subsection (5) applies.
(8) Section 40 provides for the suspension or cancellation of the approval or registration if the APVMA is not satisfied that the conditions of the approval or registration can be varied as mentioned in subsection (5).
34A Reconsideration of approval of label without notice in certain circumstances
(1) The APVMA may, at any time, reconsider the approval of a label for containers for a chemical product for the purpose of deciding whether the particulars on the label contain adequate instructions relating to matters prescribed by the regulations for the purposes of this section.
(2) The matters that may be prescribed must be matters that are also prescribed by the regulations in relation to such a label for the purposes of paragraph 14(3)(d) or subparagraph 14(3)(g)(x).
(3) If the APVMA considers that the particulars do not contain adequate instructions in relation to a matter, the APVMA must:
(a) both:
(i) vary the relevant particulars; and
(ii) record in the relevant APVMA file the relevant particulars as varied and the date on which the record is made; and
(b) give written notice to the interested person in relation to the product, or to an approved person, setting out particulars of the variation.
(5) Sections 30 to 34 do not apply to a reconsideration under this section.
Division 4A—Limits on use of information
Subdivision A—Preliminary
34B Explanation of Division
(1) This Division limits for a period the use the APVMA can make of information given to it:
(a) in connection with an application under section 10 or 27 relating to:
(i) approval of an active constituent for a chemical product; or
(ii) registration of a chemical product; or
(iii) approval of a label for a container for a chemical product; or
(b) under section 161 in connection with a registered chemical product.
(2) During the period, the APVMA cannot use the information for granting another application, or for a reconsideration of an approval or registration, unless:
(a) the APVMA is given a written statement made by a person who can authorise the use of the information consenting to the use; or
(b) certain other conditions are met.
(3) The object of limiting use of the information in this way is to encourage innovation by making it easier for a person who made an investment in finding out the information to get a return on that investment.
Subdivision B—Limits on use of information
34C APVMA must not use some information during some periods for some purposes
(1) During the period described in an item of the table, the APVMA must not use information described in the item for a purpose described in the item.
Limits on use of information |
| The APVMA must not use this information: | During this period: | For this purpose: |
1 | Information that the applicant or an approved person gives the APVMA: (a) in connection with an application under section 10 or 27; and (b) before the APVMA makes a preliminary assessment under section 11A or 28A of the application | The period: (a) starting when the information is given; and (b) ending when the APVMA makes the preliminary assessment | Making a decision under section 14, 29 or 34 (except a decision on the application) |
2 | Information that the applicant or an approved person gives the APVMA: (a) in connection with an application under section 10 or 27; and (b) as required by the APVMA or section 160A | The period: (a) starting when the APVMA makes a preliminary assessment under section 11A or 28A of the application; and (b) ending when the APVMA treats the application as having been withdrawn or grants or refuses the application | Making a decision under section 14, 29 or 34 (except a decision on the application) |
3 | Information that: (a) was given to the APVMA by the applicant or an approved person in connection with an application under section 10 or 27; and (b) was given as required by the APVMA or section 160A; and (c) was relied on by the APVMA to grant the application | The relevant period described in section 34F | Making a decision under section 14, 29 or 34 |
4 | Information that the interested person for a registered chemical product gives the APVMA under section 161 in connection with the product | The period: (a) starting when the person gives the APVMA the information; and (b) ending 5 years later if the product is an agricultural chemical product or 3 years later if the product is a veterinary chemical product | Making a decision under section 14, 29 or 34 |
Note 1: Section 34D sets out exceptions to this subsection.
Note 2: Section 161 may require an interested person for an approved active constituent to give the APVMA information in connection with the constituent, even though this table does not deal with that requirement.
(2) This section applies only to information given to the APVMA:
(a) in connection with an application made after the commencement of this section; or
(b) under section 161 in connection with a chemical product that was registered as a result of an application made after the commencement of this section.
(3) The use of information in contravention of subsection (1) for making a decision does not affect the validity of the decision.
(4) An action or proceeding does not lie against any of the following for any loss directly or indirectly sustained because of the use of information in contravention of subsection (1):
(a) the Commonwealth;
(b) the APVMA;
(c) a person who is or has been:
(i) a director of the APVMA; or
(ii) the Chief Executive Officer of the APVMA; or
(iii) a delegate of the APVMA; or
(iv) a member of the staff of the APVMA.
Subdivision C—Exceptions to limits on use of information
34D Exceptions
(1) Section 34C does not prevent the APVMA from using information for making a decision:
(a) under section 14 or 29 about an application; or
(b) under section 34 about a reconsideration of an approval or registration;
if a condition in subsection (2), (3), (4), (5) or (6) of this section is met.
Evidence of consent for use
(2) One condition is that the applicant, an approved person or the interested person for the approval or registration gives the APVMA a written statement by the authorising party of that party’s consent to the APVMA using the information for making the decision. This condition is met even if the authorising party:
(a) later states that it has not consented; or
(b) withdraws the consent (whether before or after the APVMA is given the statement of consent).
Note: Chapter 7 of the Criminal Code creates offences relating to false and misleading statements and forgery.
Use in the public interest
(3) Another condition is that the APVMA is satisfied, having regard to the criteria (if any) prescribed by the regulations, that the use of the information is in the public interest.
Note: Section 34E sets out other rules that are relevant to the exception based on this condition.
Information does not favour the applicant or interested person
(4) Another condition is that:
(a) the decision relates to:
(i) a proposed or existing approval of an active constituent for a proposed or existing chemical product; or
(ii) a proposed or existing registration of a proposed or existing chemical product; and
(b) the information meets a condition in paragraph 160A(4)(b) or (c) or 161(2)(b) or (c) (which are about showing that use or dealing with the product may have adverse effects or that the product may be ineffective), whether or not the information was given to the APVMA under section 160A or 161.
Identical information whose use is not limited
(5) Another condition is that the APVMA is satisfied that there is identical information, or information to the same effect, whose use is not prevented by section 14B or 34C or Part 3.
Information given to APVMA in connection with certain applications
(6) Another condition is that the application mentioned in subsection 34C(1) was one of the following:
(a) an application for approval, as an active constituent for a chemical product, of a substance that was a previously endorsed active constituent on the commencement of this Division;
(b) an application for the variation of the relevant particulars or conditions of the approval of an active constituent for a chemical product;
(c) an application for the registration of a companion animal product each active constituent for which was a previously endorsed active constituent at the time of the preliminary assessment of the application under section 11A;
(d) an application for variation of the relevant particulars or conditions of the registration of a companion animal product;
(e) an application for the approval of a label for a container for a companion animal product each active constituent of which was a previously endorsed active constituent at the time of the preliminary assessment of the application under section 11A;
(f) an application for variation of the relevant particulars or conditions of the approval of a label for a container for a companion animal product.
34E Further rules about public interest exception
(1) This section applies if the APVMA is satisfied under subsection 34D(3) that it is in the public interest to use information that section 34C would otherwise prohibit the APVMA from using for making a decision:
(a) under section 14 or 29 about an application; or
(b) under section 34 about a reconsideration of an approval or registration.
(2) As soon as practicable after becoming satisfied, the APVMA must give written notice of its satisfaction to:
(a) the applicant, an approved person or the interested person for the approval or registration; and
(b) the person whom the APVMA believes is the authorising party for the information.
(3) Section 168 provides for additional matters to be included in the notice.
(4) The APVMA must not make the decision using the information before the end of 28 days after the day on which the notice is given.
(5) However, subsections (3) and (4) do not apply if:
(a) the APVMA believes it is necessary to make the decision before the end of 28 days after the notice is given, to prevent imminent risk to public health or occupational health or safety; and
(b) states that belief in the notice.
Subdivision D—Period of limit on use of information
34F Period of limit on future use of information relied on in granting application
(1) Subsection 34C(1) prohibits the APVMA from using, during the period described in an item of the following table, information that:
(a) was given to the APVMA by the applicant or an approved person in connection with an application described in the item; and
(b) was given as required by the APVMA or section 160A; and
(c) was relied on by the APVMA to grant the application.
The period starts when the application was granted.
Period for which the APVMA must not use the information |
| Application | Period |
1 | Application made under section 10 for approval of an active constituent (for a proposed or existing chemical product) that was not a previously endorsed active constituent on the commencement of this Division | 8 years |
2 | Application made under section 10 for: (a) registration of a chemical product at least one of whose active constituents was not a previously endorsed active constituent when the application was acknowledged; or (b) approval of a label for a container for a chemical product at least one of whose active constituents was not a previously endorsed active constituent when the application was acknowledged | 8 years |
3 | Application (except one covered by item 2) made under section 10 for: (a) registration of an agricultural chemical product; or (b) approval of a label for a container for an agricultural chemical product | 5 years |
4 | Application (except one covered by item 2) made under section 10 for: (a) registration of a veterinary chemical product; or (b) approval of a label for a container for a veterinary chemical product | 3 years |
5 | Application made under section 27 for variation of the relevant particulars or conditions of: (a) the registration of an agricultural chemical product; or (b) the approval of a label for a container for an agricultural chemical product | 5 years |
6 | Application made under section 27 for variation of the relevant particulars or conditions of: (a) the registration of a veterinary chemical product; or (b) the approval of a label for a container for a veterinary chemical product | 3 years |
Note 1: This section has effect for the purposes of item 3 of the table in subsection 34C(1) (and not for any of the other items in that table).
Note 2: This section is not relevant to information if section 34D provides an exception to the prohibition in subsection 34C(1) on the APVMA using the information.
Extension of 8‑year limits
(2) The period mentioned in item 1 or 2 of the table in subsection (1) in relation to:
(a) an application for an approval of an active constituent (a key constituent); or
(b) an application for registration of a chemical product containing an active constituent (also a key constituent) that had not been approved when the application was acknowledged; or
(c) an application for approval of a label for a container for a chemical product containing an active constituent (also a key constituent) that had not been approved when the application was acknowledged;
is extended by 1 year for each 5 distinct uses that meet the requirements in subsections (3), (4) and (5).
(3) The first requirement is that the uses are uses of a chemical product (an extension product) for which the following conditions are met:
(a) the key constituent is an active constituent for the product;
(b) the product was registered as a result of an application that:
(i) was made by the applicant mentioned in subsection (1); and
(ii) was acknowledged before the approval of the key constituent.
(4) The second requirement is that each of the uses is included in an approved label for a container for an extension product as a result of an application that:
(a) is for:
(i) the approval of the label; or
(ii) the variation of the relevant particulars or conditions of approval of the label; and
(b) was made by the applicant mentioned in subsection (1) or by the interested person in relation to the approval of the key constituent; and
(c) was acknowledged before the end of 6 years after the date of the approval of the key constituent as a result of an application by the applicant mentioned in subsection (1).
(5) The third requirement is that all 5 of the uses are prescribed by the regulations at the latest time an application described in subsection (4) is granted.
(6) However, the period mentioned in item 1 or 2 of the table in subsection (1) cannot be extended so that it exceeds 11 years.
Subdivision E—Ancillary provisions
34G Identifying information relied on in advice APVMA relied on
(1) This section has effect if:
(a) the APVMA made a decision under subsection 14(1) or 29(1) to grant an application made after the commencement of this section; and
(b) in making the decision, the APVMA relied on advice given by a person, body or Government the APVMA consulted under section 8 or 8A of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
(2) The APVMA must cause to be published a summary of the advice.
(3) The summary must:
(a) identify the information that the person, body or Government relied on in giving the advice; and
(b) include the matters (if any) prescribed by the regulations.
Division 5—Suspension or cancellation of approval or registration
35 Notice of proposed suspension or cancellation to be given to co‑ordinators
The APVMA must not suspend or cancel an approval or registration unless:
(a) it has given notice of the proposed suspension or cancellation to each co‑ordinator designated for a jurisdiction; and
(b) a period of 10 working days, or any other period that the APVMA thinks adequate in a particular case, has elapsed since the notice was given.
36 Suspension or cancellation of approval or registration for breach of condition
If there is a contravention of a condition of the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product or the approval of a label for containers for a chemical product, the APVMA may suspend or cancel the approval or registration.
37 Suspension of approval or registration for failing to give information, or results of trials or experiments, to APVMA
(1) If:
(a) at the end of the period stated in a notice given to a person under subsection 32(2), the APVMA is satisfied that the interested person or an approved person is aware of information relevant to the reconsideration but the information has not been given to the APVMA; or
(b) at the end of the period stated in a notice given to a person under subsection 33(1), the APVMA is satisfied that the interested person has not conducted, or caused to be conducted, the trials or experiments or has not given the results of the trials or experiments to the APVMA;
the APVMA may suspend the approval or registration.
(2) Subject to subsection (4), the APVMA must revoke a suspension imposed under paragraph (1)(a) when it is satisfied that all the information relevant to the reconsideration has been given to it.
(3) Subject to subsection (4), the APVMA must revoke a suspension imposed under paragraph (1)(b) when it has received the results of the trials or experiments.
(4) If the information or the results of the trials or experiments are not given to the APVMA within a period after the suspension takes place that the APVMA thinks reasonable, the APVMA may cancel the approval or registration.
38 Suspension of approval or registration for failing to give information, report or sample to APVMA
(1) If the interested person in relation to an approved active constituent for a proposed or existing chemical product, or in relation to a chemical product, or an approved person fails, without reasonable excuse, to comply with a requirement contained in a notice under section 159 or with section 160A or 161, the APVMA may suspend the approval or registration.
(2) Subject to subsection (3), the APVMA must revoke a suspension imposed under subsection (1) if it is satisfied that the relevant information, report or sample has been given to it.
(3) If the information, report or sample is not given to the APVMA within a reasonable period after the suspension takes place, the APVMA may cancel the approval or registration.
39 Suspension of approval or registration if compensation for use of protected information cannot be arbitrated
(1) If:
(a) the primary applicant in relation to a primary active constituent and the secondary applicant in relation to a secondary active constituent or a secondary chemical product were parties to an arbitration under Division 3 of Part 3 as to the terms of compensation; and
(b) the arbitrator gives notice to the APVMA under section 68 in respect of the failure of each party to the arbitration to make a fresh proposal as to the terms of the compensation or to make a fresh proposal as to those terms that the arbitrator thinks reasonable;
the APVMA may suspend the approval of the primary active constituent or may suspend the approval of the secondary active constituent or the registration of the secondary chemical product, as the case may be, or may do both of those things.
(2) If:
(a) the primary applicant in relation to a primary chemical product and the secondary applicant in relation to a secondary chemical product were parties to an arbitration under Division 3 of Part 3 as to the terms of compensation; and
(b) the arbitrator gives notice to the APVMA under section 68 in respect of the failure of each party to the arbitration to make a fresh proposal as to the terms of the compensation or to make a fresh proposal as to those terms that the arbitrator thinks reasonable;
the APVMA may suspend the registration of either or both of those products.
40 Suspension or cancellation of approval or registration following reconsideration of continued approval or registration
(1) If, in the course of reconsidering the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product or the approval of a label for containers for a chemical product, the APVMA is not satisfied that the relevant particulars or the conditions of the approval or registration can be varied in such a way that the prescribed requirements for continued approval or registration will be complied with, the APVMA may suspend or cancel the approval or registration.
(2) If, in the course of reconsidering the approval of a label for containers for a chemical product:
(a) the APVMA is satisfied that the relevant particulars of the approval of the label can be varied in such a way that the requirements prescribed by the regulations for continued approval will be complied with (see subsection 34(5)); and
(b) the interested person does not satisfy the APVMA that a label, including the particulars as proposed to be varied by the APVMA, will be attached to the containers for the chemical product;
the APVMA may suspend or cancel the approval.
41 Suspension or cancellation of approval or registration for non‑compliance with criteria for registration or approval
(1) The APVMA may suspend or cancel the approval of an active constituent for a proposed or existing chemical product, or the registration of a chemical product, if it appears to the APVMA that, having regard to the matters referred to in subsection 14(4) or (5), as the case requires, the continued use of, or any other dealing with, the constituent or product in accordance with the instructions for its use or for such a dealing that the APVMA has approved:
(a) may be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(b) may be likely to have an effect that is harmful to human beings; or
(c) may be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(d) may unduly prejudice trade or commerce between Australia and places outside Australia.
(2) The APVMA may suspend or cancel the registration of a chemical product if it appears to the APVMA that, having regard to the matters referred to in subsection 14(6), the continued use of the product in accordance with the instructions for its use that the APVMA has approved may not be effective according to criteria determined by the APVMA for the product.
(3) If it appears to the APVMA that any of the instructions on an approved label for containers for a chemical product that relates to a matter referred to in paragraph 14(3)(g) may no longer be adequate, the APVMA may suspend or cancel the approval.
(4) If:
(a) the APVMA considers that the particulars on a label for containers for a chemical product do not contain adequate instructions relating to matters prescribed by the regulations for the purposes of subsection 34A(1); and
(b) the interested person does not satisfy the APVMA that a label, including the particulars as proposed to be varied by the APVMA, will be attached to the containers for the chemical product;
the APVMA may suspend or cancel the approval of the label.
42 Cancellation of approval or registration at request of interested person
(1) If:
(a) the interested person in relation to an approval or registration or an approved person gives to the APVMA a written notice:
(i) requesting the APVMA to cancel the approval or registration; and
(ii) stating the reasons for the request; and
(b) the APVMA is satisfied that there are no valid reasons why it should not agree to the request;
the APVMA must cancel the approval or registration.
(2) The APVMA must give written notice of its decision on a request under subsection (1) to the person or persons who made the request.
43 Effect of suspension of approval or registration
(1) A suspension of an approval or registration must be for a stated period.
(2) An approval or registration is taken for the purposes of this Code other than sections 74 and 75 not to be in force during any period in which it is suspended.
(3) An approval or registration may be cancelled even though it is suspended.
44 Inter‑related suspensions and cancellations
(1) If the APVMA suspends or cancels the only approval, or all the approvals, of an active constituent for a proposed or existing chemical product, it must also suspend or cancel any registration of that product.
(2) If the APVMA suspends or cancels the registration of a chemical product, it may also suspend or cancel, as the case may be, any approval relating to a label for containers for the product.
(3) If the APVMA suspends or cancels the approval of the only approved label, or all the approved labels, for containers for a chemical product, it may also suspend or cancel, as the case may be, the registration of the product.
45 How approval or registration is suspended or cancelled
(1) Suspension or cancellation of an approval or registration is made by entering in the relevant Record or Register or recording in the relevant file:
(a) the fact that the approval or registration has been suspended or cancelled; and
(b) in respect of a suspension—the period of the suspension; and
(c) the date on which the entry or record is made.
45A Notice of suspension or cancellation
(1) Subject to subsection (3), if the APVMA suspends or cancels an approval or registration, it must, as soon as practicable, give written notice of the suspension or cancellation to the interested person, or an approved person, and to any other person to whom, in its opinion, such a notice should be given.
(2) A notice given to a person under subsection (1):
(a) must tell the person of the suspension or cancellation; and
(b) in respect of a suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product—must contain the following matters:
(i) brief reasons for the suspension or cancellation; and
(ii) instructions for possessing, having custody of, using or otherwise dealing with the constituent or product; and
(iii) a warning of the consequences if the person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to possess or have custody of the constituent or product with the intention of supply, or to supply the constituent or product; and
(iv) any other warnings or explanations in relation to the constituent or product that the APVMA thinks desirable;
excluding any matters that the APVMA thinks it unnecessary for the notice to contain.
(3) Subsection (1) does not require notice of the cancellation under section 42 of an approval or registration to be given to the person who requested the cancellation.
(4) Section 168 provides for additional matters to be included in a notice given under subsection (1).
(5) After a notice of the suspension or cancellation of the approval or registration is given to a person under this section, that person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the constituent or product, or the product containing the label, as the case may be, in accordance with the instructions contained in the notice until:
(a) 2 years after the day of the suspension or cancellation; or
(b) the APVMA revokes the suspension or cancellation; or
(c) the APVMA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the constituent or product;
whichever first occurs.
(6) Subject to subsection (8), if:
(a) a notice of the suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product is given to a person under this section; and
(b) the person has possession or custody of the constituent or product with the intention of supply;
the person may only possess, have custody of or otherwise deal with the constituent or product if the possession, custody or dealing is in accordance with the instructions contained in the notice.
Penalty: 300 penalty units.
(7) In paragraph (6)(a), strict liability applies to the physical element of circumstance, that the notice is a notice given to the person under this section.
Note: For strict liability, see section 6.1 of the Criminal Code.
(8) Subsection (6) does not apply to a possession, custody or dealing with a constituent or product if the constituent was an approved active constituent or the product was a registered chemical product or a reserved chemical product when the possession, custody or dealing took place because of its having been approved or registered or having become reserved after its previous approval or registration had been cancelled.
46 How suspension or cancellation is revoked
(1) Suspension or cancellation of an approval or registration is revoked by entering in the relevant Record or Register or recording in the relevant file:
(a) the fact that the suspension or cancellation has been revoked; and
(b) the date on which the entry is made.
(2) If the APVMA revokes the suspension or cancellation of an approval or registration, it must, as soon as practicable, give written notice of the revocation to the interested person or an approved person and to any other person to whom, in its opinion, such a notice should be given.
(3) If the cancellation of an approval or registration is revoked, the cancellation is taken never to have occurred.
Division 6—Duration and renewal of approval or registration
47 Period of approval or registration
(1) The approval of an active constituent for a proposed or existing chemical product continues in force unless it is cancelled.
(2) Subject to subsection (3), the registration of a chemical product ends at the end of 30 June next following the day on which the registration was granted or renewed, or last renewed, as the case may be.
(3) The registration of a chemical product that is taken to have been effected by subsection 172(2) or paragraph 174(1)(a) or 176(1)(c) ends at the end of 3 months after the commencement of this Code unless the registration is renewed.
(4) The approval of a label for containers for a chemical product ends when the registration of the product ends.
(4A) If:
(a) the registration of a chemical product ends; but
(b) a person is taken under subsection 54(2) to have been issued with a permit to possess, have custody of, use or otherwise deal with the product;
the approval of a label for containers for the product continues in force until the permit ceases to have effect.
(5) This section has effect subject to:
(a) any condition of a kind referred to in:
(i) subsection 23(3) to which an approval or registration is subject; or
(ii) subsection 23A(4) to which an approval of a label for containers for a chemical product is subject; and
(b) subsection 43(2), which relates to suspension of an approval or registration; and
(c) the following provisions of this Division.
48 Application for renewal of registration of chemical product
(1) The interested person may apply for the renewal, or further renewal, as the case may be, of the registration of a chemical product.
(2) Subject to subsection (3), the application must be made not later than one month, or a shorter period that the APVMA permits, before the registration ends.
(3) In circumstances that are prescribed by the regulations and upon payment of the prescribed fee (if any), the APVMA may accept a late application if the application is made on or before a date that the APVMA determines.
49 How application for renewal of registration is to be made
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the APVMA requires; and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the APVMA.
(2) The APVMA may, with the written consent of an approved person, alter the application.
(3) At any time after an application has been made and before it has been determined, the applicant may withdraw the application by giving to the APVMA written notice of the withdrawal signed by an approved person.
(4) Subject to subsection (5), the APVMA must grant the application:
(a) if the application was made in accordance with subsection 48(2)—before the registration ends; or
(b) if the application was made in accordance with subsection 48(3)—within one month after the application was made;
and must give written notice to an approved person of the renewal and the period of the renewal.
(5) If an amount (including an amount in respect of a tax or penalty) that is payable (whether by the applicant or by any other person) to the APVMA in respect of the product under any law in force in any jurisdiction has not been paid, the APVMA may refuse to grant the application for renewal.
(6) If the application was made in accordance with subsection 48(2) and the APVMA fails to grant the application before the registration ends, the registration continues in force until:
(a) the APVMA grants the application; or
(b) if the APVMA decides to refuse to grant the application because of non‑payment of an amount as mentioned in subsection (5)—the APVMA gives written notice of its decision to an approved person.
(7) If the APVMA accepts a late application under subsection 48(3) and grants the application, the registration continues in force, or is taken to have continued in force, as the case may be, until the application is or was granted.
50 Renewal of registration of chemical product
The renewal of registration of a chemical product:
(a) is granted by entering in the Register of Chemical Products a statement that the registration has been renewed and the date on which the renewed registration ends; and
(b) takes effect, or is to be regarded as having taken effect, as the case may be, at the beginning of the day immediately following the day on which the previous registration ends or ended.
51 Renewal of approval of label
If the registration of a chemical product is renewed:
(a) any approval of a label for containers for the product is, by this section, also renewed; and
(b) the renewal of that approval takes effect, or is to be regarded as having taken effect, as the case may be, at the beginning of the day immediately following the day on which the previous registration of the product ends or ended; and
(c) the APVMA must record in the relevant file a statement that the approval of the label has been renewed and the date on which the renewed approval ends.
Division 7—Publication of notices by APVMA
52 Publication of notice of approval of active constituent or registration of chemical product
(1) If the APVMA approves an active constituent for a proposed or existing chemical product, it must, as soon as practicable after the approval, cause notice of the approval to be published in accordance with subsection (3).
(2) If the APVMA registers a chemical product, it must, as soon as practicable after the registration, cause notice of the registration to be published in accordance with subsection (3), unless the APVMA thinks it unnecessary, in the circumstances, to publish such a notice.
(3) The notice:
(a) is to be published in the Gazette and in any other manner that the APVMA thinks appropriate; and
(b) must state that the constituent has been approved or the product has been registered, as the case may be, and state the date of the approval or registration; and
(c) must contain a brief statement of the conditions of the approval or registration that directly regulate the use of the constituent or product, as the case may be.
53 Publication of notice of variations of approval of active constituent or registration of chemical product
(1) If the APVMA varies any of the relevant particulars of an approval of an active constituent for a proposed or existing chemical product or of the registration of a chemical product or any of the conditions of such an approval or registration, the APVMA must, unless it thinks that, in the circumstances, it is unnecessary to do so, cause notice of the variation to be published in the Gazette and in any other manner that it thinks appropriate.
(2) The notice must:
(a) state that the relevant particulars or conditions have been varied and state the date of the variation; and
(b) contain a brief statement of the nature of, and reasons for, the variation.
54 Publication of notice of end of registration of chemical product
(1) If the registration of a chemical product ends and is not renewed, the APVMA must, as soon as practicable, cause to be published in the Gazette, and in any other manner that it thinks appropriate, a notice:
(a) stating that the registration has ended; and
(b) setting out the date on which the registration ended; and
(ba) containing instructions for possessing, having custody of, using or otherwise dealing with the product; and
(bb) containing a warning of the consequences if a person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to possess or have custody of the product with the intention of supply, or to supply the product; and
(bc) containing any other warnings or explanations in relation to the product that the APVMA thinks desirable; and
(c) containing any other information that the APVMA thinks appropriate;
unless the APVMA thinks that, in the circumstances it is it unnecessary to publish such a notice.
(2) If, after the publication under this section of a notice stating that the registration of a chemical product has ended, a person possesses, has custody of, uses or otherwise deals with the product in accordance with the instructions contained in the notice, the person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the product in accordance with those instructions until:
(a) 2 years after the day on which the registration ended; or
(b) the APVMA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the product;
whichever first occurs.
(3) Subject to subsection (5), if:
(a) a notice stating that the registration of a chemical product has ended has been published under this section; and
(b) a person has possession or custody of the product for the purpose of supply;
the person may only possess, have custody of or otherwise deal with the product if the possession, custody or dealing is in accordance with the instructions contained in the notice.
Penalty: 300 penalty units.
(4) In paragraph (3)(a), strict liability applies to the physical element of circumstance, that the publishing of the notice was under this section.
Note: For strict liability, see section 6.1 of the Criminal Code.
(5) Subsection (3) does not apply to a possession, custody or dealing with a product if the product was a registered chemical product or a reserved chemical product when the possession, custody or dealing took place because of its having been registered or having become reserved after the previous registration had ended.
(6) If a notice stating that the registration of a chemical product has ended is published under this section, the APVMA must:
(a) as soon as practicable cause a copy of the notice to be given to the interested person in relation to the product or to an approved person; and
(b) cause a copy of the notice to be given to any other person who, in the opinion of the APVMA, should be given notice of the ending of the registration and of the instructions, warnings and explanations contained in the notice.
55 Publication of notice of suspension or cancellation of approval or registration
(1) If the APVMA suspends or cancels the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product or the approval of a label for containers for a chemical product, it must, as soon as practicable, cause to be published in the Gazette, and in any other manner that it thinks appropriate, notice of the suspension or cancellation containing any information that it thinks relevant.
(2) If the reason, or one of the reasons, for the suspension or cancellation was:
(a) that the continued use of, or other dealing with, the constituent or product:
(i) might be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(ii) might be likely to have an effect that is harmful to human beings; or
(iii) might be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(b) that the continued use of the product might not be effective according to criteria determined by the APVMA for the product; or
(c) that an instruction on a label for containers for the product might no longer be adequate;
the notice must contain the following:
(d) a statement to that effect;
(e) instructions for possessing, having custody of, using or otherwise dealing with the constituent or product;
(f) a warning of the consequences if a person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to have possession or custody of the constituent or product with the intention of supply, or to supply the constituent or product;
(g) any other warnings or explanations in relation to the constituent or product that the APVMA thinks desirable.
(3) If, after the publication under this section of a notice of the suspension or cancellation of an approval or registration, a person possesses, has custody of, uses or otherwise deals with the constituent or product, or a product containing a label, as the case may be, in accordance with the instructions contained in the notice, the person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the constituent or product, or a product containing the label, in accordance with those instructions until:
(a) 2 years after the day of the suspension or cancellation; or
(b) the APVMA revokes the suspension or cancellation; or
(c) the APVMA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the constituent or product, as the case may be;
whichever first occurs.
(4) Subject to subsection (5), if:
(a) a notice of the suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product or the approval of a label for containers for a chemical product has been published under this section; and
(b) a person has possession or custody of that constituent or product with the intention of supply;
the person must not possess, have custody of or otherwise deal with the constituent or product except in accordance with the instructions contained in the notice.
Penalty: 300 penalty units.
(5) Subsection (4) does not apply to a possession, custody or dealing with a constituent or product if the constituent was an approved active constituent, the product was a registered chemical product, or the label on the product was an approved label, when the possession, custody or dealing took place because of its having been approved or registered again after its previous approval or registration had been cancelled.
(6) It is a defence to a prosecution of a person for an offence against subsection (4) if the person proves that, when the person possessed, had custody of or dealt with the constituent or product, the person did not know, and could not reasonably be expected to have known, of the existence of the notice or that the possession, custody or dealing was not in accordance with the instructions contained in the notice.
(6A) In paragraph (4)(a), strict liability applies to the physical element of circumstance, that the publishing of the notice was under this section.
Note: For strict liability, see section 6.1 of the Criminal Code.
(7) If the APVMA causes a notice of the suspension or cancellation of the registration of a chemical product to be published under this section, the APVMA must:
(a) as soon as practicable cause a copy of the notice to be given to each person who is an interested person for the product to which the notice relates or an approved person; and
(b) cause a copy of the notice to be given to any other person who, in the opinion of the APVMA, should be given notice of the suspension or cancellation and of the instructions, warnings and explanations contained in the notice.
(8) If the APVMA causes a notice of the suspension or cancellation of the approval of a label for containers for a chemical product to be published under this section, the APVMA must:
(a) as soon as practicable cause a copy of the notice to be given to the interested person in relation to the chemical product or an approved person; and
(b) cause a copy of the notice to be given to any other person who, in the opinion of the APVMA, should be given notice of the suspension or cancellation and of the instructions, warnings and explanations contained in the notice.
56 Notice of revocation of suspension or cancellation to be published
If the APVMA revokes the suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product or the approval of a label for containers for a chemical product, it must, as soon as practicable, cause to be published in the Gazette, and in any other manner that it thinks appropriate, notice of the revocation containing any information that it thinks relevant.
Part 2A—Listable chemical products
Division 1—Preliminary
56A Explanation of Part
(1) This Part contains provisions relating to:
(a) the listing of, and the establishment of standards for, certain chemical products; and
(b) the listed registration of those chemical products.
(2) Division 2 provides for the regulations to list certain chemical products that can be granted listed registration.
(3) Division 3 provides for the establishment of standards for the listable chemical products.
(4) Division 4 provides how applications for listed registration are to be dealt with.
(5) Division 5 deals with applications to vary listed registrations or to vary the conditions of any listed registrations.
(6) Division 6 provides for the APVMA to reconsider listed registrations for the purpose of deciding whether they should remain in force.
(7) Division 7 sets out the circumstances in which the APVMA may suspend or cancel listed registrations.
(8) Division 8 specifies the period for which listed registrations are to continue in force and makes provision for their renewal.
(9) Division 9 provides for the APVMA to publish notices telling the public of actions that it has taken under this Part.
56B Exclusion of restricted chemical products
This Part does not apply to chemical products that are restricted chemical products.
Division 2—Schedule of listable chemical products
56C Regulations may contain schedule of listable chemical products
(1) The regulations may contain a schedule listing chemical products, or classes of chemical products, that can be granted listed registration under this Part.
(2) Before the Governor‑General makes a regulation listing a chemical product, or a class of chemical products:
(a) the listing of the product, or class of products, must have been recommended to the Minister by the APVMA; and
(b) the APVMA must have given to the Minister:
(i) written particulars of the product or class of products; and
(ii) a draft of the standard that the APVMA proposes to submit for approval by the Minister for the product, or for products in the class, if the product or class is granted listed registration; and
(iii) a written explanation as to why the APVMA is satisfied that use of the product, or use of products in the class, in accordance with instructions contained in the established standard for the product would satisfy the APVMA of all the matters mentioned in paragraphs 56E(1)(a) to (e) having regard to matters (relevant matters) mentioned in subsection 56E(2) where information about the relevant matters is readily available; and
(iv) a written statement identifying the consultations held by, and setting out the advice given to, the APVMA in relation to the proposed listing of the products or class of products.
(3) The Minister may, before the Governor‑General makes a regulation listing a chemical product or class of chemical products, require the APVMA to cause to be published in the Gazette, and to be published in any other manner that the Minister thinks appropriate, a notice:
(a) stating that it has recommended the listing of the product or class of products; and
(b) setting out particulars of the product or of products in the class; and
(c) giving the reasons for the recommendation; and
(d) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice appears in the Gazette, a written submission to the APVMA as to whether the recommendation should be confirmed or withdrawn and stating the grounds on which the submission is based, which must be grounds relating to the matters mentioned in paragraphs 56E(1)(a) to (e).
(4) If the Minister requires the APVMA to publish a notice under subsection (3), the APVMA must take into account any submissions made in accordance with the invitation contained in the notice and must inform the Minister whether it confirms or withdraws its recommendation.
Division 3—Establishing standards for listable chemical products
56D APVMA to prepare standards
(1) This section applies in respect of each listable chemical product, whether or not the product is the subject of a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary) or in a similar publication.
(2) The APVMA must prepare in writing a standard for each listable chemical product and must submit the standard to the Minister for his or her approval of the standard. A particular standard may relate to a specified chemical product or specified chemical products or to each chemical product in a specified class of chemical products.
(3) The standard for a listable chemical product must require that the product be labelled in a manner, or kept in containers that comply with requirements, specified in the standard.
(4) Without limiting the generality of subsection (3), the APVMA may, in a standard, direct that the particulars required by the standard be set out, in a manner specified in the standard, on:
(a) chemical products, or a class of chemical products, identified in the standard; or
(b) a container containing chemical products, or a class of chemical products, identified in the standard; or
(c) a label for containers for chemical products, or a class of chemical products, identified in the standard.
(5) Without limiting the generality of the preceding provisions of this section, a standard for a listable chemical product:
(a) may be specified by reference to any one or more of the following:
(i) the composition and form of the constituents of the product;
(ii) the physical and chemical properties of the chemical product;
(iii) the quantity of the chemical product when contained in specified containers;
(iv) procedures to be carried out in the manufacture of the chemical product;
(v) a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary);
(vi) a monograph in another publication approved by the APVMA for the purposes of this subparagraph;
(vii) a monograph referred to in subparagraph (v) or (vi) as modified in a manner specified in the standard;
(viii) a standard published by Standards Australia;
(ix) such other matters as the APVMA thinks fit; and
(b) may require that a matter relating to the standard be determined in accordance with a particular test.
(6) If the Minister decides not to approve a standard for a listable chemical product:
(a) the Minister must inform the APVMA of the reasons for the decision; and
(b) the APVMA must prepare in writing such revised standard or standards for the product as may be required until the Minister endorses his or her approval on the instrument containing the standard concerned.
(7) If the Minister decides to approve a standard for a listable chemical product:
(a) the approval is effected by the Minister endorsing his or her approval on an instrument containing the standard; and
(b) that standard becomes the standard established for the product from the time of endorsement.
(8) The APVMA must cause a copy of the standard established for a listable chemical product to be published in the Gazette.
56E Matters to be taken into account in preparing a standard
(1) The APVMA must not submit a standard for a chemical product to the Minister for approval unless the APVMA is satisfied that use of the product in accordance with the standard:
(a) would ensure that the product would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(b) would ensure that the product would not be likely to have an effect that is harmful to human beings; and
(c) would ensure that the product would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(d) would not unduly prejudice trade or commerce between Australia and places outside Australia; and
(e) would be effective according to criteria determined by the APVMA for the product; and
(f) would contain, or would require a label for containers for the product to contain, adequate instructions relating to such of the following as are appropriate:
(i) the circumstances in which the product should be used;
(ii) how the product should be used;
(iii) the times when the product should be used;
(iv) the frequency of the use of the product;
(v) the withholding period after the use of the product;
(vi) the re‑entry period after the use of the product;
(vii) the disposal of the product when it is no longer required;
(viii) the disposal of containers of the product;
(ix) the safe handling of the product and first aid in the event of an accident caused by the handling of the product;
(x) any other matters prescribed by the regulations.
(2) In satisfying itself for the purposes of subsection (1) whether a standard would ensure that a chemical product would not be an undue hazard as mentioned in paragraph (1)(a), would not be likely to have an effect that is harmful as mentioned in paragraph (1)(b) or would not be likely to have an unintended effect that is harmful as mentioned in paragraph (1)(c), the APVMA may have regard to such matters as it thinks relevant but must have regard to the following:
(a) the toxicity of the product and its residues in relation to relevant organisms and ecosystems, including human beings;
(b) the relevant poison classification of the product under the law in force under this jurisdiction;
(c) how the product is formulated;
(d) the composition and form of the constituents of the product;
(e) the acceptable daily intake of each active constituent contained in the product;
(f) whether any trials or laboratory experiments have been carried out to determine the residues of the product and, if so, the results of those trials or experiments and whether those results show that the residues of the product will not be greater than limits that the APVMA has approved or approves;
(g) the stability of the product;
(h) the specifications for containers for the product;
(i) any other matters prescribed by the regulations.
(3) In satisfying itself for the purposes of paragraph (1)(e) whether the use of a product in accordance with a standard would be effective, the APVMA must have regard to:
(a) whether any trials or laboratory experiments have been carried out to determine the efficacy of the product and, if so, the results of those trials or experiments; and
(b) any other matters prescribed by the regulations.
56F Variation or revocation of standards
(1) The APVMA may at any time prepare, in writing, a variation of the standard established for a listable chemical product and submit the variation to the Minister for his or her approval.
(2) If the Minister decides to approves the variation:
(a) the approval is effected by the Minister endorsing his or her approval on an instrument varying the standard; and
(b) the standard as varied becomes the established standard for the product from the time of endorsement.
(3) The APVMA may, by writing, with the approval of the Minister, revoke the standard established for a listable chemical product.
(4) The APVMA must cause a copy of an instrument of variation or revocation of the standard established for a listable chemical product to be published in the Gazette.
56G Date of effect of standards
(1) A standard established for a listable chemical product takes effect on the day on which a copy of the instrument containing the standard is published in the Gazette or on such later day as is specified in that instrument.
(2) An instrument varying or revoking a standard established for a listable chemical product takes effect on the day on which a copy of the instrument of variation or revocation is published in the Gazette or on such later day as is specified in that instrument.
56H Standards to be disallowable
Instruments containing standards, and instruments varying or revoking standards, established for listable chemical products are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.
Division 4—Application for registration of listable chemical products
56I Application
A person may apply to the APVMA for a chemical product:
(a) that is a listable chemical product; and
(b) for which there is an established standard;
to be granted listed registration.
56J How application is to be made
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, any information that the APVMA requires; and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the APVMA.
(2) The APVMA may, with the written consent of an approved person, alter the application.
(3) At any time after an application has been made and before it has been determined, an approved person:
(a) may give to the APVMA information additional to or varying information previously given to the APVMA; and
(b) may withdraw the application by giving to the APVMA a written notice of the withdrawal signed by an approved person.
56K Grant or refusal of application
(1) The APVMA must grant an application under section 56I if it is satisfied:
(a) that the applicant has complied with subsection 56J(1); and
(b) that any requirement made under section 157 or 159 has been complied with; and
(c) that, if necessary, paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with; and
(d) that the chemical product complies with the relevant established standard and with such other requirements as are prescribed by the regulations; and
(e) that the fee (if any) prescribed in respect of the listed registration, and any other amount (including an amount in respect of a tax or penalty) that is payable (whether by the applicant or by any other person) to the APVMA in respect of the product under this Code or any other law in force in this or any other jurisdiction, have been paid.
(2) In satisfying itself for the purposes of subsection (1), the APVMA may:
(a) have regard to the results of its own inquiries; or
(b) rely on a written declaration produced to it by an approved person;
as it thinks appropriate.
(3) If the APVMA is not satisfied as mentioned in subsection (1) it must refuse the application.
56L Multiple listed registrations
The listed registration of a chemical product on the application of a person does not preclude the listed registration of the same chemical product on the application of another person.
56M How listed registration of chemical product is effected
(1) If the APVMA grants an application for a listable chemical product to be granted listed registration, it must give a distinguishing number to the product and grant listed registration in respect of the product in accordance with this section, either unconditionally or subject to conditions as mentioned in section 56O.
(2) Listed registration of a chemical product takes place by entering in the Register of Chemical Products:
(a) the relevant particulars, which are a notation that the product is a listable chemical product, the distinguishing number and any other particulars that are prescribed by the regulations; and
(b) any conditions of the listed registration.
56N Date of listed registration
(1) The date of listed registration of a chemical product is the date on which the relevant particulars are entered in the Register of Chemical Products.
(2) If:
(a) any of the relevant particulars of the listed registration of a chemical product; or
(b) any of the conditions of such a listed registration;
are varied pursuant to an application or request made under this Part, then, the date of the listed registration of the product, as varied, or as subject to the varied conditions, is the date on which particulars of the variations are entered in the Register of Chemical Products.
56O Conditions of listed registration
(1) The conditions of the listed registration of a chemical product are the conditions that the APVMA thinks appropriate.
(2) Without limiting subsection (1), listed registration of a chemical product may be granted:
(a) on the condition that the product is supplied only in a container of a kind referred to in the condition or prescribed by the regulations; or
(b) on the condition that the product is not supplied in a container of a kind referred to in the condition or prescribed by the regulations.
(3) Listed registration of a chemical product may be granted on the condition that the listed registration remains in force only for a stated period that is not more than one year.
(4) If the listed registration is subject to a condition referred to in subsection (3) and the conditions of listed registration have not been varied before the end of the period referred to in the condition, or the end of that period as previously extended under this subsection, so as to remove the condition, the APVMA may vary the condition so as to extend the period for a further period of not more than one year or for further periods each of which is not more than one year.
56P Notice of listed registration
(1) If an application for listed registration of a chemical product is granted, the APVMA:
(a) must give to an approved person written notice of the listed registration; and
(b) may cause to be made publicly available, in an appropriate manner, a material safety data sheet in respect of the product.
(2) The notice referred to in paragraph (1)(a) must contain the information that is prescribed by the regulations.
(3) Section 168 provides for additional matters to be included in a notice granting listed registration in respect of a chemical product subject to conditions.
56Q Notice of refusal of application
(1) If an application for listed registration of a chemical product is refused, the APVMA must:
(a) give to an approved person written notice of the refusal; and
(b) include in the notice brief particulars of the reasons for the refusal.
(2) Section 168 provides for additional matters to be included in a notice under this section.
56R Notice of incorrectly registered particulars
(1) If a person:
(a) is the interested person in relation to a registered listed chemical product; and
(b) has reasonable cause to believe that, because of a change in circumstances, inaccurate recording or any other reason, a relevant particular or a condition entered in the Register of Chemical Products in relation to the product is not correct in a material respect;
the person must, as soon as practicable, give to the APVMA a written notice, signed by an approved person, identifying the incorrect particular or condition and informing the APVMA of the correct particular or condition.
Penalty: 60 penalty units.
(2) If the APVMA is satisfied that the particular or condition entered in the Register of Chemical Products in relation to the product is not correct, the APVMA must change the entry accordingly.
Division 5—Application for variation of relevant particulars, or of conditions, of listed registration
56S Who may apply
The interested person in relation to a registered listed chemical product may apply to the APVMA for variation of the relevant particulars, or variation of the conditions, of the listed registration.
56T How application is to be made
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the APVMA requires; and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the APVMA.
(2) The APVMA may alter the application with the written consent of an approved person.
(3) At any time after an application has been made and before it has been determined, an approved person may withdraw the application by giving to the APVMA written notice of the withdrawal signed by an approved person.
56U Grant or refusal of application
(1) If the APVMA is satisfied of the following:
(a) that subsection 56T(1) has been complied with;
(b) that any requirement made under section 157 or 159 has been complied with;
(c) that, if necessary, paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with;
(d) that any requirements prescribed by the regulations in relation to the variation of the relevant particulars, or of the conditions, of a listed registration have been complied with;
(e) that, if those particulars or conditions were varied in accordance with the application, the continued use of, or any other dealing with, the product in accordance with instructions contained in the established standard:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia; and
(v) would be effective according to criteria determined by the APVMA for the product;
(f) that the fee (if any) prescribed in respect of the listed registration, and any other amount (including an amount in respect of a tax or penalty) that is payable (whether by the applicant or by any other person) to the APVMA in respect of the product under this Code or any other law in force in this or any other jurisdiction, have been paid;
it must:
(g) grant the application and vary those particulars or conditions by entering in the Register of Chemical Products particulars of the variation and the date on which the entry is made; and
(h) give written notice to an approved person stating that the variation has been made and setting out particulars of the variation.
(2) In satisfying itself for the purposes of subparagraph (1)(e)(i), (ii) or (iii), the APVMA must have regard to the matters referred to in subsection 56E(2).
(3) In satisfying itself for the purposes of subparagraph (1)(e)(v), the APVMA must have regard to the matters referred to in subsection 56E(3).
(4) If the APVMA is not satisfied as mentioned in subsection (1), it must refuse the application.
(5) If the application is refused, the APVMA must:
(a) give to an approved person written notice of the refusal; and
(b) include in the notice brief particulars of the reasons for the refusal.
(6) Section 168 provides for additional matters to be included in a notice under subsection (5).
Division 6—Reconsideration of listed registration
56V APVMA may invite the public to propose registered listed chemical products for reconsideration
(1) The APVMA may cause to be published in the Gazette, and in any other manner it thinks appropriate, notices inviting persons to propose chemical products whose listed registration the APVMA might reconsider.
(2) A notice under subsection (1) must state the criteria that are to be taken into account by the APVMA in reconsidering the listed registration.
(3) A proposal made by a person because of an invitation contained in a notice under subsection (1) must submit reasons, based on the criteria stated in the notice, in support of the proposal.
56W APVMA may reconsider listed registration
The APVMA may at any time, in accordance with this Division, reconsider the listed registration of a chemical product.
56X APVMA may give notice of proposed reconsideration
(1) Before reconsidering the listed registration of a chemical product, the APVMA may, if it thinks it desirable to do so, cause to be published, in a manner that it thinks appropriate, a notice:
(a) stating that the APVMA proposes to reconsider the listed registration and setting out the relevant particulars of the listed registration of the product; and
(b) setting out the matters to be dealt with in the reconsideration and stating the requirement or requirements prescribed by the regulations for continued approval or registration that form the basis for the reconsideration; and
(c) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the publication of the notice, a written submission to the APVMA as to whether the listed registration complies with the prescribed requirements for continued listed registration.
(2) The APVMA must give written notice to the interested person in relation to the product or to an approved person:
(a) telling the person the matter or matters that it proposes to reconsider and its reasons for so proposing; and
(b) requiring the person, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice is given, to give to the APVMA:
(i) any information of a kind stated in the notice of which either the interested person or the approved person is aware and which is relevant to the reconsideration; or
(ii) any information of which either the interested person or the approved person is aware that is relevant to the reconsideration; and
(c) inviting the person, within that period, to make a written submission to the APVMA about the matter or matters referred to in paragraph (a).
(3) A person must comply with a requirement made of the person under paragraph (2)(b).
Penalty: 120 penalty units.
(4) In subsection (3), strict liability applies to the physical element of circumstance, that the requirement is made of the person under paragraph (2)(b).
Note: For strict liability, see section 6.1 of the Criminal Code.
(5) Subsection (3) does not apply if, before the end of the period stated in the notice, the interested person or an approved person requests the APVMA under section 56ZG to cancel the listed registration of the product and the APVMA complies with the request.
(6) The APVMA must take into account any submissions made in accordance with an invitation contained in a notice published under subsection (1) or in a notice given under subsection (2).
56Y APVMA may require trials or laboratory experiments to be conducted
(1) The APVMA may, by written notice given to the interested person in relation to a registered listed chemical product or given to an approved person, require the interested person, within a reasonable period stated in the notice:
(a) to conduct, or cause to be conducted, trials or laboratory experiments in relation to the product that the APVMA thinks necessary for the purposes of its reconsideration of the listed registration of the product; and
(b) to give the results of the trials or experiments to the APVMA.
(2) A person must comply with a requirement made of the person under subsection (1).
Penalty: 120 penalty units.
(3) In subsection (2), strict liability applies to the physical element of circumstance, that the requirement is made of the person under subsection (1).
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) Subsection (2) does not apply if, before the end of the period stated in the notice, the interested person or an approved person requests the APVMA under section 56ZG to cancel the listed registration of the product and the APVMA complies with the request.
(5) This section does not affect the APVMA’s powers under section 159.
56Z Reconsideration by APVMA of continued listed registration
(1) If the APVMA is satisfied that:
(a) any requirement made under section 159 has been complied with; and
(b) if necessary, paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with; and
(c) provided that the conditions to which a listed registration is currently subject are complied with, the continued use of, or other dealing with, the product in accordance with instructions contained in the established standard:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia; and
(v) would be effective according to criteria determined by the APVMA for the product; and
(d) any other prescribed requirements for the continued listed registration would be complied with;
the APVMA must as soon as practicable:
(e) give written notice to the interested person or to an approved person stating that it affirms the listed registration on the conditions to which the listed registration is currently subject and giving brief particulars of the reasons for its decision; and
(f) if it caused a notice to be published under subsection 56X(1) in relation to its proposed reconsideration of the listed registration—cause to be published, in the same way as the first‑mentioned notice, a notice stating that it has affirmed the listed registration on the conditions to which the listed registration is currently subject.
(2) In satisfying itself as mentioned in subparagraph (1)(c)(i), (ii) or (iii), the APVMA must have regard to the matters referred to in subsection 56E(2).
(3) If the APVMA is not satisfied as mentioned in subsection (1), subsections (4) to (6) apply.
(4) The APVMA must give written notice to the interested person or to an approved person stating that the APVMA is not so satisfied.
(5) If the APVMA is satisfied that the relevant particulars or the conditions of the listed registration can be varied in such a way that the requirements for continued listed registration will be complied with:
(a) the APVMA must vary the relevant particulars or conditions of listed registration by entering in the Register of Chemical Products particulars of the variation and the date on which the entry is made; and
(b) the APVMA must:
(i) state in the notice referred to in subsection (4) that, although the APVMA is not satisfied as mentioned in subsection (1), it is satisfied that the relevant particulars or the conditions can be so varied and has varied them accordingly; and
(ii) set out in the notice particulars of the variation.
(6) A notice given under subsection (4) must give brief particulars of the reasons for the APVMA’s decision and, if subsection (5) applies, also give brief particulars of the reasons for the variation of the conditions of the listed registration.
(7) Section 168 provides for additional matters to be included in a notice to which subsection (5) applies.
(8) Section 56ZE provides for the suspension or cancellation of the listed registration if the APVMA is not satisfied that the conditions of the listed registration can be varied as mentioned in subsection (5).
Division 7—Suspension or cancellation of listed registration
56ZA Notice of proposed suspension or cancellation to be given to co‑ordinators
The APVMA must not suspend or cancel a listed registration unless:
(a) it has given notice of the proposed suspension or cancellation to each co‑ordinator designated for a jurisdiction; and
(b) a period of 10 working days, or any other period that the APVMA thinks adequate in a particular case, has elapsed since the notice was given.
56ZB Suspension or cancellation of listed registration for breach of condition
If there is a contravention of a condition of the listed registration of a chemical product, the APVMA may suspend or cancel the listed registration.
56ZC Suspension of listed registration for failing to give information, or results of trials or experiments, to APVMA
(1) If:
(a) at the end of the period stated in a notice given to a person under subsection 56X(2), the APVMA is satisfied that the interested person or an approved person is aware of information relevant to the reconsideration but the information has not been given to the APVMA; or
(b) at the end of the period stated in a notice given to a person under subsection 56Y(1), the APVMA is satisfied that the interested person has not conducted, or caused to be conducted, the trials or experiments or has not given the results of the trials or experiments to the APVMA;
the APVMA may suspend the listed registration.
(2) Subject to subsection (4), the APVMA must revoke a suspension imposed under paragraph (1)(a) when it is satisfied that all the information relevant to the reconsideration has been given to it.
(3) Subject to subsection (4), the APVMA must revoke a suspension imposed under paragraph (1)(b) when it has received the results of the trials or experiments.
(4) If the information or the results of the trials or experiments are not given to the APVMA within a period after the suspension takes place that the APVMA thinks reasonable, the APVMA may cancel the listed registration.
56ZD Suspension of listed registration for failing to give information, report or sample to APVMA
(1) If the interested person in relation to a registered listed chemical product, or an approved person, fails to comply with a requirement contained in a notice under section 159 or with section 160A or 161, the APVMA may suspend the listed registration.
(2) Subject to subsection (3), the APVMA must revoke a suspension imposed under subsection (1) if it is satisfied that the relevant information, report or sample has been given to it.
(3) If the information, report or sample is not given to the APVMA within a reasonable period after the suspension takes place, the APVMA may cancel the listed registration.
56ZE Suspension or cancellation of listed registration following reconsideration
If, in the course of reconsidering the listed registration of a chemical product, the APVMA is not satisfied that the relevant particulars or the conditions of the listed registration can be varied in such a way that the prescribed requirements for continued listed registration will be complied with, the APVMA may suspend or cancel the listed registration.
56ZF Suspension or cancellation of listed registration for non‑compliance with criteria
(1) The APVMA may suspend or cancel the listed registration of a chemical product if it appears to the APVMA that, having regard to the matters referred to in subsection 56E(2), the continued use of, or any other dealing with, the product in accordance with instructions contained in the established standard:
(a) may be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(b) may be likely to have an effect that is harmful to human beings; or
(c) may be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(d) may unduly prejudice trade or commerce between Australia and places outside Australia.
(2) The APVMA may suspend or cancel the listed registration of a chemical product if it appears to the APVMA that, having regard to the matters referred to in subsection 56E(3), the continued use of the product in accordance with the instructions contained in the standard may not be effective according to criteria determined by the APVMA for the product.
56ZG Cancellation of listed registration on request
(1) If:
(a) the interested person in relation to a listed registration, or an approved person, gives to the APVMA a written notice:
(i) requesting the APVMA to cancel the listed registration; and
(ii) stating the reasons for the request; and
(b) the APVMA is satisfied that there are no valid reasons why it should not agree to the request;
the APVMA must cancel the listed registration.
(2) The APVMA must give written notice of its decision on a request under subsection (1) to the person or persons who made the request.
56ZH Effect of suspension of listed registration
(1) A suspension of a listed registration must be for a stated period.
(2) A listed registration is taken for the purposes of this Code other than section 75 not to be in force during any period in which it is suspended.
(3) A listed registration may be cancelled even though it is suspended.
56ZI How listed registration is suspended or cancelled
(1) Suspension or cancellation of a listed registration is made by entering in the Register of Chemical Products:
(a) the fact that the listed registration has been suspended or cancelled; and
(b) in respect of a suspension—the period of the suspension; and
(c) the date on which the entry is made.
(2) Subject to subsection (4), if the APVMA suspends or cancels a listed registration, it must, as soon as practicable, give written notice of the suspension or cancellation to the interested person, or an approved person, and to any other person to whom, in its opinion, such a notice should be given.
(3) A notice given to a person under subsection (2) must:
(a) tell the person of the suspension or cancellation; and
(b) contain the following matters:
(i) brief reasons for the suspension or cancellation;
(ii) instructions for possessing, having custody of, using or otherwise dealing with the product;
(iii) a warning of the consequences if the person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to possess or have custody of the product with the intention of supply, or to supply the product;
(iv) any other warnings or explanations in relation to the product that the APVMA thinks desirable;
excluding any matters that the APVMA thinks it unnecessary for the notice to contain.
(4) Subsection (2) does not require notice of the cancellation under section 56ZG of a listed registration to be given to the person who requested the cancellation.
(5) Section 168 provides for additional matters to be included in a notice given under subsection (2).
(6) After a notice of the suspension or cancellation of the listed registration of a chemical product is given to a person under this section, the interested person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the product in accordance with the instructions contained in the notice until:
(a) 2 years after the day of the suspension or cancellation; or
(b) the APVMA revokes the suspension or cancellation; or
(c) the APVMA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the product;
whichever first occurs.
(7) Subject to subsection (9), if:
(a) a notice of the suspension or cancellation of the listed registration of a chemical product is given to a person under this section; and
(b) the person has possession or custody of the product with the intention of supply;
the person may only possess, have custody of or otherwise deal with the product if the possession, custody or dealing is in accordance with the instructions contained in the notice.
Penalty: 300 penalty units.
(8) In paragraph (7)(a), strict liability applies to the physical element of circumstance, that the notice is given to the person under this section.
Note: For strict liability, see section 6.1 of the Criminal Code.
(9) Subsection (7) does not apply to a possession, custody or dealing with a product if the product was a registered chemical product, a registered listed chemical product or a reserved chemical product as the case may be, when the possession, custody or dealing took place because of its having been registered or granted listed registration or having become reserved after its previous listed registration had been cancelled.
56ZJ How suspension or cancellation of listed registration is revoked
(1) Suspension or cancellation of a listed registration is revoked by entering in the Register of Chemical Products:
(a) the fact that the suspension or cancellation has been revoked; and
(b) the date on which the entry is made.
(2) If the APVMA revokes the suspension or cancellation of a listed registration, it must, as soon as practicable, give written notice of the revocation to the interested person or an approved person, and to any other person to whom, in its opinion, such a notice should be given.
(3) If the cancellation of a listed registration is revoked, the cancellation is taken never to have occurred.
Division 8—Duration and renewal of listed registration
56ZK Period of listed registration
(1) The listed registration of a chemical product ends at the end of 30 June next following the day on which the listed registration was granted or renewed, or last renewed, as the case may be.
(2) This section has effect subject to:
(a) any condition of a kind referred to in subsection 56O(3) to which a listed registration is subject; and
(b) subsection 56ZH(2) (which relates to suspension of a listed registration); and
(c) the following provisions of this Division.
56ZL Application for renewal of listed registration of chemical product
(1) The interested person may apply for the renewal, or further renewal, as the case may be, of the listed registration of a chemical product.
(2) Subject to subsection (3), the application must be made not later than one month, or a shorter period that the APVMA permits, before the listed registration ends.
(3) In circumstances that are prescribed by the regulations and upon payment of the prescribed fee (if any), the APVMA may accept a late application if the application is made on or before a date that the APVMA determines.
56ZM How application for renewal of listed registration is to be made
(1) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the APVMA requires; and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the APVMA.
(2) The APVMA may, with the written consent of an approved person, alter the application.
(3) At any time after an application has been made and before it has been determined, the applicant may withdraw the application by giving to the APVMA written notice of the withdrawal signed by an approved person.
(4) Subject to subsection (5), the APVMA must grant the application:
(a) if the application was made in accordance with subsection 56ZL(2)—before the listed registration ends; or
(b) if the application was made in accordance with subsection 56ZL(3)—within one month after the application was made;
and must give written notice to an approved person of the renewal and the period of the renewal.
(5) If an amount (including an amount in respect of a tax or penalty) that is payable (whether by the applicant or by any other person) to the APVMA in respect of the product under any law in force in any jurisdiction has not been paid, the APVMA may refuse to grant the application for renewal.
(6) If the application was made in accordance with subsection 56ZL(2) and the APVMA fails to grant the application before the listed registration ends, the listed registration continues in force until:
(a) the APVMA grants the application; or
(b) if the APVMA decides to refuse to grant the application because of non‑payment of an amount as mentioned in subsection (5)—the APVMA gives written notice of its decision to the applicant.
(7) If the APVMA accepts a late application under subsection 56ZL(3) and grants the application, the listed registration continues in force, or is taken to have continued in force, as the case may be, until the application is or was granted.
56ZN Renewal of listed registration of chemical product
The renewal of the listed registration of a chemical product:
(a) is granted by entering in the Register of Chemical Products a statement that the listed registration has been renewed and the date on which the renewed listed registration ends; and
(b) takes effect, or is to be regarded as having taken effect, as the case may be, at the beginning of the day immediately following the day on which the previous listed registration ends or ended.
Division 9—Publication of notices and certain other instruments by APVMA
56ZO Publication of notice of listed registration of chemical product
(1) If the APVMA grants listed registration in respect of a chemical product, it must, as soon as practicable after the listed registration, cause notice of the listed registration to be published in accordance with subsection (2), unless the APVMA thinks it unnecessary, in the circumstances, to publish such a notice.
(2) The notice:
(a) is to be published in the Gazette and in any other manner that the APVMA thinks appropriate; and
(b) must state that the product has been granted listed registration, and state the date of the listed registration; and
(c) must contain a brief statement of the conditions of the listed registration that directly regulate the use of the product.
56ZP Publication of notice of variations of listed registration of chemical product
(1) If the APVMA varies any of the relevant particulars of the listed registration of a chemical product or any of the conditions of such a listed registration, it must, as soon as practicable after the variation, cause notice of the variation to be published in the Gazette and in any other manner that it thinks appropriate, unless the APVMA thinks it unnecessary, in the circumstances, to do so.
(2) The notice must:
(a) state that the relevant particulars or conditions have been varied and state the date of the variation; and
(b) contain a brief statement of the nature of, and reasons for, the variation.
56ZQ Publication of notice of end of listed registration of chemical product
(1) If the listed registration of a chemical product ends and is not renewed, the APVMA must, as soon as practicable, cause to be published in the Gazette, and in any other manner that it thinks appropriate, a notice:
(a) stating that the listed registration has ended; and
(b) containing instructions for possessing, having custody of, using or otherwise dealing with the product; and
(c) containing a warning of the consequences if a person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to possess or have custody of the product with the intention of supply, or to supply the product; and
(d) containing any other warnings or explanations in relation to the product that the APVMA thinks desirable; and
(e) setting out the date on which the listed registration ended; and
(f) containing any other information that the APVMA thinks appropriate;
unless the APVMA thinks that, in the circumstances, it is unnecessary to publish such a notice.
(2) If, after the publication under this section of a notice stating that the listed registration of a chemical product has ended, a person possesses, has custody of, uses or otherwise deals with the product in accordance with the instructions contained in the notice, the person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the product in accordance with those instructions until:
(a) 2 years after the day on which the registration ends; or
(b) the APVMA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the product;
whichever first occurs.
(3) Subject to subsection (5), if:
(a) a notice stating that the listed registration of a chemical product has ended has been published under this section; and
(b) a person has possession or custody of the product with the intention of supply;
the person may only possess, have custody of or otherwise deal with the product if the possession, custody or dealing is in accordance with the instructions contained in the notice.
Penalty: 300 penalty units.
(4) In paragraph (3)(a), strict liability applies to the physical element of circumstance, that the publishing of the notice was under this section.
Note: For strict liability, see section 6.1 of the Criminal Code.
(5) Subsection (3) does not apply to a possession, custody or dealing with a product if the product was a registered listed chemical product, a registered chemical product or a reserved chemical product when the possession, custody or dealing took place because of its having been granted listed registration, having been registered or having become reserved after the previous listed registration had ended.
(6) If a notice stating that the listed registration of a chemical product has ended is published under this section, the APVMA must cause a copy of the notice to be given to any person who, in the opinion of the APVMA, should be given notice of the ending of the listed registration and of the instructions, warnings and explanations contained in the notice.
56ZR Publication of notice of suspension or cancellation of listed registration
(1) If the APVMA suspends or cancels the listed registration of a chemical product, it must, as soon as practicable, cause to be published in the Gazette, and in any other manner that it thinks appropriate, notice of the suspension or cancellation containing any information that it thinks relevant.
(2) If the reason, or one of the reasons, for the suspension or cancellation was that the continued use of the product:
(a) might be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(b) might be likely to have an effect that is harmful to human beings; or
(c) might be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(d) might not be effective according to criteria determined by the APVMA for the product;
the notice must contain the following:
(e) a statement to that effect;
(f) instructions for possessing, having custody of, using or otherwise dealing with the product;
(g) a warning of the consequences if a person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to possess or have custody of the product with the intention of supply, or to supply the product;
(h) any other warnings or explanations in relation to the product that the APVMA thinks desirable.
(3) If, after the publication under this section of a notice of the suspension or cancellation of a listed registration, a person possesses, has custody of, uses or otherwise deals with the product in accordance with the instructions contained in the notice, the person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the product in accordance with those instructions until:
(a) 2 years after the day of the suspension or cancellation; or
(b) the APVMA revokes the suspension or cancellation; or
(c) the APVMA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the product;
whichever first occurs.
(4) Subject to subsection (6), if:
(a) a notice of the suspension or cancellation of the listed registration of a chemical product, has been published under this section; and
(b) a person has possession or custody of the product with the intention of supply;
the person may only possess, have custody of or otherwise deal with the product if the possession, custody or dealing is in accordance with the instructions contained in the notice.
Penalty: 300 penalty units.
(5) In paragraph (4)(a), strict liability applies to the physical element of circumstance, that the publishing of the notice was under this section.
Note: For strict liability, see section 6.1 of the Criminal Code.
(6) Subsection (4) does not apply to a possession, custody or dealing with a product if the product was a registered listed chemical product or a reserved chemical product when the possession, custody or dealing took place because of its having been granted listed registration or having become reserved after its previous listed registration had been cancelled.
(7) If the APVMA causes a notice of the suspension or cancellation of the listed registration of a chemical product to be published under this section, the APVMA must cause a copy of the notice to be given to any person who, in the opinion of the APVMA, should be given notice of the suspension or cancellation and of the instructions, warnings and explanations contained in the notice.
56ZS Notice of revocation of suspension or cancellation to be published
If the APVMA revokes the suspension or cancellation of the listed registration of a chemical product, it must, as soon as practicable, cause to be published in the Gazette, and in any other manner that it thinks appropriate, notice of the revocation containing any information that it thinks relevant.
56ZT Publication of instrument varying established standard for listable chemical product
If, after a copy of an instrument varying the established standard for a listable chemical product is published in the Gazette under section 56G, a person possesses, has custody of, uses or otherwise deals with part of any stock of the product that complies with the standard that was established for the product immediately before the variation, the person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with that part of the stock of the product in accordance with the instructions contained in the standard as in force immediately before the variation until:
(a) 2 years after the day of the publication of the notice; or
(b) the APVMA, by notice published in the Gazette, declares that this section ceases to apply in respect of the product;
whichever first occurs.
Part 2B—Reserved chemical products
56ZU Regulations may contain schedule of reserved chemical products
(1) Subject to subsection (2), the regulations may contain a schedule specifying chemical products, or classes of chemical products, that are reserved chemical products for the purposes of this Code.
(2) The schedule cannot specify a chemical product that is, or a class of chemical products that includes, a restricted chemical product.
(3) Regulations containing a schedule mentioned in subsection (1) must state the conditions to which the possession, having custody of, use of, or other dealing with, each chemical product, or each chemical product included in a class of chemical products, specified in the schedule is subject.
(4) Before the Governor‑General makes a regulation for the purposes of this section:
(a) the reservation of the product, or class of products, must have been recommended to the Minister by the APVMA; and
(b) the APVMA must have given to the Minister:
(i) written particulars of the product or class of products; and
(ii) a draft of the conditions to which the APVMA proposes the product, or products in the class, should be subject; and
(c) the APVMA must have given to the Minister a written explanation as to why the APVMA is satisfied that use of the product, or use of the products in the class, in accordance with the proposed conditions:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia; and
(v) would be effective according to criteria determined by the APVMA for the product; and
(d) the APVMA must have given to the Minister a written statement identifying the consultations held by, and setting out the advice given to, the APVMA in relation to the proposed reservation of the products or class of products.
Part 3—Compensation for provider of certain information in respect of continued registration of certain chemical products
Division 1—Preliminary
57 Explanation of Part
(1) This Part contains provisions that entitle a person who has provided protected information to the APVMA in relation to a protected active constituent or in relation to a protected chemical product, in compliance with a requirement made of the person by the APVMA, to receive compensation from anyone else who wishes the information to be used by the APVMA in connection with an application for the approval, or continued approval, of another active constituent or the registration, or continued registration, of another chemical product.
(2) Compensation is not payable in respect of the information unless:
(a) the protected active constituent or the protected chemical product is or includes a patentable invention and the term of the patent has ended or is about to end; and
(b) the information was obtained from trials or laboratory experiments and relates to the interaction between the constituent or product and:
(i) the environment; or
(ii) living organisms or naturally occurring populations in ecosystems, including human beings;
and is not information that was obtained merely for the purpose of assessing the performance of the constituent or product.
(3) Compensation is not payable in respect of information if the constituent or product is for use only in relation to a species of animals that is not a food‑producing species.
(4) The parties concerned are invited to negotiate the terms of the compensation and provision is made for the appointment of a mediator if the parties are unable to agree and for the terms to be arbitrated if the mediation is unsuccessful. If an arbitration takes place, the arbitrator is to base his or her decision on whichever of the proposals put forward by the parties is considered by the arbitrator to be the most reasonable assessment of the proportion of the cost of producing the information that it is fair for the party wishing to use it to pay to the party who provided it.
Division 2—Right to compensation
58 Right of APVMA to use information
(1) Except as provided in section 14B, Division 4A of Part 2 and this Part, the APVMA may use information obtained by it from any source for the purpose of performing any of its functions or exercising any of its powers under this Code.
(2) This Part does not affect the operation of section 169.
59 Right of originator of protected information to compensation for its use in relation to other applications
(1) Subject to subsections (1A) and (2), if, in compliance with a requirement that the APVMA:
(a) has made under paragraph 32(2)(b) or section 33; or
(b) has made under section 159 for the purposes of paragraph 159(1)(c) or (d);
protected information has been given to the APVMA in relation to:
(c) a protected active constituent for a proposed or existing chemical product (the primary active constituent); or
(d) a protected chemical product (the primary chemical product);
the APVMA must not use the information in determining whether to approve, or to continue the approval of, another active constituent for a proposed or existing chemical product (the secondary active constituent), or whether to register, or to continue the registration of, another chemical product (the secondary chemical product).
(1A) Subsection (1) does not apply if the information is the same as information previously given to the APVMA otherwise than in compliance with a requirement referred to in that subsection.
(2) Subsection (1) does not apply if:
(a) the primary applicant and the secondary applicant:
(i) have agreed as to the terms of the compensation to be paid by the secondary applicant to the primary applicant for the information to be used in relation to the secondary active constituent or the secondary chemical product, as the case may be; and
(ii) have notified the APVMA in writing that they have so agreed and of the terms of the compensation; or
(b) an arbitrator that the APVMA has appointed has determined the compensation to be so paid and the secondary applicant has given notice to the primary applicant and to the APVMA stating that the secondary applicant agrees to comply with the determination; or
(c) the protection period has elapsed since that information was given to the APVMA; or
(d) the APVMA is satisfied, having regard to such criteria (if any) as are prescribed, that it is in the public interest for the information to be so used.
(3) If the APVMA decides to use the information under paragraph (2)(d), the APVMA:
(a) must give written notice of its decision to the primary applicant and the secondary applicant; and
(b) must not make a determination using the information before the end of 28 days after the day on which the notice is given.
(4) Section 168 provides for additional matters to be included in a notice given under paragraph (3)(a).
(5) Without affecting the duty of the APVMA to comply with subsection (1):
(a) the validity of any approval, or continued approval, of the secondary active constituent or the validity of any registration, or continued registration, of the secondary chemical product is not affected by a contravention by the APVMA of that subsection or by the failure of the secondary applicant to comply with the agreement or determination; and
(b) no action or other proceeding lies against the Commonwealth, the APVMA, or a person who is or has been a delegate of the APVMA, a director of the APVMA, the Chief Executive Officer of the APVMA, or a member of the staff of the APVMA, for any loss directly or indirectly sustained because of such a contravention or failure.
60 APVMA to notify applicants
(1) This section applies if:
(a) the APVMA is unable to complete its consideration of:
(i) the approval or continued approval of an active constituent for a proposed or existing chemical product; or
(ii) the registration or continued registration of a secondary chemical product;
under this Code unless it uses protected information; and
(b) paragraph 59(2)(c) does not permit the APVMA to use the information.
(2) The APVMA must give to the secondary applicant written notice:
(a) stating that the APVMA’s consideration of:
(i) the approval or continued approval of the secondary active constituent; or
(ii) the registration or continued registration of the secondary chemical product;
cannot be completed unless the APVMA uses the information; and
(b) stating that the APVMA is precluded from using the information except in circumstances prescribed by paragraph 59(2)(a), (b) or (d) and setting out those circumstances; and
(c) requesting the secondary applicant to tell the APVMA, within a reasonable period stated in the notice, whether the secondary applicant wants the APVMA to take further action in respect of the information under this section.
(3) If the secondary applicant tells the APVMA that it wants the APVMA to take further action in respect of the information under this section, the APVMA must give to the primary applicant or each primary applicant and to the secondary applicant written notice:
(a) containing:
(i) in respect of the notice to a primary applicant—the prescribed information about the secondary applicant and about the secondary active constituent or the secondary chemical product, as the case may be; or
(ii) in respect of the notice to the secondary applicant—the prescribed information about the primary applicant and about the primary active constituent or the primary chemical product, or about each primary applicant and about each primary active constituent or primary chemical product, as the case may be; and
(b) stating that the APVMA’s consideration of the approval or continued approval of the secondary active constituent, or of the registration or continued registration of the secondary chemical product, cannot be completed unless the APVMA uses protected information given by a primary applicant but the APVMA is precluded from using that information except in circumstances prescribed by paragraph 59(2)(a), (b) or (d) and setting out those circumstances; and
(c) inviting the primary applicant or each primary applicant, and the secondary applicant, within a period stated in the notice, to negotiate as to the terms of the compensation to be paid by the secondary applicant to that primary applicant for the use of that information and to give written notice to the APVMA of the results of the negotiation; and
(d) telling them that, if they are unable to agree as to the terms of the compensation:
(i) a mediator will be appointed to try to help them to reach agreement; and
(ii) if the mediation is not successful, an arbitrator will be appointed to determine those terms in accordance with any reasonable proposals made in the course of the negotiations (including negotiations during the period of the mediation); and
(iii) if the arbitrator finds that no reasonable proposals were made, the APVMA may suspend the approval of the primary active constituent or the registration of the primary chemical product (as the case may be), or the approval of the secondary active constituent or the registration of the secondary chemical product (as the case may be), or both; and
(e) telling them of the obligations imposed on the primary applicant or each primary applicant under section 61.
61 Primary applicant to notify secondary applicant
(1) As soon as practicable after a primary applicant receives a notice under section 60, the primary applicant must give written notice to the secondary applicant setting out the following:
(a) the amount of the cost incurred by the primary applicant in obtaining the protected information excluding any part of that cost that relates to information that was obtained from a Government or public authority, whether in Australia or elsewhere, or was otherwise publicly available;
(b) particulars of the amounts included in that cost as mentioned in subsection 69(3);
(c) when the protected information was obtained by the primary applicant;
(d) when the APVMA required the primary applicant to give the protected information to the APVMA;
(e) any other information required by the regulations.
Penalty: 300 penalty units.
(2) An offence under subsection (1) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
Division 3—Mediation or arbitration as to terms of compensation
62 Application of Division
(1) This Division applies if:
(a) there is only one primary applicant and the primary applicant is unable to agree with the secondary applicant as to the terms of the compensation to be paid by the secondary applicant to the primary applicant; or
(b) there are 2 or more primary applicants and none of them is able to agree with the secondary applicant as to the terms of the compensation to be paid by the secondary applicant to the primary applicant concerned;
and the secondary applicant has notified the APVMA in writing of the failure to reach agreement.
(2) If the secondary applicant tells the APVMA at any time during the course of any negotiations, mediation or arbitration under this Division that the secondary applicant no longer wants any further action to be taken under this Division for the purposes of the secondary application, this Division ceases to apply in relation to that application.
63 Mediation
(1) The APVMA must appoint a person as a mediator to try to help the parties to the negotiations to reach agreement as to the terms of the compensation.
(2) The mediation ceases:
(a) if the parties reach agreement as to those terms; or
(b) the mediator or either party to the mediation tells the APVMA that the mediation has not been successful; or
(c) 14 days have elapsed since the appointment of the mediator.
(3) If, before the mediation ceases, the person appointed as the mediator:
(a) dies; or
(b) becomes incapable of performing, or continuing to perform, his or her functions; or
(c) resigns his or her appointment; or
(d) for any other reason refuses or fails to perform, or to complete the performance of, his or her functions as required by this section;
the APVMA may appoint another person as mediator in place of the first‑mentioned person.
(4) If another mediator is appointed under subsection (3), the period of 14 days referred to in paragraph (2)(c) is taken to have begun from the appointment of the first mediator but that period does not include any period after the occurrence of an event referred to in subsection (3) and before the appointment of the other mediator.
64 Appointment of arbitrator
(1) If the mediation has ceased without the parties having reached agreement as to the terms of the compensation, the APVMA must appoint a person as an arbitrator to determine those terms in accordance with any reasonable proposals that were made in the course of the negotiations (including negotiations during the period of the mediation).
(2) If, before the functions of an arbitrator appointed under this section (including this subsection) are fully performed, the person appointed as the arbitrator:
(a) dies; or
(b) becomes incapable of performing, or continuing to perform, his or her functions; or
(c) resigns his or her appointment; or
(d) for any other reason refuses or fails to perform, or to complete the performance of, his or her functions as required by this section;
the APVMA may appoint another person as arbitrator in place of the first‑mentioned person.
65 Determination of compensation on the basis of proposals made during negotiations
(1) The arbitrator must consider the proposals as to the terms of the compensation that were made by the parties to the negotiations or each of the negotiations.
(2) If a party to any negotiations made a proposal as to the terms of the compensation that the arbitrator considers to be reasonable and the other party failed to make any proposal as to those terms or failed to make a proposal that the arbitrator considers to be reasonable, the arbitrator must determine those terms in accordance with the first‑mentioned proposal.
(3) If each party to any negotiations made proposals as to the terms of the compensation that the arbitrator considers to be reasonable, the arbitrator must determine those terms in accordance with whichever of those proposals the arbitrator considers to be the most reasonable.
66 Arbitrator may require fresh proposals
If each party to any negotiations failed to make any proposal as to the terms of the compensation or failed to make a proposal as to those terms that the arbitrator considers to be reasonable, the arbitrator must give written notice to each of them requiring them to make fresh proposals to the arbitrator as to the terms of the compensation.
67 Determination on basis of fresh proposals
(1) If a party to an arbitration makes a fresh proposal as to the terms of the compensation that the arbitrator considers to be reasonable and the other party fails to make any fresh proposal as to those terms or fails to make a fresh proposal that the arbitrator considers to be reasonable, the arbitrator must determine those terms in accordance with the first‑mentioned proposal.
(2) If each party to an arbitration makes fresh proposals as to the terms of the compensation that the arbitrator considers to be reasonable, the arbitrator must determine those terms in accordance with whichever of those proposals the arbitrator considers to be the most reasonable.
68 What happens if fresh proposals are not made or are inadequate
If each party to an arbitration fails, within a reasonable period, to make a fresh proposal as to the terms of the compensation or to make a fresh proposal as to those terms that the arbitrator considers to be reasonable, the arbitrator must give written notice of the failure to the APVMA and, upon the giving of the notice, section 39 permits the APVMA to suspend the registration of the primary product or any of the primary products or of the secondary product, or both or all of them.
69 What constitutes a reasonable proposal for compensation
(1) A proposal as to the terms of the compensation is taken to be reasonable if, and only if, the arbitrator is satisfied that:
(a) it provides for an amount or amounts to be paid by the secondary applicant to a primary applicant; and
(b) the amount or amounts represent a fair proportion of:
(i) the amount of the cost incurred by that primary applicant in obtaining the protected information excluding any part of that cost that relates to information that was obtained from a Government or public authority, whether in Australia or elsewhere, or was otherwise publicly available; or
(ii) if the protected information was obtained by that primary applicant before the APVMA required that applicant to give that information to the APVMA—a lesser amount than the amount worked out under subparagraph (i) that is appropriate having regard to the period between the time when that information was so obtained and the time when it was given to the APVMA.
(2) The question as to what is a fair proportion of an amount referred to in subparagraph (1)(b)(i) or (ii) is to be determined by the arbitrator having regard to any matters that are prescribed by the regulations and any other matters that he or she considers appropriate.
(3) For the purposes of subsection (1), the amount of the cost incurred by a primary applicant in obtaining protected information comprises:
(a) all relevant costs incurred by that primary applicant in obtaining that information (taking into account the practices generally engaged in by persons conducting tests or laboratory experiments of the kinds used to obtain information of the kind concerned) and including, without limiting the above:
(i) the direct and indirect costs of planning, conducting, and analysing the results of, tests and laboratory experiments and giving the information to the APVMA; and
(ii) the cost of repeating, or redoing with modifications, tests or laboratory experiments if it was appropriate to repeat or redo them; and
(iii) if the tests or laboratory experiments were conducted by the use of equipment of that primary applicant—depreciation on that equipment; and
(iv) any other prescribed costs; and
(b) a reasonable rate of interest on the amount worked out under paragraph (a).
(4) The reference in paragraph (3)(a) to all relevant costs incurred by a primary applicant includes, if the primary applicant is a body corporate, an appropriate portion of any relevant costs incurred by another body corporate that is related to the primary applicant.
(5) The question whether 2 bodies corporate are related to each other is to be determined in the same way as for the purposes of the Corporations Act 2001.
70 Effect and enforcement of determination by arbitrator
(1) If the arbitrator makes a determination or determinations as to the terms of the compensation to be paid by the secondary applicant to a primary applicant or primary applicants, the following provisions apply.
(2) The arbitrator must:
(a) send the determination, or each determination, to the APVMA; and
(b) give to the primary applicant and secondary applicant to whom a determination relates a copy of the determination certified by the arbitrator to be a true copy.
(3) If there is only one such determination and the secondary applicant gives written notice to the primary applicant stating that the secondary applicant agrees to comply with the determination, the secondary applicant is liable to pay compensation to the primary applicant in accordance with the determination.
(4) If there are 2 or more such determinations and the secondary applicant gives written notice to the primary applicant to whom one of those determinations relates stating that the secondary applicant agrees to comply with that determination, the secondary applicant is liable to pay compensation to that primary applicant in accordance with that determination.
(5) If the secondary applicant to whom a determination relates gives notice under subsection (3) or (4) to the primary applicant to whom that determination relates, that secondary applicant must give a copy of the notice to the APVMA.
Penalty: 10 penalty units.
(5A) Subsection (5) does not apply if the secondary applicant has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (5A). See subsection 13.3(3) of the Criminal Code.
(5B) An offence under subsection (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(6) If a primary applicant to whom a determination by the arbitrator relates receives a notice under subsection (3) or (4) by the secondary applicant to whom that determination relates, that primary applicant may lodge a copy of the determination certified by the arbitrator, together with the notice, with a court having jurisdiction to the extent of the total amount of compensation payable under the determination and, when the determination and application have been so lodged, the determination may be enforced as a final judgment of that court.
71 Regulations to govern conduct of arbitration
(1) The regulations may make rules governing the conduct of an arbitration under this section.
(2) The regulations may provide that rules so made apply to the exclusion of any law of this jurisdiction relating to the conduct of commercial arbitrations.
Part 4—Control of chemical products
Division 1—Preliminary
72 Explanation of Part
(1) This Part regulates the supply of active constituents for chemical products and the supply of chemical products.
(2) The Part restricts:
(a) the possession of unapproved constituents and unregistered products for the purpose of supplying them; and
(b) the supply of unapproved constituents or unregistered products; and
(c) the supply of approved constituents, registered products, registered listed products or reserved products in contravention of the conditions of their approval, registration, listed registration or reservation.
(3) Section 73 contains special provisions relating to the application of this Part to veterinary surgeons.
(4) Division 2 contains provisions relating to active constituents or chemical products generally.
(5) Division 3 contains special provisions relating to the manufacture and supply of date‑controlled chemical products.
(6) Division 4 relates to the supply of certain restricted chemical products.
73 Part not to apply to veterinary surgeons acting under other laws
(1) This Part does not apply to a veterinary surgeon, or a person acting under the instructions of a veterinary surgeon, in respect of any thing done or omitted to be done by him or her if the doing of, or the omitting to do, that thing is permitted by or under a law of this jurisdiction other than the Agvet Code of this jurisdiction.
(2) Nothing in this Part affects the application to a veterinary surgeon of any other law of this jurisdiction.
Division 2—Control generally
74 Possession or custody of unapproved active constituents with the intention of supply
(1) A person must not at any time (the relevant time) have in the person’s possession or custody with the intention of supply a substance that is likely to be used as an active constituent for a chemical product unless:
(a) the substance is an approved active constituent for a proposed or existing chemical product; or
(b) the substance is exempted by the APVMA from the operation of this section; or
(c) the possession or custody is authorised by a permit; or
(d) all the following subparagraphs apply:
(i) the constituent had, at a time or times before the relevant time, been approved under this Code or a corresponding previous law;
(ii) the period beginning on the day when the constituent ceased, or last ceased, to be so approved and ending at the relevant time is not longer than a period that the APVMA has determined in relation to the constituent for the purposes of this subparagraph;
(iii) if the approval of the constituent was subject to conditions—the possession or custody is in accordance with those conditions.
Penalty: 200 penalty units.
Note: The defendant bears an evidential burden in relation to the matters in paragraphs (1)(a) to (d). See subsection 13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or on the application of a person, extend a period determined by it under subparagraph (1)(d)(ii) for a further period or periods determined by it.
(3) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that at the relevant time the person did not know, and could not reasonably be expected to have known, that the substance was not an approved active constituent.
Note: The defendant bears a legal burden in relation to the matter in subsection (3). See section 13.4 of the Criminal Code.
(4) If an application is made to the APVMA under subsection (2), the APVMA must give to the applicant written notice of its decision on the application.
(5) Section 168 provides for additional matters to be included in a notice given under subsection (4).
75 Possession or custody of chemical products, other than registered, registered listed or reserved products, with the intention of supply
(1) A person must not at any time (the relevant time) have in the person’s possession or custody with the intention of supply a chemical product that is not a registered chemical product, a registered listed chemical product or a reserved chemical product unless:
(a) the possession or custody is authorised by a permit; or
(b) the product is exempted by the APVMA from the operation of this section; or
(c) all the following subparagraphs apply:
(i) the product had, at a time or times before the relevant time, been registered under this Code or a corresponding previous law;
(ii) the period beginning on the day when the product ceased, or last ceased, to be so registered and ending at the relevant time is not longer than a period that the APVMA has determined in relation to the product for the purposes of this subparagraph;
(iii) a recall notice has not been issued in respect of the product;
(iv) if the registration of the product was subject to conditions—the possession or custody is in accordance with those conditions.
Penalty: 200 penalty units.
Note: The defendant bears an evidential burden in relation to the matters in paragraphs (1)(a) to (c). See subsection 13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or on the application of a person, extend a period determined by it under subparagraph (1)(c)(ii) for a further period or periods determined by it.
(3) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that at the relevant time the person did not know, and could not reasonably be expected to have known, that the chemical product was not a registered chemical product, a registered listed chemical product or a reserved chemical product.
Note: The defendant bears a legal burden in relation to the matter in subsection (3). See section 13.4 of the Criminal Code.
(4) If an application is made to the APVMA under subsection (2), the APVMA must give to the applicant written notice of its decision on the application.
(5) Section 168 provides for additional matters to be included in a notice given under subsection (4).
76 Supply of unapproved active constituents
(1) A person must not supply, or cause or permit to be supplied, an active constituent for a proposed or existing chemical product that is not an approved active constituent unless:
(a) the constituent is exempted by the APVMA from the operation of this section; or
(b) the supply is authorised by a permit; or
(c) all the following subparagraphs apply:
(i) the constituent had, at a time or times before the supply takes place, been approved under this Code or a corresponding previous law;
(ii) the period beginning on the day when the constituent ceased, or last ceased, to be so approved and ending on the day when the supply takes place is not longer than a period that the APVMA has determined in relation to the constituent for the purposes of this subparagraph;
(iii) the supply is a supply of part of a stock of the constituent that was in the person’s possession or custody immediately before the product so ceased, or last ceased, to be approved;
(iv) if the approval of the constituent was subject to conditions—the supply is in accordance with those conditions.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in relation to the matters in paragraphs (1)(a) to (c). See subsection 13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or on the application of a person, extend a period determined by it under subparagraph (1)(c)(ii) for a further period or periods determined by it.
(3) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that, when the person supplied the constituent, or caused or permitted the constituent to be supplied, as the case may be, the person did not know, and could not reasonably be expected to have known, that the active constituent was not an approved active constituent.
Note: The defendant bears a legal burden in relation to the matter in subsection (3). See section 13.4 of the Criminal Code.
(4) If an application is made to the APVMA under subsection (2), the APVMA must give to the applicant written notice of its decision on the application.
(5) Section 168 provides for additional matters to be included in a notice given under subsection (4).
77 Supply of approved active constituents in contravention of conditions of approval
(1) A person must not supply, or cause or permit to be supplied, an approved active constituent for a proposed or existing chemical product whose approval is subject to conditions unless the supply is in accordance with those conditions or is authorised by a permit.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in relation to establishing that the supply is in accordance with the conditions or is authorised by a permit. See subsection 13.3(3) of the Criminal Code.
(2) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that, when the person supplied the constituent, or caused or permitted the constituent to be supplied, as the case may be, the person did not know, and could not reasonably be expected to have known, that the approval of the constituent was subject to the conditions referred to in that subsection.
Note: The defendant bears a legal burden in relation to the matter in subsection (2). See section 13.4 of the Criminal Code.
78 Supply of chemical products that are not registered products, registered listed products or reserved products
(1) A person must not supply, or cause or permit to be supplied, a chemical product that is not a registered chemical product, a registered listed chemical product or a reserved chemical product unless:
(a) the supply is authorised by a permit; or
(b) the product is exempted by the APVMA from the operation of this section; or
(c) all the following subparagraphs apply:
(i) at a time or times before the supply takes place, the product had been registered, granted listed registration, or reserved, under this Code or had been registered under a corresponding previous law;
(ii) the period beginning on the day when the product ceased, or last ceased, to be so registered, granted listed registration, or reserved, and ending on the day when the supply takes place is not longer than a period that the APVMA has determined in relation to the product for the purposes of this subparagraph;
(iii) the supply is a supply of part of a stock of the product that was in the person’s possession or custody immediately before the product ceased, or last ceased, to be so registered, granted listed registration, or reserved;
(iv) a recall notice has not been given in respect of the product;
(v) the person is not the person who imported the product into, or manufactured the product in, Australia;
(vi) if the registration or listed registration of the product was subject to conditions—the supply is in accordance with those conditions.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in relation to the matters in paragraphs (1)(a) to (c). See subsection 13.3(3) of the Criminal Code.
(2) The APVMA may, on its own initiative or on the application of a person, extend a period determined by it under subparagraph (1)(c)(ii) for a further period or periods determined by it.
(3) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that, when the chemical product was supplied, or caused or permitted to be supplied, as the case may be, the person did not know, and could not reasonably be expected to have known, that the product was not a registered chemical product, a registered listed chemical product or a reserved chemical product.
Note: The defendant bears a legal burden in relation to the matter in subsection (3). See section 13.4 of the Criminal Code.
(4) If an application is made to the APVMA under subsection (2), the APVMA must give to the applicant written notice of its decision on the application.
(5) Section 168 provides for additional matters to be included in a notice given under subsection (4).
79 Supply of registered chemical products in contravention of conditions of registration
(1) A person must not supply, or cause or permit to be supplied, a registered chemical product whose registration is subject to conditions unless the supply is in accordance with those conditions or is authorised by a permit.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in relation to establishing that the supply is in accordance with the conditions or is authorised by a permit. See subsection 13.3(3) of the Criminal Code.
(2) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that, when the chemical product was supplied, or caused or permitted to be supplied, as the case may be, the person did not know, and could not reasonably be expected to have known, that the registration of the product was subject to the conditions referred to in that subsection.
Note: The defendant bears a legal burden in relation to the matter in subsection (2). See section 13.4 of the Criminal Code.
79A Supply of registered listed chemical products in contravention of conditions of listed registration
A person may only supply, or cause or permit to be supplied, a registered listed chemical product whose listed registration is subject to conditions if:
(a) the supply is in accordance with those conditions; or
(b) the supply is authorised by a permit.
Penalty: 300 penalty units.
79B Supply of reserved chemical products contrary to conditions specified in the regulations
(1) A person may only supply, or cause or permit to be supplied, a reserved chemical product if:
(a) the supply is in accordance with the conditions specified in regulations made for the purposes of section 56ZU that relate to the product; or
(b) the supply is authorised by a permit.
Penalty: 300 penalty units.
(2) In subsection (1), strict liability applies to the physical element of circumstance, that the conditions relating to the product were specified in regulations made for the purposes of section 56ZU.
Note: For strict liability, see section 6.1 of the Criminal Code.
80 Supply of chemical products without a label
(1) A person must not supply, or cause or permit to be supplied, a chemical product in a container that does not have a label attached to it unless the supply is authorised by a permit.
Penalty: 300 penalty units.
Note: The defendant bears an evidential burden in relation to establishing that the supply is authorised by a permit. See subsection 13.3(3) of the Criminal Code.
(2) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that, when the chemical product was supplied, or caused or permitted to be supplied, as the case may be, in the container, the person did not know, and could not reasonably be expected to have known, that the container did not have a label attached to it.
Note: The defendant bears a legal burden in relation to the matter in subsection (2). See section 13.4 of the Criminal Code.
81 Supply of registered chemical products with unapproved label
(1) A person may only supply, or cause or permit to be supplied, a registered chemical product in a container if:
(a) the label attached to the container:
(i) states the relevant particulars; and
(ii) does not contain information that is contrary to the relevant particulars; or
(b) the supply is authorised by a permit.
Penalty: 300 penalty units.
(2) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that, when the chemical product was supplied, or caused or permitted to be supplied, as the case may be, in the container, the person did not know, and could not reasonably be expected to have known, that the label attached to the container:
(a) did not state the relevant particulars; or
(b) contained information contrary to the relevant particulars.
Note: The defendant bears a legal burden in relation to the matter in subsection (2). See section 13.4 of the Criminal Code.
(3) Subsection (1) does not apply to the supply of a registered chemical product in a container in the circumstances mentioned in that subsection if:
(a) the label attached to the container states the relevant particulars that were required to be stated on a label (the earlier approved label) that was an approved label for containers for the product at a time before the supply takes place; and
(b) the APVMA has determined that this subsection is to apply in respect of the earlier approved label; and
(c) the supply takes place not later than 2 years (or such shorter or longer period as the APVMA allows) after the earlier approved label ceased to be the approved label for containers for the product.
82 Supply of chemical products in containers opened by inspector
(1) A person must not supply, or cause or permit to be supplied, a chemical product in a container that has been opened by an inspector under paragraph 131(1)(f).
Penalty: 300 penalty units.
(1A) Subsection (1) does not apply if the person had the written consent of an inspector to engage in the conduct concerned.
Note: The defendant bears an evidential burden in relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal Code.
(2) It is a defence to a prosecution of a person for an offence against subsection (1) if the person proves that, when the chemical product was supplied, or caused or permitted to be supplied, as the case may be, in the container, the person did not know, and could not reasonably be expected to have known, that the container had been opened by an inspector.
Note: The defendant bears a legal burden in relation to the matter in subsection (2). See section 13.4 of the Criminal Code.
(3) In subsection (1), strict liability applies to the physical element of circumstance, that, in opening the container, the inspector was acting under paragraph 131(1)(f).
Note: For strict liability, see section 6.1 of the Criminal Code.
83 Supply of substances whose constituents differ from constituents of registered chemical product
(1) A person must not supply, or cause or permit to be supplied, a substance or mixture of substances in a container to which is attached a label containing a name of a registered chemical product if:
(a) the constituents of the substance or mixture differ by more than the prescribed extent from the constituents of the registered chemical product that were shown in the particulars of the registered chemical product contained in the Register of Chemical Products; or
(b) the concentration of the constituents of the substance or mixture differs by more than the prescribed extent from the concentration of the constituents of the registered chemical product that was shown in those particulars; or
(c) the composition or purity of any constituent of the substance or mixture differs by more than the prescribed extent from the composition or purity of the corresponding constituent of the registered chemical product that was shown in those particulars.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal Code.
83A Supply of substances whose constituents differ from constituents of registered listed chemical product
(1) A person must not supply, or cause or permit to be supplied, a substance or mixture of substances in a container to which is attached a label containing a name of a registered listed chemical product if:
(a) the constituents of the substance or mixture differ by more than the prescribed extent from the constituents of the registered listed chemical product that were shown in the particulars of the registered listed chemical product contained in the Register of Chemical Products; or
(b) the concentration of the constituents of the substance or mixture differ by more than the prescribed extent from the concentration of the constituents of the registered listed chemical product that was shown in those particulars; or
(c) the composition or purity of any constituent of the substance or mixture differs by more than the prescribed extent from the composition or purity of the corresponding constituent of the registered listed chemical product that was shown in those particulars.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal Code.
84 Claims inconsistent with labels
(1) A person must not make any claim, or cause or permit any claim to be made, in respect of:
(a) a registered chemical product or registered listed chemical product; or
(b) a chemical product that contains a registered chemical product or registered listed chemical product;
that is inconsistent with any of the instructions on any approved label for containers for the registered chemical product or inconsistent with any instruction required by an established standard for the registered listed chemical product to be included on a label for a container for the registered listed chemical product, as the case may be.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply to:
(a) a claim that is exempted by the APVMA from the operation of this section; or
(b) a claim made in a notice published under section 55; or
(c) a claim that is permitted to be made under any other law of this jurisdiction.
(3) Subsection (1) does not apply to the extent that the person is authorised by a permit to engage in the conduct concerned.
Note: The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.
(4) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal Code.
85 Modification of warning prohibited
(1) A person must not, in connection with the supply of a chemical product, make a claim, or cause or permit a claim to be made, in respect of the product that is inconsistent with the expiry date required by the regulations to be contained on a label attached to a container of the product.
Penalty: 300 penalty units.
(2) Subsection (1) does not apply to a claim made in a notice published under section 55.
(3) Subsection (1) does not apply to the extent that the person is authorised by a permit to engage in the conduct concerned.
Note: The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.
(4) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal Code.
(5) In subsection (1), strict liability applies to the physical element of circumstance, that it is the regulations that require an expiry date to be contained on a label attached to a container of the product.
Note: For strict liability, see section 6.1 of the Criminal Code.
86 Labels not to be detached etc.
(1) A person commits an offence if:
(a) either:
(i) a label attached to a container of a chemical product contains any relevant particular identical to any relevant particular contained on an approved label for containers for the product; or
(ii) a label attached to a container of a chemical product contains any relevant particular identical to any matter required by an established standard for the product to be included on a label for containers for the product; and
(b) the person:
(i) detaches or otherwise removes the label; or
(ii) alters, defaces, obliterates or destroys the relevant particular; or
(iii) attaches another label to, or endorses anything upon, the container that in either case has the effect of expressly or impliedly negating, varying, or in any way detracting from, qualifying or minimising the purport or effect of, the relevant particular.
Penalty: 300 penalty units.
(2) A person commits an offence if:
(a) either:
(i) a label attached to a container of a chemical product contains any relevant particular identical to any relevant particular contained on an approved label for containers for the product; or
(ii) a label attached to a container of a chemical product contains any relevant particular identical to any matter required by an established standard for the product to be included on a label for containers for the product; and
(b) the person causes or permits:
(i) the label to be detached or otherwise removed; or
(ii) the relevant particular contained on the label to be altered, defaced, obliterated or destroyed; or
(iii) another label to be attached to the container that has the effect of expressly or impliedly negating, varying, or in any way detracting from, qualifying or minimising the purport or effect of, the relevant particular; or
(iv) anything to be endorsed upon the container that has the effect of expressly or impliedly negating, varying, or in any way detracting from, qualifying or minimising the purport or effect of, the relevant particular.
Penalty: 300 penalty units.
(3) Subparagraphs (1)(b)(ii) and (2)(b)(ii) do not apply to an alteration, defacing, obliteration or destruction of a relevant particular that is done by the destruction or disposal of the chemical product without otherwise contravening this Code.
(4) Subsections (1) and (2) do not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal Code.
87 Chemical product to conform to standard
(1) This section applies to a chemical product (other than a listable chemical product) if:
(a) a standard is prescribed in respect of the product or in respect of a constituent contained in the product; and
(b) the product is prescribed for the purposes of this section.
(2) A person must not supply the product, or cause or permit the product to be supplied, unless:
(a) if a standard is prescribed in respect of the product—the product conforms to the standard; or
(b) if a standard is prescribed in respect of a constituent contained in the product—the constituent contained in the product conforms to the standard.
Penalty: 300 penalty units.
(3) Subsection (2) does not apply to the extent that the conduct is authorised by a permit.
Note: The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.
(4) Subsection (2) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal Code.
87A Supply of registered listed chemical product that does not conform to established standard
A person may only supply, or cause or permit to be supplied, a substance or mixture of substances in a container to which is attached a label containing the name of a registered listed chemical product if:
(a) the substance or mixture conforms to the established standard for the product; or
(b) the supply is authorised by a permit.
Penalty: 300 penalty units.
88 Certain notices not to be published
(1) In this section:
chemical product does not include a reserved chemical product.
notice includes a circular and an advertisement.
publish, means publish by any means, including in a newspaper or periodical, by broadcasting or televising, in a cinematograph film or in a video recording.
(2) A person must not publish, or cause or permit to be published, a notice that offers to sell, or invites the making of offers to buy:
(a) an active constituent for a proposed or existing chemical product if the constituent is not an approved active constituent; or
(b) a chemical product that is neither a registered chemical product nor a registered listed chemical product;
unless:
(c) an application has been made for approval of the constituent or registration or listed registration of the product, as the case may be; and
(d) the notice states:
(i) that the constituent is not an approved active constituent or the product is neither a registered chemical product nor a registered listed chemical product, as the case may be; and
(ii) that such an application has been made.
Penalty: 30 penalty units.
Note: The defendant bears an evidential burden in relation to the matters in paragraphs (2)(c) and (d). See subsection 13.3(3) of the Criminal Code.
(3) It is a defence to a prosecution of a person for an offence against subsection (2) if the defendant proves that, when the notice was published, or caused or permitted to be published, as the case may be, the defendant did not know, and could not reasonably be expected to have known, that:
(a) if paragraph (2)(a) applies—the constituent was not an approved active constituent; or
(b) if paragraph (2)(b) applies—the product was neither a registered chemical product nor a registered listed chemical product.
Note: The defendant bears a legal burden in relation to the matter in subsection (3). See section 13.4 of the Criminal Code.
89 Certain statements prohibited
(1) A person must not do, or cause or permit to be done, any of the following:
(a) publish or communicate any false or misleading information about a chemical product;
(b) expressly or impliedly claim that the APVMA recommends the use of a chemical product;
(c) expressly or impliedly claim that the APVMA guarantees, warrants or assures the safety or efficacy of a chemical product;
(d) expressly or impliedly claim that the use of a chemical product is recommended:
(i) by the Commonwealth, a State or a Territory; or
(ii) by an authority of the Commonwealth, a State or a Territory; or
(iii) by an officer or employee of, or of an authority of, the Commonwealth, a State or a Territory;
(e) expressly or impliedly make a claim (however the claim is stated), without any qualification, or with a qualification that, in the APVMA’s opinion, is unjustified, to the effect that a chemical product is natural, organic, safe, harmless, non‑toxic, non‑poisonous, non‑injurious or environment‑friendly;
(f) expressly or impliedly claim that a chemical product has particular qualities if those qualities are prescribed by the regulations for the purposes of this paragraph.
Penalty: 30 penalty units.
(2) Paragraph (1)(d) does not apply:
(a) to an officer or employee of, or of an authority of, the Commonwealth, a State or a Territory when, in the course of his or her employment as such an officer or employee, he or she expressly or impliedly claims that a chemical product is recommended; or
(b) to a prescribed person when, in prescribed circumstances, the person expressly or impliedly claims that a chemical product is recommended.
(3) Subsection (1) does not prevent a person from making statements about a chemical product in circumstances prescribed by the regulations or from reporting statements so made.
(4) Paragraph (1)(b) or (c) does not apply in relation to a claim as to a recommendation, guarantee, warrant or assurance by the APVMA if a document issued to the public by the APVMA contains such a recommendation, guarantee, warrant or assurance and the APVMA did not, before the claim was made, publicly withdraw or revoke the recommendation, guarantee, warrant or assurance.
(5) Paragraph (1)(d) does not apply in relation to a claim as to a recommendation by, or by an authority of, the Commonwealth, a State or a Territory, or by an officer or employee of the Commonwealth, a State, a Territory or such an authority, if a document issued to the public by the Commonwealth, the State, the Territory or the authority, as the case may be, contains such a recommendation and the Commonwealth, State, Territory or authority did not, before the claim was made, publicly withdraw or revoke the recommendation.
(6) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (6). See subsection 13.3(3) of the Criminal Code.
(7) In paragraph (1)(f), strict liability applies to the physical element of circumstance, that the particular qualities concerned were prescribed by the regulations for the purposes of that paragraph.
Note: For strict liability, see section 6.1 of the Criminal Code.
Division 3—Date‑controlled chemical products
89A Exclusion of certain chemical products
This Division does not apply to a chemical product that is a listable chemical product or is a reserved chemical product.
90 Manufacture or import of date‑controlled chemical product
(1) A person who manufactures or imports a date‑controlled chemical product must:
(a) as soon as practicable make a record in or to the effect of the approved form and in the prescribed manner containing the date of manufacture, or the date of manufacture and import, as the case may be, of the product and any other particulars that are required by the regulations to be inserted in the record; and
(b) keep that record for at least the period prescribed by the regulations for keeping it.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal Code.
(3) In subsection (1), strict liability applies to the physical element of circumstance, that the relevant matter is prescribed by the regulations.
Note: For strict liability, see section 6.1 of the Criminal Code.
91 Supply of date‑controlled chemical product
(1) A person must not supply, or cause or permit to be supplied, a date‑controlled chemical product in a container that does not have attached to it an approved label containing:
(a) matter that the APVMA has approved as sufficient to enable the APVMA to identify the date of manufacture of the product; and
(b) the expiry date required to be contained on the label as a condition of the registration of the product.
(1A) Subsection (1) does not apply to the extent that the person’s conduct is otherwise authorised by a permit.
Note: The defendant bears an evidential burden in relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal Code.
(1B) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (1B). See subsection 13.3(3) of the Criminal Code.
(1C) In subsection (1), strict liability applies to the physical elements of circumstance, that:
(a) the APVMA has not approved the relevant matter as mentioned in paragraph (1)(a); and
(b) an expiry date was required to be contained on the label as a condition of the registration of the product.
Note: For strict liability, see section 6.1 of the Criminal Code.
(2) If the container of a date‑controlled chemical product has attached to it a label containing an expiry date, a person must not, after that date, supply, or cause or permit to be supplied, the product that is in the container unless:
(a) the person is authorised to do so by a permit; or
(b) the person does so on a date that, despite the date on the label, is earlier than the date that is required to be contained on the label as a condition of the registration of the product.
Penalty: 120 penalty units.
(3) Subsection (2) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.
92 Abuse of warning on label prohibited
(1) If a label attached to a container of a chemical product contains any matter (the approved matter) that is, or has been, required to be contained on the label by or under subsection 91(1), a person must not do, or cause or permit to be done, any of the following:
(a) detach or otherwise remove the label;
(b) alter, deface, obliterate or destroy the approved matter;
(c) attach another label to, or endorse anything upon, the container that in either case has the effect of negating, varying, or in any way detracting from, qualifying or minimising the purport or effect of, the approved matter.
(2) Paragraph (1)(b) does not apply to an alteration, defacing, obliteration or destruction of matter that is done by the destruction or disposal of the chemical product without otherwise contravening this Code.
Penalty: 120 penalty units.
(3) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.
Division 4—Restricted chemical products
93 Restricted chemical product
(1) Subject to subsection (2), the regulations may declare a chemical product to be a restricted chemical product.
(2) A chemical product may not be declared by the regulations to be a restricted chemical product unless the APVMA has certified in writing that it is in the public interest for the product to be so declared.
(3) In deciding whether to give a certificate in relation to a chemical product under subsection (2), the APVMA must have regard to the following:
(a) whether the product may have an effect that is harmful to human beings;
(b) whether the product may have any unintended effect that is harmful to any animal, plant or thing or to the environment;
(c) whether any special knowledge, skill or qualification is required in the preparation or handling of the product;
(d) whether any special equipment is required to use the product with safety.
94 Restricted chemical products may be supplied only to authorised persons
(1) A person must not supply a restricted chemical product, or cause or permit a restricted chemical product to be supplied, to a person who is not authorised to use the product under another law of this jurisdiction.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal Code.
95 Labels for restricted chemical products
(1) A person must not supply a restricted chemical product, or cause or permit a restricted chemical product to be supplied, unless the label attached to the container for the product contains the words “RESTRICTED CHEMICAL PRODUCT—ONLY TO BE SUPPLIED TO OR USED BY AN AUTHORISED PERSON”.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal Code.
Part 5—Analysis
96 Explanation of Part
This Part sets out the procedure by which samples or substances are to be analysed and states how evidence of the results of the analysis may be given in proceedings under this Code.
97 Analysis by approved analysts
(1) An inspector may give a portion of a sample taken under paragraph 131(1)(c) or 132(1)(d) to an approved analyst for analysis.
(2) If an analysis has been made by, or under the personal supervision of, an approved analyst in respect of a sample given for analysis under this Code, the analyst must give to the APVMA a certificate in or to the effect of the approved form in respect of the analysis.
Penalty: 10 penalty units.
(2A) An offence under subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) The APVMA must, if asked to do so by an inspector, give to the inspector a copy of a certificate given under subsection (2).
(4) The APVMA must, upon receipt of the prescribed fee (if any), give a copy of a certificate given to it under subsection (2) to a person who appears to it to be:
(a) the owner of the substance from which the sample analysed was taken or the person in whose possession or custody, or under whose control, the substance was when the sample was taken; or
(b) an applicant for approval of that substance as an active constituent or for registration or listed registration of that substance as a chemical product.
(5) If a person referred to in paragraph (4)(a) or (b) so requests, the APVMA must give to the person a portion of the sample that is sufficient to enable the person to have a further analysis made.
(6) A person must not, for trade purposes or for advertisement, use a certificate given under subsection (2) or any matter contained in it.
Penalty: 60 penalty units.
(6A) Subsection (6) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (6A). See subsection 13.3(3) of the Criminal Code.
(6B) An offence under subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(7) This section applies in respect of a substance seized under section 131 or 132 in the same way as it applies in respect of a sample of a substance taken under paragraph 131(1)(c) or 132(1)(d) and references in this section to a sample or to a substance from which a sample was taken include references to a substance so seized.
98 Evidence of results of analysis
(1) Subject to subsection (3), in any proceedings under this Code, a certificate of an approved analyst in or to the effect of the approved form stating, in respect of a sample of a substance in relation to which the offence is alleged to have been committed, any of the following:
(a) that the analyst signing the certificate is an approved analyst;
(b) when and from whom the sample of the substance was received;
(c) what, if any, labels or other means of identifying the sample of the substance accompanied it when it was received;
(d) what container or containers the sample of the substance was contained in when it was received;
(e) a description of the sample of the substance received;
(f) when the sample of the substance, or a portion of it, was analysed;
(g) a description of the method of analysis;
(h) the results of the analysis;
(i) how the sample of the substance was dealt with after handling by the analyst, including details of:
(i) the quantity kept; and
(ii) the name of the person, if any, to whom any quantity so kept was given; and
(iii) measures taken to secure any quantity so kept;
is admissible as prima facie evidence of the matters stated in the certificate and, if the certificate states the results of the analysis, of the correctness of those results.
(2) Unless the contrary is proved, a document purporting to be a certificate under subsection (1) is taken to be such a certificate and to have been duly given.
(3) A certificate must not be admitted in evidence under subsection (1) in proceedings for an offence unless:
(a) the person charged with the offence or a barrister or solicitor who has appeared for the person in those proceedings has, at least 14 days before the certificate is sought to be so admitted, been given a copy of the certificate together with reasonable notice of the intention to produce the certificate as evidence in the proceedings; or
(b) reasonable efforts were made to give the copy and notice as required by paragraph (a) but those efforts were unsuccessful.
(4) Subject to subsection (5), if, under subsection (1), a certificate of an analyst is admitted in evidence in a proceeding for an offence, the person charged with the offence may require the analyst to be called as a witness for the prosecution and the analyst may be cross‑examined as if he or she had given evidence of the matters stated in the certificate.
(5) Subsection (4) does not entitle a person to require an analyst to be called as a witness for the prosecution unless:
(a) the prosecutor has been given at least 4 days’ notice of the person’s intention to require the analyst to be so called; or
(b) the court, by order, allows the person to require the analyst to be so called.
(6) This section applies in respect of a substance seized under section 131 or 132 in the same way as it applies in respect of a sample of a substance taken under paragraph 131(1)(c) or 132(1)(d) and references in this section to a sample or to a substance from which a sample was taken include references to a substance so seized.
99 Analysis of chemical products
(1) If a person has possession or custody of a substance or mixture of substances that is intended for supply as a chemical product under a particular name, the following provisions apply.
(2) If a chemical product having that name is registered under Division 2 of Part 2, or has been granted listed registration under Division 4 of Part 2A, and the APVMA, on the advice of an inspector, reasonably suspects that:
(a) the constituents of the substance or mixture differ by more than the prescribed extent from the constituents stated in relation to the chemical product in the Register of Chemical Products; or
(b) the concentration of the constituents of the substance or mixture differs by more than the prescribed extent from the concentration of the constituents stated in relation to the chemical product in the Register of Chemical Products; or
(c) the composition or purity of a constituent of the substance or mixture differs by more than the prescribed extent from the composition or purity of that constituent stated in relation to the chemical product in the Register of Chemical Products;
the APVMA may, by written notice given to the person, require the person to have the substance or mixture analysed to find out its constituents, their concentration and the composition and purity of each of them.
(3) If the APVMA, on the advice of an inspector, reasonably suspects that the substance or mixture does not comply with any prescribed standard, established standard or other prescribed requirement, the APVMA may, by written notice given to the person, require the person to have the substance or mixture analysed to find out whether it complies with any prescribed standard, established standard or other prescribed requirement.
(4) Without limiting subsections (2) and (3), a notice given to a person under either of those subsections may require any one or more of the following:
(a) that samples of the substance or mixture are taken:
(i) under the supervision of an inspector; or
(ii) in the manner stated in the notice;
(b) that the analysis is carried out:
(i) under the supervision of an approved analyst; or
(ii) in the manner stated in the notice;
(c) that the analysis is carried out at a prescribed laboratory;
(d) that the analysis is carried out within a period stated in the notice;
(e) that the analysis is carried out at the expense of the person.
(5) A person to whom a notice is given under subsection (2) or (3) must not fail:
(a) to comply with the notice; and
(b) to give the analyst’s certificate to the APVMA not later than 5 working days after the person received that certificate.
Penalty: 120 penalty units.
(5A) Subsection (5) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (5A). See subsection 13.3(3) of the Criminal Code.
(5B) An offence under subsection (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(6) The APVMA may cause to be published in a manner that it thinks appropriate:
(a) the name, and the address of the place of business, of:
(i) the person who had possession or custody of the substance or mixture; and
(ii) if the substance or mixture is intended for supply as a chemical product and the person referred to in subparagraph (i) is not the interested person in relation to the product—the interested person; and
(b) the result of the analysis of the substance or mixture.
(7) If a requirement made under this section is inconsistent with an earlier requirement made under this section, the earlier requirement is, to the extent of the inconsistency, of no effect.
(8) Section 168 provides for additional matters to be included in a notice given under subsection (2) or (3).
Part 6—Recall notices
100 Explanation of Part
This Part sets out various circumstances in which the APVMA may issue recall notices requiring persons who have, or have had, stocks of chemical products in their possession to stop supplying the products and to take action in relation to the products as directed by the APVMA. The power of the APVMA to issue recall notices is in addition to powers conferred on the Australian Competition and Consumer Commission under the Competition and Consumer Act 2010.
101 Recall of products that are not registered and do not have listed registration or whose registration or listed registration is being reconsidered
(1) If:
(a) a chemical product (other than a reserved chemical product) is not registered, and has not been granted listed registration, under the Agvet Code of this jurisdiction; or
(b) the APVMA is reconsidering:
(i) the registration of a chemical product under Division 4 of Part 2 of that Code; or
(ii) the listed registration of a chemical product under Division 6 of Part 2A of that Code;
the APVMA may give written notice to any person (the notified person) who has, or has had, possession or custody of stocks of the product, or of a particular batch of the product, in this jurisdiction, requiring the notified person to do any one or more of the things mentioned in subsection (2).
(2) The things that the notified person may be required to do under subsection (1) are as follows:
(a) not to supply, or to stop supplying, the product, or that batch, in this jurisdiction either immediately or within a stated period;
(b) to take any action stated in the notice that the notified person is reasonably capable of taking to recover stocks of the product or of that batch from any other person in this jurisdiction:
(i) to whom the product or that batch has been supplied by the notified person; or
(ii) who has possession or custody of any such stocks directly or indirectly because of a supply by the notified person;
(c) if the product is not registered and has not been granted listed registration—to destroy, as stated in the notice, stocks of the product or of that batch in the possession or custody of, or recovered by, the notified person in this jurisdiction or to deal with them as stated in the notice;
(d) to report to the APVMA within a stated period on the action taken by the notified person under the notice.
(3) Section 168 provides for additional matters to be included in a notice under subsection (1).
102 Recall of products in certain circumstances
(1) If it appears to the APVMA that:
(a) having regard to the matters referred to in subsection 14(5) or (6), as the case requires, the continued use of a registered chemical product in accordance with the instructions on an approved label for containers for the product:
(i) may be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(ii) may be likely to have an effect that is harmful to human beings; or
(iii) may be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(iv) may unduly prejudice trade or commerce between Australia and places outside Australia; or
(v) may not be effective according to criteria that the APVMA has determined for the product; or
(aa) having regard to the matters referred to in subsection 56E(2), the continued use of a registered listed chemical product in accordance with the established standard for the product:
(i) may be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(ii) may be likely to have an effect that is harmful to human beings; or
(iii) may be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(iv) may unduly prejudice trade or commerce between Australia and places outside Australia; or
(v) may not be effective according to criteria that the APVMA has determined for the product; or
(b) the constituents of stocks of a registered chemical product or of a particular batch of a registered chemical product differ by more than the prescribed extent from the constituents stated in relation to the product in the Register of Chemical Products; or
(ba) the constituents of stocks of a registered listed chemical product or of a particular batch of such a product differ by more than the prescribed extent from the constituents stated in relation to the product in the Register of Chemical Products; or
(c) the concentration of the constituents of stocks of a registered chemical product or of a particular batch of a registered chemical product differs by more than the prescribed extent from the concentration of the constituents stated in relation to the product in the Register of Chemical Products; or
(ca) the concentration of the constituents of stocks of a registered listed chemical product or of a particular batch of such a product differs by more than the prescribed extent from the concentration of the constituents stated in relation to the product in the Register of Chemical Products; or
(d) the composition or purity of any constituent of stocks of a registered chemical product or of a particular batch of a registered chemical product differs by more than the prescribed extent from the composition or purity of that constituent stated in relation to the product in the Register of Chemical Products;
(e) the composition or purity of any constituent of stocks of a registered listed chemical product or of a particular batch of such a product differs by more than the prescribed extent from the composition or purity of the constituent stated in relation to the product in the Register of Chemical Products; or
the APVMA may give written notice to any person (the notified person) who has, or has had, possession or custody in this jurisdiction of any of the stocks or of the batch, or of stocks or a batch of the product in containers to which the label is attached, as the case may be, requiring the notified person to do any one or more of the things mentioned in subsection (2).
(2) The things that the notified person may be required to do under subsection (1) are as follows:
(a) not to supply, or to stop supplying, any of those stocks or of that batch, either immediately or within a stated period;
(b) to take any action stated in the notice that the notified person is reasonably capable of taking to recover stocks of the product or of that batch from any other person in this jurisdiction:
(i) to whom the product or that batch has been supplied by the notified person; or
(ii) who has possession or custody of any such stocks directly or indirectly because of a supply by the notified person;
(c) to take any action that is stated in the notice, or that the notified person thinks necessary, to prevent or reduce any harmful effects that may have resulted from the use of the product;
(d) to destroy, as stated in the notice, any of those stocks or any of that batch in the possession or custody of, or recovered by, the notified person in this jurisdiction or to deal with them as stated in the notice;
(e) to report to the APVMA within a stated period on the action taken by the notified person under the notice.
(3) Section 168 provides for additional matters to be included in a notice under subsection (1).
103 Recall of products with labels that are not approved or are not authorised by an established standard
(1) If it appears to the APVMA:
(a) that labels attached to the containers of stocks of a registered chemical product, or of a particular batch of a registered chemical product, differ from the approved label for the product; or
(b) that labels attached to the containers of stocks of a registered listed chemical product, or of a particular batch of a registered listed chemical product, differ from the label required by the relevant standard for the product;
the APVMA may give written notice to any person (the notified person) who has, or has had, possession or custody of any of those stocks or of that batch in this jurisdiction requiring the person to do any one or more of the things mentioned in subsection (2).
(2) The things that the notified person may be required to do under subsection (1) are as follows:
(a) not to supply, or to stop supplying, any of those stocks or of that batch, either immediately or within a stated period;
(b) to take any action stated in the notice that the notified person is reasonably capable of taking to recover stocks of the product or of that batch from any other person in this jurisdiction:
(i) to whom the product or that batch has been supplied by the notified person; or
(ii) who has possession or custody of any such stocks directly or indirectly because of a supply by the notified person;
(c) to attach labels to the containers that are the same as the approved label for the product or the label required by the established standard for the product, as the case may be or to destroy any of those stocks or of that batch in the possession or custody of, or recovered by, the notified person or to deal with them as stated in the notice;
(d) to report to the APVMA within a stated period on the action taken by the notified person under the notice.
(3) Section 168 provides for additional matters to be included in a notice under subsection (1).
104 Notice of recall to be published
(1) If the APVMA issues a recall notice, it must, as soon as practicable, cause notices of the issue of the recall notice to be published in the Gazette and in any other manner that it thinks appropriate.
(2) Each notice must contain a brief statement of the matters to which the recall notice relates.
105 Non‑compliance with recall notice
(1) A person to whom a recall notice is given must not fail to comply with the notice.
Penalty: 120 penalty units.
(2) Subsection (1) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal Code.
(3) An offence under subsection (1) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
106 Recall under Competition and Consumer Act
Section 128 of Schedule 2 to the Competition and Consumer Act 2010, as that section applies as a law of the Commonwealth, imposes obligations on certain persons who voluntarily recall chemical products.
107 Inconsistent requirements
If a requirement made under section 101, 102 or 103 is inconsistent with an earlier requirement made under any of those sections, the earlier requirement is, to the extent of the inconsistency, of no effect.
Part 7—Permits
108 Explanation of Part
(1) This Part sets up a system under which a person who wants to do something in respect of an active constituent for a proposed or existing chemical product, or in respect of a chemical product, that would otherwise be prohibited by this Code or another law of this jurisdiction may obtain a permit in respect of the doing of the thing. The permit does not have any practical operation unless a law of this jurisdiction permits the thing to be done by the holder of such a permit.
(2) Examples of circumstances in which a permit could be sought are:
(a) if someone wants to conduct a trial or experiment in relation to a constituent that is not an approved constituent, or in relation to a chemical product that is not a registered chemical product, a registered listed chemical product or a reserved chemical product, in order to decide whether to make an application for approval, registration or listed registration; or
(b) if someone wants to use a registered chemical product in a way that is not authorised by the approved label for containers for the product; or
(c) if someone wants to use a registered listed chemical product in a way that is not authorised by the labels for containers for the product as required by the standard approved for the product.
109 Definition of permit
In this Part:
permit means a permit, in respect of an active constituent for a proposed or existing chemical product, or in respect of a chemical product, to do or omit to do any thing stated in the permit the doing of which, or the omission to do which, would, apart from the permit, be:
(a) an offence against section 74, 75, 76, 77, 78, 79, 79A, 79B, 80, 81, 84, 85, 87, 87A or 91; or
(b) an offence against an eligible law of this jurisdiction.
110 How application is made
(1) Any person may apply to the APVMA, on behalf of that person, a class of persons or persons generally, for a permit in respect of an active constituent for a proposed or existing chemical product or in respect of a chemical product.
(2) The application must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the APVMA requires; and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any).
(3) The APVMA may, with the written consent of the applicant, alter the application.
(4) At any time after an application has been made and before it has been determined, the applicant may withdraw the application by giving to the APVMA written notice of the withdrawal signed by an approved person.
111 Functions of co‑ordinators
(1) If there is a co‑ordinator designated for this or another jurisdiction:
(a) the APVMA must, unless it thinks it inappropriate to do so, give the co‑ordinator a copy of the application and of any accompanying documents; and
(b) if:
(i) the APVMA has given a copy of the application and documents referred to in paragraph (a) to a co‑ordinator; and
(ii) the co‑ordinator requests any additional information for the purpose of enabling him or her to make a recommendation to the APVMA about the application;
then, unless the APVMA has reasonable grounds for refusing the request:
(iii) the APVMA must, by written notice given to the applicant, require the applicant to give the additional information to the APVMA; and
(iv) when the APVMA receives the additional information, it must, as soon as practicable, give the information to the co‑ordinator; and
(c) when the co‑ordinator is satisfied that he or she has sufficient information to enable a recommendation to be made about the application, the co‑ordinator may give to the APVMA a recommendation as to whether the application should be granted.
(2) Any information given by a person to a co‑ordinator because of a requirement made under subsection (1) must be in writing and be signed by an approved person.
112 APVMA may grant or refuse application
(1) The APVMA must consider the application and take into account any recommendations made by a co‑ordinator.
(2) The APVMA must grant the application if it is satisfied of the following:
(a) that, having regard to criteria determined by it, the applicant is a suitable person to hold the permit applied for;
(b) that the applicant has complied with subsection 110(2) and any requirement made by a co‑ordinator to the APVMA under paragraph 111(1)(b);
(c) that any requirement made under section 157 or 159 has been complied with;
(d) that, if necessary, section 158 has been complied with;
(e) that any requirements prescribed by the regulations in relation to such an application have been complied with;
(f) that, having regard to the matters referred to in subsection 14(4) or (5), as the case requires, the use of, or any other dealing with, the constituent or product as proposed in the application for the permit:
(i) would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
(ii) would not be likely to have an effect that is harmful to human beings; and
(iii) would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(iv) would not unduly prejudice trade or commerce between Australia and places outside Australia;
(g) that, having regard to the matters referred to in subsection 14(6), the use of the product as proposed in the application for the permit would be effective according to criteria that the APVMA has determined for the product;
(h) that any requirements prescribed by the regulations in relation to the issue of such a permit have been complied with;
(i) if an application has not been made for approval of the constituent or registration or listed registration of the product or such an application has not been determined—that there are reasonable grounds for the application not having been made or for issuing the permit pending determination of the application, as the case may be.
(3) If the APVMA is not satisfied as mentioned in subsection (2), it must refuse the application.
(4) If the APVMA refuses the application, it must:
(a) give written notice of the refusal to the applicant and to each co‑ordinator to whom a copy of the application was given; and
(b) include in the notice brief particulars of the reasons for the refusal.
(5) Section 168 provides for additional matters to be included in a notice of refusal of an application for a permit.
113 Record of Permits
(1) For the purposes of this Code, the APVMA must keep a record, in a form determined by it, to be known as the Record of Permits.
(2) The Record of Permits is to be kept in 2 parts as provided by subsections (3) and (4).
(3) One part is to contain:
(a) information about permits the making of applications for which is confidential commercial information; and
(b) confidential commercial information about other permits.
(4) The other part is to contain information about the other permits referred to in paragraph (3)(b) that is not confidential commercial information.
(5) The APVMA must permit any person to inspect the part of the Record of Permits referred to in subsection (4) at any time during ordinary office hours on a working day.
(6) Subject to subsection (7), if a person asks for a copy of a permit other than a permit to which paragraph (3)(a) applies and pays the prescribed fee (if any), the APVMA must give the person a copy of the permit.
(7) If a permit referred to in subsection (6) contains confidential commercial information, the APVMA must delete that information from the copy given under that subsection.
114 Issue of permit
(1) The APVMA may, on its own initiative or on an application made under section 110, issue a permit to a person.
(1A) Before issuing a permit, the APVMA must be satisfied that, if necessary, paragraph 8A(2)(d) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with.
(2) When issuing a permit, the APVMA must give a distinguishing number to the permit.
(3) The permit may be unconditional or subject to any conditions that the APVMA thinks appropriate.
(4) The permit must:
(a) contain the distinguishing number given to the permit; and
(b) state whether it applies to persons generally and, if not, state the persons or class of persons to whom it applies, other than persons to whom it applies because of subsection 116(3); and
(c) state the active constituent or chemical product in respect of which it is issued; and
(d) state the things authorised by the permit to be done or omitted to be done; and
(e) state any conditions of the permit.
(5) As soon as practicable after a permit is issued, the APVMA must:
(a) place a copy of the permit in the Record of Permits; and
(b) if there is a co‑ordinator designated for this or another jurisdiction, tell the co‑ordinator that the permit has been issued and tell him or her of any conditions to which the permit is subject; and
(c) in prescribed circumstances, tell a prescribed authority that the permit has been issued.
115 Duration of permit
(1) Subject to this section, a permit is in force until it is surrendered under section 117 or the APVMA cancels it under section 119.
(2) Subject to subsection (3), a permit may be expressed to be in force only for a period stated in the permit.
(3) The holder of a permit to which subsection (2) applies may apply in writing to the APVMA for an extension or extensions of the permit and, if such an application is made and the prescribed fee (if any) is paid, the APVMA may extend the permit for a further period that it thinks appropriate.
(4) This section has effect subject to subsection 118(6).
(5) If an application is made to the APVMA under subsection (3), the APVMA must give to the applicant written notice of its decision on the application.
(6) Section 168 provides for additional matters to be included in a notice refusing to extend a permit.
116 Effect of permit
(1) If, while a permit in respect of an active constituent for a proposed or existing chemical product, or in respect of a chemical product, is in force:
(a) a person to whom the permit applies who, in accordance with the conditions (if any) stated in the permit, does or omits to do any thing in respect of the constituent or product that the permit states may be done or omitted to be done; and
(b) a provision of this Code or of an eligible law of this jurisdiction prohibits the doing of, or the omitting to do, that thing unless authorised by a permit;
the person does not commit an offence against that provision.
(2) The persons to whom a permit applies are:
(a) if the permit states that it applies to persons generally—any person; or
(b) otherwise—the person or each person named, or included in a class of persons stated, in the permit.
(3) If a permit names a person or states a class of persons as mentioned in paragraph (2)(b), the permit also applies to:
(a) any qualified employee of the person, or of a person in the class, acting in the course of his or her employment; and
(b) if a person, or a person in the class, is a body corporate—any qualified person acting in his or her capacity as a director of the body corporate.
(4) In this section:
qualified means qualified under another law of this jurisdiction in relation to the things authorised by the permit to be done or omitted to be done.
117 Surrender of permit
(1) The holder of a permit may surrender it by giving to the APVMA a written notice, signed by an approved person, stating that the holder surrenders the permit.
(2) The surrender of a permit takes effect when the APVMA receives the notice of surrender.
(3) If there is a co‑ordinator designated for this or another jurisdiction, the APVMA must, as soon as practicable, tell the co‑ordinator that the permit has been surrendered.
118 Suspension of permit
(1) The APVMA, by written notice given to the holder of a permit, may suspend the permit if it appears to the APVMA that:
(a) having regard to the matters referred to in subsection 14(4) or (5), as the case requires, the continued use of, or any other dealing with, an active constituent for a proposed or existing chemical product, or a chemical product, in accordance with the permit:
(i) may be an undue hazard to the safety of people exposed to the constituent or product during its handling or people using anything containing its residues; or
(ii) may have an effect that is harmful to human beings; or
(iii) may have an unintended effect that is harmful to animals, plants or things or to the environment; or
(iv) may unduly prejudice trade or commerce between Australia and places outside Australia; or
(v) is inappropriate for any other reason; or
(b) having regard to the matters referred to in subsection 14(6), the continued use of a chemical product in accordance with the permit may not be effective according to criteria that the APVMA has determined for the product.
(2) If the holder of a permit fails, without reasonable excuse, to comply with a requirement contained in a notice under section 159 or with section 161, the APVMA may, by written notice given to the holder of the permit, suspend the permit.
(3) The APVMA may, for any reason that it thinks sufficient, suspend a permit that is taken by section 181 to have been issued under section 114.
(4) A suspension of a permit under subsection (1), (2) or (3) must be for a stated period.
(5) If the holder of a permit is proceeded against for an offence against, or has failed to comply with a lawful direction or requirement of an inspector given under, the Agvet Code of this or another jurisdiction, the APVMA may, by written notice given to the holder of the permit, suspend the permit until the proceeding has been disposed of or the direction or requirement has been complied with, as the case may be.
(6) A permit is not in force during any period in which it is suspended.
(7) A notice of suspension of a permit must include brief particulars of the reasons for the suspension.
(8) Section 168 provides for additional matters to be included in a notice of suspension of a permit.
(9) If a permit is suspended, the APVMA may, by written notice given to the holder of the permit, revoke the suspension.
(10) If:
(a) the APVMA suspends, or revokes the suspension of, a permit; and
(b) there is a co‑ordinator designated for this or another jurisdiction;
the APVMA must, as soon as practicable, tell the co‑ordinator of the suspension or revocation.
119 Cancellation of permit
(1) The APVMA, by written notice given to the holder of a permit, may cancel the permit if it appears to the APVMA that:
(a) having regard to the matters referred to in subsection 14(4) or (5), as the case requires, the continued use of, or any other dealing with, an active constituent for a proposed or existing chemical product, or a chemical product, in accordance with the permit:
(i) may be an undue hazard to the safety of people exposed to the constituent or product during its handling or people using anything containing its residues; or
(ii) may have an effect that is harmful to human beings; or
(iii) may have an unintended effect that is harmful to animals, plants or things or to the environment; or
(iv) may unduly prejudice trade or commerce between Australia and places outside Australia; or
(v) is inappropriate for any other reason; or
(b) having regard to the matters referred to in subsection 14(6), the continued use of a chemical product in accordance with the permit may not be effective according to criteria that the APVMA has determined for the product.
(2) If a permit is suspended under subsection 118(2) and the information, report or sample referred to in section 159 or 161 is not given within a reasonable period after the suspension takes place, the APVMA may cancel the permit.
(3) The APVMA may, for any reason that it thinks sufficient, cancel a permit that is taken by section 181 to have been issued under section 114.
(4) The APVMA may, by written notice given to the holder of a permit, cancel the permit if the holder:
(a) has been convicted of an offence against the Agvet Code of this or another jurisdiction, or an offence against another law of this or another jurisdiction relating to chemical products or to active constituents for proposed or existing chemical products; or
(b) contravenes a condition of the permit.
(5) A permit may be cancelled even though it is suspended.
(6) If information about the holder of a permit comes to the APVMA’s knowledge and it is of the opinion that, if it had been in possession of the information before it issued the permit, it would have refused to issue the permit, it may, by written notice given to the holder, cancel the permit.
(7) A notice of cancellation of a permit must include brief particulars of the reasons for the cancellation.
(8) Section 168 provides for additional matters to be included in a notice of cancellation of a permit.
(9) If a permit is cancelled, the APVMA may, by written notice to the person who held the permit, revoke the cancellation.
(10) If the cancellation of a permit is revoked, the cancellation is taken never to have occurred.
(11) If:
(a) a permit is cancelled or the cancellation of a permit is revoked; and
(b) there is a co‑ordinator designated for this or another jurisdiction;
the APVMA must, as soon as practicable, tell the co‑ordinator of the cancellation or revocation.
Part 8—Manufacture of chemical products
120 Explanation of Part
(1) This Part:
(a) prohibits the manufacture of certain chemical products; and
(b) provides for the licensing of manufacturers of other chemical products.
(2) A licensee is required by this Part to comply with manufacturing principles determined by the APVMA, which may include codes of good manufacturing practice.
(3) Section 121 does not come into force until a date to be prescribed by regulations that is not later than 12 months after the date of commencement of this Code.
120A Exclusion of certain chemical products
This Part does not apply to chemical products that are listable chemical products or are reserved chemical products.
121 Offences relating to manufacture and licences
(1) Subject to subsection (2), this section applies on and after a date to be prescribed by the regulations for the purposes of this Part.
(2) If this section does not apply under subsection (1) before the end of the period of 12 months after the date of commencement of this Code, it applies on and after the first day after the end of that period.
(3) A person must not carry out a step in the manufacture of a prohibited chemical product at premises in this jurisdiction.
Penalty: 240 penalty units.
(4) A person must not carry out a step in the manufacture of chemical products at premises in this jurisdiction unless:
(a) under the regulations, the products are exempt products or the person is an exempt person in relation to the manufacture of the products; or
(b) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the products at those premises; or
(c) both the following subparagraphs apply:
(i) the person was engaged in the manufacture of the products at those premises at the commencement of this Code;
(ii) before this section began to apply the person applied for a licence authorising the carrying out of that step in relation to the products at those premises but the APVMA has not dealt with the application.
Penalty: 240 penalty units.
(5) A person who is the holder of a licence must not contravene a condition of the licence.
Penalty for a contravention of this subsection: 120 penalty units.
(6) Subsections (3), (4) and (5) do not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (6). See subsection 13.3(3) of the Criminal Code.
(7) An offence under subsection (3), (4) or (5) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
122 Application for licence
(1) An application for a licence must:
(a) be in writing in or to the effect of the approved form; and
(b) contain, or be accompanied by, the information that the APVMA requires; and
(c) be signed by an approved person; and
(d) be accompanied by the prescribed fee (if any); and
(e) be lodged with the APVMA.
(2) The APVMA may, in relation to an application for a licence, by written notice given to an approved person, require the applicant:
(a) to give to the APVMA, within a reasonable time stated in the notice, the further information concerning the application that is mentioned in the notice; or
(b) to allow an inspector, or another person authorised in writing by the APVMA, at any reasonable time set out in the notice, to inspect the premises, equipment, processes and facilities that are proposed to be used in the manufacture of the chemical products, or to inspect other goods on those premises.
123 Issue of licence
(1) If a person has made an application to carry out steps in the manufacture of chemical products (other than prohibited chemical products) at particular premises and complied with section 122, the APVMA must issue to the person a licence to carry out those steps at those premises unless:
(a) the APVMA is satisfied that:
(i) the person will be unable to comply with the manufacturing principles; or
(ii) the premises are not satisfactory for the manufacture of the products; or
(b) a licence previously issued to the person was cancelled except at the request of the person; or
(c) the person:
(i) has been convicted of an offence against the Agvet Code of this or another jurisdiction, or an offence against another law of this or another jurisdiction relating to chemical products; or
(ii) has failed on more than 2 occasions in any 12 months to observe any one or more of the manufacturing principles in connection with the manufacture of chemical products, whether the failures related to the same manufacturing principle or to different manufacturing principles.
(2) Despite paragraph (1)(b) or (c), the APVMA may issue a licence to a person to whom, apart from this subsection, it could not issue a licence because of that paragraph if, in the opinion of the APVMA, special circumstances make it appropriate to do so.
(3) A licence is subject to conditions as mentioned in section 126.
(4) The licence must state:
(a) the person to whom it is issued; and
(b) the products to which it relates; and
(c) any conditions (other than conditions referred to in subsection 126(4)) to which the licence is subject when it is issued.
(5) If the APVMA issues a licence, the APVMA must cause particulars of the licence to be published in the Gazette, and in any other manner that it thinks appropriate, as soon as is practicable after the licence is issued.
124 Refusal of application
(1) If the APVMA refuses an application for a licence, it must:
(a) give written notice of the refusal to an approved person; and
(b) include in the notice brief particulars of the reasons for the refusal.
(2) Section 168 provides for additional matters to be included in a notice of refusal of an application for a licence.
125 Period of licence
(1) A licence comes into force on the day stated in the licence and, subject to subsection (2), remains in force until it is cancelled.
(2) A licence is not in force during any period in which it is suspended.
126 Conditions of licences
(1) The conditions to which a licence may be subject are:
(a) the conditions that the APVMA imposes for the purpose of ensuring that the holder of the licence manufactures the chemical products in accordance with the manufacturing principles and any standards that apply to the products; and
(b) any other conditions relating to the manufacture of the products that the APVMA thinks appropriate to impose.
(2) The APVMA may, by written notice given to the holder of a licence, impose new conditions on the licence or vary or remove existing conditions.
(3) The imposition or variation of a condition under subsection (2) takes effect:
(a) if the notice states that the action is necessary to prevent imminent risk to public health or occupational health or safety, or imminent risk of impact on trade or commerce between Australia and places outside Australia—on the day on which the notice is given to the person; or
(b) otherwise—on a day stated for the purpose in the notice that is not earlier than 28 days after the notice is given to the person.
(4) In addition to any conditions imposed in accordance with subsection (1) or (2), each licence is, except as otherwise stated in the licence, subject to the conditions that the holder of the licence will:
(a) ensure that the chemical products conform to any standard that applies to them; and
(b) comply with any other conditions prescribed by the regulations for the purposes of this section.
(5) Section 168 provides for additional matters to be included in a notice imposing a new condition on a licence or varying an existing condition.
127 Suspension and cancellation of licences
(1) Subject to subsection (2), the APVMA may, in relation to a licence, by written notice given to an approved person, suspend the licence for a period stated in the notice, or cancel the licence, if:
(a) the holder has been convicted of an offence against the Agvet Code of this or another jurisdiction, or an offence against another law of this or another jurisdiction in relation to chemical products or active constituents for proposed or existing chemical products; or
(b) the holder has contravened a condition of the licence; or
(c) the holder has failed on more than 2 occasions in any 12 months to comply with any one or more of the manufacturing principles in connection with the manufacture of chemical products, whether the failures related to the same manufacturing principle or to different manufacturing principles; or
(d) the holder has asked in writing that the licence be suspended or cancelled, as the case may be; or
(e) the holder ceases to carry on the business of manufacturing the chemical products to which the licence relates; or
(f) a prescribed fee in connection with the licence has not been paid.
(2) If the APVMA proposes to suspend or cancel a licence except when asked to do so by the holder of the licence, the APVMA must, unless it thinks that failure to suspend or cancel the licence immediately would create an imminent risk to public health or occupational health or safety, or an imminent risk of impact on trade or commerce between Australia and places outside Australia:
(a) by written notice given to an approved person, set out the action that the APVMA proposes to take and the reasons for the proposed action; and
(b) except if the proposed action is to be taken because of a failure to pay a prescribed fee—give the holder an opportunity to make, within a reasonable time stated in the notice, written submissions to the APVMA in relation to the proposed action.
(3) If the holder makes written submissions in accordance with paragraph (2)(b), the APVMA is not to make a decision relating to the suspension or cancellation of the licence before taking the submissions into account.
(4) A licence may be cancelled even though it is suspended.
(5) A notice suspending or cancelling a licence must include brief particulars of the reasons for the suspension or cancellation.
(6) Section 168 provides for additional matters to be included in a notice suspending or cancelling a licence.
(7) If a licence is suspended or cancelled, the APVMA may, by written notice given to the holder of the licence, revoke the suspension or cancellation.
(8) If the APVMA suspends or cancels, or revokes the suspension or cancellation of, a licence, the APVMA must cause particulars of the suspension, cancellation or revocation to be published in the Gazette, and in any other manner that it thinks appropriate, as soon as is practicable after the suspension, cancellation or revocation takes place.
(9) If the cancellation of a licence is revoked, the cancellation is taken never to have occurred.
128 Publication of list of manufacturers etc.
The APVMA may, from time to time and in a manner determined by it, publish a list of the holders of licences, the chemical products to which the licences relate, the steps of manufacture that the licences authorise and the addresses of the premises to which the licences relate.
Part 9—Enforcement
Division 1—Preliminary
129 Explanation of Part
(1) This Part contains provisions for the enforcement of this Code.
(2) Division 2 empowers any person to seek an injunction to enforce compliance with this Code.
(3) Division 3 contains provisions authorising inspectors to monitor compliance with this Code and, if contraventions are suspected to have occurred, to obtain search warrants. Inspectors are, or may be, given powers to enter and search premises and seize things. They may also require the giving of information or the production of documents.
(4) Division 4 contains various ancillary provisions.
Division 2—Injunctions
130 Injunctions
(1) If a person has engaged, or is proposing to engage, in any conduct that was or would be an offence against this Code, a court of competent jurisdiction may, on the application of any person, grant an injunction restraining the first‑mentioned person from engaging in the conduct and, if in the court’s opinion it is desirable to do so, requiring that person to do a particular thing.
(2) If in the opinion of the court it is desirable to do so, the court may grant an interim injunction pending determination of an application under subsection (1).
(3) The court may discharge or vary an injunction granted under subsection (1) or (2).
(4) The power of the court to grant an injunction restraining a person from engaging in conduct may be exercised:
(a) whether or not it appears to the court that the person intends to engage again, or to continue to engage, in conduct of that kind; and
(b) whether or not the person has previously engaged in conduct of that kind; and
(c) whether or not the conduct involves a serious and immediate risk of:
(i) an effect that is harmful to human beings; or
(ii) an unintended effect that is harmful to animals, plants or things or to the environment.
(5) The power of the court to grant an injunction requiring a person to do a particular thing may be exercised:
(a) whether or not it appears to the court that the person intends to refuse or fail again, or to continue to refuse or fail, to do that thing; and
(b) whether or not the person has previously refused or failed to do that thing; and
(c) whether or not there is a serious and immediate risk of:
(i) an effect that is harmful to human beings; or
(ii) an unintended effect that is harmful to animals, plants or things or to the environment;
if the person refuses or fails to do that thing.
Division 3—Powers of entry, search and seizure
131 Searches to monitor compliance with Code
(1) Subject to this section, to the extent that it is reasonably necessary to do so for the purpose of finding out whether this Code has been complied with, an inspector, with any necessary help, may enter, at any time during ordinary working hours on any day, any premises that the inspector has reasonable cause to believe are premises at which active constituents for proposed or existing chemical products, or chemical products, or records relating to any such constituents or products, are kept and may do any one or more of the following:
(a) search the premises and any thing found at the premises;
(b) inspect and take photographs (including video recordings), or make sketches, of the premises or any thing at the premises;
(c) take and keep samples of any thing at the premises;
(d) inspect any document kept at the premises;
(e) seize any thing at the premises if the inspector believes on reasonable grounds that it is necessary to seize the thing in order to prevent its concealment, loss or destruction or to protect the health of the public or of any person;
(f) open any container at the premises for the purpose of inspecting, or taking a sample of, its contents provided that the container is resealed after the inspection is made or the sample is taken;
(g) if a thing is seized under paragraph (e), direct the occupier of the premises or the owner of that thing to keep it at the premises, or at other premises under the control of the occupier or owner that will, in the opinion of the inspector, cause least danger to the health of the public or of any person;
(h) give any other directions for, or with respect to, the detention of a thing that has been seized under paragraph (e);
(i) destroy or make harmless, or give directions for the destruction or making harmless of, a chemical product at the premises.
(2) An inspector may not:
(a) under paragraph (1)(c)—take samples of a thing; or
(b) under paragraph (1)(e)—seize a thing;
that appears to the inspector to be in the possession or custody of a person unless the inspector makes out and tenders to the person a receipt in or to the effect of the approved form for the sample taken or thing seized.
(3) An inspector may not, under subsection (1), enter premises that are a residence unless the occupier of the premises has consented to the entry.
(4) An inspector may not exercise any powers under subsection (1) in relation to premises if:
(a) the occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and
(b) the inspector fails to comply with the requirement.
(5) The powers conferred on an inspector under paragraph (1)(i) may not be exercised unless:
(a) the APVMA believes on reasonable grounds that it is necessary in the interest of the health of the public or of any person for those powers to be exercised and authorises the inspector concerned to do so; or
(b) the owner of the chemical product concerned authorises the inspector to exercise those powers in respect of the product.
(6) If a direction given by an inspector under this section is inconsistent with an earlier direction given by an inspector under this section, the earlier direction is, to the extent of the inconsistency, of no effect.
(7) If a direction given by an inspector under this section is inconsistent with a requirement that the APVMA has made under section 99, 101, 102 or 103, the direction is, to the extent of the inconsistency, of no effect.
(8) A person must not refuse or fail to comply with the direction given by an inspector under this section.
Penalty: 30 penalty units.
(9) Subsection (8) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (9). See subsection 13.3(3) of the Criminal Code.
(10) An offence under subsection (8) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
132 Offence‑related searches and seizures
(1) If an inspector has reasonable grounds for suspecting that there may be at any premises a particular thing that may be evidence of the commission of an offence against this Code, the inspector, with any necessary help, may:
(a) with the consent of the occupier of the premises; or
(b) under a warrant issued under section 133;
enter the premises and:
(c) search the premises for the thing; and
(d) if the thing is found, take photographs (including video recordings) of the premises or thing, take samples of the thing, seize the thing or undertake more than one of those activities; and
(e) give any directions for, or with respect to, the detention of a thing that has been seized under paragraph (d).
(2) If, in the course of searching, under a warrant issued under section 133, for a particular thing in relation to a particular offence, an inspector finds a thing that the inspector believes, on reasonable grounds, to be:
(a) a thing that may be evidence of the commission of the offence, although not the thing stated in the warrant; or
(b) a thing that may be evidence of the commission of another offence against this Code or an offence against the Agvet Code of another jurisdiction;
and the inspector believes, on reasonable grounds, that it is necessary to seize that thing in order to prevent its concealment, loss or destruction, or its use in committing, continuing or repeating the offence or the other offence, the warrant is taken to authorise the inspector to seize that thing.
(3) If an inspector seizes a thing under paragraph (1)(d) and the inspector is authorised by the APVMA to exercise powers under this subsection, the inspector may do any one or more of the following:
(a) if the seizure related to a substance and the inspector suspects that there has been a contravention of this Code in respect of any of its constituents, or in respect of the concentration, composition or purity of any of its active constituents—supervise the reformulation of the substance so that there is no such contravention;
(b) if the seizure related to a substance and its container and the inspector suspects that there has been a contravention of this Code in respect of the container—supervise the placing of the substance in a container in respect of which there is no such contravention;
(c) if the seizure related to a substance and its container and the inspector suspects that there has been a contravention of this Code in respect of the label attached to the container—supervise the attaching to the container of a label in respect of which there is no such contravention.
133 Offence‑related warrants
(1) An inspector may apply to a magistrate for a warrant under this section in relation to particular premises.
(2) Subject to subsection (3), a magistrate may issue the warrant in accordance with the prescribed form if he or she is satisfied, by information on oath, that there are reasonable grounds for suspecting that there is, or may be within the next 72 hours, at the premises a particular thing that may be evidence of the commission of an offence against this Code.
(3) A magistrate must not issue a warrant under subsection (2) unless the informant or some other person has given to the magistrate, either orally or by affidavit, any further information that the magistrate requires about the grounds on which the issue of the warrant is being sought.
(4) The warrant must:
(a) state the nature of the offence; and
(b) state the purpose for which the warrant is issued; and
(c) authorise an inspector named in the warrant, with any help, and using any force, that is necessary and reasonable, to enter the premises and exercise the powers referred to in paragraphs 132(1)(c), (d) and (e) in respect of the thing; and
(d) state whether entry is authorised to be made at any time of the day or night or during stated hours of the day or night; and
(e) state a day, not later than 7 days after the day of issue of the warrant, upon which the warrant ceases to have effect.
134 Announcement before entry
(1) An inspector who is authorised to enter premises under a warrant issued under section 133 or a person helping such an inspector must, before any person enters the premises under the warrant:
(a) announce that he or she is authorised by the warrant to enter the premises; and
(b) give any person at the premises an opportunity to allow entry to the premises.
(2) The inspector or a person helping the inspector does not have to comply with subsection (1) if he or she believes on reasonable grounds that immediate entry to the premises is required to ensure:
(a) the safety of a person (including the inspector and any person helping the inspector); or
(b) that the effective execution of the warrant is not frustrated.
135 Details of warrant to be given to occupier
(1) If a warrant under section 133 in relation to premises is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the inspector or a person helping the inspector must make a copy of the warrant available to that person.
(2) The inspector must identify himself or herself to the person at the premises.
(3) The copy of the warrant referred to in subsection (1) need not include the signature of the magistrate who issued the warrant.
136 Use of equipment to examine or process things
(1) An inspector who enters premises under section 131 or 132 or a person helping the inspector may bring to the premises any equipment reasonably necessary for the examination or processing of things found at the premises in order to determine whether they are things that may be seized under that section.
(2) If:
(a) it is not practicable to examine or process the things at the premises; or
(b) the occupier of the premises consents in writing;
the things may be moved to another place so that the examination or processing can be carried out in order to determine whether they are things that may be seized under section 131 or 132, as the case may be.
(3) If things containing electronically stored information are moved to another place for the purpose of examination or processing under subsection (2), the inspector must, if it is practicable to do so:
(a) tell the occupier the address of the place and the time at which the examination or processing will be carried out; and
(b) allow the occupier or a representative of the occupier to be present during the examination or processing.
(4) The inspector or a person helping the inspector may operate equipment already at the premises to carry out the examination or processing of a thing found at the premises in order to determine whether it is a thing that may be seized under section 131 or 132, as the case may be, if the inspector or person helping believes on reasonable grounds that:
(a) the equipment is suitable for the examination or processing; and
(b) the examination or processing can be carried out without damage to the equipment or the thing.
137 Use of electronic equipment at premises
(1) Subject to subsection (4), if a thing found at premises that an inspector has entered under section 131 or 132 is or includes records of information in a written or electronic form, the inspector or a person helping the inspector may operate, or the inspector may require the occupier or an employee of the occupier who is present to operate, equipment at the premises to see whether:
(a) the equipment; or
(b) a disk, tape or other storage device that:
(i) is at the premises; and
(ii) can be used with, or is associated with, the equipment;
contains records that are relevant to determining whether this Code has been complied with.
(2) If the inspector or a person helping the inspector, after equipment at the premises is operated, finds that the equipment contains records of that kind or that a disk, tape or other storage device at the premises contains records of that kind, he or she may:
(a) seize the equipment or the disk, tape or other storage device; or
(b) if the records can, by using facilities at the premises, be put in documentary form—operate the facilities to put the records in that form and seize the documents so produced; or
(c) if the records can be transferred to a disk, tape or other storage device that:
(i) is brought to the premises; or
(ii) is at the premises and whose use for the purpose has been agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the records to the storage device and remove the storage device from the premises.
(3) An inspector or person helping an inspector may seize equipment under paragraph (2)(a) only if:
(a) it is not practicable to put the relevant records in documentary form as mentioned in paragraph (2)(b) or to copy the records as mentioned in paragraph (2)(c); or
(b) possession by the occupier of the equipment could be an offence.
(4) An inspector or a person helping an inspector must not operate equipment for the purpose mentioned in subsection (1) unless the inspector or person helping believes on reasonable grounds that the operation of the equipment can be carried out without damage to the equipment.
138 Compensation for damage to electronic equipment
(1) If:
(a) equipment is damaged because of being operated as mentioned in section 136 or 137; and
(b) the damage was caused by:
(i) insufficient care being exercised in selecting the person who was to operate the equipment; or
(ii) insufficient care being exercised by the person operating the equipment;
the APVMA must pay compensation for the damage to the owner of the equipment.
(2) In determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and the employees and agents of the occupier, if they were available at the time, had provided any warning or guidance as to the operation of the equipment that was appropriate in the circumstances.
139 Copies of seized things to be given
(1) Subject to subsection (2), if an inspector who has entered premises under section 131 or 132 seizes:
(a) a document, film, computer file or other thing that can be readily copied; or
(b) a storage device the information in which can be readily copied;
the inspector must, if asked to do so by the occupier of the premises or another person who apparently represents the occupier and is present when the seizure takes place, give a copy of the thing or the information to that person as soon as practicable after the seizure.
(2) Subsection (1) does not apply if:
(a) the thing that has been seized was seized under paragraph 137(2)(b) or (c); or
(b) possession by the occupier of the document, film, computer file, thing or information could be an offence.
140 Return of things that are seized
(1) If an inspector seizes a thing under section 131 or 132, the inspector must take reasonable steps to return it if the reason for its seizure no longer exists.
(2) If the thing has not been returned before the end of 60 days after its seizure, the inspector must take reasonable steps to return it unless:
(a) proceedings in which the thing may be used in evidence were begun before the end of the 60 days and the proceedings (including an appeal to a court in relation to the proceedings) have not been completed; or
(b) the inspector may keep the thing because of an order under section 141; or
(c) the inspector is authorised by this Code or by an order of a court to keep, destroy or dispose of the thing.
(3) If the thing has to be returned, it must be returned to the person from whom it was seized or, if that person is not entitled to possess it, to the owner.
(4) If there is a dispute as to the ownership of the thing, the inspector may keep the thing until the dispute is resolved.
(5) This section has effect subject to sections 141 and 150.
141 Court of summary jurisdiction may permit a thing to be kept
(1) If:
(a) before the end of 60 days after an inspector seizes a thing under section 131 or 132; or
(b) before the end of a period previously stated in an order of a court under this section in respect of a thing seized by an inspector as mentioned in paragraph (a);
proceedings in which the thing may be used in evidence have not been brought, the inspector may apply to a court of summary jurisdiction for an order that he or she may keep the thing for a further period.
(2) If the court is satisfied that it is necessary for the inspector to continue to keep the thing:
(a) for the purposes of an investigation as to whether an offence has been committed; or
(b) to enable evidence of an offence to be secured for the purposes of a prosecution;
the court may order that the inspector may keep the thing for a period stated in the order.
(3) If the court thinks that notice of the application should be given to any person, it may require such a notice to be given before it hears the application.
142 Certain expenses to be recoverable by APVMA
(1) Any expense incurred by the APVMA under paragraph 131(1)(i) in respect of the destruction or making harmless of a chemical product is a debt due to the APVMA by the owner of the product.
(2) Any expense incurred by the APVMA under subsection 132(3) in supervising:
(a) the reformulation of a substance; or
(b) the placing of a substance in a container; or
(c) the attaching of a label to a container;
is a debt due to the APVMA:
(d) if paragraph (a) or (b) applies—by the owner of the substance; or
(e) if paragraph (c) applies—by the owner of the substance in the container.
(3) Any expense incurred by the APVMA under paragraph 140(2)(c) in destroying or disposing of a thing is a debt due to the APVMA by the owner of the thing.
(4) Any expense incurred by the APVMA under section 140 in returning a thing to a person is a debt due to the APVMA by the person.
(5) Any expense incurred by the APVMA under section 150 in disposing of a thing that has been forfeited to the APVMA is a debt due to the APVMA by the person whose property the thing was before it was forfeited.
(6) The APVMA may recover a debt due by a person under this section by action against the person.
143 Warrants may be granted by telephone in urgent circumstances
(1) If, because of circumstances of urgency, an inspector considers it necessary to do so, the inspector may apply for a warrant under subsection 133(1), by telephone, in accordance with this section.
(2) Before so applying, an inspector must prepare an information of a kind referred to in subsection 133(2) that sets out the grounds on which the issue of the warrant is being sought, but the inspector may, if it is necessary to do so, apply before the information has been sworn.
(3) If a magistrate to whom an application under subsection (1) is made is satisfied:
(a) after having considered the terms of the information prepared in accordance with subsection (2); and
(b) after having received any further information that the magistrate requires about the grounds on which the issue of the warrant is being sought;
that there are reasonable grounds for issuing the warrant, the magistrate must complete and sign such a search warrant as the magistrate would have issued under section 133 if the application had been made in accordance with that section.
(4) If a magistrate signs a warrant under subsection (3):
(a) the magistrate must notify the inspector of the terms of the warrant and the date on which and the time at which it was signed, and write on it the reasons for the granting of the warrant; and
(b) the inspector must complete a form of warrant in the terms notified to the inspector by the magistrate and write on it the name of the magistrate and the date on which and the time at which the warrant was signed.
(5) If an inspector completes a form of warrant in accordance with subsection (4), the inspector must, not later than the day after the day on which the warrant ended or was executed, whichever is the earlier, send to the magistrate who signed the warrant the form of warrant completed by the inspector and the information duly sworn in connection with the warrant.
(6) Upon receiving the documents referred to in subsection (5), the magistrate must attach to them the warrant signed by the magistrate and deal with the documents in the manner in which the magistrate would have dealt with the information if the application for the warrant had been made in accordance with section 133.
(7) A form of warrant duly completed by an inspector in accordance with subsection (4) is, if it is in accordance with the terms of the warrant signed by the magistrate, authority for any entry, search, seizure or direction that the warrant so signed authorises.
(8) If it is material, in any proceedings, for a court to be satisfied that an entry, search, seizure or direction was authorised in accordance with this section, and the warrant signed by a magistrate in accordance with this section authorising the entry, search, seizure or direction is not produced in evidence, the court must assume, unless the contrary is proved, that the entry, search, seizure or direction was not authorised by such a warrant.
144 Power of inspector to require information or documents
(1) Subject to subsection (2), an inspector who has entered premises under this Division may, to the extent that it is reasonably necessary for the purpose of finding out whether this Code has been complied with, require a person to give information to the inspector and to produce any documents referred to by the inspector.
(2) An inspector is not entitled to make a requirement of a person under subsection (1) unless the inspector produces his or her identity card for inspection by the person.
(3) A person must not refuse or fail to comply with a requirement made under subsection (1).
Penalty: 30 penalty units.
(4) Subsection (3) does not apply if the person has a reasonable excuse.
Note: The defendant bears an evidential burden in relation to the matter in subsection (4). See subsection 13.3(3) of the Criminal Code.
(5) An offence under subsection (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
145 False or misleading information or document
(1) A person commits an offence if, for the purposes of, or in connection with, the consideration by the APVMA, in the course of the performance of any of its functions or the exercise of any of its powers under this Code, of any matters referred to in subsection 14(4), (5) or (6), subsection 56K(1) or paragraph 123(1)(a), the person:
(a) gives information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or
(b) produces a document that the person knows to be false or misleading in a material particular without:
(i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and
(ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information.
(2) The penalty for an offence against subsection (1) is a fine not exceeding 300 penalty units.
(3) A person commits an offence if, for the purposes of, or in connection with, the consideration by the APVMA, in the course of the performance of any of its functions or the exercise of any of its powers under this Code, of any matters other than matters referred to in subsection (1), the person:
(a) gives information (whether orally or in writing) that the person knows to be false or misleading in a material particular; or
(b) produces a document that the person knows to be false or misleading in a material particular without:
(i) indicating to the person to whom the document is produced that it is false or misleading and the respect in which it is false or misleading; and
(ii) providing correct information to that person if the person producing the document is in possession of, or can reasonably acquire, the correct information.
(4) The penalty for an offence against subsection (3) is a fine not exceeding 60 penalty units.
Division 4—Miscellaneous enforcement provisions
146 Self‑incrimination to be a reasonable excuse for non‑compliance with requirement
It is a reasonable excuse for a person to refuse or fail to give information, produce a document or do any other thing that the person is required to do by or under this Code that the information, the production of the document or the doing of that other thing would tend to incriminate the person.
147 Time for bringing prosecutions
A prosecution for an offence against this Code may be begun at any time within 2 years after the commission of the offence.
148 Copying of documents
If an inspector inspects a document under section 131 or seizes a document under section 131 or 132 or a person produces a document to an inspector in accordance with a requirement under subsection 144(1), the inspector may make copies of, or take extracts from, the document.
149 Evidential certificates
(1) This section has effect for the purposes of any proceeding:
(a) under or for the purposes of this Code or an eligible law of this jurisdiction; and
(b) before a court or tribunal of this jurisdiction or an authority or person having power to require the production of documents or the answering of questions in this jurisdiction;
other than a proceeding for an offence that is directly punishable by imprisonment.
(2) A certificate that states a matter referred to in subsection (3) is evidence of that matter if it is signed by the Chief Executive Officer of the APVMA, or by a member of the staff of the APVMA whom the APVMA has authorised to give certificates under this section.
(3) The matters that may be stated in a certificate referred to in subsection (2) are as follows:
(a) that a substance referred to in the certificate was, or was not, at a particular time, or during a particular period, an active constituent, or an approved active constituent, for a proposed or existing chemical product;
(b) that a chemical product referred to in the certificate was, or was not, at a particular time, or during a particular period, a chemical product, a registered chemical product or a registered listed chemical product;
(c) that a label referred to in the certificate was, or was not, at a particular time, or during a particular period, an approved label for containers for a chemical product or a label for containers for a chemical product that is required by an established standard for the product;
(d) that a permit or exemption referred to in the certificate was in force at a particular time or during a particular period;
(e) that an approval, registration, permit or exemption referred to in the certificate was suspended at a particular time or during a particular period;
(f) that an approval, registration, permit or exemption referred to in the certificate is, or was at a particular time or during a particular period, subject to a stated condition;
(g) that the matter appearing on an approved label or on a label for containers for a chemical product that is required by an established standard for the product, or in a permit, referred to in the certificate is identical to matter set out in, or in a writing annexed to, the certificate;
(h) that a person named in the certificate was an inspector at a particular time or during a particular period;
(i) that a document referred to in the certificate that purports to be a copy of, or an extract from, a record, register or file kept under this Code is a true copy or extract, as the case may be;
(j) that a notice, direction or requirement referred to in the certificate was given at a particular time to a particular person under this Code;
(k) that the APVMA had not received by a particular time an application, statement, report or other document, or any sample or other thing, referred to in the certificate that was required or permitted to be made or given to the APVMA by a person under this Code;
(l) that a document referred to in the certificate is, or was at a particular time or during a particular period, a standard, rule, code, specification or method of a particular association, body or institution;
(m) that a licence referred to in the certificate was in force at a particular time or during a particular period;
(n) that a licence referred to in the certificate was suspended at a particular time or during a particular period;
(o) that a licence referred to in the certificate is, or was at a particular time or during a particular period, subject to a stated condition;
(p) that a particular statement contained in a document referred to in the certificate is, or was at a particular time or during a particular period, a manufacturing principle that the APVMA has determined.
(4) Unless the contrary is proved, a document purporting to be a certificate referred to in subsection (2) is taken to be such a certificate and to have been duly given.
(5) Unless the contrary is proved, evidence that a label attached to a sealed container contained any matter at any time in a manner prescribed or required by this Code in relation to a chemical product is also evidence that the product was in the container at that time.
150 Forfeiture
(1) If a person is convicted of an offence against this Code in respect of a thing that the court finds to be the property of that person, the court may order all or any part of the thing to be forfeited to the APVMA.
(2) If the court makes an order under subsection (1) in respect of, or in respect of part of, a thing, the thing, or that part of the thing, as the case may be, becomes the property of the APVMA and, subject to section 162, may be dealt with or disposed of in any manner that the APVMA thinks appropriate.
151 Conduct by directors, servants and agents
(1) Subject to subsection (2), in proceedings against a body corporate for an offence against this Code:
(a) any conduct engaged in by a director, servant or agent of the body corporate within the actual or apparent scope of his or her employment or within his or her actual or apparent authority is taken to have been engaged in also by the body corporate; and
(b) it is taken to be established that conduct (the relevant conduct) was engaged in by the body corporate intentionally, knowingly or recklessly if it is proved:
(i) that the directors of the body corporate intentionally, knowingly or recklessly engaged in the relevant conduct or expressly, tacitly or impliedly authorised or permitted the relevant conduct to be engaged in; or
(ii) that a servant or agent of the body corporate with duties of such responsibility that his or her conduct may fairly be assumed to represent the policy of the body corporate intentionally, knowingly or recklessly engaged in the relevant conduct or expressly, tacitly or impliedly authorised or permitted the relevant conduct to be engaged in.
(2) Subparagraph (1)(b)(ii) does not apply if the body corporate proves that it exercised due diligence to prevent the relevant conduct.
(3) Subject to subsection (4), in proceedings against an individual for an offence against this Code:
(a) any conduct engaged in by a servant or agent of the individual within the actual or apparent scope of his or her employment or within his or her actual or apparent authority is taken to have been engaged in also by the individual; and
(b) it is taken to be established that conduct (the relevant conduct) was engaged in by the individual intentionally, knowingly or recklessly if it is proved that a servant or agent of the individual with duties of such responsibility that his or her conduct may fairly be assumed to represent the policy of the individual intentionally, knowingly or recklessly engaged in the relevant conduct or expressly, tacitly or impliedly authorised or permitted the relevant conduct to be engaged in.
(4) Paragraph (3)(b) does not apply if the individual proves that he or she exercised due diligence to prevent the relevant conduct.
(5) If:
(a) an individual is convicted of an offence against this Code; and
(b) the individual would not have been convicted of the offence if subsections (3) and (4) had not been enacted;
the individual is not liable to be punished by imprisonment for the offence.
(6) A reference in this section to engaging in conduct includes a reference to failing or refusing to engage in conduct.
152 Liability of persons acting on behalf of non‑residents
(1) If:
(a) a person does any thing in this jurisdiction on behalf of another person who is not a resident of, and does not carry on business in, Australia; and
(b) the doing of that thing is an offence against this Code;
this Code has effect, in addition to the effect that it has apart from this subsection, as if the first‑mentioned person did that thing on that person’s own account and not on behalf of the other person.
(2) If:
(a) a person who is not a resident of, and does not carry on business in, Australia fails to do a thing in this jurisdiction in relation to:
(i) an active constituent for a proposed or existing chemical product in respect of which that person is the interested person; or
(ii) a chemical product in respect of which that person is the interested person; and
(b) the failure of that person to do that thing is an offence against this Code;
the approved person who signed the application for the approval of the constituent or the registration or listed registration, or the renewal of the registration or listed registration, of the product is taken to have been under the same liability under this Code as the first‑mentioned person to do that thing and, if the thing is not done by the approved person, is punishable accordingly.
(3) For an offence that arises because of subsection (2), strict liability applies to paragraphs (2)(a) and (b).
Note: For strict liability, see section 6.1 of the Criminal Code.
Part 10—Miscellaneous
153 Explanation of Part
This Part contains miscellaneous provisions (other than enforcement provisions) that relate generally to other provisions of this Code. Most provisions that affect only a particular part of this Code are contained in that Part.
154 Recognition of things done under corresponding laws
(1) In this Code, unless the contrary intention appears, a reference to any thing done by or in relation to the APVMA is a reference to such a thing done under or for the purposes of the Agvet Code of this jurisdiction or of another jurisdiction.
(2) In this Code, unless the contrary intention appears, a reference to any thing done by or in relation to a court is a reference to such a thing done under or for the purposes of the Agvet Code of this jurisdiction or of another jurisdiction.
155 Discharge of obligations under this Code
(1) Except as expressly provided in this Code, any thing done, whether within Australia or elsewhere, which, if it had been done under or for the purposes of this Code, would have discharged an obligation under this Code, discharges that obligation.
(2) Subject to subsection (3), any thing that has to be done under this Code may, for the purposes of this Code, be done anywhere in Australia, whether within or outside this jurisdiction.
(3) Subsection (2) does not affect the operation of any provision of this Code that:
(a) expressly requires a particular thing to be done within this jurisdiction; or
(b) expressly or by implication permits a particular thing to be done outside Australia.
156 The making of single applications or the giving of single notices under the Agvet Codes of all jurisdictions
(1) This section facilitates the administration, on a national basis, of the Agvet Codes of all jurisdictions by permitting the making of a single application, or the giving or publication of a single notice, under the Agvet Codes of all jurisdictions.
(2) If an application is expressed to be made under the Agvet Codes (rather than under the Agvet Code of a particular jurisdiction), it has effect as an application under the relevant provision of the Agvet Code of this jurisdiction in addition to any effect that it may have under the Agvet Code of any other jurisdiction.
(3) If a notice is expressed to be given or published by the APVMA under the Agvet Codes (rather than under the Agvet Code of a particular jurisdiction), it has effect as a notice given or published under the relevant provision of the Agvet Code of this jurisdiction in addition to any effect that it may have under the Agvet Code of any other jurisdiction.
157 Samples to be given for analysis
(1) If the APVMA so requires, a person who makes an application under this Code must:
(a) if the application relates to an active constituent or active constituents for a proposed or existing chemical product—give a sample of that constituent or of each of those constituents; or
(b) if the application relates to a chemical product—give a sample of any constituent of the product or a sample of the product, or both;
to the APVMA or to a body named by the APVMA, for the purpose of analysis by an approved analyst.
(2) The sample must:
(a) be of a quantity; and
(b) be taken on a day; and
(c) be taken in a manner; and
(d) be taken from a batch;
that the APVMA has directed.
(3) The applicant must pay to the APVMA the amount that the APVMA notifies the applicant in writing to be the cost of the analysis referred to in subsection (1), including the cost of packaging and transporting the sample or samples for analysis.
159 APVMA or other authority may require, or require additional, information, report or sample in certain circumstances
(1) For the purposes of:
(a) an application under this Code in relation to:
(i) an active constituent for a proposed or existing chemical product; or
(ii) a chemical product; or
(iii) a label for containers for a chemical product; or
(b) an application under this Code in relation to a permit in respect of:
(i) an active constituent for a proposed or existing chemical product; or
(ii) a chemical product; or
(c) reconsidering the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product, the approval of a label for containers for a chemical product or the listed registration of a chemical product; or
(d) deciding whether to suspend or cancel:
(i) an approval of an active constituent for a proposed or existing chemical product; or
(ii) the registration of a chemical product; or
(iii) the approval of a label for containers for a chemical product; or
(iv) the listed registration of a chemical product; or
(v) a permit in respect of an active constituent for a proposed or existing chemical product or in respect of a chemical product;
the APVMA or another prescribed authority may, by written notice given to the interested person or an approved person, require the interested person, or the applicant for or holder of the relevant permit, within a reasonable period stated in the notice, or within a further period that the APVMA allows, to do any one or more of the following:
(e) give to the APVMA or that prescribed authority, as the case may be, information, of a kind stated in the notice, that may be relevant to the application, reconsideration or decision;
(f) carry out a search of published literature for information about the active constituent, or about the chemical product or any of its constituents, as the case may be, and give a report to the APVMA or that prescribed authority on the results of that search;
(g) give to the APVMA or that prescribed authority, or to another body that the APVMA or that authority has determined, a sample of the active constituent, or of the chemical product or any of its constituents, as the case may be, for the purpose of analysis by an approved analyst.
(1A) The power of the APVMA or another authority under subsection (1) to require a person to give to the APVMA or to that authority information, a report or a sample includes a power to require the person to give to the APVMA or to that authority such information or such a report or sample in addition to any information, report or sample previously given by the person to the APVMA or to that authority under any provision of this Code other than this section or under a previous application of this section.
(2) Any information or report that a person has to give to the APVMA or a prescribed authority under subsection (1) must be given in writing and be signed by an approved person.
(3) If a person fails, without reasonable excuse, to comply with a requirement under subsection (1) that was made for the purposes of an application referred to in paragraph (1)(a) or (b), the APVMA may:
(a) treat the application as having been withdrawn; or
(b) suspend further consideration of the application until the applicant complies with the requirement.
(4) If the APVMA decides in accordance with subsection (3) to treat an application as having been withdrawn or to suspend further consideration of an application, it must give written notice of its decision to the applicant.
(5) Section 168 provides for additional matters to be included in a notice under subsection (4).
160 Overseas trials or experiments
For the purposes of:
(a) an application under this Code in relation to an active constituent for a proposed or existing chemical product; or
(b) an application under this Code in relation to a chemical product (including an application in relation to a label for containers for a chemical product); or
(c) reconsidering the approval of an active constituent for a proposed or existing chemical product, the registration or listed registration of a chemical product or the approval of a label for containers for a chemical product; or
(d) deciding whether to suspend or cancel a permit in respect of an active constituent for a proposed or existing chemical product or in respect of a chemical product;
the APVMA may take account of the results of any trials or experiments already carried out in a foreign country in relation to the constituent, or in relation to the product or any of its constituents, to the extent that those results are relevant having regard to any matters it thinks appropriate, including:
(e) any significant differences in the proposed use of the constituent, or of the product, in Australia and in that foreign country; or
(f) any different environmental factors affecting the use of the constituent, or of the product, in Australia and in that foreign country; or
(g) any significant additional information relating to the properties of the constituent, or of the product or of any of its constituents, that has become available since the conduct of those trials or experiments.
160A Notification of new information to APVMA in respect of pending application
(1) This section applies if:
(a) an application has been lodged with the APVMA for:
(i) approval of an active constituent for a proposed or existing chemical product; or
(ii) registration of a chemical product; or
(iii) listed registration of a chemical product; or
(iv) a permit in respect of such an active constituent or in respect of a chemical product; or
(v) a licence in respect of the manufacture of a chemical product; and
(b) the APVMA has not determined the application; and
(c) an appropriate person becomes aware of any relevant information in relation to the constituent, or in relation to the product or any of its constituents.
(2) The appropriate person must, as soon as practicable after the person becomes aware of the information, give the information to the APVMA.
Penalty: 300 penalty units.
(3) A person is an appropriate person in relation to an application referred to in paragraph (1)(a) if:
(a) in the case of an application referred to in subparagraph (1)(a)(i), (ii) or (iii)—the person would be an interested person in relation to the constituent or product if the application were granted; or
(b) in any other case—the person who made the application.
(4) Information is relevant information if it:
(a) contradicts any information given to the APVMA under this Code; or
(b) shows that the use of, or any other dealing with, the constituent or chemical product in accordance with the proposed instructions for its use or for such a dealing contained in the application, or shows that the use of, or any other dealing with, the chemical product in accordance with the instructions for its use or for such a dealing contained in an established standard:
(i) may be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(ii) may be likely to have an effect that is harmful to human beings; or
(iii) may be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(c) shows that the use of the chemical product in accordance with the proposed instructions for its use contained in the application, or in accordance with the instructions for its use contained in an established standard, may be ineffective according to criteria determined by the APVMA for the product; or
(d) would have had to be given to the APVMA in connection with the application if the applicant had been aware of the information when the application was made.
(5) A corporation is taken to be aware of any information if a related corporation is aware of that information.
(6) The question whether 2 corporations are related to each other is to be determined in the same way as that question would be determined under the Corporations Act 2001.
(7) Any information that a person has to give to the APVMA under this section must be given in writing signed by an approved person.
161 Notification of new information to APVMA
(1) If:
(a) the interested person in relation to an approved active constituent for a proposed or existing chemical product or in relation to a registered chemical product or a registered listed chemical product; or
(b) the holder of a permit in relation to an active constituent for a proposed or existing chemical product or in relation to a chemical product;
becomes aware of any relevant information in relation to the constituent or in relation to the product or of any of its constituents, the person must, as soon as practicable after the person becomes aware of the information, give that information to the APVMA.
Penalty: 300 penalty units.
(2) Information is relevant information if it:
(a) contradicts any information given to the APVMA under this Code; or
(b) shows that the use of, or any other dealing with, the constituent or the chemical product in accordance with the instructions for its use or for such a dealing that the APVMA has approved:
(i) may be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(ii) may be likely to have an effect that is harmful to human beings; or
(iii) may be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; or
(c) shows that the use of the product in accordance with the instructions for its use that the APVMA has approved may be ineffective according to criteria determined by the APVMA for the product; or
(d) would have had to be given to the APVMA in connection with the application for the approval, registration, listed registration or permit if the applicant had been aware of the information when the application was made.
(2A) A corporation is taken to be aware of any information if a related corporation is aware of that information.
(2B) The question whether 2 corporations are related to each other is to be determined in the same way as that question would be determined under the Corporations Act 2001.
(3) Any information that a person has to give to the APVMA under this section must be given in writing signed by an approved person.
162 Disclosure of confidential commercial information
(1) A person who is or has been a director, the Chief Executive Officer, or a member of the staff, of the APVMA, or is or has been a consultant to the APVMA, a mediator or arbitrator appointed under this Code, or a co‑ordinator designated for a jurisdiction, must not disclose, directly or indirectly, to another person any information about an active constituent for a proposed or existing chemical product, about a chemical product or any of its constituents, or about a label for containers for a chemical product, that:
(a) the person knows to be confidential commercial information; and
(b) was acquired by the person in the performance of such functions or duties or the exercise of such powers.
Penalty: Imprisonment for 2 years.
(1A) Subsection (1) does not apply to the extent that the person engages in the conduct in the performance of functions or duties, or the exercise of powers, under this Code.
Note: The defendant bears an evidential burden in relation to the matter in subsection (1A). See subsection 13.3(3) of the Criminal Code.
(2) Subsection (1) does not prohibit the disclosure of information about a constituent or a chemical product to a court in any proceeding but the court must do all things necessary to prevent disclosure of that information to any other person except for the purpose of the proceeding.
(3) Despite subsection (1), a person (the authorised person) that the APVMA has authorised to act under this section may:
(a) disclose confidential commercial information about an active constituent for a proposed or existing chemical product:
(i) by disclosing a summary of an assessment of the constituent made by the APVMA or by a prescribed authority or person; or
(ii) for the purposes of the APVMA’s reconsideration of the approval of the constituent under Division 4 of Part 2—by disclosing the relevant particulars of the constituent; or
(iii) by disclosing, subject to the conditions prescribed by the regulations, information about the toxicity of the constituent and its residues in relation to relevant organisms and ecosystems, including human beings; or
(b) disclose confidential commercial information about a chemical product or any of its constituents:
(i) if the product contains an active constituent that, before the registration or listed registration of the product, was not contained in a chemical product registered in this or another jurisdiction under the Agvet Code, or a corresponding previous law, of the jurisdiction concerned—by disclosing a summary of an assessment that the APVMA has made of the product; or
(ii) for the purposes of the APVMA’s reconsideration of the registration of the product under Division 4 of Part 2 or of the listed registration of the product under Division 6 of Part 2A—by disclosing the relevant particulars of the product; or
(iii) by disclosing, subject to any conditions prescribed by the regulations, information about the toxicity of the product and its residues in relation to relevant organisms and ecosystems, including human beings; or
(c) disclose confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents, to:
(i) the Commonwealth, a State or a Territory, or an authority of the Commonwealth, of a State or of a Territory; or
(ii) a person who is expressly authorised to obtain the information by the interested person in relation to the constituent or product; or
(iii) a prescribed authority or prescribed person; or
(d) subject to subsection (4), disclose confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents, to:
(i) an overseas authority having similar functions to the APVMA; or
(ii) a prescribed international organisation;
if the authorised person thinks it is reasonable to make the disclosure and the interested person in relation to the constituent or product has consented to the disclosure or the authorised person has made reasonable efforts to obtain that consent.
(4) An authorised person must not disclose information to an authority or organisation under paragraph (3)(d) without the consent of the interested person unless:
(a) the authorised person has given to the interested person written notice of the decision to disclose the information; and
(b) a period of 28 days has elapsed since the notice was given.
(5) Section 168 provides for additional matters to be included in a notice given under paragraph (4)(a).
(6) A person who acquires information because of a disclosure under subsection (3), and any person under the control of that person, is, in respect of that information, subject to the same obligations and liabilities under subsection (1) as if that person were a person performing duties under this Code and had acquired the information in the performance of those duties.
(7) Despite subsection (1), the authorised person may permit confidential commercial information about a constituent or chemical product to be disclosed to a Government, body or person:
(a) for the purpose of enabling the Government, body or person to give advice to the APVMA or to another Government, body or person in accordance with section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; or
(b) if the person is a co‑ordinator for a jurisdiction—for the purpose of enabling the co‑ordinator to make a recommendation to the APVMA in accordance with paragraph 111(1)(c).
Note: The defendant bears an evidential burden in relation to the matter in subsection (7). See subsection 13.3(3) of the Criminal Code.
(8) A person who acquires information because of a disclosure under subsection (7), and any person who is or has been under the control of that person, must not disclose that information, directly or indirectly, to any person if the person disclosing the information knows that the information is confidential commercial information.
Penalty: Imprisonment for 2 years.
(8A) Subsection (8) does not apply to conduct engaged in with the intention of providing advice to the APVMA in accordance with section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 or making a recommendation to the APVMA in accordance with paragraph 111(1)(c).
Note: The defendant bears an evidential burden in relation to the matter in subsection (8A). See subsection 13.3(3) of the Criminal Code.
(8B) In subsection (8), strict liability applies to the physical element of circumstance, that the disclosure was under subsection (7).
Note: For strict liability, see section 6.1 of the Criminal Code.
(9) If a person who is or has been a director, the Chief Executive Officer, or a member of the staff, of the APVMA, or is or has been a consultant to the APVMA, a mediator or arbitrator appointed under this Code, or a co‑ordinator designated for a jurisdiction, has disclosed to another person, except under subsection (3) or (7), any confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents, that was acquired by the first‑mentioned person in the performance of functions or duties, or the exercise of powers, under this Code, the other person, and any person who is or has been under the control of the other person, must not disclose that information, directly or indirectly, to any person if the person disclosing the information knows that the information is confidential commercial information.
Penalty: Imprisonment for 2 years.
(9A) In subsection (9), strict liability applies to the physical elements of circumstance, that:
(a) the acquisition of the information by the first‑mentioned person was in the performance of functions or duties, or the exercise of powers, under this Code; and
(b) the disclosure mentioned first in that subsection was made other than under subsection (3) or (7).
Note: For strict liability, see section 6.1 of the Criminal Code.
(10) The powers conferred by subsection (7) are in addition to, and do not prejudice, the powers conferred by subsection (3).
(11) A notice published under section 52, 53, 54 or 55 must not contain any confidential commercial information about an active constituent for a proposed or existing chemical product or about a chemical product or any of its constituents.
(12) This section does not preclude the institution of an action or other civil proceeding against a person in respect of the disclosure, or the proposed, threatened or likely disclosure, by that person of confidential commercial information about an active constituent for a proposed or existing chemical product, or about a chemical product or any of its constituents.
(13) A reference in this section to information about an active constituent for a proposed or existing chemical product, or about a chemical product, includes a reference to the fact that:
(a) an application has been made for approval of the constituent or registration of the product; or
(b) an application has been made for a permit in respect of the constituent or product, if the making of the application is confidential commercial information.
(13A) A reference in this section to information about:
(a) an active constituent for a proposed or existing chemical product; or
(b) a chemical product; or
(c) any of the constituents of a chemical product; or
(d) a label for containers for a chemical product;
includes a reference to information about any substance or thing that was at any time such an active constituent, such a chemical product, such a constituent of a chemical product or such a label, as the case may be.
(14) In this section:
court includes a tribunal, authority or person having power to require the production of documents or the answering of questions.
disclose, in relation to information, means give or communicate in any way.
163 Notice to interested person of proposed disclosure of information that is claimed to be confidential commercial information
(1) If:
(a) a person (the disclosing person) decides to disclose to another person information about an active constituent for a proposed or existing chemical product, about a chemical product or any of its constituents, or about a label for containers for a chemical product; and
(b) the interested person in relation to the constituent, product or label has claimed to the APVMA that the information is confidential commercial information but the disclosing person does not agree with the claim; and
(c) the disclosure would, if the information were confidential commercial information, contravene section 162;
the disclosing person:
(d) must give written notice to the interested person of the decision to disclose the information stating the reasons why the disclosing person considers that the information is not confidential commercial information; and
(e) must not disclose the information until the end of 28 days after the notice is given.
Penalty: Imprisonment for 2 years.
(2) Section 168 provides for additional matters to be included in a notice given under subsection (1).
164 Fees
(1) The regulations may prescribe, or prescribe a method of working out, the fees to be paid in respect of the making of an application to the APVMA, or the doing of any thing by the APVMA or by an inspector, under this Code.
(1A) The APVMA may make a legislative instrument setting out criteria for working out which fee applies under the regulations in a particular case.
(2) Fees referred to in subsection (1) are due and payable in the manner and at the time or times that are prescribed.
(4) Two or more fees may be prescribed for the same matter.
(5) A fee is not payable in respect of the making of an application to the APVMA, or the doing of any thing by the APVMA or by an inspector, under a provision of the Agvet Code of this jurisdiction in relation to an active constituent for a proposed or existing chemical product, a chemical product, or a label for containers for a chemical product, if a corresponding fee has been paid in respect of the making of a corresponding application, or the doing of a corresponding thing, as the case may be, in relation to the same constituent, product or label, under the corresponding provision of the Agvet Code of another jurisdiction.
(6) Any fee that the APVMA receives under this Code is to be paid to the Commonwealth.
(7) If a fee has to be paid in respect of an application to the APVMA or in respect of the doing of any thing by the APVMA, the APVMA may refuse to consider the application or do that thing until the fee is paid.
(8) The APVMA may, on behalf of the Commonwealth, either on its own initiative or on application by a person, waive the whole or a part of a fee that would otherwise be payable under this Code, or remit the whole or a part of a fee that has been paid under this Code:
(a) if the fee is payable or was paid in respect of an application to the APVMA that is to be or has been withdrawn; or
(b) in any other circumstances that are prescribed by the regulations.
(9) If an application is made to the APVMA under subsection (8), it must give to the applicant written notice of its decision on the application.
(10) Section 168 provides for additional matters to be included in a notice given under subsection (9).
165 Period within which APVMA is to determine applications
(1) When an application is made under this Code to the APVMA, the APVMA must determine the application within a period stated in, or determined in accordance with, the regulations.
(1A) The APVMA may make a legislative instrument setting out criteria for working out which period stated in, or determined in accordance with, the regulations made for the purposes of subsection (1) applies in a particular case.
(2) In working out the period within which an application has to be determined, no regard is to be had to:
(a) any period beginning on the day when the APVMA makes a requirement of the applicant in connection with the application and ending on the day when the requirement is complied with; and
(b) if the APVMA has, before the application was made, caused to be published a notice in the Gazette under subsection 69EP(2) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 in relation to a hearing that is relevant to the determination of the application and the hearing did not finish before the application was made—the period beginning when the application was made and ending when the hearing finished; and
(c) if the APVMA has, after the application was made, caused such a notice to be published in the Gazette—the period beginning when the notice was published and ending when the hearing finished.
166 Reconsideration of decisions
(1) This section applies if:
(a) a decision (the original decision) on a particular matter (the relevant matter) has been made under this Code other than this section on behalf of the APVMA by a member of the staff of the APVMA; and
(b) a person is entitled to apply under section 167 to the Administrative Appeals Tribunal for review of the original decision.
(2) The person may, by writing, request the APVMA to reconsider the original decision.
(3) If a request is so made, the APVMA must reconsider the original decision and:
(a) confirm the original decision; or
(b) vary the original decision; or
(c) set aside the original decision; or
(d) set aside the original decision and make a new decision in substitution for the original decision.
(4) The APVMA must, as soon as practicable, give written notice to the person who made the request setting out the APVMA’s decision on the reconsideration.
(5) The decision on the reconsideration is taken, for the purposes of this Code other than paragraph (1)(a), to be a fresh decision on the relevant matter made under the provision of this Code under which the original decision was made.
(6) Section 168 provides for additional matters to be included in certain notices given under subsection (4).
167 Review of decisions
(1) An application may be made to the Administrative Appeals Tribunal for review of the following decisions of the APVMA:
(aa) a decision under section 11A that the application does not comply with subsection 11(1);
(ab) a decision under section 11A to defer consideration of an application for approval of an active constituent for a proposed or existing chemical product, for registration of a chemical product or for approval of a label for containers for a chemical product, or to treat such an application as having been withdrawn;
(ac) a decision under section 11A to reject an application for approval of an active constituent for a proposed or existing chemical product, for registration of a chemical product or for approval of a label for containers for a chemical product;
(ad) a decision under subparagraph 11A(3)(a)(iii) refusing to extend a period;
(a) a decision under Division 2 of Part 2 to refuse an application for approval of an active constituent for a proposed or existing chemical product, for registration of a chemical product or for approval of a label for containers for a chemical product;
(b) a decision under Division 2 of Part 2 to approve an active constituent for a proposed or existing chemical product, to register a chemical product, or to approve a label for containers for a chemical product, subject to particular conditions;
(baa) a decision under section 26A to refuse to vary:
(i) relevant particulars of the approval of an active constituent for a proposed or existing chemical product; or
(ii) relevant particulars of the registration of a chemical product; or
(iii) relevant particulars of the approval of a label for containers for a chemical product;
(ba) a decision under section 28A that the application does not comply with subsection 28(1);
(bb) a decision under section 28A:
(i) to defer consideration of an application to vary the relevant particulars, or the conditions, of an approval or registration; or
(ii) to treat such an application as having been withdrawn; or
(iii) to reject such an application;
(bc) a decision under section 28A refusing to extend a period;
(c) a decision under Division 3 of Part 2 to refuse an application to vary the relevant particulars of the approval of an active constituent for a proposed or existing chemical product, the relevant particulars of the registration of a chemical product or the relevant particulars of the approval of a label for containers for a chemical product;
(d) a decision under Division 3 of Part 2 to refuse an application to vary the conditions of the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product, or the approval of a label for containers for a chemical product;
(e) a decision under Division 4 of Part 2 to vary the conditions of the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product, or the approval of a label for containers for a chemical product;
(ea) a decision (the information decision) under subsection 34D(3) that the APVMA is satisfied that it is in the public interest to use information that section 34C would otherwise prohibit the APVMA from using for making a decision (the substantive decision):
(a) under section 14 or 29 about an application; or
(b) under section 34 about a reconsideration of an approval or registration;
(f) a decision under Division 5 of Part 2 to suspend or cancel the approval of an active constituent for a proposed or existing chemical product, the registration of a chemical product or the approval of a label for containers for a chemical product;
(fa) a decision under Division 4 of Part 2A to refuse an application for listed registration of a chemical product;
(fb) a decision under Division 4 of Part 2A to grant listed registration of a chemical product subject to particular conditions;
(fc) a decision under Division 5 of Part 2A to refuse an application to vary the relevant particulars of the listed registration of a chemical product;
(fd) a decision under Division 5 of Part 2A to refuse an application to vary the conditions of the listed registration of a chemical product;
(fe) a decision under Division 5 of Part 2A to vary the conditions of the listed registration of a chemical product;
(ff) a decision under Division 7 of Part 2A to suspend or cancel the listed registration of a chemical product;
(g) a decision under subsection 48(3) or 56ZL(3) refusing to accept a late application;
(h) a decision to use protected information under paragraph 59(2)(d);
(i) a decision under subsection 74(2), 75(2), 76(2) or 78(2) extending, or refusing to extend, a period;
(ia) a decision under subsection 81(3) shortening, or extending or refusing to extend, a period;
(j) a decision under section 99 to require the analysis of a substance or mixture of substances;
(k) a decision to issue a recall notice;
(l) a decision under Part 7 to refuse an application for a permit;
(m) a decision under Part 7 to issue a permit subject to particular conditions or for a particular period only;
(n) a decision under Part 7 to refuse to extend a permit;
(o) a decision under section 118 to suspend a permit;
(p) a decision under section 119 to cancel a permit;
(q) a decision under Part 8 to refuse an application for a licence;
(r) a decision under Part 8 to issue a licence subject to particular conditions referred to in subsection 126(1);
(s) a decision under subsection 126(2) to impose a new condition on a licence or varying an existing condition;
(t) a decision under section 127 to suspend or cancel a licence;
(u) a decision under subsection 159(3) to treat an application as having been withdrawn or to suspend further consideration of an application;
(v) a decision to disclose information to an authority or organisation under paragraph 162(3)(d) without the consent of the interested person concerned;
(w) a decision to disclose information under section 163;
(x) a decision under subsection 164(8) to refuse to waive or remit the whole or a part of a fee.
(2) For the purposes of this section, if an application made to the APVMA is not determined within the period within which the APVMA has to determine the application, the APVMA is taken to have made a decision at the end of that period to refuse the application.
(2A) Despite paragraph (1)(ea), an application may not be made to the Administrative Appeals Tribunal for review of the information decision if the APVMA stated in the notice of that decision given under section 34E that the APVMA believed it was necessary to make the substantive decision before the end of 28 days after giving the notice, to prevent imminent risk to public health or occupational health or safety.
(3) This section has effect subject to the Administrative Appeals Tribunal Act 1975.
(4) In this section:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
168 Statement to be included in certain notices of decisions
(1) If written notice of the making of a decision to which section 167 applies, or of the making of a decision under section 166 which, because of subsection 166(5), is taken to be a decision to which section 167 applies, is given to a person (other than a co‑ordinator designated for this or another jurisdiction), that notice must include a statement to the effect that:
(a) subject to the Administrative Appeals Tribunal Act 1975, application may be made by or on behalf of a person whose interests are affected by the decision to the Administrative Appeals Tribunal for review of the decision to which the notice relates; and
(b) unless subsection 28(4) of that Act applies, application may be made in accordance with section 28 of that Act by or on behalf of a person whose interests are affected by the decision for a statement in writing setting out the findings on material questions of fact, referring to the evidence or other material on which those findings were based and giving the reasons for the decision.
(2) Any failure to comply with a requirement of subsection (1) in relation to a decision does not affect the validity of the decision.
169 Documents and samples become property of APVMA
When a document or sample is given to the APVMA for any purpose of this Code, it becomes the property of the APVMA.
170 Provisions relating to offences
(1) Offences against subsections 162(1), (8) and (9) and subsection 163(1) are indictable offences.
(2) All other offences against this Code are summary offences.
(3) A provision of this Code relating to indictable offences or summary offences is taken to refer to bodies corporate as well as to individuals.
(4) If an individual is convicted of an indictable offence against this Code, the court may, if the court thinks it appropriate in all the circumstances of the case, impose, instead of, or in addition to, a penalty of imprisonment, a monetary penalty not greater than the number of penalty units worked out using the formula:
where:
Term of Imprisonment means the number of months in the maximum term of imprisonment by which the offence is punishable.
(5) If a body corporate is convicted of an offence against this Code, the court may, if the court thinks fit, impose a monetary penalty not greater than 5 times the amount of the maximum monetary penalty that could be imposed by the court on an individual convicted of the same offence.
170A Person not to use protected name or protected symbol
(1) A person must not:
(a) use in relation to a business, trade, profession or occupation; or
(b) use as the name, or as part of the name, of any firm, body corporate, institution, premises, vehicle, ship or craft (including aircraft); or
(c) apply, as a trade mark or otherwise, to goods imported, manufactured, produced, sold, offered for sale or let on hire; or
(d) use in relation to:
(i) goods or services; or
(ii) the promotion, by any means, of the supply or use of goods or services;
either:
(e) a protected name, or a name so closely resembling a protected name as to be likely to be mistaken for it; or
(f) a protected symbol, or a symbol so closely resembling a protected symbol as to be likely to be mistaken for it.
Penalty: 30 penalty units.
(2) Subsection (1) does not apply if the APVMA consents in writing to the use or application of the name or symbol.
Note: The defendant bears an evidential burden in relation to the matter in subsection (2). See subsection 13.3(3) of the Criminal Code.
(3) Nothing in subsection (1) affects rights conferred by law on a person in relation to:
(a) a trade mark that is registered under the Trade Marks Act 1995; or
(b) a design that is registered under the Designs Act 2003;
and was so registered immediately before 24 March 2004 in relation to the name or symbol.
(4) Nothing in this section affects the use, or rights conferred by law relating to the use, of the name or symbol by a person in a particular manner if, immediately before 24 March 2004, the person:
(a) was using the name or symbol in good faith in that manner; or
(b) would have been entitled to prevent another person from passing off, by means of the use of the name of the symbol or a similar name or symbol, goods or services as the goods or services of the first‑mentioned person.
(5) In this section:
protected name means:
(a) “APVMA”; or
(b) “Australian Pesticides and Veterinary Medicines Authority”.
protected symbol means the logo of the APVMA set out in the regulations.
Part 11—Transitional provisions
171 Explanation of Part
This Part contains provisions that continue in force, under the Agvet Code of this jurisdiction, certain existing clearances, registrations, approvals and permits and certain pending applications, reconsiderations and proceedings.
172 Existing clearance for registration of chemical product
(1) If:
(a) immediately before the commencement of the Agvet Code of this jurisdiction:
(i) a clearance for registration that the APVMA granted under section 15 of the repealed Act in respect of a chemical product was in force; and
(ii) the product was not registered by a previous registering authority of this jurisdiction; and
(b) a label for containers for the product becomes approved under that Code;
the following subsections apply.
(2) The product is taken to be registered by the APVMA under section 20 of that Code when the label becomes approved and to be so registered subject to the conditions (if any) to which the clearance was subject.
(3) The person who applied for the clearance is taken to be the person who applied for the registration.
173 Pending application for clearance for registration of chemical product
If:
(a) before the commencement of the Agvet Code of this jurisdiction an application for the clearance for registration of a chemical product was duly made to the APVMA under section 12 of the repealed Act but had not been disposed of by the APVMA; and
(b) the product was not registered before that commencement by a previous registering authority of this jurisdiction;
the following paragraphs apply:
(c) the application is taken to be an application for the registration of the product duly made upon that commencement to the APVMA under section 10 of that Code;
(d) any sample, particulars of trials or laboratory experiments or other information given to the APVMA under a provision of the repealed Act in connection with the application is taken to have been given to the APVMA under the provision of that Code that corresponds to that provision of the repealed Act.
174 Existing registration of chemical product
(1) If, immediately before the commencement of the Agvet Code of this jurisdiction, a chemical product was registered by the previous registering authority of this jurisdiction and a label in relation to, or in relation to containers for, that product was also registered or approved by that authority, the following paragraphs apply:
(a) the product is taken to have been registered by the APVMA under section 20 of that Code upon that commencement subject to the conditions (if any) to which its registration by that previous registering authority was subject;
(b) the person who applied for the registration of the product by the previous registering authority or, if that registration was renewed, the person who applied for the renewal or the last renewal, as the case may be, is taken to be the person who applied for the registration of the product under that Code;
(c) the label is taken to have been approved in relation to the product by the APVMA under section 21 of that Code upon that commencement:
(i) for the containers for which it was registered or approved by that previous registering authority or, if it was not registered or approved for containers, for all containers for the product; and
(ii) subject to the conditions (if any) to which its registration or approval by that previous registering authority was subject.
(2) If:
(a) immediately before the commencement of the Agvet Code of this jurisdiction, the supply of a chemical product that was not registered by the previous registering authority of this jurisdiction was permitted in this jurisdiction, either unconditionally or subject to conditions, because the product was registered by the previous registering authority of another jurisdiction; and
(b) a label for containers for the product becomes approved under that Code;
the following paragraphs apply:
(c) if the supply of the product was permitted unconditionally—the product is taken to be registered by the APVMA under section 20 of that Code when the label becomes approved;
(d) if its supply was permitted subject to conditions—the product is taken to be so registered subject to those conditions;
(e) the person who applied for the registration of the product by the previous registering authority of the other jurisdiction or, if that registration was renewed, the person who applied for the renewal or the last renewal, as the case may be, is taken to be the person who applied for the registration of the product under that Code.
(3) If, immediately before the commencement of the Agvet Code of this jurisdiction:
(a) a chemical product was registered by the previous registering authority of this jurisdiction; but
(b) it was unlawful under the law of this jurisdiction to supply the product;
the product is taken for the purposes of this section not to have been so registered immediately before that commencement.
175 Pending application for registration of chemical product
(1) If:
(a) before the commencement of the Agvet Code of this jurisdiction an application for the registration of a chemical product was duly made to the previous registering authority of this jurisdiction but had not been disposed of by that authority; and
(b) subject to subsection (2), immediately before that commencement the product was registered by a previous registering authority of another jurisdiction;
the application is taken to be an application for the registration of the product duly made upon that commencement to the APVMA under section 10 of that Code.
(2) If the APVMA directs that paragraph (1)(b) is not to apply in respect of a particular chemical product, subsection (1) applies in relation to that product as if that paragraph were omitted.
176 Existing registration or approval of label
(1) If, immediately before the commencement of the Agvet Code of this jurisdiction:
(a) no provision was made by the corresponding previous law of this jurisdiction for the registration of chemical products; but
(b) a label in relation to, or in relation to containers for, a chemical product was registered or approved by the previous registering authority of this jurisdiction;
then, upon that commencement, the following paragraphs apply:
(c) the product is taken to have been registered unconditionally by the APVMA under section 20 of that Code;
(d) the label is taken to have been approved in relation to the product by the APVMA under section 21 of that Code:
(i) for the containers for which it was registered or approved by that previous registering authority or, if it was not registered or approved for containers, for all containers for the product; and
(ii) subject to the conditions (if any) to which its registration or approval by that authority was subject.
(2) If, immediately before the commencement of the Agvet Code of this jurisdiction, a label in relation to, or in relation to containers for, a chemical product was registered or approved by the previous registering authority of this jurisdiction, the label is taken to have been approved in relation to the product by the APVMA under section 21 of that Code upon that commencement:
(a) for the containers for which it was registered or approved by that previous registering authority or, if it was not registered or approved for containers, for all containers for the product; and
(b) subject to the conditions (if any) to which its registration or approval by that authority was subject.
177 Pending application for registration or approval of label
(1) If:
(a) before the commencement of the Agvet Code of this jurisdiction, an application for the registration or approval of a label in relation to, or in relation to containers for, a chemical product was duly made to the previous registering authority of this jurisdiction but had not been disposed of by that previous registering authority; and
(b) immediately before that commencement:
(i) no provision was made by the corresponding previous law of this jurisdiction for the registration or approval of chemical products; and
(ii) the product was registered by a previous registering authority of another jurisdiction;
the following paragraphs apply:
(c) the application is taken to be an application for the registration of the product duly made upon that commencement to the APVMA under section 10 of that Code;
(d) subject to subsection (3), the application is also taken to be an application for the approval of the label duly made upon that commencement to the APVMA under that section.
(2) If:
(a) before the commencement of the Agvet Code of this jurisdiction, an application for the registration or approval of a label in relation to, or in relation to containers for, a chemical product was duly made to the previous registering authority of this jurisdiction but had not been disposed of by that authority; and
(b) subject to subsection (3), immediately before that commencement the label was registered or approved by a previous registering authority of another jurisdiction;
the application is taken to be an application for the approval of the label duly made upon that commencement to the APVMA under section 10 of that Code.
(3) If the APVMA directs that paragraph (1)(d) or (2)(b) is not to apply in respect of a particular label, this section applies in relation to that label as if that paragraph were omitted.
178 Provisions that apply in respect of existing registrations or approvals
(1) If a chemical product is taken by section 172 or 174 or subsection 176(1) of the Agvet Code of this jurisdiction to have been registered under that Code:
(a) the APVMA may, but does not have to, do either or both of the following:
(i) give a distinguishing number to the product;
(ii) enter the relevant particulars in the Register of Chemical Products; and
(b) paragraph 167(1)(b) of that Code has effect as if the registration of the product that is taken to be effected by section 172 or 174 or subsection 176(1) of that Code resulted from a decision by the APVMA under Division 2 of Part 2 of that Code to register the product subject to the conditions to which its registration is taken to be subject by that section.
(2) If a label for containers for a chemical product is taken by paragraph 174(1)(c) or section 176 of the Agvet Code of this jurisdiction to have been approved under that Code, the APVMA may, but does not have to, do either or both of the following:
(a) give a distinguishing number to the label;
(b) record the relevant particulars in the relevant APVMA file.
179 Pending application for variation of conditions
If:
(a) before the commencement of the Agvet Code of this jurisdiction an application for the variation of the conditions to which a clearance for registration in respect of a chemical product was subject under the repealed Act was duly made to the APVMA under section 13 of that Act but had not been disposed of by the APVMA; and
(b) the product is taken by section 172 or 174 of that Code to have been registered by the APVMA subject to those conditions;
the following paragraphs apply:
(c) the application is taken to be an application duly made to the APVMA under section 27 of that Code for the variation of the conditions to which the registration of the product is taken to be subject because of section 172 or 174 of that Code;
(d) any particulars of trials or laboratory experiments or other information given to the APVMA under a provision of the repealed Act in connection with the application are taken to have been given to the APVMA under the provision of that Code that corresponds to that provision of the repealed Act.
180 Reconsideration of existing clearances for registration
If:
(a) before the commencement of the Agvet Code of this jurisdiction, the APVMA had, under section 17 of the repealed Act, informed the person holding a certificate of clearance for registration issued in respect of a chemical product that it proposed to reconsider the grant of the clearance, but the APVMA had not completed its reconsideration; and
(b) the product is taken by section 172 or 174 of that Code to have been registered by the APVMA subject to conditions;
the following paragraphs apply:
(c) any notice that the APVMA has given to the person under subsection 17(1) of the repealed Act in respect of its proposed reconsideration of the clearance is taken to have been a notice of a proposed reconsideration of the registration that the APVMA has duly given, with any necessary changes, under subsection 32(2) of that Code as if that Code had been in force when the notice was given;
(ca) any information (other than particulars of trials or laboratory experiments) given to the APVMA by the person to whom the notice was given is taken to have been given by the person to the APVMA under subsection 32(2) of that Code;
(d) any particulars of trials or laboratory experiments given to the APVMA by the person to whom the notice was given is taken to have been given by the person to the APVMA under section 33 of that Code.
181 Existing permit
(1) If:
(a) immediately before the commencement of the Agvet Code of this jurisdiction, there was in force a permit or other instrument issued by the previous registering authority of this jurisdiction in respect of an active constituent for a proposed or existing chemical product or in respect of a chemical product; and
(b) the permit or other instrument authorised persons generally, or a person or class of persons, to do or omit to do any thing the doing of which, or the omission to do which, after that commencement would, apart from this section, be an offence against section 74, 75, 76, 77, 78, 79, 80, 81, 84, 85, 87 or 91 of that Code or against an eligible law of this jurisdiction;
the following subsections apply.
(2) The permit or other instrument, to the extent that it authorises a person to do or omit to do that thing, is taken to be a permit that the APVMA has issued under section 114 of that Code upon that commencement subject to the conditions (if any) to which it was subject immediately before that commencement.
(3) The person who applied for the permit or other instrument is taken to be the person who applied for the permit under that Code.
182 Pending application for permit
If:
(a) before the commencement of the Agvet Code of this jurisdiction, an application for a permit under a corresponding previous law in respect of an active constituent for a proposed or existing chemical product, or in respect of a chemical product, was duly made to the previous registering authority of this jurisdiction but had not been disposed of by that authority; and
(b) the application was for a permit to do or omit to do something which, if such a permit were not granted under that Code, would be:
(i) an offence against section 74, 75, 76, 77, 78, 79, 80, 81, 84, 85, 87 or 91 of that Code; or
(ii) an offence against an eligible law of this jurisdiction;
the application is taken to be an application for such a permit duly made upon that commencement to the APVMA under section 110 of that Code.
183 Pending proceedings before Administrative Appeals Tribunal
(1) If, before the commencement of the Agvet Code of this jurisdiction, an application had been duly made under the repealed Act to the Administrative Appeals Tribunal for review of a decision by the APVMA under that Act in respect of a chemical product but the application had not been disposed of by the Tribunal, the following provisions apply.
(2) If the application to the Tribunal was made under paragraph 41(1)(b) of the repealed Act for the review of a decision by the APVMA under section 15 of that Act to refuse an application for clearance of the product:
(a) the application for clearance of the product is taken to have been an application made under section 10 of the Agvet Code of this jurisdiction for registration of the product; and
(b) the APVMA’s decision to refuse the application for clearance of the product is taken to have been a decision by the APVMA under Division 2 of Part 2 of that Code to refuse the application for registration of the product; and
(c) the application to the Tribunal is taken to have been an application duly made under paragraph 167(1)(a) of that Code for review of that decision by the APVMA to refuse the application for registration of the product; and
(d) the Tribunal is to continue to deal with the application for review accordingly.
(3) If:
(a) the application to the Tribunal was made under paragraph 41(1)(a) of the repealed Act for the review of a decision by the APVMA under section 15 of that Act to grant clearance of the product subject to particular conditions; and
(b) the product is taken by section 172 or 174 of the Agvet Code of this jurisdiction to have been registered by the APVMA subject to those conditions;
the application is taken to have been an application duly made under paragraph 167(1)(b) of that Code for review of a decision of the APVMA under Division 2 of Part 2 of that Code to register the product subject to those conditions and the Tribunal is to continue to deal with the application accordingly.
(4) If:
(a) the application to the Tribunal was made under paragraph 41(1)(c) of the repealed Act for the review of a decision that the APVMA has made under section 16 of that Act to refuse an application to vary the conditions to which clearance of the product was subject; and
(b) the product is taken by section 172 or 174 of the Agvet Code of this jurisdiction to have been registered by the APVMA subject to those conditions;
the following paragraphs apply:
(c) the application to vary the conditions of the clearance of the product is taken to have been an application made under section 27 of that Code for the variation of conditions of the registration of the product;
(d) the application to the Tribunal is taken to have been an application duly made under paragraph 167(1)(d) of that Code for review of a decision by the APVMA under Division 3 of Part 2 of that Code to refuse the application for the variation of conditions of the registration of the product;
(e) the Tribunal is to deal with the application for review accordingly.
(5) If:
(a) the application to the Tribunal was made under paragraph 41(1)(e) of the repealed Act for the review of a decision that the APVMA made under section 17 of that Act to vary the conditions to which the clearance of the product was subject; and
(b) the product is taken by section 172 or 174 of the Agvet Code of this jurisdiction to have been registered by the APVMA subject to those conditions;
the following paragraphs apply:
(c) the product is taken to have had those conditions varied by the APVMA under subsection 29(1) of that Code;
(d) the application to the Tribunal is taken to have been an application duly made under paragraph 167(1)(e) of that Code for review of the decision by the APVMA to vary those conditions;
(e) the Tribunal is to deal with the application for review accordingly.
184 Existing notices requiring further information or samples
If, before the commencement of the Agvet Code of this jurisdiction:
(a) the APVMA duly gave a notice to a person, under section 14 of the repealed Act, in respect of a chemical product to which section 173 or 179 of that Code applies; or
(b) a previous registering authority of this jurisdiction duly gave a notice to a person, under a provision of the law of this jurisdiction to which section 159 of that Code corresponds, in respect of a chemical product to which section 174 of that Code applies or in respect of a label to which section 176 of that Code applies;
and the person had not complied with the notice before that commencement, the notice is taken to have been a notice duly given to that person by the APVMA under section 159 of that Code in respect of that product or label, as the case may be, as if that Code had been in force when the notice was given.
