AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 - SCHEDULE Agricultural and Veterinary Chemicals Code

12 APVMA to publish notice before deciding whether to approve new active constituent

13 APVMA to publish notice before deciding whether to register chemical product containing new active constituent

14A Approval of active constituents for which information is not readily available

14B APVMA not to use information for registration of new agricultural chemical product to approve a similar product after disclosure

17 APVMA must keep a Record of Approved Active Constituents for Chemical Products

Division 3--Application for variation of relevant particulars, or of conditions, of approval or registration

30 APVMA may invite the public to propose approved active constituents or registered chemical products for reconsideration

34A Reconsideration of approval of label without notice in certain circumstances

34F Period of limit on future use of information relied on in granting application

36 Suspension or cancellation of approval or registration for breach of condition

37 Suspension of approval or registration for failing to give information, or results of trials or experiments, to APVMA

38 Suspension of approval or registration for failing to give information, report or sample to APVMA

39 Suspension of approval or registration if compensation for use of protected information cannot be arbitrated

40 Suspension or cancellation of approval or registration following reconsideration of continued approval or registration

41 Suspension or cancellation of approval or registration for non‑compliance with criteria for registration or approval

52 Publication of notice of approval of active constituent or registration of chemical product

53 Publication of notice of variations of approval of active constituent or registration of chemical product

55 Publication of notice of suspension or cancellation of approval or registration

Division 5--Application for variation of relevant particulars, or of conditions, of listed registration

56V APVMA may invite the public to propose registered listed chemical products for reconsideration

56ZA Notice of proposed suspension or cancellation to be given to co‑ordinators

56ZC Suspension of listed registration for failing to give information, or results of trials or experiments, to APVMA

56ZD Suspension of listed registration for failing to give information, report or sample to APVMA

56ZE Suspension or cancellation of listed registration following reconsideration

56ZF Suspension or cancellation of listed registration for non‑compliance with criteria

56ZP Publication of notice of variations of listed registration of chemical product

56ZT Publication of instrument varying established standard for listable chemical product

Part 3--Compensation for provider of certain information in respect of continued registration of certain chemical products

59 Right of originator of protected information to compensation for its use in relation to other applications

65 Determination of compensation on the basis of proposals made during negotiations

74 Possession or custody of unapproved active constituents with the intention of supply

75 Possession or custody of chemical products, other than registered, registered listed or reserved products, with the intention of supply

77 Supply of approved active constituents in contravention of conditions of approval

78 Supply of chemical products that are not registered products, registered listed products or reserved products

79 Supply of registered chemical products in contravention of conditions of registration

79A Supply of registered listed chemical products in contravention of conditions of listed registration

79B Supply of reserved chemical products contrary to conditions specified in the regulations

83 Supply of substances whose constituents differ from constituents of registered chemical product

83A Supply of substances whose constituents differ from constituents of registered listed chemical product

87A Supply of registered listed chemical product that does not conform to established standard

101 Recall of products that are not registered and do not have listed registration or whose registration or listed registration is being reconsidered

103 Recall of products with labels that are not approved or are not authorised by an established standard

146 Self‑incrimination to be a reasonable excuse for non‑compliance with requirement

156 The making of single applications or the giving of single notices under the Agvet Codes of all jurisdictions

159 APVMA or other authority may require, or require additional, information, report or sample in certain circumstances

163 Notice to interested person of proposed disclosure of information that is claimed to be confidential commercial information

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

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

"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

"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 notified the APVMA in writing is 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 notified the APVMA in writing is authorised by that person 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.

"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.

"document" includes a book or other record.

"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.

"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.

"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 .

"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

"prescribed" means prescribed by the Agvet Code of this jurisdiction or by the regulations.

"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.

"previous registering authority" means a registering authority under a corresponding previous law.

"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

(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 distinguishing number, and the size and type of, and particulars contained on, the label kept in the relevant APVMA file as required by paragraph 21(2)(d);

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 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

(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

(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;

(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

(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.

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

(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

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

(2) Division 2 deals with the giving of approvals and the granting of registrations.

(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

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

(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 it is likely that a chemical product in relation to which an application for registration is made would, if used, be present in foods (as defined for the purposes of the Food Standards Australia New Zealand Act 1991 ) at a level that is not already permitted under the Maximum Residue Limits Standard, the APVMA must notify Food Standards Australia New Zealand of the application.

(2) The notice 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 at least 30 working days before notice of the application and public invitation for submissions is published in the Gazette under section 13 or otherwise.

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;

(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;

(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;

(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.

(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

(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;

(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;

(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 23.

(2) Approval of a label takes place by:

(a) determining (if appropriate) the size and type of the label; and

(b) giving a distinguishing number to the label; and

(c) determining the particulars that are to be contained on the label (which must include the distinguishing number, the instructions for the use of the product and any particulars that are prescribed by the regulations); and

(d) placing a label of the determined size and type, and containing the particulars mentioned in paragraph (c), in the relevant APVMA file; and

(e) recording in that file any conditions of the approval.

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

(1) 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 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, registration of a chemical product or approval of a label for containers for 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.

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 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

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

(ba) if the application relates to a label--be accompanied by a proposed new label; 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.

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;

(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 placing in the relevant APVMA file a new label containing the relevant particulars as varied and recording in the file the date on which the new label is placed in the file; 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

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

(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 placing in the relevant APVMA file a new label containing the relevant particulars as varied and recording in that file the date on which the new label is placed in the file; 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 the relevant particulars of the approval of a label if the interested person gives to the APVMA a new label containing the particulars as proposed to be varied.

Note: Subsection 40(2) provides for the suspension or cancellation of the approval of the label if the interested person does not give the APVMA a new label in accordance with a request by the APVMA.

(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) vary the relevant particulars by placing in the relevant APVMA file a new label containing the relevant particulars as varied and recording in that file the date on which the new label is placed in the file; 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.

(4) The APVMA may only vary the relevant particulars of the approval of a label if the interested person gives to the APVMA a new label containing the particulars as proposed to be varied.

Note: Subsection 41(4) provides for the suspension or cancellation of the approval of the label if the interested person does not give the APVMA a new label in accordance with a request by the APVMA.

(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
16 valign=top style='width:11.8pt;border:none;border-bottom:solid windowtext 1.5pt; padding:0cm 5.4pt 0cm 5.4pt'> 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;

(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

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

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 give the APVMA a label containing the particulars as proposed to be varied in accordance with a request by the APVMA;

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

(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 give the APVMA a label containing the particulars as proposed to be varied in accordance with a request by the APVMA;

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.

(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

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 subsection 23(3) to which an approval or registration is subject; and

(b) subsection 43(2), which relates to suspension of an approval or registration; and

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

(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

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

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

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

(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

(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 International Limited;

(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;

(d) the composition and form of the constituents of the product;

(e) the acceptable daily intake of each active constituent contained in the product;

(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

(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;

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

(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.

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.

(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.

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

(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

(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

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.

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

(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.

(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.

(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

(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

(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):

Commonwealth Consolidated Acts

AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994 - SCHEDULE Agricultural