the furthering of trade and commerce between Australia and places outside Australia; and

the present and future economic viability and competitiveness of primary industry which relies on access to chemical products and their constituents; and

a domestic industry for manufacturing and formulating chemical products and their constituents;

are essential for the well-being of the economy and require a system for regulating chemical products and their constituents that is cost effective, efficient, predictable, adaptive and responsive.

recognises that the health and safety of human beings, animals and the environment is the first priority of the system for regulating chemical products and their constituents, in part to ensure that the use of chemical products at the present time will not impair the prospects of future generations; and

reflects established best-practice principles for the assessment and management of risk, based on science; and

balances regulatory effort and any burden imposed by the system of regulation on:

holders of approvals, registrations, permits and licences; and

the domestic industry for manufacturing and formulating chemical products and their constituents; and

the users of chemical products;

with the risk of the use of the products and constituents to the health and safety of human beings, animals and the environment; and

recognises that the use of chemical products that pose unmanageable risks to the health and safety of human beings, animals and the environment is not appropriate in Australia; and

promotes community confidence in the regulation of chemical products and their constituents, is open and accountable, and gives opportunity for public involvement and participation; and

secures compliance with this Code through appropriate, proportionate, consistent and effective compliance and enforcement measures.

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

destroying a plant; or

modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity; or

modifying an effect of another agricultural chemical product; or

attracting a pest for the purpose of destroying it.

a veterinary chemical product; or

a substance or mixture of substances declared by the regulations not to be an agricultural chemical product.

preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or

curing or alleviating an injury suffered by the animal; or

modifying the physiology of the animal:

so as to alter its natural development, productivity, quality or reproductive capacity; or

so as to make it more manageable; or

modifying the effect of another veterinary chemical product.

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

a substance or mixture of substances declared by the regulations to be a veterinary chemical product.

a substance or mixture of substances that is:

prepared by a pharmacist in accordance with the instructions of a veterinary surgeon; or

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

a substance or mixture of substances declared by the regulations not to be a veterinary chemical product.

that is registered; and

that complies with the relevant particulars entered in the Register for the product.

Constituents of the chemical product

a chemical product is registered; and

(b) under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the constituents of the chemical product; and

there are regulations in force for the purposes of paragraph 83(1)(a) in relation to the chemical product; and

the constituents of the chemical product do not differ by more than the extent prescribed for the purposes of paragraph 83(1)(a);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

Concentration of constituents of the chemical product

a chemical product is registered; and

(b) under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the concentration of one or more constituents of the chemical product; and

there are regulations in force for the purposes of paragraph 83(1)(b) in relation to the chemical product; and

the concentration of the constituents of the chemical product does not differ by more than the extent prescribed for the purposes of paragraph 83(1)(b);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

Composition of constituents of the chemical product

a chemical product is registered; and

(b) under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the composition of a constituent of the chemical product; and

there are regulations in force for the purposes of paragraph 83(1)(c) in relation to the composition of that constituent of the chemical product; and

the composition of that constituent of the chemical product does not differ by more than the extent prescribed for the purposes of paragraph 83(1)(c);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

Purity of constituents of the chemical product

a chemical product is registered; and

(b) under regulations made for the purposes of paragraph 20(1)(c), a relevant particular (the subject particular) required to be entered in the Register in relation to the chemical product is the purity of a constituent of the chemical product; and

there are regulations in force for the purposes of paragraph 83(1)(c) in relation to the purity of that constituent of the chemical product; and

the purity of that constituent of the chemical product does not differ by more than the extent prescribed for the purposes of paragraph 83(1)(c);

then, for the purposes of paragraph (1)(b) of this section, the chemical product is taken to comply with the subject particular.

is not, or 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

is not, or would not be, likely to have an effect that is harmful to human beings; and

is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

must have regard to the following:

the toxicity of the constituent and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings;

the method by which the constituent is, or is proposed to be, manufactured;

the extent to which the constituent will contain impurities;

whether an analysis of the chemical composition of the constituent has been carried out and, if so, the results of the analysis;

any conditions to which its approval is, or would be, subject;

any relevant particulars that are, or would be, entered in the Record for the constituent;

whether the constituent conforms, or would conform, to any standard made for the constituent under section 6E to the extent that the standard relates to matters covered by subsection (1);

any matters prescribed by the regulations; and

may have regard to such other matters as it thinks relevant.

must have regard to the following:

the toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings;

the relevant poison classification of the product under the law in force in this jurisdiction;

how the product is formulated;

the composition and form of the constituents of the product;

any conditions to which its registration is, or would be, subject;

any relevant particulars that are, or would be, entered in the Register for the product;

whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1);

any matters prescribed by the regulations; and

may have regard to one or more of the following:

the acceptable daily intake of each constituent contained in the product;

(ii) any dietary exposure assessment prepared under subsection 82(4) of the Food Standards Australia New Zealand Act 1991 as a result of any proposed variation notified under subsection 82(3) of that Act in relation to the product, and any comments on the assessment given to the APVMA under subsection 82(4) of that Act;

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;

the stability of the product;

the specifications for containers for the product;

such other matters as it thinks relevant.

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;

any conditions to which its registration is, or would be, subject;

any relevant particulars that are, or would be, entered in the Register for the product;

whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1);

any matters prescribed by the regulations.

to the extent prescribed by the regulations; or

if there are no such regulations—to the extent that the APVMA thinks the matters are relevant.

any conditions to which its registration is, or would be, subject;

any relevant particulars that are, or would be, entered in the Register for the product;

whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1);

any matters prescribed by the regulations.

to the extent prescribed by the regulations; or

if there are no such regulations—to the extent that the APVMA thinks the matters are relevant.

the circumstances in which the product should be used;

how the product should be used;

the times when the product should be used;

the frequency of the use of the product;

the withholding period after the use of the product;

the re-entry period after the use of the product;

the disposal of the product when it is no longer required;

the disposal of containers of the product;

the safe handling of the product and first aid in the event of an accident caused by the handling of the product;

any matters prescribed by the regulations.

any conditions to which its approval is, or would be, subject;

any relevant particulars and instructions that are, or would be, entered in the relevant APVMA file for the label;

whether the label conforms, or would conform, to any standard made for the label under section 6E to the extent that the standard relates to matters covered by subsection (1);

any matters prescribed by the regulations.

make a decision of a kind determined in an instrument under subsection (1A); or

exercise any power, or comply with any obligation, related to making a decision to which paragraph (a) applies; or

do anything else related to making a decision to which paragraph (a) applies or related to exercising a power, or complying with an obligation, to which paragraph (b) applies.

made a decision; or

exercised a power or complied with an obligation; or

done something else related to the making of a decision or the exercise of a power or the compliance with an obligation;

that was made, exercised, complied with or done by the operation of a computer program under an arrangement made under subsection (1).

Substituted decisions

principles and processes for effective and efficient regulation of chemical products and their constituents; and

principles and processes relating to:

the approval of active constituents for proposed or existing chemical products; and

the registration of chemical products; and

the approval of labels for containers for chemical products; and

the variation of relevant particulars and conditions; and

the issue of permits and licences; and

the reconsideration of approvals and registrations.

constituents for chemical products;

chemical products;

labels for containers for chemical products.

writing appearing on a container is taken to have been written on a label attached to the container; and

a reference to a label attached to a container includes a reference to writing appearing on the container; and

a reference to attaching a label to a container includes a reference to putting writing on the container.

must have regard to:

the information in, or accompanying, the application as required under section 8B or any other provision of this Code; and

any information or thing given to the APVMA as required under section 157 or 159 or by section 160A in relation to the application; and

any submission made in response to an invitation given by the APVMA in relation to the application; and

may have regard to any other matter that it thinks relevant.

is given by or on behalf of the applicant in connection with the application; but

is not covered by paragraph (1)(a).

be in writing; and

set out:

the names, or proposed names, of the active constituents concerned; and

any other matters that the APVMA thinks appropriate; and

be given to Food Standards Australia New Zealand before the approval, registration, variation or permit is given, made or issued.

approves an active constituent; or

registers a chemical product; or

renews the registration of a chemical product; or

approves a label; or

varies relevant particulars or conditions (whether on notice under Division 2AA of Part 2, on application or on the initiative of the APVMA), other than under section 34A (varying relevant particulars or conditions to allow affirmation).

for an approval or registration:

state that the constituent, product or label has been approved or registered; and

set out the relevant particulars and conditions of the approval or registration; and

for a registration—state the date the registration ends; and

for the renewal of a registration:

state that the registration of the chemical product has been renewed; and

state the date the registration (as renewed) ends; and

for the variation of relevant particulars or conditions:

state that the relevant particulars or conditions have been varied; and

set out the relevant particulars or conditions as varied; and

of a registration—state the date the registration ends; and

include any information prescribed by the regulations.

state that the application has been refused; and

set out the reasons for the refusal; and

include any information prescribed by the regulations; and

specify any amount of fee that is repayable because of the refusal.

(a) be published in the Gazette, as soon as practicable, and in any other manner that the APVMA thinks appropriate; and

state that the constituent has been approved or the product has been registered and the date of the approval or registration as mentioned in section 22; and

contain a brief statement of the conditions of the approval or registration that directly regulate the use of the constituent or product; and

include any information prescribed by the regulations.

(a) be published in the Gazette, as soon as practicable, and in any other manner that the APVMA thinks appropriate; and

state that the relevant particulars or conditions have been varied and the date on which the variation took place; and

contain a brief statement of the nature of, and reasons for, the variation; and

include any information prescribed by the regulations.

the application meets the application requirements; and

the proposed holder has consented, by signed writing, to being the holder; and

if the proposed holder is not a resident of, and does not carry on business in, Australia—there will be a nominated agent for the approval or registration; and

any requirements prescribed by the regulations have been met.

the application meets the application requirements; and

the nominated person has consented, by signed writing, to being the nominated agent; and

any requirements prescribed by the regulations have been met.

the application meets the application requirements; and

the person to be the nominated agent has consented, by signed writing, to being the nominated agent; and

any requirements prescribed by the regulations have been met.

the nominated agent has notified the holder of the withdrawal; and

any requirements prescribed by the regulations have been met.

refuses an application, other than on preliminary assessment; or

approves or registers an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application; or

varies, under section 29, relevant particulars or conditions in a way other than set out in the application.

for notice under paragraph (1)(b)—set out the proposed instructions and relevant particulars; and

for notice under paragraph (1)(c)—set out the proposed variation; and

include a draft statement of reasons for the proposed course of action; and

set out the information on which the reasons are based (including information not given to the APVMA by the applicant); and

invite written submissions from the applicant within 28 days, or within such further period as is specified in the notice.

already given to the APVMA by, or on behalf of, the applicant; or

set out in the notice under paragraph (2)(d).

stating that it proposes to recommend to the Minister that the regulation be made; and

setting out particulars of the chemical products, or class of chemical products, that would be covered, or otherwise affected, by the regulation; and

setting out a draft standard the APVMA proposes to make under section 8U in relation to each chemical product that would be covered by the regulation; and

giving the reasons for the proposed recommendation; and

inviting any person, within a period of at least 28 days specified in the notice, to make a written submission to the APVMA as to whether the proposed regulation should be made and stating the grounds on which the submission is based, which must be grounds relating to the matters mentioned in paragraph 8V(a).

the APVMA must have recommended to the Minister that the regulation be made; and

the APVMA must have given to the Minister:

its reasons for the recommendation; and

written particulars of the product or class of products that would be covered, or otherwise affected, by the regulation; and

a draft of the standard that the APVMA proposes to make under section 8U for the product, or for products in the class, if the product or class is specified in the schedule; and

a written explanation as to why the APVMA is satisfied that the product, or class of products, meets the safety criteria, the trade criteria and the efficacy criteria (see section 8V); and

a written statement identifying the consultations held by, and setting out the advice given to, the APVMA in relation to the proposed regulation.

chemical products, or a class of chemical products, identified in the standard; or

a container containing chemical products, or a class of chemical products, identified in the standard; or

a label for containers for chemical products, or a class of chemical products, identified in the standard.

may be specified by reference to any one or more of the following:

the composition and form of the constituents of the product;

the physical and chemical properties of the chemical product;

the quantity of the chemical product when contained in specified containers;

procedures to be carried out in the manufacture of the chemical product;

a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary);

a monograph in another publication approved by the APVMA for the purposes of this subparagraph;

a monograph referred to in subparagraph (v) or (vi) as modified in a manner specified in the standard;

a standard published by Standards Australia;

such other matters as the APVMA thinks fit; and

may require that a matter relating to the standard be determined in accordance with a particular test.

subsection 8F(2);

subsection 8S(2);

subsection 8W(2);

subsection 17(4) or (5);

subsection 18(4) or (5);

subsection 34AB(2);

subsection 34AC(2).

approval of active constituents for proposed or existing chemical products; and

registration of chemical products; and

approval of labels for containers for chemical products.

approval of active constituents for proposed or existing chemical products; and

registration of chemical products; and

approval of labels for containers for chemical products.

Approval and registration for active constituents, chemical products or labels after assessment

for approval of an active constituent for a proposed or existing chemical product; or

for registration of a chemical product; or

for approval of a label for containers for a chemical product.

must meet the application requirements; and

for an active constituent or chemical product—must include proposed instructions for use of the constituent or product.

give written notice to the applicant:

stating that the application has passed preliminary assessment and that it will be determined under section 14; and

setting out any matters prescribed by the regulations; and

publish a summary of the application that includes any details prescribed by the regulations.

stating that the application does not meet the application requirements; and

giving particulars of the defects in the application; and

requiring the defects to be rectified within 1 month.

the APVMA is not satisfied that defects in the application can reasonably be rectified; or

the defects are not rectified to the satisfaction of the APVMA within the period mentioned in paragraph (3)(c).

has passed preliminary assessment; and

is for approval of 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.

set out the following:

the name of the constituent;

particulars of the constituent;

a summary of the APVMA’s assessment of whether the constituent meets the safety criteria;

any other matters that the APVMA thinks appropriate; and

invite any person to make, within a specified period of at least 28 days, a written submission 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 the safety criteria.

has passed preliminary assessment; and

is for registration of 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.

set out the following:

the name that the applicant intends to use to describe the product;

particulars of the product and its active constituents;

a summary of the APVMA’s assessment of whether the product meets the safety criteria, the trade criteria and the efficacy criteria;

any other matters that the APVMA thinks appropriate; and

invite any person to make, within a specified period of at least 28 days, 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 the safety criteria, the trade criteria or the efficacy criteria.

that the application meets the application requirements; and

for an active constituent—that the constituent meets the safety criteria; and

for a chemical product—that the product:

meets the safety criteria, the trade criteria and the efficacy criteria; or

complies with the established standard for the product; and

for a label for a chemical product—that the label:

meets the labelling criteria; or

complies with the established standard for the product.

either of the following applies:

the APVMA considers that information it requires in respect of the constituent is not readily available;

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 Pharmacopeia or any other publication considered by the APVMA to be appropriate; and

having regard to information that is readily available, the APVMA is satisfied that the constituent would meet the safety criteria.

despite subsection 14(2); and

whether or not an application has been made for approval of the constituent.

(a) information was given to the APVMA in connection with an application made after the commencement of this section for registration of a 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

the information related to the first product or the active constituent and:

the safety criteria; or

a matter that is prescribed by the regulations; and

the information was disclosed:

by the Commonwealth, a State or a Territory; or

by an authority of the Commonwealth, a State or a Territory (including the APVMA); or

by anyone acting on behalf of the Commonwealth, a State, a Territory or an authority of the Commonwealth, a State or a Territory; and

the information was not publicly available before the disclosure; and

(e) as a result of the disclosure, the applicant for an application for registration of a 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 determining the application.

the registration of the second product would be commercially unfair; and

the authorising party for the information does not consent to the use.

the Commonwealth;

the APVMA;

a person who is or has been:

a director of the APVMA; or

the Chief Executive Officer of the APVMA; or

a delegate of the APVMA; or

a member of the staff of the APVMA.

is for a proposed or existing chemical product; and

is of a kind:

prescribed by the regulations for the purposes of this subparagraph; or

determined by the APVMA under subsection (6).

the application meets the application requirements; and

the active constituent is a prescribed active constituent; and

none of the circumstances determined in an instrument under subsection (9) apply in relation to the applicant.

prescribed by the regulations for the purposes of this paragraph; or

determined by the APVMA under subsection (6).

meet the safety criteria, the trade criteria and the efficacy criteria; or

comply with the established standard for the kind of chemical product.

the application meets the application requirements; and

the chemical product is a prescribed chemical product; and

none of the circumstances determined in an instrument under subsection (9) apply in relation to the applicant.

for containers for a chemical product; and

that is of a kind:

prescribed by the regulations for the purposes of this subparagraph; or

determined by the APVMA under subsection (6).

meet the labelling criteria; or

comply with the established standard for the chemical product.

the application meets the application requirements; and

the label that is the subject of the application is a prescribed label for containers for a chemical product; and

none of the circumstances determined in an instrument under subsection (10) apply in relation to the applicant.

register a chemical product unless:

the APVMA also approves each active constituent for the product; and

the APVMA also approves a label for containers for the product; or

approve a label for containers for a chemical product unless it also registers the product.

an active constituent that is exempted by the APVMA from the operation of that subparagraph; or

an active constituent for a listed chemical product.

one part is to consist of confidential commercial information relating to constituents approved under section 14 or 14C;

one part is to consist of other information relating to constituents approved under section 14 or 14C;

one part is to consist of information relating to constituents approved under section 14A.

the name of the person who applied for the registration as the holder of the registration;

the name of any nominated agent for the registration;

the relevant particulars, which are the distinguishing number, any instructions for the use of the product and any other particulars prescribed by the regulations;

if the product is a listed chemical product—a notation to that effect;

any conditions of the registration imposed by the APVMA;

the date the registration ends.

be the last day of a calendar month not more than 7 years after the registration takes place; and

be worked out in accordance with the method prescribed by the regulations.

any of the relevant particulars of:

an approval of an active constituent; or

a registration of a chemical product; or

an approval of a label; or

any of the conditions of such an approval or registration imposed by the APVMA;

are varied, then, the date of approval of the constituent, registration of the product, or approval of the label, as varied, or as subject to the varied conditions, is the date on which particulars of the variation are entered in the Record, Register or relevant APVMA file.

the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and

any conditions imposed on the approval or registration as the APVMA thinks appropriate.

the approval or registration is subject to a condition referred to in subsection (2); 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 1 year.

the APVMA is satisfied that a relevant particular or condition entered in the Record or Register, or recorded in the relevant APVMA file, is incorrect in a material respect; and

the relevant particular or condition is of a kind prescribed by the regulations;

the APVMA must vary the entry or record accordingly.

a relevant particular or condition entered in the Record or Register, or recorded in the relevant APVMA file, in relation to the constituent, product or label is incorrect in a material respect; and

the relevant particular or condition is incorrect because of inaccurate recording;

the holder must, within 28 days, give to the APVMA a written notice, signed by the holder, identifying the incorrect particular or condition and informing the APVMA of the correct particular or condition.

determined by the APVMA; or

prescribed by the regulations.

A prescribed variation under Division 2A cannot be a notifiable variation.

either:

is determined by the APVMA under subsection (5); or

is prescribed by the regulations; and

is not a prescribed variation under Division 2A.

for an active constituent—the constituent would meet the safety criteria; and

for a chemical product—the product would:

meet the safety criteria, the trade criteria and the efficacy criteria; or

comply with the established standard for the product; and

for a label for a chemical product—the label would:

meet the labelling criteria; or

comply with the established standard for the product.

notify the holder in writing of that fact; and

include in the notice the reasons why the holder’s notice does not meet the notice requirements.

record in the Record, Register or relevant APVMA file, as required, the relevant particulars as varied and the day the notice was lodged; and

if the relevant particulars of a listed chemical product are varied in such a way that the product or any approved label for the product does not comply with the established standard for the product—amend the Register so that the product is no longer noted as a listed chemical product.

is in writing in the approved form; and

is signed by the holder of the approval or registration to which the notice relates; and

is accompanied by the prescribed fee; and

is lodged with the APVMA; and

contains, or is accompanied by, any information:

specified by the APVMA under subsection (2); or

prescribed by the regulations.

determined by the APVMA; or

prescribed by the regulations.

determined by the APVMA under subsection (6); or

prescribed by the regulations.

for an active constituent—the constituent would meet the safety criteria; and

for a chemical product—the product would:

meet the safety criteria, the trade criteria and the efficacy criteria; or

comply with the established standard for the product; and

for a label for a chemical product—the label would:

meet the labelling criteria; or

comply with the established standard for the product.

notify the holder in writing of that fact; and

include in the notice the reasons why the holder’s application does not meet the application requirements.

if it is satisfied that the application meets the application requirements—vary the relevant particulars as proposed in the application; or

otherwise—refuse the application.

the approval of an active constituent; or

the registration of a chemical product; or

the approval of a label for containers for a chemical product.

the registration of a chemical product; or

the approval of a label for containers for a chemical product.

give written notice to the applicant:

stating that the application has passed preliminary assessment and that it will be determined under section 29; and

setting out any matters prescribed by the regulations; and

if the variation relates to the use of a chemical product—publish a summary of the application including any details prescribed by the regulations.

stating that the application does not meet the application requirements; and

giving particulars of the defects in the application; and

requiring the defects to be rectified within 1 month.

the APVMA is not satisfied that defects in the application can reasonably be rectified; or

the defects are not rectified to the satisfaction of the APVMA within the period mentioned in paragraph (3)(c).

the applicant; and

if the applicant is not the holder—the holder.

that the application meets the application requirements; and

for an active constituent—that, if those particulars or conditions were varied in a particular way (which may not be the same way as set out in the application), the constituent would meet the safety criteria; and

for a chemical product—that, if those particulars or conditions were varied in a particular way (which may not be the same way as set out in the application), the product would:

meet the safety criteria, the trade criteria and the efficacy criteria; or

comply with the established standard for the product; and

for a label for a chemical product—that, if those particulars or conditions were varied in a particular way (which may not be the same way as set out in the application), the label would:

meet the labelling criteria; or

comply with the established standard for the product.

for an active constituent—that, if those particulars or conditions were so varied, the constituent would meet the safety criteria; and

for a chemical product—that, if those particulars or conditions were so varied, the product would:

meet the safety criteria, the trade criteria and the efficacy criteria; or

comply with the established standard for the product; and

for a label for a chemical product—that, if those particulars or conditions were so varied, the label would:

meet the labelling criteria; or

comply with the established standard for the product; and

that the constituent, product or label complies, or will comply, with any requirement prescribed by the regulations.

varies the relevant particulars or conditions; or

suspends or cancels the approval or registration (section 34AB).

the approval of an active constituent for a proposed or existing chemical product; or

the registration of a chemical product; or

the approval of a label for containers for a chemical product.

must be maintained in accordance with the regulations; and

is not a legislative instrument.

setting out the matters it proposes to deal with in the reconsideration and its reasons for so proposing; and

requiring the holder, within a period stated in the notice that ends not earlier than 28 days after the day the notice is given, to give to the APVMA either or both of the following:

any information of a kind stated in the notice of which the holder is aware and which is relevant to the reconsideration;

any information of which the holder is aware that is relevant to the reconsideration; and

inviting the holder, within that period, to make a written submission to the APVMA about the matters referred to in paragraph (a); and

setting out the work plan.

inform the person of:

the matters that it proposes to reconsider, or is reconsidering; and

the work plan; and

invite any person to make, within a specified period which must not end earlier than 28 days after the invitation is given, a written submission to the APVMA about the matters it proposes to reconsider, or is reconsidering.

requires the APVMA to deal with a particular matter as part of the reconsideration; or

prevents the APVMA from dealing with a particular matter as part of the reconsideration.

give to the APVMA information of a kind stated in the notice;

carry out a search of published literature for information and give a report to the APVMA on the results of that search;

conduct, or cause to be conducted, trials or laboratory experiments and give the results of the trials or experiments to the APVMA;

give to the APVMA, or to another body specified in the notice, a sample of an active constituent, or of a chemical product or any of its constituents, for the purpose of analysis by an approved analyst.

The information, trials, experiments or analysis must be relevant to the reconsideration.

information, a report or results must be given in writing:

signed by the holder; or

attached to a covering letter signed by the holder;

a sample must be:

labelled with a label signed by the holder; or

attached to a covering letter signed by the holder.

for an active constituent—that the constituent meets the safety criteria; and

for a chemical product—that the product meets the safety criteria, the trade criteria and the efficacy criteria; and

for a label—that the label meets the labelling criteria; and

that the constituent, product or label complies with any requirement prescribed by the regulations.

must have regard to:

any information given, or submissions made, to the APVMA in response to a notice given under subsection 32(1); and

any submissions made to the APVMA in response to an invitation under paragraph 32(2A)(b) or 34AB(2)(f); and

any information given by the holder in response to an invitation given by the APVMA (whether or not under this Code) in relation to the constituent, product or label; and

any information, report, results or sample given to the APVMA in response to a notice given under section 33; and

any information given to the APVMA as required by section 161 in relation to the constituent, product or label; and

any other information that it considers necessary to enable it to make a decision on the reconsideration; but

must not take into account any submission, information, report, results or sample not covered by paragraph (a).

is not satisfied as mentioned in subsection 34(1); but

is satisfied that the relevant particulars or conditions of the approval or registration can be varied in such a way as to allow the approval or registration to be affirmed;

the APVMA must vary the relevant particulars or conditions.

submissions, information, reports, results or samples that it had regard to under section 34;

submissions made to the APVMA in response to the invitation under paragraph 34AB(2)(f).

the APVMA is satisfied that the relevant particulars of the approval can be varied in such a way as to allow the approval to be affirmed; but

the holder does not satisfy the APVMA that a label, including the particulars as varied, will be attached to the containers for the product.

varies the relevant particulars or conditions under section 34A; or

suspends or cancels the approval or registration under section 34AA.

be given to the holder in writing; and

be given to the other persons informed of the reconsideration as mentioned in subsection 32(2):

in writing; or

in the way the persons were informed under that subsection; and

include a draft statement of reasons for the proposed course of action; and

set out the information on which the reasons are based (including information not given to the APVMA by the holder); and

for variation of relevant particulars or conditions—set out the proposed variation; and

invite written submissions from the holder or other persons within 3 months.

variation of the relevant particulars or conditions; or

suspension or cancellation of the approval or registration.

give written notice of the affirmation to the holder; and

(b) publish a notice of the affirmation in the Gazette and in any other manner that it thinks appropriate.

state that the approval or registration has been affirmed; and

set out the relevant particulars and conditions of the approval or registration as affirmed; and

state the date the registration ends; and

include any information prescribed by the regulations.

state that the approval or registration has been affirmed; and

contain a brief statement of the reasons for the affirmation.

vary the relevant particulars; and

record in the relevant APVMA file the relevant particulars as varied and the date on which the record is made; and

give written notice to the holder setting out particulars of the variation.

in connection with an application under section 10 or 27; or

under section 161.

information given to the APVMA in connection with another application made under section 10 or 27 by the applicant for the other application;

information given under section 161.

(1AA) The APVMA must not use the following information to assess or make a decision on an application made under section 14C, 14D or 14E:

information given to the APVMA in connection with an application made under section 10 or 27 by the applicant for that application;

information given under section 161.

information given to the APVMA in connection with an application made under section 10 or 27 by the applicant for the application;

information given under section 161.

applying a decision made, or a conclusion reached, based on the information;

the use of knowledge or understanding gained from the information.

in connection with an application made after the commencement of this section; or

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.

the Commonwealth;

the APVMA;

a person who is or has been:

the Chief Executive Officer of the APVMA; or

a delegate of the APVMA; or

a member of the staff of the APVMA.

Subdivision C—Exceptions

later states that it has not consented; or

withdraws the consent (whether before or after the APVMA is given the consent).

Use in the public interest

the information relates to:

a proposed or existing approval of an active constituent for a proposed or existing chemical product; or

a proposed or existing registration of a proposed or existing chemical product; and

the information shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria.

Information given again

is given to the APVMA in connection with an application and is used to assess or make a decision on the application; or

is given to the APVMA in connection with the reconsideration, under Division 4 of Part 2, of an approval or registration and is used to reconsider the approval or registration.

Protected information whose protection period has expired

the protection period in relation to that information has ended; or

if the protection period in relation to that information is extended in accordance with regulations made for the purposes of section 34KA—the protection period, as extended, has ended.

Information is publicly available

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; or

an application for the variation of the relevant particulars or conditions of the approval of an active constituent for a chemical product.

the applicant for the application in connection with which the information was given; and

if the applicant is not the authorising party for the information—the person whom the APVMA believes is the authorising party.

the APVMA believes it is necessary to use the information before the end of 28 days after the notice is given, to prevent imminent risk to persons of death, serious injury or serious illness; and

states that belief in the notice.

extending the protection period in relation to protected information;

ending such an extension.

the application is under a provision of this Part prescribed by the regulations for the purposes of this paragraph;

the application satisfies the requirements prescribed by the regulations for the purposes of this paragraph.

Maximum extension

extending the limitation period for information covered by an item of the table in subsection 34M(1);

ending such an extension.

the application is under a provision of this Part prescribed by the regulations for the purposes of this paragraph;

the application satisfies the requirements prescribed by the regulations for the purposes of this paragraph.

Maximum extension

if it is necessary to prevent imminent risk to persons of death, serious injury or serious illness (section 35A); or

if a condition of the approval or registration is contravened (section 36); or

if the holder does not comply with a requirement under section 32, 33, 159, 160A or 161 to give the APVMA information, a report or a sample (section 38); or

if a person has given information that is false or misleading (section 38A); or

if primary and secondary holders cannot agree on compensation during the course of arbitration (section 39); or

if it appears to the APVMA that the criteria for approval or registration are not, or are no longer, satisfied (section 41); or

at the request of the holder if the APVMA agrees with the reasons for the request (section 42).

certain persons are taken to have a permit to possess, have custody of or use of the constituent or product for a limited period (section 45B); and

such persons may only supply the constituent or product in accordance with instructions contained in the notice provided by the APVMA under section 45A (section 45C).

states that the APVMA proposes to suspend or cancel the approval, or suspend or cancel the registration, as the case may be; and

sets out the reasons for the proposed suspension or cancellation; and

invites the holder to make, within a reasonable period specified in the notice, submissions to the APVMA in relation to the proposed suspension or cancellation.

it has given notice of the proposed suspension or cancellation to each co-ordinator designated for a jurisdiction; and

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.

the primary holder in relation to a primary active constituent and the secondary holder 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

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.

the primary holder in relation to a primary chemical product and the secondary holder 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 arbitrator gives notice to the APVMA under section 68 in respect of the failure of each party to the arbitration to make a fresh proposal as to the terms of the compensation or to make a fresh proposal as to those terms that the arbitrator thinks reasonable;

the APVMA may suspend the registration of either or both of those products.

for an active constituent—that the constituent may not meet the safety criteria; or

for a chemical product—that the product may not meet the safety criteria, the trade criteria or the efficacy criteria; or

that the constituent or product may not comply with any requirement prescribed by the regulations.

the holder gives to the APVMA a written notice:

requesting the APVMA to suspend or cancel the approval or registration; and

stating the reasons for the request; and

the APVMA is satisfied that there are no valid reasons why it should not agree to the request;

the APVMA must suspend or cancel the approval or registration (as the case may be).

the lodging of a notice under section 26AB of one or more notifiable variations of the relevant particulars of the approval or registration or the dealing with the notice; or

an application being made under section 26B for one or more prescribed variations of the relevant particulars of the approval or registration or the dealing with the application; or

an application being made under subsection 27(1) for variation of the relevant particulars or conditions of the approval or registration or the dealing with the application; or

a variation under section 29A of the relevant particulars or conditions of the approval or registration.

give written notice of the suspension or cancellation to the holder and to any other person to whom, in its opinion, such a notice should be given; and

(b) publish 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.

(a) must include a statement that the APVMA will publish a notice of the suspension or cancellation in the Gazette; and

must contain the following matters:

brief reasons for the suspension or cancellation;

instructions for possessing, having custody of or using the constituent or product;

a warning of the consequences of failing to comply with the instructions, including a statement of any period after which it will be an offence against this Code to supply the constituent or product or to possess or have custody of the constituent or product with the intention of supplying it;

any other warnings or explanations in relation to the constituent or product that the APVMA thinks desirable.

for an active constituent—that the constituent may not meet the safety criteria; or

for a chemical product—that the product may not meet the safety criteria, the trade criteria or the efficacy criteria; or

for a label—that the label may not meet the labelling criteria;

the notice published in the Gazette must contain a statement to that effect and must include the matters mentioned in subparagraphs (2)(b)(ii), (iii) and (iv).

1 year after the day of the suspension or cancellation; or

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.

Certain persons who possess etc. constituent or product taken to have permit

given to the person under paragraph 45A(1)(a); or

published under paragraph 45A(1)(b);

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.

in paragraph (2)(a), that the notice is a notice given to the person under paragraph 45A(1)(a); and

in paragraph (2)(b), that the publishing of the notice was under paragraph 45A(1)(b).

the fact that the suspension or cancellation has been revoked; and

the date on which the entry is made.

give written notice of the revocation to the holder and to any other person to whom, in its opinion, such a notice should be given; and

(b) publish in the Gazette, and in any other manner that it thinks appropriate, notice of the revocation containing any information that it thinks relevant.

certain persons are taken to have a permit to possess, have custody of or use of the product for a limited period (section 47D); and

persons may only supply the product in accordance with instructions contained in the notice (section 47E).

the day entered in the Register as the date the registration ends;

if an application is made for renewal of the registration but is not determined by the day entered in the Register—the day on which the application is determined.

the registration of a chemical product ends; but

a person is taken under section 47D to have been issued with a permit to possess, have custody of or use the product;

the approval of a label for containers for the product continues in force until the permit ceases to have effect.

Subdivision C—Notifying the end of registrations

be published as soon as practicable after the registration ends; and

state that the registration has ended; and

set out the date on which the registration ended; and

contain instructions for possessing, having custody of or using the product; and

contain 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 supply the product or to possess or have custody of the product with the intention of supplying it; and

contain any other warnings or explanations in relation to the product that the APVMA thinks desirable; and

contain any other information that the APVMA thinks appropriate.

the APVMA thinks that, in the circumstances, it is unnecessary to publish the notice; or

the registration of the chemical product ends because it is cancelled.

as soon as practicable cause a copy of the notice to be given to the person who was the holder of the registration; and

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.

1 year after the day on which the registration ended; or

the APVMA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the product;

whichever first occurs.

earlier than 3 months before the registration ends; or

later than one month (or such shorter period as the APVMA allows) before the registration ends.

be the last day of a calendar month not less than 12 months and not more than 7 years after the renewal takes place; and

be worked out in accordance with the method prescribed by the regulations.

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

the information was obtained because of a trial or laboratory experiment and any of the following apply:

the information is of a kind mentioned in paragraph 32(1)(b) and was given to the APVMA in response to a notice under that section;

the trial or laboratory experiment was conducted in response to a notice under section 33;

the information was given to the APVMA in response to a notice under subsection 159(1) for the purposes of subparagraph 159(1)(d)(i), (ii) or (iii).

(a) a protected active constituent for a proposed or existing chemical product (the primary active constituent); or

(b) 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).

the primary holder and the secondary holder:

have agreed as to the terms of the compensation to be paid by the secondary holder to the primary holder for the information to be used in relation to the secondary active constituent or the secondary chemical product, as the case may be; and

have notified the APVMA in writing that they have so agreed and of the terms of the compensation; or

an arbitrator that the APVMA has appointed has determined the compensation to be so paid and the secondary holder has given notice to the primary holder and to the APVMA stating that the secondary holder agrees to comply with the determination; or

the protection period (including that period as extended) has elapsed since that information was given to the APVMA; or

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; or

the information was previously given to the APVMA other than as protected information and Division 4A of Part 2 does not limit the use of the information; or

the information shows that the secondary active constituent or secondary chemical product may not meet the safety criteria, the trade criteria or the efficacy criteria; or

the information is publicly available.

must give written notice of its decision to the primary holder and the secondary holder; and

must not make a determination using the information before the end of 28 days after the day on which the notice is given.

the validity of any approval, or continued approval, of the secondary active constituent or the validity of any registration, or continued registration, of the secondary chemical product is not affected by a contravention by the APVMA of that subsection or by the failure of the secondary holder to comply with the agreement or determination; and

no action or other proceeding lies against the Commonwealth, the APVMA, or a person who is or has been a delegate of the APVMA, a director of the APVMA, the Chief Executive Officer of the APVMA, or a member of the staff of the APVMA, for any loss directly or indirectly sustained because of such a contravention or failure.

vary the relevant particulars or conditions of the approval or registration; or

affirm the approval or registration under Division 4 of Part 2 (reconsidering approvals and registrations).

the APVMA is unable to complete its consideration of:

the approval or continued approval of an active constituent for a proposed or existing chemical product; or

the registration or continued registration of a secondary chemical product;

under this Code unless it uses protected information; and

paragraph 59(2) does not permit the APVMA to use the information.

stating that the APVMA’s consideration of:

the approval or continued approval of the secondary active constituent; or

the registration or continued registration of the secondary chemical product;

cannot be completed unless the APVMA uses the information; and

stating that the APVMA is precluded from using the information except in circumstances prescribed by paragraph 59(2)(a) or (b) and setting out those circumstances; and

requesting the notice recipient to tell the APVMA, before the day stated in the notice, which must be within 60 days after the notice is given, whether the notice recipient wants the APVMA to take further action in respect of the information under this section.

containing:

in respect of the notice to a primary holder—the prescribed information about the secondary holder and about the secondary active constituent or the secondary chemical product, as the case may be; or

in respect of the notice to the secondary holder—the prescribed information about the primary holder and about the primary active constituent or the primary chemical product, or about each primary holder and about each primary active constituent or primary chemical product, as the case may be; and