Commonwealth Consolidated Acts Commonwealth Consolidated Acts
Agricultural and Veterinary Chemicals Code Act 1994
1 Before section 1 of the Code set out in the Schedule
Insert:
Division 1 -- Object, definitions etc.
2 After section 1 of the Code set out in the Schedule
Insert:
(1) This Code recognises that:
(a) the furthering of trade and commerce between Australia and places outside Australia; and
(b) the present and future economic viability and competitiveness of primary industry which relies on access to chemical products and their constituents; and
(c) 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, predic table, adaptive and responsive.
(2) This Code is to be implemented in a manner that:
(a) 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
(b) reflects established best - practice principles for the assessment and management of risk, based on science; and
(c) balances regulatory effort and any burden imposed by the system of regulation on :
(i) holders of approvals, registrations , permits and licences ; and
(ii) the domestic industry for manufacturing and formulating chemical products and their constituents; and
(iii) 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
(d) 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
(e) 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
(f) secures compliance with this Code through appropriate, proportionate, consistent and effective compliance and enforcement measures.
3 Subsection 3(1) of the Code set out in the Schedule (definition of acknowledge )
Repeal the definition.
4 Subsection 3(1) of the Code set out in the Schedule (definition of adequate )
Omit all the words after "practicable, that the", substitute "product meets the safety criteria and the trade criteria ".
5 Subsection 3(1) of the Code set out in the Schedule
Insert:
"application" means an application under this Code.
6 Subsection 3(1) of the Code set out in the Schedule (definition of approved person )
Repeal the definition.
7 Subsection 3(1) of the Code set out in the Schedule
Insert:
"determine" , in relation to an application, means:
(a) approve, re - approve, register, re - register, vary or issue on the application ; or
(b) refuse the application; or
(c) if the application resulted in the reconsideration of an approval or registration as required by section 29H--cancel the approval or registration under section 34AA.
8 Subsection 3(1) of the Code set out in the Schedule
Insert:
"electronic signature" of a person means the unique identification of the person in an electronic form approved by the APVMA.
9 Subsection 3(1) of the Code set out in the Schedule (definition of established standard )
Repeal the definition, substitute:
"established standard" has the meaning given by subsection 8U(7).
10 Subsection 3(1) of the Code set out in the Schedule (definition of holder )
Repeal the definition, substitute:
"holder" :
(a) in relation to an approval or registration, means:
(i) the person entered in the Record, Register or relevant APVMA file as the holder of the approval or registration; or
(ii) if the holder 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; or
(iii) if the holder was a body corporate--a successor in law of the body corporate; or
(b) in relation to a permit or licence, means the person to whom the permit or licence was issued.
10A Subsection 3(1) of the Code set out in the Schedule
Insert:
"instructions approved by the APVMA" includes authorisations and requirements (however described) set out in a permit.
11 Subsection 3(1) of the Code set out in the Schedule (definition of instructions for use )
Repeal the definition.
12 Subsection 3(1) of the Code set out in the Schedule (definition of interested person )
Repeal the definition.
13 Subsection 3(1) of the Code set out in the Schedule
Insert:
"limitation period" has the meanings given by section 34M.
14 Subsection 3(1) of the Code set out in the Schedule (definition of listable chemical product )
Repeal the definition.
15 Subsection 3(1) of the Code set out in the Schedule
Insert:
"listed chemical product" means a chemical product that is, or is included in a class of chemical products that is, listed by regulations under section 8T.
16 Subsection 3(1) of the Code set out in the Schedule (definition of listed registration )
Repeal the definition.
17 Subsection 3(1) of the Code set out in the Schedule (definition of Listing Schedule )
Repeal the definition.
17A Subsection 3(1) of the Code set out in the Schedule
Insert:
"lodged" , in relation to an application under this Code, has the meaning prescribed by the regulations.
18 Subsection 3(1) of the Code set out in the Schedule
Insert:
"meets the application requirements" has the meaning given by section 8A.
"meets the efficacy criteria" has the meaning given by subsection 5B(1).
"meets the labelling criteria" has the meaning given by subsection 5D(1).
"meets the safety criteria" has the meaning given by subsection 5A(1).
"meets the trade criteria" has the meaning given by subsection 5C(1).
19 Subsection 3(1) of the Code set out in the Schedule
Insert:
"nominated agent" , for an approval or registration, means the person entered in the Record, Register or relevant APVMA file as the nominated agent for the approval or registration.
20 Subsection 3(1) of the Code set out in the Schedule
Insert:
"Record" means the Record of Approved Active Constituents for Chemical Products kept under section 17.
21 Subsection 3(1) of the Code set out in the Schedule (definition of Record of Approved Active Constituents )
Repeal the definition.
22 Subsection 3(1) of the Code set out in the Schedule
Insert:
"Register" means the Register of Agricultural and Veterinary Chemical Products kept under section 18.
23 Subsection 3(1) of the Code set out in the Schedule (definition of Register of Chemical Products )
Repeal the definition.
24 Subsection 3(1) of the Code set out in the Schedule (definition of registered listed chemical product )
Repeal the definition.
25 Subsection 3(1) of the Code set out in the Schedule
Insert:
"relevant APVMA file" means the file in which information about approved labels is recorded as mentioned in paragraph 21(c).
26 Subsection 3(1) of the Code set out in the Schedule (definition of relevant particulars )
Repeal the definition, substitute:
"relevant particulars" means:
(a) in relation to the approval of an active constituent--the distinguishing number, any instructions for use and any other particulars required by paragraph 19(1)(c) to be entered in the Record; and
(b) in relation to the registration of a chemical product--the distinguishing number, any instructions for use and any other particulars required by paragraph 20(1)(c) to be entered in the Register; and
(c) in relation to the approval of a label--the information required to be recorded in the relevant APVMA file by subparagraphs 21(c)(i) to (iva) ;
and includes particulars of variations of relevant particulars made under section 26, 26C, 29, 29A, 29G, 34A or 34AF.
27 After section 5 of the Code set out in the Schedule
Insert:
5A Definition of meets the safety criteria
(1) An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:
(a) 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
(b) is not, or would not be, likely to have an effect that is harmful to human beings; and
(c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
(2) For the purposes of being satisfied as to whether an active constituent meets the safety criteria, the APVMA:
(a) must have regard to the following:
(i) the toxicity of t he constituent and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings;
(ii) the method by which the constituent is, or is proposed to be, manufactured;
(iii) the extent to which the constituent will contain impurities;
(iv) whether an analysis of the chemical composition of the constituent has been carried out and, if so, the results of the analysis;
(v) any conditions to which its approval is, or would be, subject;
(vi) any relevant particulars that are, or would be, entered in the Record for the constituent;
(via) 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);
(vii) any matters prescribed by the regulations; and
(b) may have regard to such other matters as it thinks relevant.
(3) For the purposes of being satisfied as to whether a chemical product meets the safety criteria, the APVMA:
(a) must have regard to the following:
(i) the toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings;
(ii) the relevant poison classification of the product under the law in force in this jurisdiction;
(iii) how the product is formulated;
(iv) the composition and form of the constituents of the product;
(v) any conditions to which its registration is, or would be, subject;
(vi) any relevant particulars that are, or would be, entered in the Register for the product;
(via) 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);
(vii) any matters prescribed by the regulations; and
(b) may have regard to one or more of the following:
(i) 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;
(iii) 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;
(iv) the stability of the product;
(v) the specifications for containers for the product;
(vi) such other matters as it thinks relevant.
5B Definition of meets the efficacy criteria
(1) A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.
(2) For the purposes of being satisfied as to whether a chemical product meets the efficacy criteria, the APVMA must have regard to the following:
(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;
(b) any conditions to which its registration is, or would be, subject;
(c) any relevant particulars that are, or would be, entered in the Register for the product;
(ca) 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);
(d) any matters prescribed by the regulations.
(3) For the purposes of the operation of this Code in relation to a particular chemical product, the APVMA is required to have regard to the matters set out in subsections ( 1) and (2) only:
(a) to the extent prescribed by the regulations; or
(b) if there are no such regulations--to the extent that the APVMA thinks the matters are relevant.
5C Definition of meets the trade criteria
(1) A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.
(2) For the purposes of being satisfied as to whether a chemical product meets the trade criteria, the APVMA must have regard to the following:
(a) any conditions to which its registration is, or would be, subject;
(b) any relevant particulars that are, or would be, entered in the Register for the product;
(ba) 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);
(c) any matters prescribed by the regulations.
(3) For the purposes of the operation of this Code in relation to a particular chemical product, the APVMA is required to have regard to the matters set out in subsections ( 1) and (2) only:
(a) to the extent prescribed by the regulations; or
(b) if there are no such regulations--to the extent that the APVMA thinks the matters are relevant.
5D Definition of meets the labelling criteria
(1) A label for containers for a chemical product meets the labelling criteria if the label contains adequate instructions relating to such of the following as are appropriate:
(a) the circumstances in which the product should be used;
(b) how the product should be used;
(c) the times when the product should be used;
(d) the frequency of the use of the product;
(e) the withholding period after the use of the product;
(f) the re - entry period after the use of the product;
(g) the disposal of the product when it is no longer required;
(h) the disposal of containers of the product;
(i) the safe handling of the product and first aid in the event of an accident caused by the handling of the product;
(j) any matters prescribed by the regulations.
(2) For the purposes of being satisfied as to whether a label meets the labelling criteria, the APVMA must have regard to the following:
(a) any conditions to which its approval is, or would be, subject;
(b) any relevant particulars and instructions that are, or would be, entered in the re levant APVMA file for the label;
(c) 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).
28 After section 6 of the Code set out in the Schedule
Insert:
6A APVMA may make guidelines etc.
(1) The APVMA may make written guidelines for performing its functions and exercising its powers under this Code.
(2) The APVMA must have regard to the guidelines.
(3) The guidelines must include:
(a) principles and processes for effective and efficient regulation of chemical products and their constituents; and
(b) principles and processes relating to:
(i) the approval of active constituents for proposed or existing chemical products; and
(ii) the registration of chemical products; and
(iii) the approval of labels for containers for chemical products; and
(iv) the variation of relevant particulars and conditions; and
(v) th e issue of permits and licences; and
(vi) the reconsideration of approvals and registrations.
(4) The guidelines must not be inconsistent with an agvet law.
(5) The APVMA must publish the guidelines on its website.
(6) The guidelines are not a legislative instrument.
6B Varying relevant particulars and conditions
To avoid doubt, a power under this Code to vary a relevant particular or condition does not authorise the APVMA to vary a relevant particular or condition that was not imposed by the APVMA.
6C Right of APVMA to use information
(1) 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) Subsection ( 1) has effect subject to this Code.
6D Failure to comply with time limit does not affect validity
Failure by the APVMA to comply with a time limit set out in this Code does not affect the validity of anything done by the APVMA.
(1) The APVMA may, by legislative instrument, make standards for the following:
(a) constituents for chemical products;
(b) chemical products;
(c) labels for containers for chemical products.
(2) A standard made under subsection ( 1) may apply, adopt or incorporate, with or without modification, any matter contained in any instrument or other writing as in force at a particular time or as in force from time to time.
29 After section 8 A of the Code set out in the Schedule
Insert:
Division 2 -- General provisions about applications
8A Definition of meets the application requirements
An application meets the application requirements if:
(a) the application:
(i) is in writing in the approved form; and
(ii) is signed by the applicant; and
(iii) is accompanied by so much of the prescribed fee as is required to be paid when the application is made; and
(iv) is lodged with the APVMA; and
(v) contains, or is accompanied by, any information specified for the application under section 8B; and
(b) the constituent, product or label in relation to which the application is made complies, or will comply, with any requirement prescribed by the regulations; and
(c) any requirement made under section 157 or 159 in relation to the application has been complied with; and
(d) any requirement prescribed by another provision of this Code in relation to the application has been complied with; and
(e) any amount (including an amount in respect of a tax or penalty) that is payable by the applicant to the APVMA (including under a law of another jurisdiction or the agvet law), has been paid.
Note: For giving information electronically, see section 156A.
8B Information to be provided with applications
(1) The APVMA may, by legislative instrument, specify the information that must be contained in, or accompany, the application.
(2) The APVMA may specify information under subsection ( 1) only if:
(a) the inclusion of the information would enable the APVMA to determine the application; and
(b) in relation to an application under section 29D (applications for re - approval or re - registration)--the information is information that the applicant could be reasonably expected to have, or to have access to.
8C Information to be taken into account in determining applications
(1) In determining the application , the APVMA:
(a) must have regard to:
(i) the information in, or accompanying, the application as required under section 8B or any other provision of this Code; and
(ii) 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
(iii) any submission made in response to an invitation given by the APVMA in relation to the application; and
(b) may have regard to any other matter that it thinks relevant.
(2) However, the APVMA must not take into account any information that:
(a) is given by or on behalf of the applicant in connection with the application; but
(b) is not covered by paragraph ( 1)(a).
(3) This section does not apply in relation to an application under section 122 for a licence.
8D Applications may be withdrawn
At any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.
Division 3 -- General provisions about notices
8E Notice to Food Standards Australia New Zealand
(1) The APVMA must notify Food Standards Australia New Zealand if an approval, registration, variation or permit proposed under this Code (whether by application or on the initiative of the APVMA) would, if it were given, made or issued, be likely to require a variation to the Maximum Residue Limits Standard.
(2) The notice must:
(a) be in writing; and
(b) set out:
(i) the relevant particulars, or proposed relevant particulars, of the active constituents and products concerned , other than confidential commercial information; and
(ii) any other matters that the APVMA thinks appropriate; and
(c) be given to Food Standards Australia New Zealand:
(i) for an application, other than an application under section 29D--within 28 days after the APVMA completes a preliminary assessment of the application; or
(ii) for a variation under section 26C, 29, 29A, 29G, 34A or 34AF--before the variation is made.
(3) This section does not apply in relation to an approval, registration, variation or permit proposed by an application that is subject to preliminary assessment before the application has passed preliminary assessment.
8F Notice to holder of approval, registration or variation
(1) The APVMA must give written notice to the holder within 14 days if the APVMA:
(a) approves (or re - approves) an active constituent; or
(b) registers (or re - registers) a chemical product; or
(c) renews the registration of a chemical product; or
(d) approves a label; or
(e) varies relevant particulars or conditions (whether on application or on the initiative of the APVMA), other than under section 34A (varying relevant particulars or conditions to allow affirmation ).
Note: For notice s in relation to reconsideration s, see Division 4 of Part 2.
(2) The notice must:
(a) for an approval or registration:
(i) state that the constituent, product or label has been approved or registered; and
(ii) set out the relevant particulars and conditions of the approval or registration; and
(iii) state the date the approval or registration ends; and
(b) for a registration--state the date (if any) after which the registration cannot be renewed under Division 6 of Part 2; and
(c) for the renewal of a registration--state that the registration of the chemical product has been renewed; and
(d) for the variation of relevant particulars or conditions:
(i) state that the relevant particulars or conditions have been varied; and
(ii) set out the relevant particulars or conditions as varied; and
(iii) state the date the approval or registration ends; and
(iv) of a registration--state the date (if any) after which the registration cannot be renewed under Division 6 of Part 2; and
(e) include any information prescribed by the regulations.
8G Notice to applicant of refusal of application
(1) The APVMA must give written notice to the applicant within 14 days if the APVMA refuses an application.
Note: For notices in relation to reconsiderations, see Division 4 of Part 2.
(2) The notice must:
(a) state that the application has been refused; and
(b) set out the reasons for the refusal; and
(c) include any information prescribed by the regulations; and
(d) specify any amount of fee that is repayable because of the refusal.
Note: Other provisions of this Code specify additional requirements for certain notices of refusal.
8H Published notice of approvals and registrations
(1) If the APVMA approves an active constituent or registers a chemical product, it must, unless it thinks that in the circumstances it is unnecessary to do so, publish notice of the approval or registration.
(2) The notice must:
(a) be published in the Gazette , as soon as practicable, and in any other manner that the APVMA thinks appropriate; and
(b) 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
(c) if the approval or registration is a re - approval or re - registration--state that fact; and
(d) contain a brief statement of the conditions of the approval or registration that directly regulate the use of the constituent or product; and
(e) include any information prescribed by the regulations.
8J Published notice of variations of approvals and registrations
(1) If the APVMA varies any of the relevant particulars or conditions of the approval of an active constituent or the registration of a chemical product, it must, unless it thinks that in the circumstances it is unnecessary to do so, publish notice of the variation.
(2) The notice must:
(a) be published in the Gazette , as soon as practicable, and in any other manner that the APVMA thinks appropriate; and
(b) state that the relevant particulars or conditions have been varied and the date on which the variation took place; and
(c) contain a brief statement of the nature of, and reasons for, the variation; and
(d) include any information prescribed by the regulations.
8K Confidential commercial information must not be disclosed under certain provisions
(1) Engaging in conduct in the performance of functions or duties, or the exercise of powers, under any of the following provisions does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162:
(a) subsection 8F(2);
(b) subsection 8S(2);
(c) subsection 17(4) or (5);
(d) subsection 18(4) or (5);
(e) subsection 34AB(2);
(f) subsection 34AC(2);
(g) subsection 47B(4).
(2) Subsection ( 1) has effect despite subsection 162(1A).
Division 4 -- Holders of approvals and registrations and nominated agents
(1) The holder of an approval or registration may apply to the APVMA to change the holder.
(2) The APVMA must record the change in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that:
(a) the application meets the application requirements; and
(b) the proposed holder has consented, by signed writing, to being the holder; and
(c) 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
(d) any requirements prescribed by the regulations have been met.
(3) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
(1) The holder may, at any time, apply to the APVMA for the person nominated in the application to be the nominated agent for the approval or registration.
(2) The APVMA must record the person as the nominated agent in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that:
(a) the application meets the application requirements; and
(b) the nominated person has consented, by signed writing, to being the nominated agent; and
(c) any requirements prescribed by the regulations have been met.
(3) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
(4 ) It is a condition of the approval or registration that the nominated agent is a resident of, or carries on business in, Australia.
8N O verseas holder must have nominated agent
If the holder is not a resident of, and does not carry on business in, Australia, it is a condition of the approval or registration that there is a nominated agent for the approval or registration.
8P Changing the nominated agent
(1) The holder may apply to the APVMA to change the nominated agent.
(2) The APVMA must record the change in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that:
(a) the application meets the application requirements; and
(b) the person to be the nominated agent has consented, by signed writing , to being the nominated agent; and
(c) any requirements prescribed by the regulations have been met.
(3) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
8Q Nominated agent may withdraw
(1) The nominated agent may, by signed writing given to the APVMA, request to withdraw from being the nominated agent.
(2) The APVMA must record the withdrawal in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that:
(a) the nominated agent has notified the holder of the withdrawal; and
(b) any requirements prescribed by the regulations have been met.
Anything that may, or must, be done under this Code by, or in relation to, the holder, as the holder of the approval or registration, may be done by, or in relation to, either the holder or the nominated agent.
Note: For liabilities imposed on the nominated agent, see section 152.
Division 5 -- Notice of certain proposed decisions
8S Notice of certain proposed decisions
(1) The APVMA must give the applicant written notice of what it proposes to do before it:
(a) refuses an application, other than on preliminary assessment; or
(b) approves (or re - approves) or registers (or re - registers) an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application; or
(c) if the application is to vary relevant particulars or conditions--varies the relevant particulars or conditions other than in accordance with the application.
Note: For notices in relation to reconsiderations, see Division 4 of Part 2.
(2) The notice must:
(a) for notice under paragraph ( 1)(b)--set out the proposed instructions and relevant particulars; and
(b) for notice under paragraph ( 1)(c)--set out the proposed variation; and
(c) include a draft statement of reasons for the proposed course of action; and
(d) set out the information on which the reasons are based (including information not given to the APVMA by the applicant); and
(e) invite written submissions from the applicant within 28 days, or within such further period as is specified in the notice.
(3) The APVMA is not required to take account of anything given in response to the invitation under paragraph ( 2)(e) that is not related to information:
(a) already given to the APVMA by, or on behalf of, the applicant; or
(b) set out in the notice under paragraph ( 2)(d).
(4) The APVMA is not required to comply with this section more than once in relation to a particular application.
Division 6 -- Listed chemical products and established standards
8T Regulations may include schedule of listed chemical products
(1) The regulations may include a schedule specifying chemical products, or classes of chemical products, that are listed chemical products for the purposes of this Code.
(2) Before the Governor - General makes a regulation that includes, or amends, the schedule referred to in subsection ( 1), the APVMA must publish in the Gazette , and in any other manner that the APVMA thinks appropriate, a notice:
(a) stating that it proposes to recommend to the Minister that the regulation be made; and
(b) setting out particulars of the chemical products, or class of chemical products, that would be covered, or otherwise affected, by the regulation; and
(c) 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
(d) giving the reasons for the proposed recommendation; and
(e) 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).
(3) In making a recommendation to the Minister, the APVMA must take into account any submissions made in accordance with the invitation.
(4) Before the Governor - General makes a regulation that includes, or amends, the schedule referred to in subsection ( 1):
(a) the APVMA must have recommended to the Minister that the regulation be made; and
(b) the APVMA must have given to the Minister:
(i) its reasons for the recommendation; and
(ii) written particulars of the product or class of products that would be covered, or otherwise affected, by the regulation; and
(iii) 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
(iv) 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
(v) a written statement identifying the consultations held by, and setting out the advice given to, the APVMA in relation to the proposed regulation.
(1) This section applies in respect of each listed 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, by legislative instrument, make a standard for each listed chemical product. 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 listed 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) The APVMA may, in a standard, direct that the particulars required by the standard be set out, in a manner specified in the standard, on:
(a) chemical products, or a class of chemical products, identified in the standard; or
(b) a container containing chemical products, or a class of chemical products, identified in the standard; or
(c) a label for containers for chemical products, or a class of chemical products, identified in the standard.
(5) A standard for a listed chemical product:
(a) may be specified by reference to any one or more of the following:
(i) the composition and form of the constituents of the product;
(ii) the physical and chemical properties of the chemical product;
(iii) the quantity of the chemical product when contained in specified containers;
(iv) procedures to be carried out in the manufacture of the chemical product;
(v) a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary);
(vi) a monograph in another publication approved by the APVMA for the purposes of this subparagraph;
(vii) a monograph referred to in subparagraph ( v) or (vi) as modified in a manner specified in the standard;
(viii) a standard published by Standards Australia;
(ix) such other matters as the APVMA thinks fit; and
(b) may require that a matter relating to the standard be determined in accordance with a particular test.
(6) Subsections ( 4) and (5) do not limit subsection ( 3).
(7) The standard made by the APVMA in relation to a listed chemical product is the established standard for the product.
Note: The APVMA may revoke or amend a standard. See subsection 33(3) of the Acts Interpretation Act 1901 .
8V Matters to be taken into account in preparing a standard
The APVMA must not make a standard for a listed chemical product unless the APVMA is satisfied that compliance with the standard would result in:
(a) the product meeting the safety criteria, the trade criteria and the efficacy criteria; and
(b) any label for containers for the product meeting the labelling criteria.
30 Section 9 of the Code set out in the Schedule
Repeal the section, substitute:
(1) This Part contains provisions relating to:
(a) approval of active constituents for proposed or existing chemical products; and
(b) registration of chemical products; and
(c) approval of labels for containers for chemical products.
(2) Division 2 provides for approvals and registrations.
(3) Division 2A provides for variation of relevant particulars of approvals and registrations if the relevant particulars are of a kind set out in a legislative instrument made under section 26B. Only holders of approvals or registrations may apply under Division 2A.
(4) Division 3 provides generally for variation of relevant particulars or conditions of approvals and registrations. Holders and other persons may apply under Division 3.
(5) Division 3A provides for re - approval and re - registration of active constituents and chemical products.
(6) Division 4 provides for the APVMA to reconsider approvals and registrations in order to decide whether they should remain in force.
(7) Division 4A limits the use the APVMA can make of certain information given to it in connection with certain applications.
(8) Division 5 sets out the circumstances in which the APVMA may suspend or cancel approvals and registrations.
(9) Division 6 states how long approvals and registrations are to continue in force and makes provision for the renewal of registrations.
31 Division 2 of Part 2 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
Division 2 -- Approving and registering
32 Sections 10 to 14A of the Code set out in the Schedule
Repeal the sections, substitute:
(1) This Division provides for:
(a) approval of active constituents for proposed or existing chemical products; and
(b) registration of chemical products; and
(c) approval of labels for containers for chemical products.
(2) Section 10 provides for applications to be made. Applications must meet the application requirements specified in section 8A.
(3) The APVMA must complete a preliminary assessment of an application. If the application passes preliminary assessment, the APVMA must notify the applicant and publish a summary of the application (section 11).
(4) Before determining certain applications that have passed preliminary assessment, the APVMA must publish a notice inviting public submissions (sections 12 and 13).
(5) The APVMA must approve an active constituent or label, or register a chemical product, if specified criteria are met (section 14). Sections 14A to 16 set out special rules about approvals and registrations.
(6) The APVMA must keep a Record of Approved Active Constituents for Chemical Products and a Register of Agricultural and Veterinary Chemical Products (sections 17 and 18).
(7) Sections 19 to 21 set out how approvals and registrations take place, and section 22 deals with dates of approval and registration.
(8) Approvals and registrations may be subject to conditions (section 23).
(9) Section 26 provides for incorrect relevant particulars and conditions of a kind prescribed by the regulations to be corrected.
(1) A person may apply to the APVMA:
(a) for approval of an active constituent for a proposed or existing chemical product; or
(b) for registration of a chemical product; or
(c) for approval of a label for containers for a chemical product.
(2) The application:
(a) must meet the application requirements; and
(b) for an active constituent or chemical product--must include proposed instructions for use of the constituent or product.
Note: For meets the application requirements , see section 8A.
(1) The APVMA must complete a preliminary assessment of the application within 1 month after it is lodged.
(2) If it appears from the preliminary assessment that the application meets the application requirements, the APVMA must, within 14 days:
(a) give written notice to the applicant:
(i) stating that the application has passed preliminary assessment and that it will be determined under section 14; and
(ii) setting out any matters prescribed by the regulations; and
(b) publish a summary of the application that includes any details prescribed by the regulations.
(3) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
(4) The APVMA may alter the application, after it has passed preliminary assessment, with the written consent of the applicant.
12 APVMA to publish notice before deciding whether to approve new active constituent
(1) This section applies if the application:
(a) has passed preliminary assessment; and
(b) 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.
(2) The APVMA must publish a notice in the Gazette and in any other manner that it thinks appropriate.
(3) The notice must state that the APVMA has to decide whether to approve the constituent and must:
(a) set out the following:
(i) the name of the constituent;
(ii) particulars of the constituent;
(iii) a summary of the APVMA's assessment of whether the constituent meets the safety criteria;
(iv) any other matters that the APVMA thinks appropriate; and
(b) 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.
(1) This section applies if the application:
(a) has passed preliminary assessment; and
(b) 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.
(2) The APVMA must publish a notice in the Gazette and in any other manner that it thinks appropriate.
(3) The notice must state that the APVMA has to decide whether to register the product and must:
(a) set out the following:
(i) the name that the applicant intends to use to describe the product;
(ii) particulars of the product and its active constituents;
(iii) a summary of the APVMA's assessment of whether the product meets the safety criteria, the trade criteria and the efficacy criteria;
(iv) any other matters that the APVMA thinks appropriate; and
(b) 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.
(1) The APVMA must approve the active constituent or label, or register the chemical product, if it is satisfied:
(a) that the application meets the application requirements; and
(b) for an active constituent--that the constituent meets the safety criteria; and
(c) for a chemical product--that the product:
(i) meets the safety criteria, the trade criteria and the efficacy criteria; or
(ii) complies with the established standard for the product; and
(d) for a label for a chemical product--that the label:
(i) meets the labelling criteria; or
(ii) complies with the established standard for the product.
Note: For notice of approval or registration, see section 8F.
(2) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
14A Approval of active constituents for which information is not readily available
(1) The APVMA may approve an active constituent for a proposed or existing chemical product if:
(a) either of the following applies:
(i) the APVMA considers that information it requires in respect of the constituent is not readily available;
(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) having regard to information that is readily available, the APVMA is satisfied that the constituent would meet the safety criteria.
(2) Subsection ( 1) applies:
(a) despite subsection 14(2); and
(b) whether or not an application has been made for approval of the constituent.
(3) If the APVMA approves an active constituent under this section without an application having been made for the approval, the APVMA must, under paragraph 19(1)(a), be entered in the Record as the holder of the approval.
33 Section 14B of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
34 Paragraph 14B(1)(a) of the Code set out in the Schedule
Omit "an agricultural", substitute "a".
35 Paragraph 14B(1)(b) of the Code set out in the Schedule
Repeal the paragraph, substitute:
(b) the information related to the first product or the active constituent and:
(i) the safety criteria ; or
(ii) a matter that is prescribed by the regulations; and
36 Paragraph 14B(1)(e) of the Code set out in the Schedule
Repeal the paragraph, substitute:
(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.
37 Subsection 14B(2) of the Code set out in the Schedule
Omit "grant the application for registrati on of", substitute "register ".
38 Subsection 14B(3) of the Code set out in the Schedule
Omit "granting", substitute "determining".
39 Subsection 14B(3) of the Code set out in the Schedule
Omit "of the grant or".
40 Section 15 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
15 Restriction on power of APVMA to register products and approve labels
41 Paragraphs 15(1)(a) and (b) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(a) register a chemical product unless:
(i) the APVMA also approves each active constituent for the product; and
(ii) the APVMA also approves a label for containers for the product; or
(b) approve a label for containers for a chemical product unless it also registers the product.
41A Subsection 15(2) of the Code set out in the Schedule
Omit all the words after "in relation", substitute:
to:
(a) an active constituent that is exempted by the APVMA from the operation of that subparagraph; or
(b) an active constituent for a listed chemical product if the product complies with the established standard for the product.
42 Subsection 16(1) of the Code set out in the Schedule
Omit "for a proposed or existing chemical product".
42A Subsection 17(4) of the Code set out in the Schedule
Omit "that does not contain confidential commercial information".
42B At the end of subsection 17(4) of the Code set out in the Schedule
Add:
Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K.
42C Subsection 17(5) of the Code set out in the Schedule
Omit "that does not contain confidential commercial information".
42D At the end of subsection 17(5) of the Code set out in the Schedule
Add:
Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K.
42E Subsection 18(4) of the Code set out in the Schedule
Omit "that does not contain confidential commercial information".
42F At the end of subsection 18(4) of the Code set out in the Schedule
Add:
Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K.
42G Subsection 18(5) of the Code set out in the Schedule
Omit "that does not contain confidential commercial information".
42H At the end of subsection 18(5) of the Code set out in the Schedule
Add:
Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K.
43 Sections 19 to 26 of the Code set out in the Schedule
Repeal the sections, substitute:
19 How approval of active constituent takes place
(1) Approval of an active constituent takes place when the APVMA enters the following in the Record:
(a) the name of the person who applied for the approval as the holder of the approval;
(b) the name of any nominated agent for the approval;
(c) the relevant particulars, which are the distinguishing number, any instructions for the use of the constituent and any other particulars prescribed by the regulations;
(d) any conditions of the approval imposed by the APVMA;
(e) the date the approval ends.
(2) The date the approval ends must:
(a ) be worked out in accordance with the metho d prescribed by the regulations; and
(b) be the last day of a calendar month at least 7 years but not more than 15 years after the approval takes place.
(3) Despite subsection ( 2), the APVMA may approve the active constituent for a period of less than 7 years to provide for its approval to end at the same time as another approval of the active constituent.
(4) Paragraph ( 2)(b) does not apply if the approval is subject to the condition that it remains in force only for a stated period of not more than 1 year (see subsection 23(2)).
20 How registration of chemical product takes place
(1) Registration of a chemical product takes place when the APVMA enters the following in the Register:
(a) the name of the person who applied for the registration as the holder of the registration;
(b) the name of any nominated agent for the registration;
(c) the relevant particulars, which are the distinguishing number, any instructions for the use of the product and any other particulars prescribed by the regulations;
(d) if the product is a listed chemical product--a notation to that effect;
(e) any conditions of the registration imposed by the APVMA;
(f) the date the registration ends, which must be the last day of a calendar month not more than 12 months after the registration takes place;
(g) unless the product is a listed chemical product, and the product and each label for the product compl y with the established standard for the product -- the date (the last renewal date ) after which the registration cannot be renewed under Division 6.
Rules about last renewal dates
(2) The last renewal date must:
(a) be worked out in accordance with the method prescribed by the regulations; and
(b ) if the last renewal date is entered in the Register when the product is registered --be the last day of a calendar month at least 7 years but not more than 15 years after the registration takes place; and
(c) if the last renewal date is entered in the Register when the relevant particulars or conditions of the registration are varied --be the last day of a calendar month at least 7 years but not more than 15 years after the variation takes place.
Note: For entering last renewal date s when relevant particulars or conditions are varied, see sections 26D, 29B and 34A.
(3) However, the last renewal date may be less than 7 years after the registration or variation takes place to provide for the last renewal date to be the same as the last renewal date for another chemical product that contains one or more of the same active constituents.
(4) Paragraphs ( 2)(b) and (c) do not apply if the registration is subject to the condition that it remains in force only for a stated period of not more than 1 year (see subsection 23(2)).
21 How approval of label takes place
Approval of a label takes place when the APVMA:
(a) determines the particulars prescribed by the regulations that are appropriate to be contained on the label; and
(b) gives a distinguishing number to the label; and
(c) records the following information in the relevant APVMA file:
(i) the name of the person who applied for the approval as the holder of the approval;
(ii) the name of any nominated agent for the approval;
(iii) the distinguishing number;
(iv) the instructions and any particulars that are to be contained on the label;
(iva) any other particulars prescribed by the regulations;
(v) any conditions of the approval imposed by the APVMA.
22 Date of approval or registration
(1) The date of approval of an active constituent, of registration of a chemical product or of approval of a label is the date on which the relevant particulars are entered in the Record, Register or relevant APVMA file.
(2) If:
(a) any of the relevant particulars of:
(i) an approval of an active constituent; or
(ii) a registration of a chemical product; or
(iii) an approval of a label; or
(b) 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.
23 Conditions of approval or registration
(1) The approval of an active constituent, the registration of a chemical product or the approval of a label for containers for a chemical product is subject to:
(a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and
(b) any conditions imposed on the approval or registration as the APVMA thinks appropriate.
(2) An active constituent, chemical product or a label may be approved or registered on the condition that the approval or registration remains in force only for a stated period of not more than 1 year.
(3) If:
(a) the approval or registration is subject to a condition referred to in subsection ( 2); and
(b) 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.
26 Incorrect particulars and conditions
(1) If:
(a) 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
(b) the relevant particular or condition is of a kind prescribed by the regulations;
the APVMA must vary the entry or record accordingly.
Note: For notice of variation, see section 8F.
(2) If 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 because of inaccurate recording, the APVMA must vary the entry or record accordingly.
Note: For notice of variation, see section 8F.
(3) If the holder of the approval of an active constituent, the registration of a chemical product or the approval of a label for containers for a chemical product has reasonable cause to believe that:
(a) 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
(b) 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.
(4) The holder commits an offence of strict liability if the holder contravenes subsection ( 3).
Penalty: 30 penalty units.
Note: For strict liability, see section 6.1 of the Criminal Code .
(5) Subsection ( 3) is a civil penalty provision.
Note: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions.
44 Divisions 2A and 3 of Part 2 of the Code set out in the Schedule
Repeal the Divisions, substitute:
Division 2A -- Varying prescribed relevant particulars
(1) This Division provides for the variation of a relevant particular of an approval or registration if the relevant particular i s set out in a legislative instrument made under section 26B.
(2) Only the holder of the approval or registration may apply under this Division (section 26B). The application must meet the application requirements specified in section 8A.
(3) The APVMA must vary the relevant particular if specified criteria are met, otherwise it must refuse the application (section 26C).
(4) Section 26D sets out how a variation takes place.
(1) The holder may apply to the APVMA for variation of a relevant particular of an approval or registration if the relevant particular is of a kind set out in a legislative instrument made by the APVMA for the purposes of this section.
(2) The application must meet the application requirements.
Note: For meets the application requirements , see section 8A.
(3) The APVMA may alter the application with the written consent of the applicant.
26C Varying prescribed relevant particulars
(1) The APVMA must vary the relevant particular if it is satisfied:
(a) that the application meets the application requirements; and
(b) for an active constituent--that, if the particular were varied in accordance with the application, the constituent would meet the safety criteria; and
(c) for a chemical product--that, if the particular were varied in accordance with the application, the product would:
(i) meet the safety criteria, the trade criteria and the efficacy criteria; or
(ii) comply with the established standard for the product; and
(d) for a label for a chemical product--that, if the particular were varied in accordance with the application, the label would:
(i) meet the labelling criteria; or
(ii) comply with the established standard for the product.
Note: For notice of variation, see section 8F.
(2) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
(1) Variation of a relevant particular under this Divi sion takes place when the APVMA records in the Record, Register or relevant APVMA file, as required, the relevant particular as varied and the date on which the variation is made.
(2) If:
( a ) the relevant particular is varied in such a way that a listed chemical product or any approved label for the product does not comply with the established standard for the product; and
( b ) there is no date entered in the Register as the date after which the registration of the product cannot be renewed under Division 6;
the APVMA must enter such a date in the Register.
Note: See section 20 for rules about the date after which a registration cannot be renewed under Division 6.
(3 ) I f:
( a ) the relevant particular is varied in such a way that a listed chemical product and every approved label for the product comply with the established standard for the product; and
( b ) there is a date entered in the Register as the date after which the registration of the product cannot be renewed under Division 6;
the APVMA must remove the date from the Register .
Division 3 -- Varying relevant particulars and conditions
(1) This Division provides generally for variation of relevant particulars or conditions of approvals and registrations.
(2) Holders and other persons may apply under this Division.
(3) Section 27 provides for applications to be made. An application must meet the application requirements specified in section 8A.
(4) The APVMA must complete a preliminary assessment of the application. If the application passes preliminary assessment, the APVMA must notify the applicant and may be required to publish a summary of the application (section 28).
(5) The APVMA must vary the relevant particulars or conditions if specified criteria are met (section 29).
(6) The APVMA may vary relevant particulars or conditions on its own initiative with the consent of the holder (section 29A).
(7) Section 29B sets out how a variation takes place.
(1) The holder may apply to the APVMA for variation of the relevant particulars or conditions of:
(a) the approval of an active constituent; or
(b) the registration of a chemical product; or
(c) the approval of a label for containers for a chemical product.
Note: The APVMA may only vary relevant particulars or conditions that it has imposed . See section 6B.
(2) A person may, with the consent of the holder, apply to the APVMA for variation of the relevant particulars or conditions of:
(a) the registration of a chemical product; or
(b) the approval of a label for containers for a chemical product.
(3) An application under subsection ( 1) or (2) must meet the application requirements.
Note: For meets the application requirements , see section 8A.
(4) The fee (if any) for the application must be reduced (but not below zero) by the amount of any fee paid for a previous application for the variation made under Division 2A.
(1) The APVMA must complete a preliminary assessment of the application within 1 month after it is lodged.
(2) If it appears from the preliminary assessment that the application meets the application requirements, the APVMA must, within 14 days:
(a) give written notice to the applicant:
(i) stating that the application has passed preliminary assessment and that it will be determined under section 29; and
(ii) setting out any matters prescribed by the regulations; and
(b) if the variation relates to the use of a chemical product--publish a summary of the application including any details prescribed by the regulations.
(3) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
(4) The APVMA may alter the application, after it has passed preliminary assessment, with the written consent of:
(a) the applicant; and
(b) if the applicant is not the holder--the holder.
29 Varying relevant particulars and conditions
(1) The APVMA must vary the relevant particulars or conditions if it is satisfied:
(a) that the application meets the application requirements; and
(b) for an active constituent--that, if those particulars or conditions were varied in accordance with the application, the constituent would meet the safety criteria; and
(c) for a chemical product--that, if those particulars or conditions were varied in accordance with the application, the product would:
(i) meet the safety criteria, the trade criteria and the efficacy criteria; or
(ii) comply with the established standard for the product; and
(d) for a label for a chemical product--that, if those particulars or conditions were varied in accordance with the application, the label would:
(i) meet the labelling criteria; or
(ii) comply with the established standard for the product.
Note: For notice of variation, see section 8F.
(2) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
29A APVMA may vary on its own initiative with holder's consent
(1) The APVMA may, on its own initiative, and with the written consent of the holder, vary the relevant particulars or conditions of an approval or registration.
Note 1: The APVMA may only vary relevant particulars or conditions that it has imposed . See section 6B.
Note 2: For notice of variation, see section 8F.
(2) The APVMA may vary the relevant particulars or conditions only if it is satisfied:
(a) for an active constituent--that, if those particulars or conditions were so varied, the constituent would meet the safety criteria; and
(b) for a chemical product--that, if those particulars or conditions were so varied, the product would:
(i) meet the safety criteria, the trade criteria and the efficacy criteria; or
(ii) comply with the established standard for the product; and
(c) for a label for a chemical product--that, if those particulars or conditions were so varied, the label would:
(i) meet the labelling criteria; or
(ii) comply with the estab lished standard for the product; and
(d) that the constituent, product or label complies, or will comply, with any requirement prescribed by the regulations.
(3) No fee is payable in relation to a variation made under this section.
(4) Nothing in this Code requires the APVMA to make a variation under this section.
(1) Variation of relevant particulars or conditions under this Division takes place when the APVMA records in the Record, Register or r elevant APVMA file, as required , the relevant particulars or conditions as varied and the date on which the variation is made.
(2) If:
(a) the relevant particulars or conditions are varied in such a way that a listed chemical product or any approved label for the product does not comply with the established standard for the product; and
(b) there is no date entered in the Register as the date after which the registration of the product cannot be renewed under Division 6;
the APVMA must enter such a date in the Register.
Note: See section 20 for rules about the date after which a registration cannot be renewed under Division 6.
(3) If:
(a) the relevant particulars or conditions are varied in such a way that a listed chemical product and every approved label for the product comply with the established standard for the product; and
(b) there is a date entered in the Register as the date after which the registration of the product cannot be renewed under Division 6;
the APVMA must remove the date from the Register.
45 Division 4 of Part 2 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
Division 4 -- Reconsidering approvals and registrations
46 Before section 30 of the Code set out in the Schedule
Insert:
(1) This Division provides for reconsideration of approvals and registrations.
(2) The APVMA may invite proposals for reconsideration (section 30), and the APVMA may reconsider an approval or registration at any time (section 31).
(3) Before reconsidering an approval or registration, the APVMA must prepare a work plan (section 31), notify the holder and invite the holder to make a written submission on the reconsideration. The holder will also be required to give the APVMA information relevant to the reconsideration (section 32).
(4) The APVMA may inform any person that the APVMA proposes to reconsider, or is reconsidering, the approval or registration and invite written submissions (section 32).
(5) The APVMA may require the holder to conduct trials or experiments or provide information or samples for the purposes of the reconsideration (section 33).
(6) The APVMA must affirm the approval or registration if it is satisfied that the constituent or product concerned meets specified criteria (section 34).
(7) The APVMA must vary the relevant particulars or conditions of the approval or registration if the APVMA is satisfied that they can be varied in such a way as to allow the approval or registration to be affirmed (section 34A).
(8) If the APVMA does not affirm the approval or registration, it must suspend or cancel the approval or registration (section 34AA).
(9) The APVMA must give notice of what it proposes to do before it:
(a) varies the relevant particulars or conditions; or
(b) suspends or cancels the approval or registration (section 34AB).
(10) If the APVMA affirms the approval or registration:
(a) it must notify the holder and publish a notice in the Gazette (section 34AC); and
(b) if the reconsideration was required by section 29H (reconsideration if APVMA does not re - approve or re - register)--it must re - approve or re - register the constituent or product (section 34AD); and
(c) it may vary the duration of the approval or registration (section 34AE).
(11 ) The APVMA may reconsider the approval of a label to determine whether the instructions on the label are adequate (section 34AF).
47 Section 30 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
30 Inviting the public to propose reconsiderations
48 Subsection 30(1) of the Code set out in the Schedule
Omit "cause to be published", substitute "at any time publish".
49 Subsection 30(1) of the Code set out in the Schedule
Omit " for proposed or existing chemical products, or to propose chemical products,", substitute ", chemical products or labels".
50 At the end of section 31 of the Code set out in the Schedule
Add:
(2) Before commencing the reconsideration, the APVMA must prepare a work plan in accordance with any requirements prescribed by the regulations.
(3) The work plan:
(a) must be maintained in accordance with the regulations; and
(b) is not a legislative instrument.
51 Section 32 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
52 Subsections 32(1) to (3A) of the Code set out in the Schedule
Repeal the subsections, substitute:
(1) The APVMA must give written notice to the holder:
(a) setting out the matters it proposes to deal with in the reconsideration and its reasons for so proposing; and
(b) 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:
(i) any information of a kind stated in the notice of which the holder is aware and which is relevant to the reconsideration;
(ii) any information of which the holder is aware that is relevant to the reconsideration; and
(c) inviting the holder, within that period, to make a written submission to the APVMA about the matters referred to in paragraph ( a); and
(d) setting out the work plan.
(1A) The APVMA may, by written notice given to the holder, extend the period stated in the notice.
(2) The APVMA may, if it thinks it desirable to do so, inform any person, in any manner that it thinks appropriate, that the APVMA proposes to reconsider, or is reconsidering, the approval or registration.
(2A) If the APVMA informs a person as mentioned in subsection ( 2), it must:
(a) inform the person of:
(i) the matters that it proposes to reconsider, or is reconsidering; and
(ii) the work plan; and
(b) 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.
(2B) Nothing in subsections ( 1), (2) or (2A):
(a) requires the APVMA to deal with a particular matter as part of the reconsideration; or
(b) prevents the APVMA from dealing with a particular matter as part of the reconsideration.
(3) The holder must comply with a requirement made of the holder under paragraph ( 1)(b).
Note: A person does not commit an offence by failing to do something the p erson is not capable of doing. S ee subsections 4.2(1) and (4) of the Criminal Code .
53 Subsection 32(4) of the Code set out in the Schedule
Omit "interested person or an approved person", substitute "holder".
54 Subsection 32(5) of the Code set out in the Schedule
Repeal the subsection, substitute:
(5) The holder commits an offence of strict liability if the holder contravenes subsection ( 3).
Penalty: 120 penalty units.
Note 1: For strict liability, see section 6.1 of the Criminal Code .
Note 2: A defendant bears an evidential burden in relation to the matter in subsection ( 4). See subsection 13.3(3) of the Criminal Code .
(6) Subsection ( 3) is a civil penalty provision.
Note 1: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions.
Note 2: For the evidential burden in civil penalty proceedings in relation to the matter in subsection ( 4), see section 145CD.
55 Section 33 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
33 APVMA may require information, reports, results or samples
56 Subsections 33(1) to (2A) of the Code set out in the Schedule
Repeal the subsections, substitute:
(1) The APVMA may, by written notice given to the holder, require the holder, within a reasonable period stated in the notice or such further period as the APVMA allows, to do one or more of the following for the purposes of the reconsideration:
(a) give to the APVMA information of a kind stated in the notice;
(b) carry out a search of published literature for information and give a report to the APVMA on the results of that search;
(c) conduct, or cause to be conducted, trials or laboratory experiments and give the results of the trials or experiments to the APVMA;
(d) 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.
(1A) The period stated in the notice must be no longer than the period prescribed by the regulations.
(1B) The APVMA may allow a further period only in the circumstances prescribed by the regulations.
(1C) The power under subsection ( 1) includes the power to require the holder to give to the APVMA information, a report, results or a sample in addition to any information, report, results, or sample previously given by the holder to the APVMA under any provision of this Code other than this section.
(1D) Any information, report, results or sample that the holder has to give to the APVMA or another body under subsection ( 1) must be given as follows:
(a) information, a report or results must be given in writing:
(i) signed by the holder; or
(ii) attached to a covering letter signed by the holder;
(b) a sample must be:
(i) labelled with a label signed by the holder; or
(ii) attached to a covering letter signed by the holder.
Note: For giving information electronically, see section 156A.
(2) The holder must comply with a requirement made of the holder under subsection ( 1).
Note: A person does not commit an offence by failing to do something the person is not capable of doing. See subsections 4.2(1) and (4) of the Criminal Code .
57 Subsection 33(3) of the Code set out in the Schedule
Omit "interested person or an approved person", substitute "holder".
58 Subsection 33(4) of the Code set out in the Schedule
Repeal the subsection, substitute:
(4) The holder commits an offence of strict liability if the holder contravenes subsection ( 2).
Penalty: 120 penalty units.
Note 1: For strict liability, see section 6.1 of the Criminal Code .
Note 2: A defendant bears an evidential burden in relation to the matter in subsection ( 3). See subsection 13.3(3) of the Criminal Code .
(5) Subsection ( 2) is a civil penalty provision.
Note 1: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions.
Note 2: For the evidential burden in civil penalty proceedings in relation to the matter in subsection ( 3), see section 145CD.
59 Sections 34 and 34A of the Code set out in the Schedule
Repeal the sections, substitute:
(1) The APVMA must affirm the approval or registration if, and only if, it is satisfied:
(a) for an active constituent--that the constituent meets the safety criteria; and
(b) for a chemical product--that the product meets the safety criteria, the trade criteria and the efficacy criteria; and
(c) for a label--that the label meets the labelling criteria; and
(d) that the constituent, product or label complies with any requirement prescribed by the regulations.
(2) Subsection ( 1) applies only to the extent that the APVMA decides to reconsider matters covered by the subsection.
(3) For the purposes of subsection ( 1), the APVMA:
(a) must have regard to:
(i) any information given , or submissions made , to the APVMA in response to a notice given under subsection 32(1); and
(ii) any submissions made to the APVMA in response to an invitation under paragraph 32(2A)(b) or 34AB(2)(f); and
(iii) 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
(iv) any information, report, results or sample given to the APVMA in response to a notice given under section 33; and
(v) any information given to the APVMA as required by section 161 in relation to the constituent, product or label; and
(vi) any other information that it considers necessary to enable it to make a decision on the reconsideration; but
(b) must not take into account any submission, information, report, results or sample not covered by paragraph ( a).
34A Varying relevant particulars or conditions to allow affirmation
(1) If the APVMA:
(a) is not satisfied as mentioned in subsection 34(1); but
(b) 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.
Note: The APVMA may only vary relevant particulars or conditions that it has imposed . See section 6B.
(2) For the purposes of paragraph ( 1)(b), the APVMA may have regard only to the following:
(a) submissions, information, reports, results or samples that it had regard to under section 34;
(b) submissions made to the APVMA in response to the invitation under paragraph 34AB(2)(f).
(3) If the variation would affect any instructions for the use of an active constituent or chemical product, or any instructions on a label, 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.
(4) If the APVMA varies the relevant particulars or conditions, it must record in the Record, Register or r elevant APVMA file, as required , the relevant particulars or conditions as varied and the date on which the variation is made.
(5) If:
(a) the relevant particulars or conditions are varied in such a way that a listed chemical product or any approved label for the product does not comply with the established standard for the product; and
(b) there is no date entered in the Register as the date after which the registration of the product cannot be renewed under Division 6;
the APVMA must enter such a date in the Register.
Note: See section 20 for rules about the date after which a registration cannot be renewed under Division 6.
(6) If:
(a) the relevant particulars or conditions are varied in such a way that a listed chemical product and every approved label for the product comply with the established standard for the product; and
(b) there is a date entered in the Register as the date after which the registration of the product cannot be renewed under Division 6;
the APVMA must remove the date from the Register.
34AA Suspension or cancellation
(1) If the APVMA does not affirm the approval or registration, it must suspend or cancel the approval or registration.
(2) If the reconsideration is of the approval of a label for containers for a chemical product, the APVMA must suspend or cancel the approval if:
(a) 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
(b) the holder does not satisfy the APVMA that a label, including the particulars as varied, will be attached to the containers for the product.
(3) Subsection ( 2) has effect despite subsection 34A(1).
Note: For general requirements in relation to suspension and cancellation, see Division 5.
34AB Notice of proposed decision
(1) The APVMA must give notice of what it proposes to do before it:
(a) varies the relevant particulars or conditions under section 34A; or
(b) suspends or cancels the approval or registration under section 34AA.
(2) The notice must:
(a) be given to the holder in writing; and
(b) be given to the other persons informed of the reconsideration as mentioned in subsection 32(2):
(i) in writing; or
(ii) in the way the persons were informed under that subsection; and
(c) include a draft statement of reasons for the proposed course of action; and
(d) set out the information on which the reasons are based (including information not given to the APVMA by the holder); and
(e) for variation of relevant particulars or conditions--set out the proposed variation; and
(f) invite written submissions from the holder or other persons within 3 months.
(3) The APVMA is not required to comply with this section more than once in relation to:
(a) variation of the relevant particulars or conditions; or
(b) suspension or cancellation of the approval or registration.
34AC Notice of decision on reconsideration
(1) If the APVMA affirms the approval or registration, the APVMA must, within 14 days:
(a) 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.
(2) The notice given to the holder must:
(a) state that the approval or registration has been affirmed; and
(b) set out the relevant particulars and conditions of the approval or registration as affirmed; and
(c) state the date the approval or registration ends; and
(d) for registration--state the date (if any) after which the registration cannot be renewed under Division 6; and
(e) include any information prescribed by the regulations.
(3) The notice in the Gazette must:
(a) state that the approval or registration has been affirmed; and
(b) contain a brief statement of the reasons for the affirmation.
Note: If the APVMA does not affirm the appr oval or registration, it must suspend or cancel the approval or registration under section 34AA. For notice of suspension or cancellation, see Division 5.
34AD Affirmation leading to re - approval or re - registration
If:
(a) the APVMA affirms the approval or registration; and
(b) the reconsideration was required by section 29H (reconsideration if APVMA does not re - approve or re - register);
the APVMA must, as soon as practicable, re - approve or re - register the constituent or product.
34AE Varying duration of approval or registration
(1) If the APVMA affirms the approval or registration, it may vary:
(a) the date (the end date ) the approval ends, which, if varied, must be the last day of a calendar month at least 7 years but not more than 15 years after the approval is affirmed; or
(b) either or both of the following:
(i) the date the registration ends, which must be the last day of a calendar month;
(ii) if , before the reconsideration began, there was a date entered in the Register as the date after which the registration cannot be renewed under Division 6 --that date (the last renewal date ) .
(2) If varied, the end date or last renewal date must:
(a) be worked out in accordance with the method prescribed by the regulations; and
(b) be the last day of a calendar month at least 7 years but not more than 15 years after the approval or registration is affirmed.
(3) However, the end date or renewal date, as varied , may be less than 7 years after the approval or registration is affirmed to provide for the date to be the same as:
(a) for an approval--the end date for another approval of the active constituent; or
(b) for a registration--the last renewal date for another chemical product that contains one or more of the same active constituents.
(4) Paragraph ( 2)(b) does not apply if the approval or registration is subject to the condition that it remains in force only for a stated period of not more than 1 year (see subsection 23(2)).
(5) Nothing in this Code requires the APVMA to make a variation under this section.
(6) This section does not apply in relation to a reconsideration required by section 29H (reconsideration if APVMA does not re - approve or re - register).
34AF Reconsideration of approval of label without notice in certain circumstances
(1) The APVMA may, at any time, reconsider the approval of a label for the purpose of deciding whether the label contains 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 covered by the definition of meets the labelling criteria .
(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; and
(b) record in the relevant APVMA file the relevant particulars as varied and the date on which the record is made; and
(c) give written notice to the holder setting out particulars of the variation.
(4) Sections 30 to 34AE do not apply to a reconsideration under this section.
60 Section 40 of the Code set out in the Schedule
Repeal the section.
61 Subsection 43(2) of the Code set out in the Schedule
After "sections", insert "29D,".
62 Division 7 of Part 2 of the Code set out in the Schedule
Repeal the Division.
63 Part 2A of the Code set out in the Schedule
Repeal the Part.
64 Subsection 56ZU(3) of the Code set out in the Schedule
Omit "having custody of, use of, or other dealing with, each", substitute "custody or use of each".
65 Paragraph 56ZU(4)(c) of the Code set out in the Schedule
Repeal the paragraph, substitute:
(c) the APVMA must have given to the Minister 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; and
66 Paragraphs 72(2)(a), (b) and (c) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(a) the supply of unapproved active constituents for chemical products and unregistered chemical products; and
(b) their possession for the purposes of supply; and
(c) the supply of active constituents for chemical products that have been approved and the supply of chemical products that have been registered or reserved in contravention of the conditions of their approval, registration or reservation.
67 Subsection 72(4) of the Code set out in the Schedule
Omit "or", substitute "for chemical products and".
68 Subsection 74(5) of the Code set out in the Schedule
Repeal the subsection.
69 Section 75 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
70 Subsection 75(1) of the Code set out in the Schedule
Omit ", a registered listed chemical product".
71 Subsection 75(3) of the Code set out in the Schedule
Omit ", a registered listed chemical product".
72 Subsection 75(5) of the Code set out in the Schedule
Repeal the subsection.
73 Subsection 76(5) of the Code set out in the Schedule
Repeal the subsection.
74 Section 78 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
78 Supply of chemical products that are not registered products or reserved products
75 Subsection 78(1) of the Code set out in the Schedule
Omit ", a registered listed chemical product".
76 Subparagraph 78(1)(c)(i) of the Code set out in the Schedule
Omit ", granted listed registration, or reserved,", substitute "or reserved".
77 Subparagraph 78(1)(c)(ii) of the Code set out in the Schedule
Omit ", granted listed registration,".
78 Subparagraph 78(1)(c)(iii) of the Code set out in the Schedule
Omit ", granted listed registration,".
78A Subparagraph 78(1)(c)(vi) of the Code set out in the Schedule
Omit "or listed registration".
79 Subsection 78(3) of the Code set out in the Schedule
Omit ", a registered listed chemical product".
80 Subsection 78(5) of the Code set out in the Schedule
Repeal the subsection.
81 Paragraph 83(1)(a) of the Code set out in the Schedule
Omit "of Chemical Products".
82 Section 83A of the Code set out in the Schedule
Repeal the section.
83 Paragraph 84(1)(a) of the Code set out in the Schedule
Omit "or registered listed chemical product".
84 Paragraph 84(1)(b) of the Code set out in the Schedule
Omit "or registered listed chemical product".
85 Subsection 84(1) of the Code set out in the Schedule
Omit "listed" (last 2 occurring).
86 Subsection 87(1) of the Code set out in the Schedule
Repeal the subsection, substitute:
(1) This section applies to a chemical product if:
(a) a standard is prescribed in respect of the product or in respect of a constituent contained in the product; and
(b) the product is:
(i) a listed chemical product; or
(ii) prescribed for the purposes of this section.
87 Paragraph 88(2)(b) of the Code set out in the Schedule
Omit "neither a registered chemical product nor a registered listed", substitute "not a registered".
88 Paragraph 88(2)(c) of the Code set out in the Schedule
Omit "or listed registration".
89 Subparagraph 88(2)(d)(i) of the Code set out in the Schedule
Omit "neither a registered chemical product nor a registered listed", substitute "not a registered".
90 Paragraph 88(3)(b) of the Code set out in the Schedule
Omit "neither a registered chemical product nor a registered listed", substitute "not a registered".
91 Section 89A of the Code set out in the Schedule
Omit "listable", substitute "listed".
92 Paragraph 97(4)(b) of the Code set out in the Schedule
Omit "or listed registration".
93 Section 99 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
99 Analysis of chemical products and active constituents
94 Subsection 99(1) of the Code set out in the Schedule
Omit "If", substitute "This section applies if".
95 Subsection 99(1) of the Code set out in the Schedule
Omit ", the following provisions apply".
96 Subsection 99(2) of the Code set out in the Schedule
Omit ", or has been granted listed registration under Division 4 of Part 2A,".
97 Paragraphs 99(2)(a), (b) and (c) of the Code set out in the Schedule
Omit "of Chemical Products".
98 Subsection 99(6) of the Code set out in the Schedule
Omit "cause to be published", substitute "publish".
99 Subparagraph 99(6)(a)(ii) of the Code set out in the Schedule
Omit "interested person in relation to the product--the interested person", substitute "holder of the registration--the holder".
100 Subsection 99(8) of the Code set out in the Schedule
Repeal the subsection.
101 Section 101 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
101 Recall of products that are not registered or whose registration is being reconsidered
102 Paragraph 101(1)(a) of the Code set out in the Schedule
Omit ", and has not been granted listed registration,".
103 Paragraph 101(1)(b) of the Code set out in the Schedule
Repeal the paragraph, substitute:
(b) the APVMA is reconsidering the registration of a chemical product under Division 4 of Part 2 of that Code;
104 Paragraph 101(2)(c) of the Code set out in the Schedule
Omit "and has not been granted listed registration".
105 Subsection 101(3) of the Code set out in the Schedule
Repeal the subsection.
106 Paragraphs 102(1)(a) and (aa) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(a) a chemical product may not meet the safety criteria, the trade criteria or the efficacy criteria; or
107 Paragraph 102(1)(b) of the Code set out in the Schedule
Omit "of Chemical Products".
108 Paragraph 102(1)(ba) of the Code set out in the Schedule
Repeal the paragraph.
109 Paragraph 102(1)(c) of the Code set out in the Schedule
Omit "of Chemical Products".
110 Paragraph 102(1)(ca) of the Code set out in the Schedule
Repeal the paragraph.
111 Paragraph 102(1)(d) of the Code set out in the Schedule
Omit "of Chemical Products".
112 Paragraph 102(1)(e) of the Code set out in the Schedule
Repeal the paragraph.
113 Subsection 102(3) of the Code set out in the Schedule
Repeal the subsection.
114 Subsection 103(1) of the Code set out in the Schedule
Repeal the subsection, substitute:
(1) If it appears to the APVMA that labels attached to the containers:
(a) of stocks of a registered chemical product; or
(b) of a particular batch of a registered chemical product;
differ from the approved label for the product or the label required by the established standard for the product, the APVMA may give written notice to any person (the notified person ) who has, or has had, possession or custody of any of those stocks or of that batch in this jurisdiction requiring the person to do any one or more of the things mentioned in subsection ( 2).
115 Subsection 103(3) of the Code set out in the Schedule
Repeal the subsection.
116 Subsection 104(1) of the Code set out in the Schedule
Repeal the subsection, substitute:
(1) If the APVMA issues a recall notice, it must, within 14 days, publish notice of the issue of the recall notice in the Gazette and in any other manner that it thinks appropriate.
117 Paragraph 108(2)(a) of the Code set out in the Schedule
Omit ", a registered listed chemical product".
118 Paragraph 108(2)(a) of the Code set out in the Schedule
Omit ", registration or listed", substitute "or".
119 Paragraph 108(2)(b) of the Code set out in the Schedule
Omit "product; or", substitute "product.".
120 Paragraph 108(2)(c) of the Code set out in the Schedule
Repeal the paragraph.
121 Section 110 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
122 Subsections 110(2) to (4) of the Code set out in the Schedule
Repeal the subsections, substitute:
(2) The application must meet the application requirements.
Note: For meets the application requirements , see section 8A.
123 After section 110 of the Code set out in the Schedule
Insert:
(1) The APVMA must complete a preliminary assessment of the application within 1 month after it is lodged.
(2) If it appears from the preliminary assessment that the application meets the application requirements, the APVMA must, within 14 days, give written notice to the applicant:
(a) stating that the application has passed preliminary assessment and that it will be determined under section 112; and
(b) setting out any matters prescribed by the regulations.
(3) If it appears from the preliminary assessment that the application does not meet the application requirements but that the defects in the application can reasonably be rectified, the APVMA must, within 14 days, give written notice to the applicant:
(a) stating that the application does not meet the application requirements; and
(b) giving particulars of the defects in the application; and
(c) requiring the defects to be rectified within 1 month.
(4) The APVMA must refuse the application if:
(a) the APVMA is not satisfied that defects in the application can reasonably be rectified; or
(b) the defects are not rectified to the satisfaction of the APVMA within the period mentioned in paragraph ( 3)(c).
Note: For notice of refusal, see section 8G.
(5) The APVMA may alter the application, after it has passed preliminary assessment, with the written consent of the applicant.
124 Paragraph 111(1)(c) of the Code set out in the Schedule
Omit "application should be granted", substitute "permit should be issued".
125 Section 112 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
126 Subsections 112(2) to (5) of the Code set out in the Schedule
Repeal the subsections, substitute:
(2) The APVMA must issue the permit if it is satisfied:
(a) that the application meets the application requirements; and
(b) that the applicant has complied with any requirement made by the APVMA under subparagraph 111(1)(b)(iii); and
(c) for an active constituent--that the constituent would meet the safety criteria; and
(d) for a chemical product--that the product would meet the safety criteria, the trade criteria and the efficacy criteria; and
(e) that any requirements prescribed by the regulations in relation to the issue of a permit under this section have been complied with; and
(f) if an application has not been made for approval of the constituent or registration of the product or such an application has not been determined--that there are reasonable grounds for the application not having been made or for issuing the permit pending determination of the application; and
(g) if the application is for a permit to do, or omit to do, any thing which would, apart from the permit, be an offence against subsection 121(4A) or (5A) or a contravention of the civil penalty provision set out in subsection 121(4) or (5)--that there are exceptional circumstances that justify issuing the permit.
Note: For how permits are issued, see section 114.
(3) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
(4) Despite subsection ( 2), the APVMA must also refuse the application if it is satisfied that:
(a) the applicant will be unable to comply with the conditions of the permit; or
(b) at least one of the following persons:
(i) the applicant;
(ii) any other person who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against an agvet law; or
(v) been convicted of an offence against a law of this or another jurisdiction relating to chemical products; or
(vi) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vii) been ordered to pay a pecuniary penalty for the contravention of an agvet penalty provision; or
(viii) been ordered to pay a pecuniary penalty for the contravention of another law of this or another jurisdiction relating to chemical products; or
(ix) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(x) held a permit that was cancelled under subsection 119(2) or section 119B of this Code or under a corresponding provision of the Agvet Code of another jurisdiction; or
(xi) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph ( iv), (v), (vi), (vii), (viii), (ix) or (x) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate.
(5) A reference in paragraph ( 4)(b) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(6) However, the APVMA may issue the permit despite subsection ( 4) if, in the opinion of the APVMA, special circumstances make it appropriate to do so.
(7) If the APVMA refuses the application, it must give written notice of the refusal to each co - ordinator to whom a copy of the application was given.
127 After section 112 of the Code set out in the Schedule
Insert:
112A APVMA may issue permit on its own initiative
(1) The APVMA may, on its own initiative and in accordance with this section, issue a permit to a person in respect of an active constituent for a proposed or existing chemical product or in respect of a chemical product.
(2) The APVMA may issue the permit if it is satisfied of the following:
(a) that the active constituent or chemical product in respect of which the permit is to be issued meets the safety criteria, the trade criteria and the efficacy criteria;
(b) that any requirements prescribed by the regulations in relation to the issue of a permit under this section have been complied with;
(c) if an application has not been made for approval of the constituent or registration of the product or such an application has not been determined--that there are reasonable grounds for the application not having been made or for issuing the permit pending determination of the application, as the case may be;
(d) if the permit would authorise a person to do, or omit to do, any thing which would, apart from the permit, be an offence against subsection 121(4A) or (5A) or a contravention of the civil penalty provision set out in subsection 121(4) or (5)--that there are exceptional circumstances that justify issuing the permit.
Note: For how permits are issued, see section 114.
(3) However, the APVMA must not issue the permit to a person (the proposed permit holder) if it is satisfied that:
(a) the proposed permit holder will be unable to comply with the conditions of the permit; or
(b) at least one of the following persons:
(i) the proposed permit holder;
(ii) any other person who makes, or participates in making, decisions that affect the whole, or a substantial part, of the proposed permit holder's affairs;
(iii) if the proposed permit holder is a body corporate--a major interest holder of the body corporate;
has, within the previous 10 years:
(iv) been convicted of an offence against an agvet law; or
(v) been convicted of an offence against a law of this or another jurisdiction relating to chemical products; or
(vi) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vii) been ordered to pay a pecuniary penalty for the contravention of an agvet penalty provision; or
(viii) been ordered to pay a pecuniary penalty for the contravention of another law of this or another jurisdiction relating to chemical products; or
(ix) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(x) held a permit that was cancelled under subsection 119(2) or section 119B of this Code or under a corresponding provision of the Agvet Code of another jurisdiction; or
(xi) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph ( iv), (v), (vi), (vii), (viii), (ix) or (x) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate.
(4) A reference in paragraph ( 3)(b) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(5) However, the APVMA may issue the permit despite subsection ( 3) if, in the opinion of the APVMA, special circumstances make it appropriate to do so.
(6) If the active constituent or chemical product in respect of which the permit is to be issued is approved or registered, the APVMA :
(a) must, before issuing the permit, give written notice of its intention to do so to the holder of the approval or registration ; and
(b) must not issue the permit before the end of 28 days after the day on which the notice is given.
(7) However, subsection ( 6) does not apply to the extent that, in the opinion of the APVMA, special circumstances make it appropriate to:
(a) issue the permit without giving written notice to the holder of the approval or registration ; or
(b) issue the permit before the end of the 28 days.
128 Section 114 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
129 Subsections 114(1) and (1A) of the Code set out in the Schedule
Repeal the subsections.
130 Subsection 114(5) of the Code set out in the Schedule
Omit "As soon as practicable", substitute "Within 14 days".
131 Subsection 115(3) of the Code set out in the Schedule
Omit all the words after "extensions of the permit".
132 After subsection 115(3) of the Code set out in the Schedule
Insert:
(3A) The APVMA may extend the permit for a further period that it thinks appropriate if it is satisfied that:
(a) the application meets the application requirements; and
(b ) any requirements prescribed by the regulations have been met.
(3B) If the APVMA does not extend the permit, it must refuse the application.
Note: For notice of refusal, see section 8G.
133 At the end of subsection 115(5) of the Code set out in the Schedule
Add:
Note: For notice of refusal, see section 8G.
134 Subsection 115(6) of the Code set out in the Schedule
Repeal the subsection.
135 Subsection 117(1) of the Code set out in the Schedule
Omit "an approved person", substitute "the holder".
136 Subsection 117(3) of the Code set out in the Schedule
Omit "as soon as practicable", substitute "within 14 days".
137 Subsection 118(8) of the Code set out in the Schedule
Repeal the subsection.
138 Subsection 118(10) of the Code set out in the Schedule
Omit "as soon as practicable", substitute "within 14 days".
139 Subsection 119(8) of the Code set out in the Schedule
Repeal the subsection.
140 Subsection 119(11) of the Schedule
Omit "as soon as practicable", substitute "within 14 days".
141 Section 120A of the Code set out in the Schedule
Omit "listable", substitute "listed".
142 Paragraphs 122(1)(a) to (e) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(a) be in writing in the approved form; and
(b) be signed by the applicant; and
(c) be accompanied by so much of the prescribed fee as is required to be paid when the application is made; and
(d) be lodged with the APVMA; and
(e) contain, or be accompanied by, any information specified for the application under section 8B.
143 Subsection 122(2) of the Code set out in the Schedule
Omit "in relation to an application for a licence, by written notice given to an approved person", substitute "by written notice given to the applicant".
144 Subsection 123(1) of the Code set out in the Schedule
Repeal the subsection, substitute:
(1) If an application is made for a licence to carry out steps in the manufacture of chemical products (other than prohibited chemical products) at particular premises, the APVMA must issue the licence to the applicant unless the APVMA is satisfied that:
(a) the applicant has not complied with subsection 122(1) or any requirement under subsection 122(2); or
(b) any requirement prescribed by the regulations in relation to the application or the issue of the licence has not been complied with; or
(c) the applicant will be unable to comply with the conditions of the licence; or
(d) the applicant will be unable to comply with the manufacturing principles; or
(e) at least one of the following persons:
(i) the applicant;
(ii) any other person who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against an agvet law; or
(v) been convicted of an offence against a law of this or another jurisdiction relating to chemical products; or
(vi) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vii) been ordered to pay a pecuniary penalty for the contravention of an agvet penalty provision; or
(viii) been ordered to pay a pecuniary penalty for the contravention of another law of this or another jurisdiction relating to chemical products; or
(ix) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(x) contravened a condition of a manufacturing licence issued under an agvet law; or
(xi) held a manufacturing licence or permit that was cancelled under an agvet law, other than paragraph 127(1)(d) or (e) of this Code or a corresponding provision of the Agvet Code of another jurisdiction; or
(xii) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph ( iv), (v), (vi), (vii), (viii), (ix), (x) or (xi) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
(f) at least one of the following persons:
(i) the applicant;
(ii) any other person who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 5 years immediately before the application, failed to comply with a manufacturing principle in connection with the manufacture of chemical products.
(1A) If the APVMA does not issue the licence, it must refuse the application.
Note: For notice of refusal, see section 8G.
(1B) A reference in paragraph ( 1)(e) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914 ; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1C) Paragraph ( 1)(f) does not apply to the extent that the APVMA thinks the failure to comply with the manufacturing principle is not relevant.
145 Subsection 123(2) of the Code set out in the Schedule
Omit "(b) or (c)", substitute "(e) or (f)".
146 Subsection 123(5) of the Code set out in the Schedule
Omit "cause", substitute "publish".
147 Subsection 123(5) of the Code set out in the Schedule
Omit "to be published".
148 Section 124 of the Code set out in the Schedule
Repeal the section.
149 Paragraph s 126(3)(a) and (b) of the Code set out in the Schedule
Repeal the paragraph s , substitute:
(a) on the day on which the notice is given to the holder, but only if the notice states that the action is necessary to p revent one or more of the following :
(i) an imminent risk to persons of death, serious injury or serious illness;
(ii) an imminent risk of unintended harm to animals, plants or things, or to the environment;
(iii) an imminent risk of impact on trade or commerce between Australia and places outside Australia; or
(b) otherwise--on a day stated for the purpose in the notice that, unless the APVMA and the holder agree, is not earlier than 28 days after the notice is given to the holder.
150 Subsection 126(5) of the Code set out in the Schedule
Repeal the subsection.
151 Subsection 127(1) of the Code set out in the Schedule
Omit "in relation to a licence, by written notice given to an approved person", substitute "by written notice given to the holder of a licence".
152 Paragraph 127(2)(a) of the Code set out in the Schedule
Omit "an approved person", substitute "the holder".
153 Subsection 127(6) of the Code set out in the Schedule
Repeal the subsection.
154 Paragraph 149(3)(b) of the Code set out in the Schedule
Omit ", a registered chemical product or a registered listed", substitute "or a registered".
155 Paragraph 152(2)(a) of the Code set out in the Schedule
Omit "a person", substitute "the holder of an approval or registration".
156 Paragraph 152(2)(a) of the Code set out in the Schedule
Omit all the words after "jurisdiction", substitute "in relation to an active constituent or chemical product covered by the approval or registration; and".
157 Paragraph 152(2)(b) of the Code set out in the Schedule
Omit "that person", substitute "the holder".
158 Subsection 152(2) of the Code set out in the Schedule
Omit "approved person who signed the application for the approval of the constituent or the registration or listed registration, or the renewal of the registration or listed registration, of the product", substitute "nominated agent for the approval or regis t ration".
159 Subsection 152(2) of the Code set out in the Schedule
Omit "first - mentioned person", substitute "holder".
160 Subsection 152(2) of the Code set out in the Schedule
Omit "approved person" (second occurring), substitute "nominated agent".
161 After section 156 of the Code set out in the Schedule
Insert:
156A Giving information electronically
(1) If, under this Code, a person is required or permitted to give the APVMA information (including an application) in writing, that requirement is taken to have been met if:
(a) the APVMA consents to the information being given electronically; and
(b) the person gives the information electronically in accordance with any requirements mentioned in subsection ( 3); and
(c) in a case where this Code requires the signature of an applicant or holder--the information includes the electronic signature of the applicant or holder.
(2) If, under this Code, a person is required or permitted to give the APVMA information in writing, the regulations may, despite any other provision of this Code, require that the information be given only electronically and in accordance with any requirements mentioned in subsection ( 3).
(3) For the purposes of subsections ( 1) and (2), the APVMA may require that the information be given, in accordance with particular information technology requirements, by means of a particular kind of electronic communication.
(4) If, under this Code, the APVMA is required or permitted to give a person information in writing, that requirement is taken to have been met if:
(a) the person consents to the information being given electronically; and
(b) the APVMA gives the information electronically; and
(c) where applicable, the information includes the Chief Executive Officer's electronic signature; and
(d) in a case where a person's failure to do, or not do, a thing set out in the information is an offence against this Code or the contravention of a civil penalty provision--the APVMA has adequate systems for proving the person received the information.
(5) This section applies to a requirement or permission to give information, whether the expression "give", "lodge", "send" or "serve", or any other expression, is used.
(6) For the purposes of this section, giving information includes, but is not limited to, the following:
(a) making or withdrawing an application;
(b) making or lodging a claim;
(c) giving, sending or serving a notification;
(d) giving a report;
(e) making a request;
(f) making a declaration;
(g) lodging or issuing a certificate;
(h) giving a statement of reasons.
162 Subsection 157(1) of the Code set out in the Schedule
Omit "If the APVMA so requires, a person who makes an application under this Code must", substitute "For the purposes of determining an application under this Code, the APVMA may require the applicant to".
163 Paragraphs 159 (1) (a) and (b) of the Code set out in the Schedule
Before "an application", insert "determining".
164 Paragraph 159(1)(c) of the Code set out in the Schedule
Repeal the paragraph.
165 Subparagraph 159(1)(d)(iv) of the Code set out in the Schedule
Repeal the subparagraph.
166 Subsection 159(1) of the Code set out in the Schedule
Omit "interested person or an approved person, require the interested person, or the applicant for or holder of the relevant permit", substitute "applicant (for the purposes of paragraph ( a) or (b)) or the holder (for the purposes of paragraph ( d)), require the applicant or holder".
167 Paragraph 159(1)(e) of the Code set out in the Schedule
Omit ", that may be relevant to the application, reconsideration or decision".
168 After subsection 159(1) of the Code set out in the Schedule
Insert:
(1AA) The period stated in the notice must be no longer than the period prescribed by the regulations.
(1AB) The APVMA may allow a further period only in the circumstances prescribed by the regulations.
169 Subsection 159(2) of the Code set out in the Schedule
Omit "a person", substitute "an applicant or holder".
170 Subsection 159(2) of the Code set out in the Schedule
Omit "an approved person", substitute "the applicant or holder".
171 At the end of subsection 159(2) of the Code set out in the Schedule
Add:
Note: For giving information electronically, see section 156A.
172 Subsection 159(3)
Repeal the subsection.
174 Subsections 159(4) and (5) of the Code set out in the Schedule
Repeal the subsections.
175 Section 160 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
160 Overseas trials and experiments etc.
176 Section 160 of the Code set out in the Schedule
Omit "For", substitute "(1) This section applies for".
177 Paragraph 160(a) of the Code set out in the Schedule
Before "an application", insert "determining".
178 Paragraph 160(b) of the Code set out in the Schedule
Before "an application" (first occurring), insert "determining".
179 Paragraph 160(c) of the Code set out in the Schedule
Omit "registration or listed".
180 Paragraph 160(d) of the Code set out in the Schedule
Omit "product;", substitute "product.".
181 Section 160 of the Code set out in the Schedule
Omit all the words from and including "the APVMA".
182 At the end of section 160 of the Code set out in the Schedule
Add:
(2) The APVMA may take account of any of the following:
(a) the results of any trials or experiments already carried out in a foreign country in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or any of its constituents;
(b) any decisions or evaluations made by regulators of agricultural or veterinary chemicals in a foreign country;
(c) any information on which a decision or evaluation mentioned in paragraph ( b) is based;
to the extent that those results, decisions or evaluations are, or that information is, relevant having regard to any matters the APVMA thinks appropriate, including any of the matters mentioned in subsection ( 3).
(3) The matters are:
(a) any significant differences in the proposed use of the constituent, or of the product, in Australia and in that foreign country; or
(b) any different environmental factors affecting the use of the constituent, or of the product, in Australia and in that foreign country; or
(c) any significant additional information relating to the properties of the constituent, or of the product or of any of its constituents, that has become available since the conduct of those trials or experiments; or
(d) any significant differences in the way decisions or evaluations are made in Australia and by the national regulatory authority in that foreign country.
183 Subparagraph 160A(1)(a)(iii) of the Code set out in the Schedule
Repeal the subparagraph.
184 Paragraph 160A(1)(c) of the Code set out in the Schedule
Omit "an appropriate person", substitute "the applicant".
185 Subsection 160A(2) of the Code set out in the Schedule
Omit "appropriate person", substitute "applicant".
186 Subsection 160A(2) of the Code set out in the Schedule
Omit "practicable after the person", substitute "the applicant".
187 Subsection 160A(3) of the Code set out in the Schedule
Repeal the subsection.
188 Paragraphs 160A(4)(a) to (d) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(a) contradicts any information that:
(i) was given to the APVMA by the applicant in an application mentioned in paragraph ( 1)(a); and
(ii) relates to particulars prescribed by the regulations for the purposes of paragraph 19(1)(c) or 20(1)(c); or
(b) shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria.
189 Subsection 160A(7) of the Code set out in the Schedule
Omit "that a person has to give", substitute "given".
190 Subsection 160A(7) of the Code set out in the Schedule
Omit "an approved person", substitute "the applicant".
191 At the end of subsection 160A(7) of the Code set out in the Schedule
Add:
Note: For giving information electronically, see section 156A.
192 Paragraph 161(1)(a) of the Code set out in the Schedule
Repeal the paragraph, substitute:
(a) the holder of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product; or
193 Subsection 161(1) of the Code set out in the Schedule
Omit "person must, as soon as practicable after the person", substitute "holder must, as soon as the holder".
194 Paragraphs 161(2)(a) to (d) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(a) contradicts any information entered in the Record, Register or Record of Permits for the constituent or product; or
(b) shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria.
195 Subsection 161(3) of the Code set out in the Schedule
Omit "that a person has to give", substitute "given".
196 Subsection 161(3) of the Code set out in the Schedule
Omit "an approved person", substitute "the holder".
197 At the end of subsection 161(3) of the Code set out in the Schedule
Add:
Note: For giving information electronically, see section 156A.
198 Subparagraph 162(3)(a)(i) of the Code set out in the Schedule
Omit "assessment", substitute "evaluation".
199 Subparagraph 162(3)(b)(i) of the Code set out in the Schedule
Omit "or listed registration".
200 Subparagraph 162(3)(b)(i) of the Code set out in the Schedule
Omit "assessment", substitute "evaluation".
201 Subparagraph 162(3)(b)(ii) of the Code set out in the Schedule
Omit "or of the listed registration of the product under Division 6 of Part 2A".
201A After subparagraph 162(3)(c)(i) of the Code set out in the Schedule
Insert:
(ia) the authorising party for the information; or
202 Subparagraph 162(3)(c)(ii) of the Code set out in the Schedule
Omit "interested person in relation to the constituent or product", substitute " authorising party for the information ".
203 Paragraph 162(3)(d) of the Code set out in the Schedule
Omit "interested person in relation to the constituent or product", substitute " authorising party for the information ".
204 Subsection 162(4) of the Code set out in the Schedule
Omit "interested person" (first occurring), substitute " authorising party for the information ".
205 Paragraph 162(4)(a) of the Code set out in the Schedule
Omit "interested person", substitute " authorising party ".
206 Subsection 162(5) of the Code set out in the Schedule
Repeal the subsection.
207 Section 163 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
208 Subsection 163(1) of the Code set out in the Schedule
Omit "(1)".
209 Paragraph 163(1)(b) of the Code set out in the Schedule
Omit "interested person in relation to the constituent, product or label", substitute "applicant or holder concerned".
210 Paragraph 163(1)(d) of the Code set out in the Schedule
Omit "interested person", substitute "applicant or holder".
211 Subsection 163(2) of the Code set out in the Schedule
Repeal the subsection.
212 Subsection 164(10) of the Code set out in the Schedule
Repeal the subsection.
213 Paragraph 165(2)(a) of the Code set out in the Schedule
Repeal the paragraph, substitute:
(a) if the application is for re - approval of an active constituent or re - registration of a chemical product:
(i) any period beginning on the day when the APVMA makes a requirement of the applicant in connection with the application and ending on the day when the requirement is complied with; or
(ii) any period during which the approval or registration concerned is being reconsidered as required by subsection 29H(1); and
214 Paragraph 165(2)(b) of the Code set out in the Schedule
Omit "caused to be".
215 Paragraph 165(2)(c) of the Code set out in the Schedule
Omit "caused such a notice to be published", substitute "published such a notice".
216 At the end of subsection 165(2) of the Code set out in the Schedule
Add:
; and (d) if the APVMA has given written notice to a n applicant under subsection 8S(1) --the 28 day period after the notice is given, or such further period as is specified in the notice, within which submissions may be made.
217 At the end of section 165 of the Code set out in the Schedule
Add:
(3) If, at the end of the period referred to in subsection ( 1), the application has not been determined, the applicant may give the APVMA written notice that the applicant wishes to treat the application as having been refused.
(4) The notice may be given at any time after the end of the period referred to in subsection ( 1) and before the application is determined.
(5) If the notice is given, this Code has effect as if:
(a) the APVMA had refused the application; and
(b) the APVMA had confirmed the refusal under section 166; and
(c) the decisions mentioned in paragraphs ( a) and (b) had been made on the day on which notice was given to the APVMA under subsection ( 3).
218 After section 165 of the Code set out in the Schedule
Insert:
165A Period within which APVMA is to conclude reconsiderations under Division 4 of Part 2
(1) If the APVMA reconsiders an approval or registration under Division 4 of Part 2, the APVMA must conclude the reconsideration within a period stated in, or determined in accordance with, the regulations.
(2) The APVMA may make a legislative instrument setting out criteria for working out which period stated in, or determined in accordance with, the regulations applies in a particular case.
(3) In working out the period within which the reconsideration is to be concluded, no regard is to be had to:
(a) the period, stated in the notice given to the holder under subsection 32(1), within which information must be given and submissions may be made; and
(b) if the APVMA has given written notice to the holder under subsection 33(1)--the period stated in the notice within which any information, report, results or sample must be given to the APVMA.
219 Section 166 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
166 Internal review of decisions
220 Paragraph 166(1)(a) of the Code set out in the Schedule
Omit "other than this section".
221 After subsection 166(1) of the Code set out in the Schedule
Insert:
(1A) This section also applies if:
(a) a decision (the original decision ) on a particular matter (the relevant matter ) has been made under this Code on behalf of the APVMA by a member of the staff of the APVMA; and
(b) the original decision is:
(i) a decision under subsection 14(2), 26C(2), 29(2), 29E(3) or 115(3B) to refuse an application based only on requirements set out in paragraph 8A(a) or (b); or
(ii) a decision under subsection 112(3) to refuse an application based only on requirements set out in paragraph 8A(a) or (b) or a requirement made by the APVMA under subparagraph 111(1)(b)(iii); or
(iii) a decision under subsection 123(1A) to refuse an application based only on requirements set out in subsection 122(1); and
(c) if the original decision were reviewable by the Administrative Appeals Tribunal, a person would be entitled to apply to the Administrative Appeals Tribunal for review of the original decision.
221A Subsection 166(2) of the Code set out in the Schedule
After "by writing", insert "within 42 days after the original decision is made".
222 Subsection 166(3) of the Code set out in the Schedule
Omit "decision and", substitute "decision having regard only to the information used to make it, and must".
223 Subsection 166(6) of the Code set out in the Schedule
Repeal the subsection, substitute:
(6) If the APVMA has not given notice under subsection ( 4) of its decision on the reconsideration within 90 days after the request is made, the person who made the request may, by writing, notify the APVMA that the person considers that the APVMA has confirmed the original decision.
(7) If the person so notifies the APVMA, the decision on the reconsideration is taken to be a decision to confirm the original decision.
224 Section 167 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
167 Review of decisions by Administrative Appeals Tribunal
225 Paragraphs 167(1)(aa) to (e) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(a) a decision under subsection 14(1) to approve or register a constituent, product or label :
(i) with an instruction or relevant particular other than an instruction or particular set out in the application for the approval or registration; or
(ii) subject to particular conditions;
(b) a decision under subsection 14(2) to refuse an application for approval or registration, other than a decision based only on requirements set out in paragraph 8A(a) or (b);
(c) a decision under subsection 26C(2) to refuse an application to vary relevant particulars, other than a decision based only on requirements set out in paragraph 8A(a) or (b);
(d) a decision under subsection 29(2) to refuse an application to vary relevant particulars or conditions, other than a decision based only on requirements set out in paragraph 8A(a) or (b);
(da) a decision under subsection 29D(3) to refuse to accept a late application;
(db) a decision under subsection 29G(1) to vary relevant particulars or conditions;
(e) a decision under subsection 34A(1) or 34AF(3) to vary relevant particulars or conditions;
226 Paragraph 167(1)(ea) of the Code set out in the Schedule
Omit "34D(3)", substitute "34J(3)".
227 Paragraph 167(1)(ea) of the Code set out in the Schedule
Omit "34C", substitute "34G".
228 Paragraph 167(1)(ea) of the Code set out in the Schedule
Omit all the words from and including " substantive decision )", substitute " substantive decision );".
229 Paragraph 167(1)( f ) of the Code set out in the Schedule
After "under", insert "section 34AA or".
230 Paragraphs 167(1)(fa) to (ff) of the Code set out in the Schedule
Repeal the paragraphs.
231 Paragraph 167(1)(g) of the Code set out in the Schedule
Omit "or 56ZL(3)".
232 At the end of paragraph 167(1)(l) of the Code set out in the Schedule
Add ", other than a decision based only on requirements set out in paragraph 8A(a) or (b) or a requirement made by the APVMA under subparagraph 111(1)(b)(iii)".
232A At the end of paragraph 167(1)(n) of the Code set out in the Schedule
Add "other than a decision based only on requirements set out in paragraph 8A(a) or (b)".
233 Paragraphs 167(1)(o) and (p) of the Code set out in the Schedule
Repeal the paragraphs, substitute:
(o) a decision under section 118, 119, 119A or 119B to suspend or cancel a permit;
233A At the end of paragraph 167(1)(q) of the Code set out in the Schedule
Add "other than a decision based only on requirements set out in subsection 122(1)".
234 Paragraph 167(1)(u) of the Code set out in the Schedule
Repeal the paragraph.
235 Paragraph 167(1)(v) of the Code set out in the Schedule
Omit "interested person", substitute "applicant or holder".
235A At the end of subsection 167(1) of the Code set out in the Schedule
Add:
; (y) a decision under this Code prescribed by the regulations.
236 Subsection 167(2) of the Code set out in the Schedule
Repeal the subsection.
237 Subsection 167(2A) of the Code set out in the Schedule
Omit "34E", substitute "34K".
238 Subsection 167(2A) of the Code set out in the Schedule
Omit "to public health or occupational health or safety", substitute " to persons of death, serious injury or serious illness".
239 Subparagraph 178(1)(a)(ii) of the Code set out in the Schedule
Omit "of Chemical Products".
240 Paragraphs 180(c) and (ca) of the Code set out in the Schedule
Omit "32(2)", substitute "32(1)".
241 Paragraph 184(a) of the Code set out in the Schedule
Repeal the paragraph.
242 After paragraph 184(b) of the Code set out in the Schedule
Insert:
; and (c) the person had not complied with the notice before that commencement;
243 Section 184 of the Code set out in the Schedule
Omit "and the person had not complied with the notice before that commencement,".