Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013 (Cth)

Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013

No. 179, 2013 as amended

made under the

Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994; Agricultural and Veterinary Chemicals (Administration) Act 1992; Agricultural and Veterinary Chemicals Code Act 1994; Agricultural and Veterinary Chemicals Legislation Amendment Act 2013

Compilation start date: 1 July 2014

Includes amendments up to: SLI No. 67, 2014

About this compilation

This compilation

This is a compilation of the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013 as in force on 1 July 2014. It includes any commenced amendment affecting the legislation to that date.

This compilation was prepared on 1 July 2014.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

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

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.

Contents

1............ Name of regulation............................................................................. 1

2............ Commencement.................................................................................. 1

3............ Authority............................................................................................ 1

4............ Schedule(s)......................................................................................... 1

Schedule 1—Amendments 2

Agricultural and Veterinary Chemical Products (Collection of Levy) Regulations 1995 2

Agricultural and Veterinary Chemicals (Administration) Regulations 1995 3

Agricultural and Veterinary Chemicals Code Regulations 1995 8

Endnotes119

Endnote 1—About the endnotes 119

Endnote 2—Abbreviation key 121

Endnote 3—Legislation history 122

Endnote 4—Amendment history 123

Endnote 5—Uncommenced amendments [none] 124

Endnote 6—Modifications [none] 124

Endnote 7—Misdescribed amendments [none] 124

Endnote 8—Miscellaneous [none] 124

1Name of regulation

This regulation is the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013.

2Commencement

This regulation commences on 1 July 2014.

3Authority

This regulation is made under the following Acts:

(a)the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994;

(b)the Agricultural and Veterinary Chemicals (Administration) Act 1992;

(c)the Agricultural and Veterinary Chemicals Code Act 1994;

(d)the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013.

4Schedule(s)

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

Agricultural and Veterinary Chemical Products (Collection of Levy) Regulations 1995

1 Subregulation 6A(3) (heading)

Repeal the heading, substitute:

2013‑2014 financial year

2 Subregulation 6A(3)

Omit “and each succeeding financial year”.

3 At the end of regulation 6A

Add:

2014‑2015 financial year and subsequent years

(4) For section 12C of the Act, the following rates are prescribed in respect of the 2014‑2015 financial year and each succeeding financial year:

(a) for the part of leviable disposals not exceeding $1 000 000—0.63%;

(b) for the part of leviable disposals exceeding $1 000 000 but not exceeding $5 000 000—0.35%;

4 Regulation 7

Repeal the regulation, substitute:

8 Disclosure of information to collecting agency

(1) This regulation applies if the Minister has specified an agency under section 3A of the Act to be the collecting agency.

(2) The APVMA may give the collecting agency any information that the collecting agency reasonably requires in order to carry out its functions under the Act and these Regulations.

5 Schedule 2

Repeal the Schedule.

Agricultural and Veterinary Chemicals (Administration) Regulations 1995

6 After Part 1

Insert:

Part 1A—Annual operational plan and annual report

1A.1 Information for inclusion in annual report

The APVMA must include in its annual report a list of:

(a) the standards made under section 6E of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 during the year to which the annual report relates; and

(b) the standards made under section 6E that were varied by the APVMA during the year to which the annual report relates.

1A.2 Information for inclusion in annual operational plan

For paragraph 55(2)(c) of the Act, the following information is prescribed:

(a) the number of reconsiderations to be commenced by the APVMA under section 31 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) during the period to which the annual operational plan relates;

(b) the number of reconsiderations to be concluded by the APVMA under Division 4 of Part 2 of the Schedule to the Agvet Code Act during that period;

1A.3 Performance indicators for inclusion in annual report

For subparagraph 61(2)(c)(ii) of the Act, the following performance indicators are prescribed:

(a) the number of reconsiderations commenced by the APVMA under section 31 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) during the year to which the annual report relates;

(b) the number of reconsiderations concluded by the APVMA under Division 4 of Part 2 of the Schedule to the Agvet Code Act during that year;

(d) the number of applications mentioned in each item of Part 2 of Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995 that were:

(i) made under the Schedule to the Agvet Code Act during that year; and

(ii) not determined within the period required for the application by regulations made under section 165 of that Schedule;

(e) the number of reports (known as adverse experience reports) received by the APVMA during that year;

(f) the number of adverse experience reports mentioned in paragraph (e) that the APVMA determined were related to each of the following:

(i) human health;

(ii) environment;

(iii) animal health;

(iv) crop health;

(v) efficacy for agricultural chemical products or veterinary chemical products;

(g) a summary of any action taken by the APVMA during that year in relation to adverse experience reports.

Note: Adverse experience reports are received under the Adverse Experience Reporting Program (AERP) which is a post‑registration quality assurance program established by the APVMA.

7 After Part 3

Insert:

Part 3A—Infringement notices

3A.01 Infringement notices

(1) For the definition of prescribed civil penalty provision in section 4 of the Act, each civil penalty provision mentioned in Schedule 5 is prescribed.

(2) For subsection 69EKA(3) of the Act:

(a) the amount (in penalty units) mentioned for an individual in an item of Schedule 5 is the amount that applies for an alleged contravention by the individual of the provision mentioned in the item in the circumstances (if any) mentioned in the item; and

(b) the amount (in penalty units) mentioned for a corporation in an item of Schedule 5 is the amount that applies for an alleged contravention by the corporation of the provision mentioned in the item in the circumstances (if any) mentioned in the item.

8 Regulation 4.15

Repeal the regulation, substitute:

4.15 Method of securing samples

(1) This regulation applies to an inspector who exercises:

(a) the monitoring power mentioned in paragraph 69EAC(1)(g) of the Act to take and keep samples of any thing on any premises; or

(b) the investigation power mentioned in paragraph 69EBA(1)(g) of the Act to take a sample and keep samples of any thing on any premises.

(2) The inspector must ensure that:

(a) the sample is contained and sealed in an appropriate vessel or package; and

(b) the vessel or package is so marked as to clearly identify the sample; and

(d) the sample is stored and transported in such a way that the composition of the sample is not altered.

9 Schedules 2 to 5

Repeal the Schedules, substitute:

Schedules 2 to 4

Note: Schedules 2 to 4 are reserved for future use.

Schedule 5—Infringement notices

Note: See regulation 3A.01.

Penalty amounts for infringement notices
Item	Civil penalty provision	Amount for individual (penalty units)	Amount for corporation (penalty units)
Civil penalty provisions of the Act
1	A contravention of subparagraph 69B(1)(a)(i) of the Act involving: (a) at least 10 kg of an active constituent for a veterinary chemical product; or (b) at least 100 kg of an active constituent for an agricultural chemical product	90	750
2	A contravention of subparagraph 69B(1)(a)(i) of the Act involving: (a) at least 1 kg, but less than 10 kg, of an active constituent for a veterinary chemical product; or (b) at least 10 kg, but less than 100 kg, of an active constituent for an agricultural chemical product	45	375
3	A contravention of subparagraph 69B(1)(a)(i) of the Act involving: (a) less than 1 kg of an active constituent for a veterinary chemical product; or (b) less than 10 kg of an active constituent for an agricultural chemical product	9	75
4	A contravention of subparagraph 69B(1)(a)(ii) involving at least 500 containers	90	750
5	A contravention of subparagraph 69B(1)(a)(ii) involving at least 50 containers but fewer than 500 containers	45	375
6	A contravention of subparagraph 69B(1)(a)(ii) involving fewer than 50 containers	9	75
7	A contravention of subsection 69CD(1)	15	125
8	A contravention of section 69E	15	125
9	A contravention of subsection 69EA(1)	15	125
10	A contravention of subsection 69EA(1A)	15	125
Civil penalty provisions of the Collection Act
11	A contravention of section 15 of the Collection Act	15	125
12	A contravention of section 20 of the Collection Act	15	125
13	A contravention of section 36 of the Collection Act	15	125

10 Schedule 6

Repeal the Schedule.

Agricultural and Veterinary Chemicals Code Regulations 1995

11 Before regulation 1

Insert:

Division 1.1A—Name and commencement

12 After regulation 2

Insert:

Division 1.1—Definitions

13 Subregulation 3(1)

Insert:

application information details, for an item of information contained in or accompanying an application, means the following details:

(a) the title shown on the item of information;

(b) the name of the author, or each of the authors, of the information;

(d) if no date is shown on the item of information—the date when the preparation of the information was completed;

(e) if the information was published:

(i) the date when it was published; and

(ii) the name of the publication in which it was published;

(f) a unique identifier for the item of information that indicates the location of the item in the application;

(g) the name and address of the authorising party for the information.

Example: An example for paragraph (f) is the volume and page number where the item of information is located in the application.

14 Subregulation 3(1) (definition of approved active constituent)

Repeal the definition.

15 Subregulation 3(1)

Insert:

APVMA CEO means the Chief Executive Officer of the APVMA.

16 Subregulation 3(1)

Insert:

collecting agency has the meaning given by subsection 3(1) of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.

17 Subregulation 3(1) (definition of CSIRO)

Omit “Organization”, substitute “Organisation”.

18 Subregulation 3(1) (definition of emergency use)

Repeal the definition, substitute:

emergency use, in relation to a chemical product or an active constituent, means a use of the product or constituent in the genuine belief that the use is required because of an emergency or impending emergency.

19 Subregulation 3(1)

Insert:

FAO and WHO Specifications for Pesticides means specifications for pesticides or plant protection products published by the Food and Agriculture Organization of the United Nations or the World Health Organization of the United Nations.

20 Subregulation 3(1) (definition of FAO Specifications for Plant Protection Products)

Repeal the definition.

21 Subregulation 3(1)

Insert:

formulation type means:

(a) for an agricultural chemical product—the formulation code and description that:

(i) are set out in guidelines made under section 6A of the Code as in force from time to time; and

(ii) apply to the product; and

(b) for a veterinary chemical product—the form of the product.

Examples:A capsule, emulsifiable concentrate, injectable solution, implant, intramammary treatment, oral drench or tablet.

GMP audit: see subregulation 61(8).

identifying information, for a person, means the following information:

(a) the person’s name;

(b) the person’s ABN or ACN (if any);

(d) whether the person is an individual or a body corporate;

(e) the person’s street address;

(f) if the person’s postal address is different from the person’s street address—the person’s postal address.

timeshift application means an application that:

(a) is for:

(i) approval of an active constituent that is not a previously endorsed active constituent; or

(ii) registration of a chemical product containing an active constituent that is not an active constituent contained in any other registered chemical product; and

(b) will, by agreement of the applicant and the APVMA, be assessed in accordance with assessment periods set out in a project plan for the application agreed to by the applicant and the APVMA.

22 Subregulation 3(1) (note)

Omit “interested person”, substitute “holder”.

23 After regulation 4

Insert:

5A Meaning of lodged

(1) For the definition of lodged in subsection 3(1) of the Code, an application is lodged when the applicant gives:

(a) the information in the approved form for the application; and

(b) any other information specified for the application under section 8B of the Code;

to the APVMA, in the manner (if any) required by regulation 65.

(2) However, if the applicant does not give the information mentioned in paragraph (1)(b) to the APVMA within 7 days of giving the information mentioned in paragraph (1)(a) to the APVMA, the applicant is taken to have lodged the application 7 days after giving the APVMA the information mentioned in paragraph (1)(a).

24 Regulation 6

Repeal the regulation.

25 At the end of Part 1

Add:

8AA Safety criteria—active constituents

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

8AB Safety criteria—chemical products

(1) For subparagraph 5A(3)(a)(vii) of the Code, the following are prescribed matters for a chemical product:

(a) for all chemical products—the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product;

(b) for a product manufactured in Australia—whether each step in the manufacture of the product complies, or will comply, with the manufacturing principles and the Australian GMP Code;

(c) for a product manufactured outside Australia—whether each step in the manufacture of the product complies, or will comply, with a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code;

(d) for a molluscicide in the form of a bait and of which the active constituent is metaldehyde:

(i) whether the product contains sufficient green pigment or dye to colour the bait a distinctive green colour; and

(ii) whether the product contains, in the bait, any bone meal or other product of animal origin;

(e)for a molluscicide in the form of a bait and of which the active constituent is methiocarb:

(i) whether the product contains sufficient blue pigment or dye to colour the bait a distinctive blue colour; and

(ii) whether the product contains, in the bait, any bone meal or other product of animal origin;

(f)for an agricultural chemical product to be applied to seeds to be stored before planting or sowing—whether the product contains sufficient pigment or dye to colour the seed to enable the seed to be readily distinguished from seed to which the product has not been applied.

(2) However, paragraphs (1)(b) and (c) do not apply if the product is:

(a) an exempt product within the meaning given by regulation 59; or

(b) a listed chemical product; or

8AD Trade criteria

(1) For subsection 5C(3) of the Code, this regulation sets out the extent to which the APVMA is required to have regard to the matters set out in subsections 5C(1) and (2) of the Code in determining whether a chemical product meets the trade criteria.

(2) If it can be reasonably expected that the chemical product will be used in relation to:

(a) a crop or animal, a product of which might be provided to a place outside Australia; or

(b) a crop that will be fed to an animal mentioned in paragraph (a);

the APVMA must have full regard to all of the matters set out in subsections 5C(1) and (2) of the Code.

(3) In any other case, the APVMA is to have regard to the matters set out in subsections 5C(1) and (2) of the Code to the extent that the APVMA thinks is relevant.

8AE Labelling criteria

(1) For paragraph 5D(1)(j) of the Code, the following are prescribed matters:

(a) for a chemical product that is a veterinary chemical product—the duration of any treatment using the product;

(b) the prevention of undue prejudice to trade or commence between Australia and places outside of Australia;

(d) for a chemical product that is a date‑controlled chemical product—the storage of containers for the product;

(e) any other matter determined by the APVMA CEO under subregulation (2).

(2) For paragraph 6(2)(c) of the Act, the APVMA CEO may determine matters in relation to which a label must contain adequate instructions.

8AF Standards made by APVMA

(1) Before making a standard for a chemical product, a constituent of a chemical product, or a label for containers for a chemical product under section 6E of the Code, or varying a standard made under that section, the APVMA must:

(a) consider whether it is necessary to make the standard or variation, having regard to any relevant standards specified in any of the following:

(i) the British Pharmacopoeia;

(ii) the British Pharmacopoeia (Veterinary);

(iii) the European Pharmacopoeia;

(iv) the United States Pharmacopoeia;

(v) the FAO and WHO Specifications for Pesticides; and

(b) publish a notice in the Gazette and on the APVMA’s website stating:

(i) that it proposes to make or vary the standard; and

(ii) the reasons that the APVMA considers it is necessary to make the standard or variation; and

(iii) how to obtain more information about the proposed standard or variation; and

(d) publish on the APVMA’s website:

(i) the draft standard or variation; and

(ii) if the APVMA determines that the standard or variation is necessary to prevent imminent risk to persons of death, serious injury or serious illness—a statement to that effect; and

(iii) an invitation to the public to make a written submission on the draft standard or variation within the period stated in the invitation.

(2) The period mentioned in subparagraph (1)(d)(iii) must be not less than 28 days after the publication of the invitation, unless the APVMA determines that the standard or variation is necessary to prevent imminent risk to persons of death, serious injury or serious illness.

(3) In deciding whether to make the standard or variation, the APVMA must consider any submissions received in accordance with the invitation mentioned in subparagraph (1)(d)(iii).

(4) If the APVMA makes or varies a standard for a chemical product or active constituent, the APVMA must publish a notice in the Gazette and on the APVMA’s website stating:

(a) that it has made the standard or variation for the product or constituent; and

(b) its reasons for making or varying the standard; and

(5) If the APVMA decides, after taking into account the matters mentioned in subregulation (3), not to make the standard or variation, the APVMA must publish a notice in the Gazette stating:

(a) that it has abandoned the development of the standard or variation; and

(b) the reasons for abandoning the development of the standard or variation; and

Division 1.2—General provisions about applications

8AG Application requirements—timeshift applications

(1) For paragraph 8A(d) of the Code, a timeshift application must include a project plan agreed to by the applicant and the APVMA that includes:

(a) timeframes for the applicant to provide information; and

(b) assessment periods for assessing the application.

(2) The applicant and the APVMA may, at any time, agree to vary a timeframe or assessment period set out in the project plan.

8AH Application requirements—copies of applications

For paragraph 8A(d) of the Code, if the APVMA gives an applicant a notice under regulation 8AO, 8AP or 8AQ asking the applicant to provide copies of the application, the applicant must provide the requested number of copies, in the form requested, to the APVMA within 28 days of the date of the notice.

Division 1.3—General provisions about notices

8AK Information to be given in notice to holder

For paragraph 8F(2)(e) of the Code, the following information is prescribed for a notice given to a holder under subsection 8F(1) of the Code:

(a) for the approval of an active constituent:

(i) the information required by section 8H of the Code in relation to the approval; and

(ii) the date of the approval under section 22 of the Code; and

(iii) the date on which the notice is given to the holder; and

(iv) any other details entered in the Record about the active constituent that the APVMA thinks appropriate;

(b) for the registration of a chemical product:

(i) the information required by section 8H of the Code in relation to the registration; and

(ii) the date of the registration under section 22 of the Code; and

(iii) the distinguishing name of the chemical product; and

(iv) the date on which the notice is given to the holder; and

(v) any other details about the chemical product, entered in the Register, that the APVMA thinks appropriate;

(i) the date of the approval under section 22 of the Code; and

(ii) the distinguishing number of the label; and

(iii) the date on which the notice is given to the holder; and

(iv) any other details about the label, entered in the relevant APVMA file, that the APVMA thinks appropriate;

(d) for the variation of a relevant particular or condition:

(i) the information required by section 8J of the Code in relation to the variation; and

(ii) the date of the variation under section 22 of the Code; and

(iii) the date on which the notice is given to the holder; and

(iv) for a variation of a relevant particular or condition of an approval of an active constituent—any other details entered in the Record about the active constituent that the APVMA thinks appropriate; and

(v) for a variation of a relevant particular or condition of a registration of a chemical product—any other details about the chemical product, entered in the Register, that the APVMA thinks appropriate; and

(vi) for a variation of a relevant particular or condition of an approval of a label—any other details about the label, entered in the relevant APVMA file, that the APVMA thinks appropriate.

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

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

(a) the holder may apply to have the particular varied under Division 3 of Part 2 of the Code; and

(b) if such an application is made, the fee for the application must be reduced by the amount of any fee paid for the application under Division 2A of Part 2 of the Code, in accordance with subsection 27(4) of the Code.

8AM Publication requirements—approvals and variations of approvals of active constituents

(1) For paragraphs 8H(2)(e) and 8J(2)(d) of the Code, this regulation sets out the information that must be included in a notice published in the Gazette under those sections in relation to:

(a) the approval of an active constituent; or

(b) the variation of the relevant particulars or conditions of the approval of an active constituent.

(2) The information is:

(a) the name of the applicant for the approval or variation; and

(b) the application number for the application for approval or variation; and

(d) the distinguishing number given to the active constituent by the APVMA when the APVMA approved the active constituent; and

(e) a short description of the application and its purpose, including the way in which the active constituent is intended to be used.

(3) The following information must also be published by the APVMA on the APVMA website:

(a) the information mentioned in paragraphs (2)(a) to (e);

(b) brief details about the APVMA’s decision.

(4) For each item of information relied on by the APVMA in making its decision, the following details must also be published by the APVMA on the APVMA website:

(a) the details for the information mentioned in paragraphs (a) to (e) of the definition of application information details in subregulation 3(1);

(b) if the item of information was given to the APVMA in connection with the application by the applicant or a person on behalf of the applicant:

(i) the data number given to the item of information by the APVMA; and

(ii) unless the information is publicly available—the name and address of the authorising party for the item of information.

8AN Publication requirements—registrations, variations of registrations and approval of labels

(1) For paragraphs 8H(2)(e) and 8J(2)(d) of the Code, this regulation sets out the information that must be included in a notice published in the Gazette under those sections in relation to:

(a) the registration of a chemical product; or

(b) the approval of a label for containers for a chemical product; or

(i) the registration of a chemical product; or

(ii) the approval of a label for a container for a chemical product.

(2) The information is:

(a) the name of the applicant for the registration, approval or variation; and

(b) the application number for the application for registration, approval or variation; and

(d) for a registration of a chemical product or variation of the relevant particulars or conditions of the registration of a chemical product—the distinguishing number given to the product by the APVMA when the APVMA registered the product; and

(e) for approval of a label or variation of the relevant particulars or conditions of the approval of a label—the distinguishing number given to the label by the APVMA when the APVMA approved the label; and

(f) the name of the active constituents of the chemical product; and

(g) a short description of the application and its purpose, including the way in which the chemical product is intended to be used.

(3) The following information must also be published by the APVMA on the APVMA website:

(a) the information mentioned in paragraphs (2)(a) to (e);

(b) brief details about the APVMA’s decision.

(4) For each item of information relied on by the APVMA in making its decision, the following details must also be published by the APVMA on the APVMA website:

(a) the details for the information mentioned in paragraphs (a) to (e) of the definition of application information details in subregulation 3(1);

(b) if the item of information was given to the APVMA in connection with the application by the applicant or a person on behalf of the applicant:

(i) the data number given to the item of information by the APVMA; and

(ii) unless the information is publicly available—the name and address of the authorising party for the item of information.

8AO Matters for notice following preliminary assessment

(1) For paragraphs 29E(2)(b) and 110A(2)(b) and subparagraphs 11(2)(a)(ii) and 28(2)(a)(ii) of the Code, this regulation sets out the matters that must be included in a notice under subsection 11(2), 28(2), 29E(2) or 110A(2) of the Code.

(2) The matters are the following:

(a) that the application to which the notice relates has passed preliminary assessment;

(b) the section of the Code under which the application will be determined;

(d) if an amount of application fee payable in relation to the application under subregulation 70(2) is unpaid:

(i) the balance of the application fee that is payable; and

(ii) that the balance must be paid within 28 days of the date of the notice;

(e) for an application other than an application under section 29D of the Code:

(i) that the APVMA may determine that:

(A) the application is more correctly categorised as an application mentioned in a different item in Part 2 of Schedule 6 to the item in relation to which any fee has been paid; or

(B) different modules, levels and types mentioned in Schedule 7 are necessary for the application; and

(ii) that if it does so, a further amount of application fee may be payable and the assessment period may change;

(f) the number of copies (if any) of the application that must be given to the APVMA and the form in which those copies must be given;

(g) that if copies of the application are required, the copies must be given to the APVMA within 28 days of the date of the notice;

(h) the assessment period for the application and the expected date by which the application will be determined;

(i) if the modular assessment period applies to the application—the modules to be completed in relation to the application;

(j) that if the APVMA or another prescribed authority makes a request under section 159 of the Code:

(i) for an application for re‑approval or re‑registration—the applicant must comply with the request within 28 days of the request; and

(ii) in any other case—the assessment period will be extended;

(k) for an applicant who is a nominated agent for an approval or registration—the applicant’s obligations under subsection 152(2) of the Code;

(l) that if the applicant becomes aware of any information (new information) that contradicts any information given to the APVMA or shows that the constituent or product to which the application relates may not meet the safety criteria, the trade criteria or the efficacy criteria, the applicant must give the new information to the APVMA in accordance with section 160A of the Code;

(m) that if the APVMA does not determine the application within the assessment period for the application and any extension to the assessment period, the applicant may notify the APVMA that it wishes to treat the application as having been refused, and may seek review of the refusal in accordance with subsection 165(3) of the Code;

(n) that the applicant may withdraw the application in accordance with section 8D of the Code.

8AP Matters for notice for technical assessment

(1) This regulation applies to an application for a technical assessment under regulation 8AS.

(2) Within 1 month of receiving the application, the APVMA must give the applicant a notice setting out the following:

(a) that a technical assessment will be provided for that regulation;

(b) the date on which the technical assessment will commence;

(c) if an amount of application fee payable in relation to the application under subregulation 70(2) is unpaid—that the balance must be paid within 28 days of the date of the notice;

(d) the number of copies (if any) of the application that must be given to the APVMA and the form in which those copies must be given;

(e) that any copies must be given to the APVMA within 28 days of the date of the notice;

(f) the assessment period for the application and the expected date by which the application will be determined;

(g) the modules to be completed in relation to the application;

(h) that the assessment period will be extended if the APVMA or another prescribed authority makes a request under section 159 of the Code;

(i) that if the APVMA does not determine the application within the assessment period for the application and any extension to the assessment period, the applicant may notify the APVMA that it wishes to treat the application as having been refused, and may seek review of the refusal in accordance with subsection 165(3) of the Code;

(j) that the applicant may withdraw the application in accordance with section 8D of the Code.

8AQ Matters for notice in relation to extension of permit

(1) This regulation applies to an application for an extension or extensions of a permit under subsection 115(3) of the Code.

(2) Within 1 month of receiving the application, the APVMA must give the applicant a notice setting out the following:

(a) that the application will be determined under section 115 of the Code;

(b) the date on which the assessment of the application will commence;

(c) if an amount of application fee payable in relation to the application under subregulation 70(2) is unpaid—that the balance must be paid within 28 days of the date of the notice;

(d) the number of copies (if any) of the application that must be given to the APVMA and the form in which those copies must be given;

(e) that any copies must be given to the APVMA within 28 days of the date of the notice;

(f) the assessment period for the application and the expected date by which the application will be determined;

(g) if the modular assessment period applies to the application—the modules to be completed in relation to the application;

(h) that if the applicant becomes aware of any information (new information) that contradicts any information given to the APVMA or shows that the constituent or product to which the application relates may not meet the safety criteria, the trade criteria or the efficacy criteria, the applicant must give the new information to the APVMA in accordance with section 160A of the Code;

(j) that the applicant may withdraw the application in accordance with section 8D of the Code.

Division 1.6—Listed chemical products

8AR Listed chemical products

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

26 Before Division 2.1 of Part 2

Insert:

Division 2.1A—Pre‑application assessments and assistance

8AS APVMA may provide technical assessments

If a person applies to the APVMA for an assessment of a technical nature (a technical assessment) before making an application, the APVMA may provide the technical assessment.

Examples: Assessment of a trial protocol.

Assessment of data an applicant is considering submitting to the APVMA as part of a proposed application for registration of a chemical product or approval of an active constituent.

Note: Regulation 70 provides for fees for making an application for a technical assessment.

8AT APVMA may provide pre‑application assistance

(1) A person may apply to the APVMA for assistance (pre‑application assistance) in preparing or making an application to the APVMA under the Code or these Regulations.

(2) If a person makes an application for pre‑application assistance in accordance with subregulation (1), the APVMA may provide the pre‑application assistance.

Note: Regulation 69B prescribes the fees payable for pre‑application assistance.

27 Regulation 8A

Repeal the regulation.

28 Regulation 8B (heading)

Repeal the heading, substitute:

8B Summaries of applications for active constituents for chemical products

29 Subregulation 8B(1)

Omit “product that is not a companion animal product”, substitute “product”.

30 Subregulation 8B(2)

Omit “subregulation 11B (2)”, substitute “paragraph 11(2)(b)”.

31 Paragraph 8B(2)(g)

Omit “details set out in subregulation (3)”, substitute “application information details for the item of information”.

32 Subregulation 8B(3)

Repeal the subregulation.

33 Regulation 8C

Repeal the regulation.

34 Regulation 8D (heading)

Repeal the heading, substitute:

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

35 Paragraph 8D(1)(a)

Repeal the paragraph, substitute:

(a) registration of a chemical product that is not a chemical product mentioned in paragraph 8E(1)(a); or

36 Subregulation 8D(2)

Omit “subsection 11B (2)”, substitute “paragraph 11(2)(b)”.

37 Paragraph 8D(2)(i)

Omit “details set out in subregulation (3)”, substitute “application information details for the item of information”.

38 Subregulation 8D(3)

Repeal the subregulation.

39 Regulation 8E (heading)

Repeal the heading, substitute:

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

40 Subdivision 2.1.2

Repeal the Subdivision.

41 Subregulation 15(1)

Omit “19 (2) (a)”, substitute “19(1)(c)”.

42 Paragraph 15(1)(c)

Repeal the paragraph, substitute:

43 Paragraph 15(1)(g)

Repeal the paragraph, substitute:

(g) identifying information for the holder of the approval of the active constituent;

44 Paragraph 15(1)(j)

Repeal the paragraph, substitute:

(j) identifying information for any nominated agent for the approval.

45 Regulation 16

Omit “20 (2) (a)”, substitute “20(1)(c)”.

46 Paragraph 16(a)

Repeal the paragraph, substitute:

(a) the distinguishing name of the chemical product;

47 After paragraph 16(d)

Insert:

(da) the formulation type for the chemical product;

(db) the net contents for the chemical product;

48 Paragraph 16(e)

Repeal the paragraph, substitute:

(e) identifying information for the holder of the registration of the chemical product;

49 Paragraph 16(k)

Repeal the paragraph, substitute:

(k) identifying information for any nominated agent for the registration.

50 Subregulation 17(1)

Omit “21 (2) (a)”, substitute “21(a)”.

51 Paragraph 17(1)(b)

Before “name”, insert “distinguishing”.

52 Paragraphs 17(1)(g) and (i)

Repeal the paragraphs.

53 Paragraph 17(1)(j)

After “the APVMA”, insert “CEO”.

54 Subregulation 17(1) (note)

Repeal the note.

55 Subregulation 17(2)

After “the APVMA”, insert “CEO”.

56 At the end of regulation 17

Add:

(3) For subparagraph 21(c)(iva) of the Code, the following information is prescribed in relation to the approval of a label for a chemical product, unless the information has already been recorded for the approval of the label as part of the registration of the chemical product:

(a) identifying information for the holder of the approval;

(b) identifying information for any nominated agent for the approval.

57 After Subdivision 2.1.3

Insert:

Subdivision 2.1.3A—End dates for approvals and last renewal dates for registrations

17A End date for approvals and re‑approvals of active constituents

(1) For subsections 19(2), 29J(2) and 34AE(2) of the Code, this regulation prescribes the method for working out the end date for an approval of an active constituent, including:

(a) an approval as re‑approval of the active constituent; and

(b) a variation of the end date by the APVMA following a reconsideration of the approval under Division 4 of Part 2 of the Code.

(2) The end date for the approval of an active constituent mentioned in column 1 of an item in the following table is as follows:

(a) if the APVMA determines that the end date should be aligned with the end date for another approval of the same active constituent—the date mentioned in column 2 for the item;

(b) in any other case—the date mentioned in column 3 for the item.

End date for approvals and re‑approvals of active constituents
Item	Column 1 Active constituent	Column 2 End date if approval aligned with another approval	Column 3 End date if approval not aligned with another approval
1	Active constituent mentioned in Part 2 or 3 of Schedule 1 to the Agricultural and Veterinary Chemicals (Administration) Regulations 1995	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the approval event.	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the approval event.
2	Methyl bromide (bromomethane)	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the approval event.	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the approval event.
3	Active constituent mentioned in Schedule 9 or Appendix C to the current Poisons Standard	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the approval event.	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the approval event.
4	Active constituent mentioned in Schedule 8 to the current Poisons Standard, other than an active constituent mentioned in item 1, 2 or 3	The date determined by the APVMA. The date must be not less than 7 years, and less than 10 years, after the approval event.	The date determined by the APVMA. The date must be not less than 8 years, and less than 10 years, after the approval event.
5	Active constituent contained in a restricted chemical product mentioned in Schedule 4 to these Regulations, other than an active constituent mentioned in item 1, 2, 3 or 4	The date determined by the APVMA. The date must be not less than 7 years, and less than 10 years, after the approval event.	The date determined by the APVMA. The date must be not less than 8 years, and less than 10 years, after the approval event.
6	Active constituent: (a) mentioned in Schedule 7 to the current Poisons Standard; and (b) classified in Table 3.1 of Annex VI to the European Community Regulation Number 1272/2008 as Aquatic Acute 1 or Aquatic Chronic 1; other than an active constituent mentioned in any of items 1 to 5	The date determined by the APVMA. The date must be not less than 7 years, and less than 10 years, after the approval event.	The date determined by the APVMA. The date must be not less than 8 years, and less than 10 years, after the approval event.
7	Active constituent mentioned in Schedule 7 to the current Poisons Standard, other than an active constituent mentioned in any of items 1 to 6	The date determined by the APVMA. The date must be not less than 7 years, and less than 13 years, after the approval event.	The date determined by the APVMA. The date must be not less than 10 years, and less than 13 years, after the approval event.
8	Active constituent classified in Table 3.1 of Annex VI to the European Community Regulation Number 1272/2008 as Aquatic Acute 1 or Aquatic Chronic 1, other than an active constituent mentioned in any of items 1 to 7	The date determined by the APVMA. The date must be not less than 7 years, and less than 13 years, after the approval event.	The date determined by the APVMA. The date must be not less than 10 years, and less than 13 years, after the approval event.
9	Active constituent not mentioned in any of items 1 to 8	The date determined by the APVMA. The date must be not less than 7 years, and less than 15 years, after the approval event.	The date determined by the APVMA. The date must be not less than 13 years, and less than 15 years, after the approval event.

Note: The APVMA may also determine an end date that is less than 7 years so that the end date is the same as the end date for another approval of the same active constituent: see subsections 19(3), 29J(3) and 34AE(3) of the Code.

(3) An end date determined by the APVMA under this regulation must be the last day of a calendar month.

(4) In determining an end date under this regulation, the APVMA must have regard to the efficient allocation of the resources of the APVMA for determining and assessing re‑approval and re‑registration applications.

(5) In this regulation:

approval event:

(a) for the approval of an active constituent—means the date on which the approval takes place; and

(b) for the approval as re‑approval of an active constituent—means the date on which the re‑approval takes place; and

(c) for a variation of the end date for the approval of an active constituent, following a reconsideration of the approval under Division 4 of Part 2 of the Code—means the date on which the variation takes place.

end date, for an approval of an active constituent, means the date on which the approval ends.

(6) In this regulation, references to the European Community Regulation Number 1272/2008 are to that Regulation as amended from time to time.

17B Last renewal dates for registrations and re‑registrations of chemical products

(1) For subsections 20(2), 29K(2) and 34AE(2) of the Code, this regulation prescribes the method for working out the last renewal date for the registration of a chemical product, including:

(a) a registration as re‑registration of the chemical product; and

(b) a variation of the last renewal date by the APVMA following a reconsideration of the registration under Division 4 of Part 2 of the Code.

Note: See also sections 26D, 29B and 34A of the Code for entering last renewal dates when relevant particulars or conditions are varied.

(2) The last renewal date for the registration of a chemical product mentioned in column 1 for an item in the following table is as follows:

(a) if the APVMA determines that the last renewal date should be aligned with the last renewal date for another chemical product containing one or more of the same active constituents—the date mentioned in column 2 for the item;

(b) in any other case—the date mentioned in column 3 for the item.

Last renewal dates for registrations and re‑registrations of chemical products
Item	Column 1 Chemical product	Column 2 Last renewal date if aligned with last renewal date for another chemical product	Column 3 Last renewal date if not aligned with last renewal date for another chemical product
1	Chemical product containing an active constituent mentioned in Part 2 or 3 of Schedule 1 to the Agricultural and Veterinary Chemicals (Administration) Regulations 1995	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the registration event.	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the registration event.
2	Chemical product containing methyl bromide (bromomethane)	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the registration event.	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the registration event.
3	Chemical product containing an active constituent mentioned in Schedule 9 or Appendix C of the current Poisons Standard	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the registration event.	The date determined by the APVMA. The date must be not less than 7 years, and less than 8 years, after the registration event.
4	Chemical product containing an active constituent mentioned in Schedule 8 to the current Poisons Standard, other than a chemical product mentioned in item 1, 2 or 3	The date determined by the APVMA. The date must be not less than 7 years, and less than 10 years, after the registration event.	The date determined by the APVMA. The date must be not less than 8 years, and less than 10 years, after the registration event.
5	Chemical product containing an active constituent contained in a restricted chemical product mentioned in Schedule 4 to these Regulations, other than a chemical product mentioned in item 1, 2, 3 or 4	The date determined by the APVMA. The date must be not less than 7 years, and less than 10 years, after the registration event.	The date determined by the APVMA. The date must be not less than 8 years, and less than 10 years, after the registration event.
6	Chemical product containing an active constituent: (a) mentioned in Schedule 7 to the current Poisons Standard; and (b) classified in Table 3.1 of Annex VI to the European Community Regulation Number 1272/2008 as Aquatic Acute 1 or Aquatic Chronic 1; other than a chemical product mentioned in any of items 1 to 5	The date determined by the APVMA. The date must be not less than 7 years, and less than 10 years, after the registration event.	The date determined by the APVMA. The date must be not less than 8 years, and less than 10 years, after the registration event.
7	Chemical product containing an active constituent mentioned in Schedule 7 to the current Poisons Standard, other than a chemical product mentioned in any of items 1 to 6	The date determined by the APVMA. The date must be not less than 7 years, and less than 13 years, after the registration event.	The date determined by the APVMA. The date must be not less than 10 years, and less than 13 years, after the registration event.
8	Chemical product containing an active constituent classified in Table 3.1 of Annex VI to the European Community Regulation Number 1272/2008 as Aquatic Acute 1 or Aquatic Chronic 1, other than a chemical product mentioned in any of items 1 to 7	The date determined by the APVMA. The date must be not less than 7 years, and less than 13 years, after the registration event.	The date determined by the APVMA. The date must be not less than 10 years, and less than 13 years, after the registration event.
9	Chemical product containing an active constituent, other than a chemical product mentioned in any of items 1 to 8	The date determined by the APVMA. The date must be not less than 7 years, and less than 15 years, after the registration event.	The date determined by the APVMA. The date must be not less than 13 years, and less than 15 years, after the registration event.

Note: The APVMA may also determine a last renewal date that is less than 7 years so that the last renewal date is the same as the last renewal date for the registration of another chemical product containing one or more of the same active constituents: see subsections 20(3), 29K(3) and 34AE(3) of the Code.

(3) If more than one item in the table in subregulation (2) applies to a chemical product, the item with the lowest item number is to be used to work out the last renewal date for the product.

Example: If the chemical product contains methyl bromide (active constituent in item 2) and an active constituent mentioned in item 7, the last renewal date is to be determined in accordance with item 2.

(4) A last renewal date determined by the APVMA under this regulation must be the last day of a calendar month.

(5) In determining a last renewal date under this regulation, the APVMA must have regard to the efficient allocation of the resources of the APVMA for determining and assessing re‑approval and re‑registration applications.

(6) In this regulation:

last renewal date, for the registration of a chemical product, means the date after which the registration cannot be renewed under Division 6 of Part 2 of the Code.

registration event:

(a) for the registration of a chemical product—means the date on which the registration takes place; and

(b) for the registration as re‑registration of a chemical product—means the date on which the re‑registration takes place; and

(c) for a variation of the last renewal date for the registration of a chemical product, following a reconsideration of the registration under Division 4 of Part 2 of the Code—means the date on which the variation takes place.

(7) In this regulation, references to the European Community Regulation Number 1272/2008 are to that Regulation as amended from time to time.

58 Before regulation 18 in Subdivision 2.1.4

Insert:

17C Conditions of approval or registration—active constituents and chemical products

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

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

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

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

(3) Items 3 and 4 of the table in subregulation (2) do not apply in relation to a chemical product if:

(a) the chemical product is:

(i) an exempt product within the meaning given by regulation 59; or

(ii) a listed chemical product; or

(iii) a reserved chemical product; or

(b) the holder of the registration of the product is an exempt person within the meaning given by regulation 59A, 59B, 59C or 59D.

59 Regulation 18 (heading)

Repeal the heading, substitute:

18 Conditions of registration of chemical products—containers

60 Subregulation 18(1)

Repeal the subregulation, substitute:

(1) For paragraph 23(1)(a) of the Code, the registration of a chemical product is subject to the condition that the product is supplied only in a container that meets the requirements mentioned in subregulation (2).

61 Regulation 18B

Repeal the regulation, substitute:

18B Prescribed conditions for approval of labels

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

62 At the end of subregulation 18D(1)

Add:

; (e) the name and address of the person primarily responsible for marketing the product.

63 Subregulation 18G(1)

Omit “An interested person”, substitute “The holder of the approval of the label”.

64 Paragraph 18G(2)(b)

Omit “section 55”, substitute “paragraph 45A(1)(b)”.

65 Subregulations 18H(1) and 18I(1)

Omit “An interested person in relation to the label”, substitute “The holder of the approval of the label”.

66 Paragraph 18I(4)(a)

Omit “to public health or to occupational health or safety”, substitute “to persons of death, serious illness or serious injury”.

67 After regulation 18I

Insert:

18J Identifying information recorded for holder and nominated agent

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

68 After Subdivision 2.1.6

Insert:

Subdivision 2.1.6A—Incorrect particulars and conditions

18K Incorrect particulars and conditions APVMA must correct

For paragraph 26(1)(b) of the Code, the following kinds of relevant particulars or conditions are prescribed:

(a) the signal words required by the current Poisons Standard in relation to an approved label;

(b) the information mentioned at paragraphs (e) and (f) of the definition of identifying information in subregulation 3(1) for:

(i) the holder of an approval or registration; and

(ii) the nominated agent (if any) of a holder of an approval or registration.

69 Subdivision 2.1.7

Repeal the subdivision.

70 Regulations 19AA, 19AB and 19AC

Repeal the regulations.

71 Regulation 19AD (heading)

Repeal the heading, substitute:

19AD Summaries of applications for variation for chemical products

72 Subregulation 19AD(1)

Repeal the subregulation, substitute:

(1) This regulation applies to an application for variation of the relevant particulars or conditions of:

(a) the registration of a chemical product; or

(b) the approval of a label for a container for a chemical product.

73 Subregulation 19AD(2)

Omit “subsection 28B (2)”, substitute “paragraph 28(2)(b)”.

74 Paragraph 19AD(2)(i)

Omit “details set out in subregulation (3)”, substitute “application information details for the item of information”.

75 Subregulation 19AD(3)

Repeal the subregulation.

76 Subdivision 2.2.2

Repeal the Subdivision.

77 Before Division 2.3

Insert:

Division 2.2A—Re‑approving and re‑registering

19A Late application for re‑approval or re‑registration

(1) This regulation is made for subsection 29D(3) of the Code.

(2) The APVMA may accept a late application for re‑approval of an active constituent, or re‑registration of a chemical product, if the fee mentioned in subregulation (3) is paid when the application is made.

(3) The fee payable for making a late application is $500, and is payable in addition to the application fee payable under regulation 70.

Note 1: Subsection 29D(3) of the Code sets out when the application must be made.

Note 2: For the end date for approvals and last renewal date for registrations, following re‑approval or re‑registration, see regulations 17A and 17B.

78 Regulations 20 to 22AA

Repeal the regulations, substitute:

20 Reconsideration work plan

(1) For subsection 31(2) of the Act, a work plan for a proposed reconsideration must include the following:

(a) the date of any relevant notice published under section 30 of the Code;

(b) the date on which the APVMA will commence the reconsideration;

(d) the matters the APVMA proposes dealing with in the reconsideration;

(e) the expected date on which a notice will be given to the holder under subsection 32(1) of the Code;

(f) the expected date on which any information will be given under subsection 32(2) of the Code, and the anticipated recipients of that information;

(g) the expected date on which a notice (if any) will be given to the holder under subsection 33(1) of the Code, and a summary of the type of information, report, result or sample it is anticipated will be required by the notice;

(h) the expected date on which a notice (if any) will be given under section 34AB of the Code, and the anticipated recipients of the notice;

(i) the expected date on which a decision will be made in relation to the reconsideration under section 34 of the Code.

(2) For paragraph 31(3)(a) of the Code:

(a) the APVMA must review and update the work plan at least once a year; and

(b) if the APVMA issues a notice or information mentioned in paragraph (1)(e), (f), (g) or (h), the APVMA must update the work plan to include the date the notice or information was issued; and

(c) if the APVMA makes a decision in relation to the reconsideration under section 34 of the Code, the APVMA must include in the work plan details of the decision and the date of the decision; and

(d) if the APVMA varies the instructions on a label for containers for a chemical product under section 34A of the Code in relation to the reconsideration—the APVMA must include in the work plan details of the variation; and

(e) if the APVMA issues a permit in relation to the reconsideration—the APVMA must include in the work plan details of the permit; and

(f) if the APVMA takes any suspension, cancellation or recall action, in relation to the reconsideration, under section 34AA, 41, 101, 102 or 103 of the Code, the APVMA must include in the work plan details of the action taken and the date of the action.

21 Period for giving information, reports, results or samples

(1) For subsection 33(1A) of the Code, the period stated in a notice issued under subsection 33(1) of the Code must not exceed the period that is half of the period in which the APVMA is required, under regulation 78B, to conclude the reconsideration to which the notice relates.

(2) For subregulation (1), the period in which the APVMA is required, under regulation 78B, to conclude the reconsideration, is to be calculated as at the date of the notice.

(3) For subsection 33(1B) of the Code, the APVMA may allow a further period if an extraordinary event or circumstance beyond the control of the holder prevents the holder from fulfilling the holder’s obligations in the notice.

22 Notice of decision on reconsideration

For paragraph 34AC(2)(e) of the Code, the following information is prescribed:

(a) particulars of the notice published under paragraph 34AC(1)(b) of the Code in relation to the affirmation;

(b) the date on which the notice is given to the holder;

(d) for an affirmation of a registration of a chemical product—the distinguishing name of the chemical product;

(e) for an affirmation of an approval of a label—the distinguishing number of the label;

(f) any other details entered in the Record, Register or relevant APVMA file for the active constituent, chemical product or label that the APVMA thinks appropriate.

Note: For the end dates for approvals and last renewal dates for registrations, see regulations 17A and 17B.

22AA Reconsideration by APVMA of approval of label

For subsection 34AF(1) of the Code, the prescribed matters are:

(a) the matters mentioned in paragraphs 5D(1)(g), (h) and (i) of the Code; and

(b) the matters mentioned in subregulation 8AE(1).

79 Division 2.4 of Part 2

Repeal the Division.

80 Division 2.5 of Part 2

Repeal the Division, substitute:

Division 2.5—Variation of dates for approval or registration

22D Prescribed overseas regulatory action

For paragraph 47A(1)(a) of the Code, the following foreign regulators of agricultural or veterinary chemicals are prescribed:

(a) the United States Environmental Protection Agency;

(b) the Centre for Veterinary Medicine of the US Food and Drug Administration;

(d) the New Zealand Environmental Protection Authority;

(e) the Pest Management Regulatory Agency of Health Canada;

(f) the Veterinary Drugs Directorate of Health Canada;

(g) the Chemicals Regulation Directorate of the Health and Safety Executive of the United Kingdom;

(h) the Veterinary Medicines Directorate of the Department for Environment, Food and Rural Affairs of the United Kingdom.

81 Part 2A

Repeal the Part.

82 Division 1 of Part 3 (heading)

Repeal the heading, substitute:

Division 3.1—Notices

83 Regulation 24 (heading)

Repeal the heading, substitute:

24 Protected registered information—notice to primary holder

84 Regulation 24

Omit “a primary applicant”, substitute “each primary holder”.

85 Regulation 24

Omit “secondary applicant” (wherever occurring), substitute “secondary holder”.

86 Subparagraph 24(a)(i)

Omit “of Chemical Products”.

87 Subparagraph 24(a)(ii)

Repeal the subparagraph, substitute:

(ii) the particulars of the secondary chemical product entered in the Register or, if each primary holder so requests, the particulars of the approved active constituent entered in the Record; and

88 Subparagraph 24(a)(iii)

Repeal the subparagraph, substitute:

(iii) the matters about the approved label recorded in the relevant APVMA file for paragraph 21(c) of the Code.

89 Regulation 25 (heading)

Repeal the heading, substitute:

25 Protected registered information—notice to secondary holder

90 Regulation 25

Omit “applicant” (wherever occurring), substitute “holder”.

91 Paragraph 25(b)

Repeal the paragraph, substitute:

(b) the particulars of each primary chemical product, entered in the Register or, if the secondary holder so requests, the particulars of each approved active constituent, entered in the Record; and

92 Paragraph 25(c)

Repeal the paragraph, substitute:

93 Division 2 of Part 3 (heading)

Repeal the heading, substitute:

Division 3.2—Conduct of arbitration

94 Paragraphs 27(1)(a) and (b)

Omit “applicant”, substitute “holder”.

95 Subregulation 27(2)

Omit “a reasonable period”, substitute “14 days”.

96 Regulation 28

Omit “an applicant”, substitute “a holder”.

97 Regulation 28

Omit “the applicant”, substitute “the holder”.

98 Regulation 29

Omit “applicants”, substitute “holders”.

99 Regulation 31 (heading)

Repeal the heading, substitute:

31 Arbitrator to give parties notice of hearing

100 Regulation 32 (heading)

Repeal the heading, substitute:

32 Arbitrator’s powers if holder does not attend hearing

101 Regulation 32

Omit “applicant”, substitute “holder”.

102 Subregulation 34(3)

Omit “an applicant”, substitute “a holder”.

103 Regulation 36

Omit “a primary applicant”, substitute “each primary holder”.

Note: The terms category 1 licence, category 2 licence, category 3 licence, category 4 licence and category 6 licence are defined at regulation 3.

171 Clause 1.1 of Part 1 of Schedule 6 (definition of major food crop)

Repeal the definition.

172 Schedule 6 (heading)

Repeal the heading, substitute:

Schedule 6—Application fees and assessment periods

Note: See regulations 70, 70B, and 76 to 78.

173 Part 2 of Schedule 6

Repeal the Part, substitute:

Part 2—Table of fees and assessment periods

Table of fees and assessment periods
Item	Column 1 Description of application	Column 2 Assessment period (months)	Column 3 Extended assessment period (months)	Column 4 Maximum pre application assistance rebate ($)	Column 5 Fee from 1 July 2014 ($)	Column 6 Fee from 1 January 2015 ($)
Applications for approval of active constituent contained in a chemical product, registration of the chemical product and approval of the product label
1	Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring a full assessment of the active constituent and chemical product (other than a timeshift application)	18	25	1 400	84 115	96 135
2	Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring less than full assessment of the active constituent and chemical product (other than a timeshift application)	The modular assessment period	One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month	1 400	The modular assessment fee	The modular assessment fee
Applications for registration of a chemical product containing an approved active constituent and approval of the product label
3	Application for registration of a chemical product containing an approved active constituent, and approval of the product label (other than a timeshift application), if: (a) there is no registered chemical product containing the active constituent; and (b) a full assessment of the chemical product is required	18	25	1 050	56 545	64 620
4	Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if: (a) there is a registered chemical product containing the active constituent; and (b) a full assessment of the chemical product is required; and (c) there are no relevant maximum residue limits; and (d) poison schedule classification is required	18	25	1 050	32 090	36 675
5	Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if: (a) the chemical product is similar to a registered chemical product; and (b) chemistry and manufacture, efficacy or target species safety data is the only data required to demonstrate the similarity of the chemical product to the registered chemical product	8	12	700	4 260	4 870
6	Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if: (a) the chemical product is closely similar to a registered chemical product; and (b) efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and (c) chemistry and manufacture data are required	8	12	700	3 755	4 290
7	Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if: (a) the chemical product is closely similar to a registered chemical product; and (b) efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and (c) chemistry and manufacture data are not required	3	5	350	1 535	1 755
8	Application for registration of a chemical product containing an approved active constituent, and approval of the product label, if: (a) the chemical product is the same as a registered chemical product; and (b) the chemical product is to be registered with a different name	3	5	350	1 455	1 655
9	Application for registration of a listed chemical product and approval of a product label where the product and label comply with an established standard that has been approved in accordance with section 8U of the Code	2	4	350	1 395	1 595
10	Application for registration of a chemical product containing an approved active constituent (or an active constituent for which the APVMA has received an application for approval) and approval of the product label for all situations other than those described in items 3 to 9	The modular assessment period	One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month	350	The modular assessment fee	The modular assessment fee
Applications to vary a registration or label approval
11	Application to vary particulars or conditions of registration or label approval where a full assessment of the chemical product is required	10	15	1 050	25 035	28 610
12	Application to vary particulars or conditions of registration or label approval if: (a) the variation is to allow a minor change; and (b) no data of a technical nature is required	3	5	350	1 020	1 170
13	Application to vary particulars or conditions of registration or label approval if: (a) the variation is to allow a minor change; and (b) no data of a technical nature is required; and (c) the variation is a change required by the APVMA	3	5	Nil	Nil	Nil
Applications to vary relevant particular of an approval or registration
13A	Application to vary a relevant particular of an approval or registration where the relevant particular is set out in a legislative instrument made for section 26B of the Code	2	4	Nil	385	385
14	Application to vary particulars or conditions of registration or label approval if the application is not of a kind described in any of items 11 to 13A	The modular assessment period	One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month	350	The modular assessment fee	The modular assessment fee
Applications for approval of an active constituent
15	Application for approval of an active constituent requiring a full assessment (other than a timeshift application)	14	20	1 400	26 730	30 550
16	Application for approval of an active constituent requiring less than full assessment but requiring a toxicological assessment	9	13	700	16 455	18 805
17	Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment	7	11	700	2 760	3 155
Applications for variation to an approved active constituent
18	Application to vary particulars or conditions of an approved active constituent	7	11	700	2 155	2 465
Applications for permits
19	Application for a permit, or extension of a permit, to possess or supply, other than for use in Australia, an active constituent that is not an approved active constituent or a chemical product that is not a registered chemical product, where no data of a technical nature is required	3	5	350	350	350
20	Application for a permit, or extension of a permit, where a previous assessment remains valid and no data of a technical nature is required	3	5	350	350	350
21	Application for a permit, or extension of a permit, where the proposed use is a minor use	The modular assessment period	The modular assessment period, plus 6 months (unless the APVMA and the applicant agree to a shorter period)	350	350	350
22	Application for a permit, or extension of a permit, in respect of a chemical product or an active constituent if the proposed use of the chemical product or active constituent is determined by the APVMA to be an emergency use	Not applicable—(see regulation 76)	Nil—(see paragraph 70(8)(b))	Nil	Nil	Nil
23	Application for a permit, or extension of a permit, in respect of a chemical product or an active constituent if the application is not of a kind described in any of items 19 to 21	The modular assessment period	One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month	350	The modular assessment fee	The modular assessment fee
Other applications
24	Application made under section 10 of the Code (other than those of the kinds described in any of items 1 to 10, 15, 16 or 17) requiring assessment of a technical nature	The modular assessment period	One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month	350	The modular assessment fee	The modular assessment fee
25	Application for a technical assessment made under regulation 8AS	The modular assessment period	One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month	Nil	The modular assessment fee	The modular assessment fee
26	Application for re‑approval or re‑registration made under section 29D of the Code	12 months after the day the approval of the constituent ends or the registration of the product cannot be renewed	Not applicable	Nil	700	700
27	Timeshift application	The modular assessment period	Not applicable	1400	The modular assessment fee	The modular assessment fee

174Schedule 7

Repeal the Schedule, substitute:

Schedule 7—Table of fees and periods for completion of modules, levels and types of assessments

Note:See regulations 70A and 77.

Table of fees and periods for completion of modules, levels and types of assessments
Item	Column 1 Module, level or type	Column 2 Period for completion	Column 3 Fee from 1 July 2014 ($)	Column 4 Fee from 1 January 2015 ($)
1	Preliminary assessment	620	710
2	Chemistry
2.1	Chemistry—level 1	13 months	8 065	9 220
2.2	Chemistry—level 2	9 months	2 690	3 075
2.3	Chemistry—level 3	6 months	1 380	1 580
2.5	Chemistry—timeshift application	As set out in the project plan	8 065	9 220
3	Toxicology (not requiring poison schedule classification)
3.1	Toxicology—level 1	13 months	24 430	27 920
3.2	Toxicology—level 2	9 months	14 620	15 795
3.3	Toxicology—level 3	5 months	3 540	4 050
3.4	Toxicology—timeshift application	As set out in the project plan	24 430	27 920
4	Toxicology (requiring poison schedule classification)
4.1	Toxicology requiring poison schedule classification	13 months	2 435	2 435
4.2	Toxicology requiring poison schedule classification—timeshift application	As set out in the project plan	2 435	2 435
5	Residues
5.1	Residues—level 1	13 months	15 900	18 170
5.2	Residues—level 2	8 months	9 210	10 525
5.3	Residues—level 3	8 months	7 175	8 200
5.4	Residues—level 4	4 months	6 535	7 465
5.5	Residues—level 5	4 months	1 750	2 000
5.6	Residues—timeshift application	As set out in the project plan	15 900	18 710
6	Occupational health and safety
6.1	Occupational health and safety—level 1	13 months	4 310	4 410
6.2	Occupational health and safety—level 2	7 months	2 900	3 185
6.3	Occupational health and safety—level 3	4 months	3 480	3 980
6.4	Occupational health and safety—timeshift application	As set out in the project plan	4 310	4 410
7	Environment
7.1	Environment—level 1	13 months	23 095	26 390
7.2	Environment—level 2	7 months	6 400	7 315
7.3	Environment—level 3	4 months	1 505	1 720
7.4	Environment—timeshift application	As set out in the project plan	23 095	26 390
8	Efficacy and safety
8.1	Efficacy and safety—level 1	6 months	2 075	2 370
8.2	Efficacy and safety—level 2	4 months	855	975
8.3	Efficacy and safety—level 3	3 months	505	580
8.4	Efficacy and safety—timeshift application	As set out in the project plan	2 075	2 370
9	Non‑food trade	6 months	1 175	1 175
10	Special data
10.1	Special data—level 1	13 months	nil	nil
10.2	Special data—level 2	7 months	nil	nil
10.3	Special data—level 3	7 months	nil	nil
10.4	Special data—timeshift application	As set out in the project plan	nil	nil
11	Finalisation
11.1	Finalisation—type 1	3 months	3 545	4 055
11.2	Finalisation—type 2	2 months	1 350	1 545
11.3	Finalisation—type 3	2 months	755	865
12	Data protection	400	460

Endnotes

Endnote 1—About the endnotes

The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments

Endnote 6—Modifications

Endnote 7—Misdescribed amendments

Endnote 8—Miscellaneous

If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.

Abbreviation key—Endnote 2

The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended the compiled law. The information includes commencement information for amending laws and details of application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.

Uncommenced amendments—Endnote 5

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in endnote 5.

Modifications—Endnote 6

If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.

Misdescribed amendments—Endnote 7

An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.

Miscellaneous—Endnote 8

Endnote 8 includes any additional information that may be helpful for a reader of the compilation.

Endnote 2—Abbreviation key

ad = added or inserted	pres = present
am = amended	prev = previous
c = clause(s)	(prev) = previously
Ch = Chapter(s)	Pt = Part(s)
def = definition(s)	r = regulation(s)/rule(s)
Dict = Dictionary	Reg = Regulation/Regulations
disallowed = disallowed by Parliament	reloc = relocated
Div = Division(s)	renum = renumbered
exp = expired or ceased to have effect	rep = repealed
hdg = heading(s)	rs = repealed and substituted
LI = Legislative Instrument	s = section(s)
LIA = Legislative Instruments Act 2003	Sch = Schedule(s)
mod = modified/modification	Sdiv = Subdivision(s)
No = Number(s)	SLI = Select Legislative Instrument
o = order(s)	SR = Statutory Rules
Ord = Ordinance	Sub‑Ch = Sub‑Chapter(s)
orig = original	SubPt = Subpart(s)
par = paragraph(s)/subparagraph(s) /sub‑subparagraph(s)

Endnote 3—Legislation history

Number and year	FRLI registration or gazettal	Commencement	Application, saving and transitional provisions
179, 2013	29 June 2013 (see F2013L01458)	1 July 2014
67, 2014	13 June 2014 (see F2014L00714)	Sch 2: (a)	—

(a)Section 2 (item 3) of the Agricultural and Veterinary Chemicals Legislation Amendment Regulation 2014 provides as follows:

2Each provision of this regulation specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2
Provision(s)	Commencement
3. Schedule 2	Immediately before the commencement of the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013.

The Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013 commenced on 1 July 2014.

Endnote 4—Amendment history

Provision affected	How affected
Sch 1
s 23......................................	am No 67, 2014

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]