Agricultural and Veterinary Chemicals Code Amendment Regulations 2005 (No. 1)1 Select Legislative Instrument 2005 No. 105
I, PHILIP MICHAEL JEFFERY, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Agricultural and Veterinary Chemicals Code Act 1994. Dated 7 June 2005 P. M. JEFFERY Governor-General By His Excellency’s Command RICHARD COLBECK Parliamentary Secretary to the Minister for Agriculture, Fisheries and Forestry
Contents 1 Name of Regulations 2 2 Commencement 2 3 Amendment of Agricultural and Veterinary Chemicals Code Regulations 1995 2 Schedule 1 Amendments commencing on the day after registration 3 Schedule 2 Amendments commencing on 1 July 2005 10
1 Name of Regulations These Regulations are the Agricultural and Veterinary Chemicals Code Amendment Regulations 2005 (No. 1). 2 Commencement These Regulations commence as follows: (a) on the day after they are registered — regulations 1 to 3 and Schedule 1; (b) on 1 July 2005 — Schedule 2. 3 Amendment of Agricultural and Veterinary Chemicals Code Regulations 1995 Schedules 1 and 2 amend the Agricultural and Veterinary Chemicals Code Regulations 1995.
Schedule 1 Amendments commencing on the day after registration (regulation 3) [1] Regulation 3, definition of total leviable value substitute total leviable value has the same meaning as in the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994. [2] Regulations 22A (first occurring), 22B and 22A (second occurring) substitute 22A Prescribed uses (Code, s 34F (5)) (1) For subsection 34F (5) of the Code, a use is prescribed if: (a) the use is: (i) a non-major crop use (that is, a use for a food crop listed in Column 4 (‘Non-major uses’) of Part 1 of Schedule 3A, or a non-food crop or situation use listed in Column 4 (‘Non-major uses’) of Part 3 of that Schedule); or (ii) a non-major animal use (that is, a use for an animal listed in Column 4 (‘Non-major uses’) of Part 2 of Schedule 3A); and (b) an application has been made to the APVMA, data has been submitted to the APVMA for the purposes of the application, and the data is directly and specifically relevant to the use; and (c) the data was required, and relied on, by the APVMA to grant the application; and (d) the use is specified on a label. (2) For paragraph (1) (d), a non-major crop use is taken to be specified on a label if, on the label, there is specified a crop group listed in Column 2 (‘Crop/situation group’) of: (a) the item that, in Part 1 of Schedule 3A, mentions the relevant non-major food crop; or (b) the item that, in Part 3 of that Schedule, mentions the relevant non-food crop or situation. 22B Summaries of advice on applications for active constituents (1) For paragraph 34G (3) (b) of the Code, this regulation sets out the matters that must be included in the summary of the advice if the advice was for an application for: (a) approval of an active constituent for a proposed or existing chemical product; or (b) variation of the relevant particulars or conditions of the approval of an active constituent for a proposed or existing chemical product. (2) The matters are: (a) the name of the applicant; and (b) the application number; and (c) the name of the active constituent; and (d) the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and (e) a short description of the application and its purpose, including the way in which the active constituent is intended to be used; and (f) brief details about the APVMA’s decision to grant the approval; and (g) a summary of the advice given by the person, body or Government that the APVMA consulted, including: (i) the kind of information given to the APVMA with the advice; and (ii) any advice given in relation to any trials or related matters mentioned in the application; and (iii) a summary of the results from any trials mentioned in the advice as relevant; and (iv) the conclusions included in the advice; and (h) a list of the items of information that the person, body or Government considered relevant to giving the advice, including the details set out in subregulation (3); and (i) any other information given with the advice that the APVMA considers was relevant to its decision on the application. (3) For paragraph (2) (h), the details for each item of information are: (a) the data number given to the information by the APVMA; and (b) the title shown on the item of information; and (c) the name of the author, or of each of the authors, of the information; and (d) if a date is shown on the item of information — the date shown; and (e) if no date is shown on the item of information — the date when the preparation of the information was completed; and (f) if the information was published: (i) the date when it was published; and (ii) the name of the publication in which it was published; and (g) the reference number shown on the item of information; and (h) the name and address of the authorising party for the information. 22C Summaries of advice on applications for chemical products (1) For paragraph 34G (3) (b) of the Code, this regulation sets out the matters that must be included in the summary of the advice if the advice was for an application for: (a) registration of a chemical product; or (b) variation of the relevant particulars or conditions of: (i) the registration of a chemical product; or (ii) the approval of a label for a container for a chemical product. (2) The matters are: (a) the name of the applicant; and (b) the application number; and (c) the name of the chemical product; and (d) if the application was for registration of a chemical product — the distinguishing number that the APVMA gave to the product when it decided to register the product; and (e) the name of the active constituents of the chemical product; and (f) a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and (g) brief details about the APVMA’s decision to grant the application; and (h) a summary of the advice given by the person, body or Government that the APVMA consulted, including: (i) the kind of information given; and (ii) any advice given in relation to any trials or related matters mentioned in the application; and (iii) a summary of the results from any trials mentioned in the advice as relevant; and (iv) the conclusions included in the advice; and (i) a list of the items of information that the person, body or Government considered relevant to giving the advice, including the details set out in subregulation (3); and (j) any other information given with the advice that the APVMA considers was relevant to its decision on the application. (3) For paragraph (2) (i), the details for each item of information are: (a) the data number given to the information by the APVMA; and (b) the title shown on the item of information; and (c) the name of the author, or of each of the authors, of the information; and (d) if a date is shown on the item of information — the date shown; and (e) if no date is shown on the item of information — the date when the preparation of the information was completed; and (f) if the information was published: (i) the date when it was published; and (ii) the name of the publication in which it was published; and (g) the reference number shown on the item of information; and (h) the name and address of the authorising party for the information. [3] Subregulation 70 (1), note substitute Note Regulations 70A, 71, 71A, 72 and 72A make further provision regarding fees payable in respect of applications under the Code. [4] Regulations 71A and 71B substitute 71A Annual fees for continued registration of chemical product (1) For paragraph 49 (1) (d) of the Code, the fee payable for an application for the renewal of the registration of a chemical product in respect of the financial year commencing on 1 July 2005 or any subsequent financial year is $390. (2) For paragraph 56ZM (1) (d) of the Code, the fee payable for an application for the renewal of the listed registration of a chemical product in respect of the financial year commencing on 1 July 2005 or any subsequent financial year is $390. [5] After subregulation 72 (1) insert (2) For the purposes of paragraph 164 (8) (b) of the Code, the APVMA may waive or remit, up to $100, the whole or part of a fee payable or paid under the Code. [6] Subregulations 72A (6) and (7) substitute (6) Despite subregulations (2) and (5), the amount of the instalment of the fee due in the following year for the issue of a licence is one-half of the amount worked out in accordance with subregulations (2) and (5) if the holder of the licence provides evidence, to the satisfaction of the APVMA, that: (a) for the year that began on 1 January 1997 and any succeeding calendar year up to and including 2003 — the total notional wholesale value of all the veterinary chemical products manufactured in a calendar year at the premises specified in the licence is less than $50 000; and (b) for the six-month period commencing on 1 January 2004 — the total notional wholesale value of all the veterinary chemical products manufactured in that six-month period at the premises specified in the licence is less than $25 000; and (c) for the financial year commencing on 1 July 2004 and subsequent financial years — the total notional wholesale value of all the veterinary chemical products manufactured in the financial year at the premises specified in the licence is less than $50 000. (7) In subregulation (6): (a) notional wholesale value has the same meaning as in the Agricultural and Veterinary Chemicals (Collection of Levy) Act 1994; and (b) the notional wholesale value of a batch of a veterinary chemical product is the notional wholesale value at the time of completion of manufacture of the batch; and (c) a reference to ‘veterinary chemical products manufactured’ does not include veterinary chemical products that are exempt products for the purposes of section 121 of the Code. Note 1 Section 3 of the Agricultural and Veterinary Chemicals (Collection of Levy) Act 1994 has the following definition: notional wholesale value, in relation to a chemical product at a particular time, means the amount that the APVMA determines would have been received: (a) if the product is an Australian product—by the manufacturer; or (b) if the product is an imported product—by the importer; in respect of the product if, at that time, the product had been sold by the manufacturer or importer, as the case may be, by wholesale to a person with whom the manufacturer or importer was dealing at arm’s length. Note 2 For exempt products for the purposes of section 121 of the Code, see regulation 59. [7] Paragraph 73 (1) (a) omit of the Cod — insert of the Code — [8] Paragraph 73 (1) (c) omit [9] Paragraph 73 (1) (f) omit all the words before subparagraph (i), insert (f) for the disclosure, under section 162 of the Code, of confidential commercial information: Schedule 2 Amendments commencing on 1 July 2005 (regulation 3) [1] Subregulations 23 (2) and (3) substitute (2) The fee payable for acceptance of a late application for the renewal of the registration of a chemical product (other than an application to which paragraph (1) (a) applies) is $50. [2] Subregulations 23F (2) and (3) substitute (2) The fee payable for acceptance of a late application for the renewal of the listed registration of a chemical product (other than an application to which paragraph (1) (a) applies) is $30. [3] Subregulation 47 (2) omit $200 insert $275 [4] Subregulation 70 (2) substitute (2) The fee payable in respect of an application of a kind specified in Column 2 of an item in Part 2 of Schedule 6 is the fee (if any) specified for the item in Column 4 of that Schedule. [5] Subregulation 70 (3) omit item in Schedule 6 insert item in Part 2 of Schedule 6 [6] Subregulation 70 (4) substitute (4) The fee that is required to be paid at the time of making an application of a kind specified in an item in Part 2 of Schedule 6 is: (a) if a modular assessment fee is payable for the application — $460; or (b) if a fee is specified in Column 4 of the item — the fee specified in that column. Note Paragraph 11 (1) (d) of the Code states that an application must be accompanied by: (i) if only part of the prescribed fee is required to be paid at the time of making the application — the amount required to be paid; or (ii) otherwise — the whole of the prescribed fee (if any). (5) For the purposes of subsection 11A (4) of the Code, the component of the fee in respect of the preliminary assessment of an application made under section 10 of the Code (that is, the component of the fee paid under subregulation (4) in respect of the application that will not be repayable if the APVMA rejects an application on the ground that the application has not been properly made) is: (a) in the case of an item in Part 2 of Schedule 6 for which a modular assessment fee is payable — $460; and (b) in the case of an item in Part 2 of Schedule 6 for which the fee specified in Column 4 is nil or less than $460 — that fee specified in that column; and (c) in the case of an item in Part 2 of Schedule 6 for which the fee specified in Column 4 is $460 or more — $460. [7] Paragraph 70 (6) (a) substitute (a) if: (i) the applicant is: (A) the Commonwealth, a State or Territory; or (B) an authority or agency of the Commonwealth, a State or a Territory; or (C) an officer or employee of the Commonwealth, a State or a Territory, or of an authority or agency of the Commonwealth, a State or a Territory; and (ii) the permit is in support of the Commonwealth’s, State’s or Territory’s core activities; and (iii) the permit is for a use that does not have a commercial benefit; or [8] Regulation 71 substitute 71 Modular assessment fee (1) Schedule 7 sets out the assessment modules that may be necessary to determine an application for which a modular assessment fee is payable. (2) An assessment module may have different levels or types of assessment. (3) The fee payable for a module, level or type of assessment is set out in Column 4 of Schedule 7. (4) The modular assessment fee for an application is the sum of the fees payable for: (a) the screening assessment module in item 1 in Schedule 7; and (b) the other modules, levels and types of assessment that the APVMA considers necessary for the application to undergo; and (c) the type of finalisation assessment module in items 11.1 to 11.4 in Schedule 7 that the application must undergo. Note 1 The APVMA intends to make, under subsection 164 (1A) of the Code, a legislative instrument, Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005, setting out criteria for working out which fees apply under these Regulations in a particular case. Note 2 Under subregulation 70 (5), the APVMA will retain the $460 that, under subregulation 70 (4), accompanied an application for which a modular assessment fee is payable if the APVMA rejects the application on the ground that the application had not been properly made. (5) For the purposes of subsection 164 (2) of the Code, any balance of the modular assessment fee is due and payable on the date specified by the APVMA in a notice under paragraph 78 (3) (b) or subregulation 78A (2). [9] Paragraphs 73 (2) (a) and (b) omit $20 insert $90 [10] Paragraph 73 (2) (c) substitute (c) 20 cents for each photocopied page in excess of the first 100 pages; and [11] Paragraph 73 (3) (a) omit paragraph (1) (a), (b) or (c) — insert paragraph (1) (a) or (b) — [12] Subregulations 76 (1) and (2) omit item in Schedule 6 insert item in Part 2 of Schedule 6 [13] Subregulation 76 (3) omit [14] Regulation 77 substitute 77 Modular assessment period (1) In addition to setting out the fees for modules, levels and types of assessment, Schedule 7 sets out in Column 3 of the Schedule the period within which some of those modules, levels and types must be completed. (2) The modular assessment period referred to in Column 3 of an item in Part 2 of Schedule 6 (that is, the period within which an assessment of an application must be completed) is the sum of: (a) the longest of the periods for such other modules or levels of assessment in other items in Schedule 7 that the APVMA considers necessary for the application to undergo; and (b) the period for the type of finalisation assessment module in items 11.1 to 11.4 in Schedule 7 that the application must undergo. [15] Regulation 78 substitute 78 Commencement of period for determining applications made under section 10 of the Code (1) In the case of an application of a kind specified in item 1, 3, 4, 5, 6, 7, 8, 15, 16 or 17 in Part 2 of Schedule 6, the period specified in Column 3 of the item commences at the first moment of the day after the later of: (a) the day on which the APVMA gives notice under subsection 11A (2) of the Code that the application has passed preliminary assessment; and (b) the day on which the correct fee specified in respect of the application is paid. (2) In the case of an application of a kind specified in item 2, 10 or 24 in Part 2 of Schedule 6, the modular assessment period commences immediately after the day on which the balance of the modular assessment fee is paid. Note Notice of passing preliminary assessment for, or rejection of, applications made under section 10 of the Code are given under subsections 11A (2) and (5) of the Code, respectively. (3) If the APVMA gives notice under subsection 11A (2) of the Code in relation to an application, the APVMA must also notify the applicant in writing: (a) that if, under section 159 of the Code, the APVMA requires a person to give further information about the application, consideration of the application may be suspended, or the application may be treated as withdrawn, if the person fails to comply with the requirement; and (b) if the application is of a kind specified in item 2, 10 or 24 in Part 2 of Schedule 6: (i) of the modules that the application must undergo; and (ii) of the balance of the modular assessment fee payable; and (iii) that the balance is due and payable on the date specified in the notice. Note The balance payable in relation to an application for which a modular assessment fee is payable is the difference between the modular assessment fee and the $460 that accompanied the application. 78A Commencement of period for determining other applications (1) In the case of an application of a kind specified in item 9, 11, 12, 13, 14, 18, 19, 20, 21, 23 or 25 in Part 2 of Schedule 6, the period specified in Column 3 of the item commences at the first moment of the day after the later of: (a) the day the APVMA gives notice under subregulation (2) that the APVMA will proceed with the technical evaluation and assessment of the application; or (b) the day on which the correct specified fee (if any) in respect of the application is paid. (2) The APVMA must, within 1 month after receiving an application referred to in subregulation (1), notify the applicant in writing: (a) whether the APVMA will proceed with the technical evaluation and assessment of the application; and (b) that if, under section 159 of the Code, the APVMA requires a person to give further information about the application, consideration of the application may be suspended, or the application may be treated as withdrawn, if the person fails to comply with the requirement; and (c) if the APVMA will proceed with technical evaluation and assessment and a modular assessment fee is payable for the application: (i) of the modules that the application must undergo; and (ii) of the balance of the modular assessment fee payable; and (iii) that the balance is due and payable on the date specified in the notice. Note 1 The balance payable in relation to an application for which a modular assessment fee is payable is the difference between the modular assessment fee and the $460 that accompanied the application. Note 2 For an application of a kind specified in item 22 in Part 2 of Schedule 6 (permit if the proposed use a chemical product or active constituent is determined by the APVMA to be an emergency use), subregulation 76 (4) states that the APVMA must determine the application as soon as is practicable in the circumstances of the case. [16] Schedule 3A, note following heading substitute Note The text of Parts 1 and 2 of this Schedule is derived from that of the Codex Alimentarius. The ‘Codex number’ column and the ‘Major uses’ column are included because they are of assistance to users of the Codex. The food crops listed in the ‘Major uses’ column of Part 1of this Schedule are also used for the purposes of the definition of major food crop in Schedule 6. [17] Schedules 6 and 7 substitute Schedule 6 Applications — fees and assessment periods (regulations 70, 76, 77, 78 and 78A) Part 1 Preliminary 1.1 Definitions In this Schedule: closely similar, used of 2 chemical products, has the meaning given in section 1.2. major change, in relation to a registered chemical product or approved label, means a change to a registered chemical product or its approved label that is expected to require data for technical assessment of one or more of the following: (a) efficacy; (b) potential risks to the safety of humans, the environment or the host crop or animal; (c) potential risks to Australian trade. major food crop means a food crop listed in Column 3 (‘Major uses’) of Part 1 of Schedule 3A. maximum residue limit means the maximum concentration of a residue, resulting from the officially authorised safe use of an agricultural or veterinary chemical, that is recommended to be legally permitted or recognised as acceptable in or on a food, agricultural commodity, or animal feed. minor change means a change that is not a major change. protected information has the meaning given in section 1.5. similar, used of 2 chemical products, has the meaning given in section 1.3. the same, used of 2 chemical products, has the meaning given in section 1.4. 1.2 When chemical products are closely similar (1) Subject to subsection (2), an agricultural chemical product (the proposed chemical product) and a reference chemical product are closely similar if: (a) the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and (b) the concentration of the active constituents referred to in paragraph (a) are the same; and (c) either: (i) the other ingredients in the formulations of the proposed and reference chemical products are the same; or (ii) if the other ingredients in the formulations of the proposed and reference chemical products are different, those other ingredients perform similar functions (for example, as emulsifiers, surfactants, dyes or solvents); and (d) the formulation type of the proposed and reference chemical products are the same; and (e) the label of the proposed chemical product refers to the same crops, situations and pests as the approved label of the reference chemical product (that is, the proposed chemical product must have no uses additional to those of the reference chemical product); and (f) the label of the proposed chemical product includes similar instructions on how to use the product, and precautionary or safety instructions, as the approved label of the reference chemical product; and (g) either: (i) the claims on the labels of the proposed and reference chemical products are the same; or (ii) if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product. (2) However, the proposed agricultural chemical product and the reference chemical product are taken not to be closely similar if information about the reference chemical product is protected information. (3) Subject to subsection (4), a veterinary chemical product (the proposed chemical product) and a reference chemical product are closely similar if: (a) the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and (b) the concentration of the active constituents referred to in paragraph (a) are the same; and (c) either: (i) the non-active constituents in the formulations of the proposed and reference chemical products are the same, or are equivalent substances, at the same or equivalent concentrations; or (ii) if the non-active constituents in the formulations of the proposed and reference chemical products are neither the same nor equivalent, the differences in the formulations are minor and are not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues; and (d) either: (i) the proposed and reference chemical products specifications (including release and expiry limits and test methods) and physico-chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period) are the same or equivalent; or (ii) if the specifications and physico-chemical properties of the proposed and reference chemical products are neither the same nor equivalent, the differences in the specifications and properties are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues; and Note for paragraphs (c) and (d) Efficacy, safety and residues data are not required to demonstrate similarity of the proposed chemical product to the reference chemical product. (e) the dose form and formulation type of the proposed and reference chemical products are the same; and (f) the use patterns (including target animal species, dose rates, routes of administration and withholding periods) and instructions on the labels of the proposed and reference chemical products are the same; and (g) either: (i) the claims on the labels of the proposed and reference chemical products are the same; or (ii) if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product. (4) However, the proposed veterinary chemical product and the reference chemical product are taken not to be closely similar if information about the reference chemical product is protected information. 1.3 When chemical products are similar (1) Subject to subsection (2), an agricultural chemical product (the proposed agricultural chemical product) and a reference chemical product are similar if the conditions in paragraphs 1.2 (1) (a), (d), (e), (f) and (g) are complied with in relation to the products. (2) However, the proposed agricultural chemical product and the reference chemical product are taken not to be similar if information about the reference chemical product is protected information. (3) Subject to subsection (4), a veterinary chemical product (the proposed veterinary chemical product) and a reference chemical product are similar if: (a) the conditions in paragraphs 1.2 (3) (a), (b), (e), (f) and (g) are complied with in relation to the products; and (b) the non-active constituents in the proposed and reference chemical products have similar properties and are in similar proportions; and (c) efficacy, safety or residues data is required to demonstrate similarity of the proposed chemical product to the reference chemical product. (4) However, the proposed veterinary chemical product and the reference chemical product are taken not to be similar if information about the reference chemical product is protected information. 1.4 When chemical products are the same (1) Subject to subsection (2), a proposed chemical product and a reference chemical product are the same if they are the same in all respects except their names, their distinguishing numbers, and the name and business address of the applicant. (2) However, a proposed chemical product and a reference chemical product are taken not to be the same if information about the reference chemical product is protected information. 1.5 Meaning of protected information For this Schedule, information is protected information if: (a) it is information about an approved active constituent, a registered chemical product or an approved label for containers for a chemical product; and (b) any of the following provisions limits its use by the APVMA: (i) Division 4A of Part 2 of the Code; (ii) Part 3 of the Code; (iii) Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992. 1.6 Effect of Part 2 where information is protected information (1) If information about an active constituent is protected information, the fee payable for an application that would otherwise rely on or utilise that information is to be determined as if the active constituent were not approved. (2) If information about a registered chemical product is protected information, the fee payable for an application that would otherwise rely on or utilise that information is to be determined as if the chemical product were not registered. (3) If information about an approved label for containers for a chemical product is protected information, the fee payable for an application that would otherwise rely on or utilise that information is to be determined as if the label were not approved. 1.7 Fee when application for registration preceded by application for permit If: (a) an application for the registration of a chemical product is preceded by an application for a permit in relation to the product; and (b) the assessment of the permit is relevant to, and included as, part of the assessment of the product; despite anything else in Part 2 or in Schedule 7, the fee for the application for the registration of the product is to be worked out using the modular assessment fee only for any additional assessments that are actually undertaken by the APVMA at the time of the assessment. Part 2 Table of fees and assessment periods
Column 1
Item
Description of application
Column 2
Assessment period
Column 3
Fee ($)
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
15 months
48 860
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
The modular assessment period
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, if: (a) there is no registered chemical product containing the active constituent; and (b) a full assessment of the chemical product is required
15 months
31 750
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) the chemical product is to be used on a major food crop; and (c) there are no relevant maximum residue limits; and (d) poison schedule classification is required
15 months
21 210
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
5 months
3 300
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
5 months
2 245
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 months
600
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 months
540
9
Application for a listed registration of a chemical product containing an approved active constituent and approval of a product label for which an established standard has been approved in accordance with section 56D of the Code
3 months
495
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
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 the variation is to extend the use of the chemical product to a new major food crop
8 months
14 260
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 months
560
13
Application to vary particulars or conditions of registration or listed 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 months
nil
14
Application to vary particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in any of items 11 to 13
The modular assessment period
The modular assessment fee
Applications for approval of an active constituent
15
Application for approval of an active constituent requiring a full assessment
12 months
23 430
16
Application for approval of an active constituent requiring less than full assessment but requiring a toxicological assessment
8 months
4 025
17
Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment
5 months
1 435
Applications for variation to an approved active constituent
18
Application to vary particulars or conditions of an approved active constituent
5 months
915
application for a permit
19
Application for 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
3 months
320
20
Application for a permit where a previous assessment remains valid and no data of a technical nature is required
3 months
320
21
Application for a permit where the proposed use is a minor use
The modular assessment period
320
22
Application for 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 subregulation 76 (4))
nil — (see paragraph 70 (6) (b))
23
Application for 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
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, 2, 3, 4, 5, 6, 7, 8, 10, 15, 16 or 17) requiring assessment of a technical nature
The modular assessment period
The modular assessment fee
25
Any other application: (a) that is not made under section 10 of the Code; and (b) that is not of a kind listed in an item of this Schedule; requiring assessment of a technical nature
The modular assessment period
The modular assessment fee
Schedule 7 Table of fees and periods for completion of modules, levels and types of assessments (regulations 71 and 77)
Column 1
Item
Column 2
Module, level or type
Column 3
Period for completion
Column 4
Fee ($)
1
Screening
460
2
Chemistry
2.1
Chemistry — level 1
12 months
2 960
2.2
Chemistry — level 2
8 months
2 025
2.3
Chemistry — level 3
5 months
935
2.4
Chemistry — level 4
3 months
180
3
Toxicology (not requiring poison schedule classification)
3.1
Toxicology — level 1
12 months
17 720
3.2
Toxicology — level 2
8 months
13 290
3.3
Toxicology — level 3
4 months
2 635
4
Toxicology (requiring poison schedule classification)
12 months
3 380
5
Residues
5.1
Residues — level 1
12 months
5 085
5.2
Residues — level 2 (registration only)
6 months
4 330
5.3
Residues — level 3 (permit only)
6 months
2 265
5.4
Residues — level 4 (registration only)
3 months
2 025
5.5
Residues — level 5 (permit only)
3 months
1 070
6
Occupational health and safety
6.1
Occupational health and safety — level 1
12 months
3 920
6.2
Occupational health and safety — level 2
6 months
2 635
6.3
Occupational health and safety — level 3
4 months
1 305
7
Environment
7.1
Environment — level 1
12 months
11 460
7.2
Environment — level 2
6 months
2 960
7.3
Environment — level 3
4 months
565
8
Efficacy and safety
8.1
Efficacy and safety — level 1
5 months
1 695
8.2
Efficacy and safety — level 2
4 months
680
8.3
Efficacy and safety — level 3
3 months
455
9
Non-food trade
5 months
1 070
10
Special data
10.1
Special data — level 1
12 months
nil
10.2
Special data — level 2
6 months
nil
10.3
Special data — level 3
6 months
nil
11
Finalisation
11.1
Finalisation — type 1
3 months
2 025
11.2
Finalisation — type 2 (registration only)
2 months
1 070
11.3
Finalisation — type 3 (permit only)
2 months
565
11.4
Finalisation — type 4
2 months
145
12
Data protection
155
Note 1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.frli.gov.au.
