Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsNote: See regulations 70, 70B, and 76 to 78.
In this Schedule:
"closely similar" , used of 2 chemical products, has the meaning given by clause 1.2 and subclause 1.5(1).
"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.
"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.
"restricted" , in relation to the use of information by the APVMA in determining an application: see subclause 1.5(2).
"similar" , used of 2 chemical products, has the meaning given by clause 1.3 and subclause 1.5(1).
"the same" , used of 2 chemical products, has the meaning given by clause 1.4 and subclause 1.5(1).
1.2 When chemical products are closely similar
(1) Subject to clause 1.5, 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.
(3) Subject to clause 1.5, 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.
1.3 When chemical products are similar
(1) Subject to clause 1.5, 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.
(3) Subject to clause 1.5, 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) chemistry and manufacture, efficacy or target species safety data is required to demonstrate similarity of the proposed chemical product to the reference chemical product.
1.4 When chemical products are the same
Subject to clause 1.5, 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.
1.5 When chemical products are not closely similar , similar or the same
(1) Despite clauses 1.2, 1.3 and 1.4, a proposed chemical product and a reference chemical product are not closely similar , similar or the same if:
(a) the APVMA is required to use information in determining an application in respect of the proposed chemical product; and
(b) the use of the information by the APVMA in determining that application is restricted.
(2) The use of information by the APVMA in determining an application is restricted if the APVMA is restricted from using the information in determining the application by:
(a) Division 4A of Part 2 of the Code; or
(b) Part 3 of the Code.
1.6 Effect on fees when the use of information is restricted
(1) If the use of information by the APVMA about an active constituent is restricted, 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 the use of information by the APVMA about a registered chemical product is restricted, 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 the use of information by the APVMA about an approved label for containers for a chemical product is restricted, 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 -- Assessment periods and fees
2.1 Table of assessment periods and fees
The following table sets out the assessment periods and fees for different kinds of applications under the Code.
Fees and assessment periods | |||||
Item | Column 1 Description of application | Column 2 Assessment period | Column 3 Extended assessment period | Column 4 Maximum pre - application assistance rebate | Column 5 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 | 18 months | 25 months | $1,400 | $116,501 |
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 | 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 |
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 | 18 months | 25 months | $1,050 | $83,511 |
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 months | 25 months | $1,050 | $44,644 |
5 | Application for: (a) registration of a chemical product containing an approved active constituent and approval of the product label; or (b) registration of a chemical product, approval of the active constituent in the chemical product and approval of the product label; or (c) registration of a chemical product and approval of the product label; if: (d) the chemical product is similar to a registered chemical product; and (e) chemistry and manufacture data, efficacy data and target species safety data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product; and (f) for an application mentioned in paragraph (b)--the active constituent complies with a monograph or compendial standard in the British Pharmacopoeia, British Pharmacopoeia (Veterinary), European Pharmacopoeia or United States Pharmacopeia; and (g) for an application mentioned in paragraph (c)--a separate application for the approval of the active constituent in the chemical product has been lodged | 8 months | 12 months | $700 | $7,566 |
6 | Application for: (a) registration of a chemical product containing an approved active constituent and approval of the product label; or (b) registration of a chemical product, approval of the active constituent in the chemical product and approval of the product label; or (c) registration of a chemical product and approval of the product label; if: (d) the chemical product is closely similar to a registered chemical product; and (e) chemistry and manufacture data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product; and (f) for an application mentioned in paragraph (b)--the active constituent complies with a monograph or compendial standard in the British Pharmacopoeia, British Pharmacopoeia (Veterinary), European Pharmacopoeia or United States Pharmacopeia; and (g) for an application mentioned in paragraph (c)--a separate application for the approval of the active constituent in the chemical product has been lodged | 8 months | 12 months | $700 | $6,406 |
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 | 5 months | $350 | $2,632 |
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 | 5 months | $350 | $2,632 |
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 months | 4 months | $350 | $2,632 |
10 | Application for: (a) registration of a chemical product containing an approved active constituent and approval of the product label; or (b) registration of a chemical product and approval of the active constituent in the chemical product; or (c) registration of a chemical product and approval of the product label (but only if a separate application for the approval of the active constituent in the chemical product has been lodged); for all situations other than those described in items 1 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 |
10A | Application for approval of a label for containers for a registered chemical product | 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 |
Applications for approval or registration for prescribed active constituents, chemical products or labels | |||||
10B | Application under subsection 14C(1), 14D(1) or 14E(1) of the Code | A period specified in, or worked out in accordance with, a legislative instrument made by the APVMA | A period specified in, or worked out in accordance with, a legislative instrument made by the APVMA | An amount (if any) specified in, or worked out in accordance with, a legislative instrument made by the APVMA | An amount specified in, or worked out in accordance with, a legislative instrument made by the APVMA |
Applications to vary a registration or approval | |||||
11 | Application to vary relevant particulars or conditions of registration or label approval where a full assessment of the chemical product is required | 10 months | 15 months | $1,050 | $36,205 |
12 | Application to vary relevant 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 | 5 months | $350 | $2,018 |
13 | Application to vary relevant 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 months | 5 months | Nil | Nil |
13A | Application to vary a relevant particular of an approval or registration where the variation of the relevant particular is a prescribed variation under section 26B of the Code | 1 month | Not applicable | Nil | $175 |
14 | Application to vary relevant 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 |
Applications for approval of an active constituent | |||||
15 | Application for approval of an active constituent requiring a full assessment | 14 months | 20 months | $1,400 | $38,776 |
16 | Application for approval of an active constituent requiring less than full assessment but requiring a toxicological assessment | 9 months | 13 months | $700 | $27,031 |
17 | Application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment (unless item 5, 6 or 10 applies) | 7 months | 11 months | $700 | $5,442 |
Applications for variation to an approved active constituent | |||||
18 | Application to vary relevant particulars or conditions of an approved active constituent | 7 months | 11 months | $700 | $4,252 |
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 months | 5 months | $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 months | 5 months | $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 |
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 subregulation 76(4)) | Not applicable | Nil (see paragraph 70(8)(b)) | Nil (see paragraph 70(8)(b)) |
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 22 | 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 |
Other applications | |||||
24 | Application made under: (a) section 10 of the Code requiring assessment of a technical nature (other than those of the kinds described in any of items 1 to 10, 15, 16 or 17); or (b) section 27 of the Code requiring assessment of a technical nature (other than those of the kinds described in any of items 11 to 14 or 18). | 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 |
25 | Application made under regulation 8AS for a technical assessment | 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, plus GST |
27 | Timeshift application (see regulation 3BA) | The modular assessment period | Not applicable | $1,400 | The modular assessment fee |
28 | Application made under subclause 10(1) of Schedule 3AA to make or vary an ingredient determination | 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 |
29 | Application made under regulation 19AEB to make an interchangeable constituent determination | 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 |