Table of 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 |
This Act’s bill:Explanatory statement
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