Extended assessment period and maximum response period

The assessment period in which the APVMA is required to determine an application varies depending on the complexity of the application. The APVMA’s regulations prescribe assessment period, the extended assessment period if a notice under section 159 of the Agvet Code requiring additional information is issued and the maximum period an applicant has to response to this notice (see tables 1 and 2).

Table 1: Approvals and registrations made under section 10 of the Agvet Code
Item Description of application Assessment period Extended Assessment period Maximum Response period
1 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 product 18 months 25 months 6 months
2* 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 product Modular assessment period One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month Extended assessment period, minus the assessment period, minus 1 month
3 Registration of a chemical product containing an approved active constituent, and approval of the product label, if there is no registered chemical product containing the active constituent and a full assessment of the product is required 18 months 25 months 6 months
4 Registration of a chemical product containing an approved active constituent, and approval of the product label, if there is a registered chemical product containing the active constituent and a full assessment of the product is required and there are no relevant maximum residue limits and poison schedule classification is required 18 months 25 months 6 months
5 Registration of a chemical product containing an approved active constituent, and approval of the product label, if the product is similar to a registered chemical product and chemistry and manufacture, efficacy or target species safety data is the only data required to demonstrate the similarity of the product to the registered chemical product 8 months 12 months 3 months
6 Registration of a chemical product containing an approved active constituent, and approval of the product label, if the product is closely similar to a registered chemical product and efficacy and safety data are not required to demonstrate the similarity of the product to the registered chemical product and chemistry and manufacture data are required 8 months 12 months 3 months
7 Registration of a chemical product containing an approved active constituent, and approval of the product label, if the product is closely similar to a registered chemical product and efficacy and safety data are not required to demonstrate the similarity of the product to the registered chemical product and chemistry and manufacture data are not required 3 months 5 months 1 month
8 Registration of a chemical product containing an approved active constituent, and approval of the product label, if the chemical product is the same as a registered chemical product and the product is to be registered with a different name 3 months 5 months 1 month
9 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 1 month
10* 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 Modular assessment period One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month Extended assessment period, minus the assessment period, minus 1 month
15 Approval of an active constituent requiring a full assessment 14 months 20 months 5 months
16 Approval of an active constituent requiring less than a full assessment but requiring a toxicological assessment 9 months 13 months 3 months
17 Approval of an active constituent requiring less than a full assessment but not requiring a toxicological assessment 7 months 11 months 3 months
24* Approval or registration under section 10 of the code requiring assessment of a technical nature (other than of the kinds described in any of items 1 to 10, 15, 16 or 17) Modular assessment period One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month Extended assessment period, minus the assessment period, minus 1 month
27* Timeshift application for approval of an active constituent that is not a previously endorsed active constituent or registration of a chemical product containing an active constituent that is not an active constituent contained in any other registered chemical product Modular assessment period One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month Extended assessment period, minus the assessment period, minus 1 month
Table 2: Variation of approval or registration relevant particulars or conditions made under section 26B or 27 of the Agvet Code
Item Description of application Assessment period Extended Assessment period Maximum Response period
11 Vary particulars or conditions of registration or label approval where a full assessment of the chemical product is required 10 months 15 months 4 months
12 Vary particulars or conditions of registration or label approval if the variation is to allow a minor change and no data of a technical nature is required 3 months 5 months 1 month
13 Vary particulars or conditions of registration or label approval if the variation is to allow a minor change and  no data of a technical nature is required and  the variation is a change required by the APVMA 3 months 5 months 1 month
13A 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 Not applicable
14* 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 Modular assessment period One and one third of the modular assessment period, rounded up to the nearest whole month, plus 1 month Extended assessment period, minus the assessment period, minus 1 month
18 Vary particulars or conditions of an approved active constituent 7 months 11 months 3 months

*We cannot specify the maximum response period for Items 2, 10, 14, 24 and 27 as this will vary, depending on the nature of the application and the modules specified for that particular application.

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