Extended assessment period and maximum response period

The assessment period in which the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to determine an application varies depending on the complexity of the application. The APVMA’s regulations prescribe the relevant assessment periods, 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 respond to this notice.

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

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 Pharmacopeia (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 3 months
6

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 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 Pharmacopeia (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 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*

For all situations other than those described in items 1–9:

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)

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
10A Approval of a label for containers of a registered 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
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?(unless item 5, 6 or 10 applies) 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
25 Technical assessment application made under regulation 8AS 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 Modular assessment period Not applicable As agreed between the APVMA and the Applicant
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.

Table 3: Permits – extended timeframes

Item

Description of application

Assessment period

Extended assessment period

Maximum response period

19

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

1 month

20

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

1 month

21

A permit, or extension of a permit, where the proposed use is a minor use

Modular assessment period

The modular assessment period plus 6 months. (unless the APVMA and applicant agree to a shorter period)

5 months (unless the APVMA and applicant agree to a shorter period)

22

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

As soon as practicable in the circumstances.

23

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

Modular assessment period

One and one-third of the modular assessment period, rounded up to the nearest whole month, plus one month

Extended assessment period, minus the assessment period, minus 1 month

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