Timeframes for chemical reviews

Prior to July 2014, chemical reconsiderations (reviews) were not time limited – the timeframe of individual reviews was determined by the scope and specific details of the review. Since 1 July 2014, a time frame has applied to chemical reviews. The Agvet Code Regulation 78B specifies a formula to calculate the period within which the Australian Pesticides and Veterinary Medicines Authority (APVMA) must conclude a review. The maximum period prescribed in the Regulations for the most complex review is 57 months.

The table below provides details about how the timeframe for individual reviews is calculated. The module descriptions are available on the APVMA website and reflect the changes implemented on 1 February 2023, including combined toxicology and occupational health and safety assessment modules. These changes do not affect the maximum timeframe for completion of a review.

The period, in months, within which the APVMA is to complete a review is calculated by the formula below with reference to the assessment modules set out in Schedule 7 of the Agvet Code Regulations and indicated in Table 1.

A + B + 2E + 3C + J + D + X

Table 1 - Period within which the APVMA is to conclude a reconsideration
The maximum period, in months, within which the APVMA is to complete a review
Formula A B 2E 3C J D X Total
Maximum period in months 13 13 2×6 3×3 3 or 0 4 3 or 0 57

A means the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 3.1 to 3.5 (where toxicology assessment is required), 4.1, 7.1 to 7.4 of Schedule 7 that the APVMA determines are necessary for the reconsideration (maximum 13 months).

B means the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of the items 2.1 to 2.5, 5.1 to 5.5, 3.1, 3.3, 3.4 or 3.5 (where worker safety assessment is required) 9 and 10.1 to 10.3 of Schedule 7 that the APVMA determines are necessary for the reconsideration (maximum 13 months).

C means the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 11.1, 11.2 or 11.3 of Schedule 7 that the APVMA determines are necessary for the reconsideration (maximum 3 months).

D means 4 months.

E means the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 8.1, 8.2 or 8.3 of Schedule 7 that the APVMA determines are necessary for the reconsideration (maximum 6 months).

J means:

(a)  if the APVMA must consult each coordinator designated for a jurisdiction about the reconsideration in accordance with subsection 34A(3) of the Code – 3 months

(b)  in any other case – nil.

X means:

(a)  if the APVMA appoints an arbitrator under section 64 of the Code – 3 months

(b)  in any other case – nil.

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