Period within which APVMA is to conclude reconsiderations
78B Period within which APVMA is to conclude reconsiderations
This regulation is made for subsection 165A(1) of the Code.
The reconsideration period starts immediately after the end of the period specified in the notice given by the APVMA in relation to the reconsideration under paragraph 32(1)(b) of the Code.
A reconsideration of an approval or registration is concluded when the APVMA:
gives a notice in relation to the reconsideration under paragraph 34AC(1)(a) of the Code; or
suspends or cancels the approval or registration under section 34AA of the Code.
The period in which the APVMA must conclude a reconsideration of an approval or registration (the reconsideration assessment period) is to be worked out in accordance with the formula in subregulation (5).
The formula is:
where:
A means:
if an assessment relating to toxicology is required for the purposes of the reconsideration—the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 3.1 to 3.5, 4.1 and 7.1 to 7.4 of Schedule 7 that the APVMA determines are necessary for the reconsideration; or
in any other case—the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 4.1 and 7.1 to 7.4 of Schedule 7 that the APVMA determines are necessary for the reconsideration.
If the APVMA determines that items 3.1 and 7.3 of Schedule 7 are necessary for the reconsideration, A is the longest of the periods in column 2 for those items, which is 13 months (the period for item 3.1).
B means:
if an assessment relating to work health and safety is required for the purposes of the reconsideration—the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 2.1 to 2.5, 3.1, 3.3 to 3.5, 5.1 to 5.5, 9 and 10.1 to 10.3 of Schedule 7 that the APVMA determines are necessary for the reconsideration; or
in any other case—the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 2.1 to 2.5, 5.1 to 5.5, 9 and 10.1 to 10.3 of Schedule 7 that the APVMA determines are necessary for the reconsideration.
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.
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.
J means:
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; and
in any other case—nil.
X means:
if the APVMA appoints an arbitrator under section 64 of the Code—3 months; and
in any other case—nil.
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