Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies to a reconsideration begun under Division 4 of Part 2 of the old Code before 1 July 2014, but not concluded by 1 July 2015.
(2) Section 31 of the new Code applies to the reconsideration as if the reference in subsection 31(2) to "commencing the reconsideration" were a reference to "1 July 2015".
Note: Section 31 of the new Code requires the APVMA to prepare and maintain a work plan for each reconsideration.
(3) For subsection 165A(1) of the Code, the remaining period, after 30 June 2015, within which the APVMA must conclude the reconsideration (the reconsideration assessment period ) is to be worked out in accordance with the formula:
where:
"A" means the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 3.1, 3.2, 3.3, 4.1, 7.1, 7.2, and 7.3 of Schedule 7 that the APVMA determines are necessary after 1 July 2015 for the reconsideration.
Example: If the APVMA determines that items 3.1, 4.1 and 7.3 of Schedule 7 are necessary after 1 July 2015 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 the longest of the periods, in months, mentioned in column 2 of Schedule 7 for whichever of items 2.1 to 2.3, 5.1, 5.2, 5.4, 6.1 to 6.3, 9, and 10.1 to 10.3 of Schedule 7 that the APVMA determines are necessary after 1 July 2015 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 after 1 July 2015 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 after 1 July 2015 for the reconsideration.
"J" means:
(a) if the APVMA must, after 1 July 2015, consult each coordinator designated for a jurisdiction about the reconsideration in accordance with subsection 34A(3) of the Code--3 months; and
(b) in any other case--nil.
"X" means:
(a) if the APVMA appoints an arbitrator under section 64 of the Code after 1 July 2015--3 months; and
(b) in any other case--nil.
(4) The remaining period within which the APVMA must conclude the reconsideration, worked out in accordance with subregulation (3), commences on 1 July 2015.
(5) However, if:
(a) the APVMA issues a notice in relation to the reconsideration under subsection 33(1) or 159(1) of the old Code before 1 July 2015; and
(b) the holder of the approval or registration under reconsideration has not, before 1 July 2015, complied with the notice; and
(c) the time specified in the notice for complying with the notice (the compliance date ) ends on or after 1 July 2015;
the remaining period does not start until the earliest of the following dates:
(a) the day the holder complies with the notice;
(b) the compliance date.
(6) Subregulations (3) to (5) have effect despite regulation 78B.