Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.
(2) If, on or after 31 August 2019 and before the commencement of subregulations 45(7) to (9):
(a) a person made a request (an opioid reform request ) that:
(i) was made in relation to prescription opioids that were registered goods; and
(ii) was made under subsection 9D(2) or (3) of the Act; and
(iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and
(b) the person paid the fee prescribed in Schedule 9 to these Regulations in relation to the request;
the Secretary must, on behalf of the Commonwealth, refund to the person an amount equal to the fee paid.
(3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:
(a) under subsection 9D(2) of the Act, to do either or both of the following:
(i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;
(ii) reduce the class of persons for whom the goods were suitable; or
(b) under subsection 9D(3) of the Act, to introduce a smaller pack size in relation to the goods.
(4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:
(a) the opioid reform request was made under subsection 9D(3) of the Act; and
(b) paragraphs 9D(3)(b) to (c) of the Act were satisfied in relation to the request; and
(c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.