Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:45:p3
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 45 (pt 3/4)
Character Range: 421506–424166

the evaluation of the medicine for registration; and
 (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.
 (6) The Secretary may:
 (a) reduce the application fees specified in Schedule 9 that are payable in relation to the application to $1,299; and
 (b) reduce the evaluation fees specified in Schedule 9 that are payable in relation to the application to $5,187.

Fee waivers for prescription opioids
 (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:
 (a) it is made in relation to prescription opioids that are registered goods;
 (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;
 (c) it is made under subsection 9D(2) or (3) of the Act;
 (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).
 (8) For the purposes of subregulation (7), an opioid reform request is made for an opioid reform purpose if it is 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 does 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 are suitable; or
 (b) under subsection 9D(3) of the Act, to introduce a smaller pack size in relation to the goods.
 (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:
 (a) the opioid reform request is made under subsection 9D(3) of the Act; and
 (b) paragraphs 9D(3)(b) to (c) of the Act are satisfied in relation to the request; and
 (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.

Waiver of application and registration fees for designated orphan drugs
 (12) The Secretary must waive the following fees:
 (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;
 (b) a fee that would have been payable, but for this subregulation, as part of an application under