Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:45:p4
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 45 (pt 4/4)
Character Range: 423933–425336

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 subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;
 (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;
 (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.

Fee waiver for requests to vary product information for medicine
 (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:
 (a) the request is in relation to therapeutic goods that are registered; and
 (b) the therapeutic goods are medicine; and
 (c) paragraphs 9D(3)(b) to (c) of the Act are satisfied in relation to the request; and
 (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and
 (e) the request is made in the period beginning on 1 January 2020 and ending at the end of 31 December 2020.