Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:69
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 69
Character Range: 132550–133801

69  Waiver of fees for provision of list management services
 (1) The Secretary may, in writing and on request by a person made in accordance with subsection (2), decide whether or not to waive the fee payable by the person under Part 5 for list management services provided in response to a list management application.
Note: A decision not to waive a fee that is payable is reviewable (see section 71).
 (2) The request must be included in the list management application.
 (3) The Secretary must decide under subsection (1) to waive the fee if:
 (a) the list management application involves the public interest; and
 (b) payment of the fee would make the application financially unviable.
 (4) Without limiting subsection (3), a list management application involves the public interest if:
 (a) it concerns a drug, medicinal preparation or vaccine that would represent suitable therapy for a patient population; and
 (b) the patient population is not large enough to make the application financially viable; and
 (c) the drug, medicinal preparation or vaccine is to be used:
 (i) for palliative care; or
 (ii) as a paediatric medicine; or
 (iii) for medical treatment of Aboriginal or Torres Strait Islander peoples.

Part 8—Review of decisions