Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies if:
(a) a person applies to the Secretary under regulation 16H to designate a medicine as an orphan drug; and
(b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and
(c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and
(d) after the person pays the fee, the Secretary designates the medicine as an orphan drug under regulation 16J.
(2) The Secretary must refund the fee to the person (whether or not the Secretary makes the determination).