Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 43AE

Fee for application for provisional determination relating to medicine--refund in certain circumstances

  (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).

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