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NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES--COST RECOVERY) REGULATIONS 2022 - REG 52

Determining pricing category that pricing application is in

  (1)   After having had regard to the matters in sections   42 to 47, the Secretary may, in writing, determine that a pricing application is in one of the pricing categories.

Note:   The Secretary may initiate a review of the decision to make the determination (see section   74).

  (2)   If the Secretary determines, under subsection   (1), that a pricing application is in a different pricing category from the pricing category used to work out the fee notified to the applicant under section   50 (or previously under this section), the Secretary must notify the applicant, in writing, accordingly.

  (3)   A notification under subsection   (2) to an applicant must specify:

  (a)   the amounts of the fees payable for the pricing services that applied when the notification for the pricing application was given under section   50; and

  (b)   the fee amounts (if any) already paid, or refunded, for the pricing services; and

  (c)   the fee amount that is to be refunded to, or is payable by, the applicant based on the amounts referred to in paragraphs   (a) and (b); and

  (d)   the manner for paying the amount (if any) referred to in paragraph   (c) that is payable by the applicant; and

  (e)   the applicant's review rights under Part   8 in relation to the determination under subsection   (1).

Note 1:   The fee specified in a notification given under subsection   (2) is payable to the Commonwealth (see subsection   99YBA(4) of the Act) unless the fee is waived under section   68 of this instrument.

Note 2:   Part   6 deals with the payment of fees, including the time for payment (see paragraph   62(1)(b)).



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