National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
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National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
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(1) After having had regard to the matters in Division 2 of this Part and consulting with the Chair of the Committee, the Secretary may, in writing, determine that a submission is in one of the evaluation categories.
Note: The Secretary may initiate a review of the decision to make the determination (see section 74).
(2) To avoid doubt, the Secretary may determine under subsection (1) that a submission is in an evaluation category (the determined category) other than the category that the submission, or the notice of intent in relation to the submission given under subsection 30(1), states that the submission is likely to be in, even if the determined category is an evaluation category described in section 29 (about evaluation categories of certain remade submissions). (3) If the Secretary determines, under subsection (1), that a submission is in a different evaluation category from the evaluation category used to work out the fee notified, under section 33 (or previously under this section), to the person who made the submission, the Secretary must notify the person, in writing, accordingly. (4) A notification to a person under subsection (3) must specify: (a) the amounts of the fees payable for the submission services that applied when the notification for the submission was given under section 33; and (b) the fee amounts (if any) already paid, or refunded, for the submission services; and (c) the fee amount that is to be refunded to, or is payable by, the person 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 person; and (e) the person’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 (3) 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)).