National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
33Notification, including amount of fee payable
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33 Notification, including amount of fee payable
Notification after receipt of notice of intent—no fee exemption or waiver sought (1) If the Department receives a notice of intent in relation to a proposed submission from a person under subsection 30(1), the Secretary must, at least 10 business days before the submission due day for the submission, notify the person in writing: (a) that the Department has received the notice of intent; and (b) based on the statement in the notice of intent about the evaluation category the proposed submission is likely to be in—of the amount of the fee that is payable for providing submission services in response to the proposed submission; and (c) of the manner for paying the fee.
Note 1: The fee must be paid within a period starting when this notification is given (see paragraph 62(1)(b)).
Note 2: If it is later found that a fee exemption or waiver under section 67 or 68 applies, a refund may be payable (see subsection 62(4)).
Notification after receipt of notice of intent—fee exemption or waiver sought (2) However, if the notice of intent includes either of the following relating to the fee for providing submission services in response to the proposed submission: (a) reasons why section 67 is expected to apply to provide an exemption from the fee; (b) a request for waiver of the fee; then the Secretary must, at least 5 business days before the submission due day for the submission, notify the person in writing: (c) that the Department has received the notice of intent; and (d) whether the fee exemption applies, or the fee is waived; and (e) if waiver was requested and the fee is not waived—of the person’s review rights under Part 8; and (f) if the fee exemption does not apply and the fee is not waived: (i) of the amount of the fee that is payable for providing submission services in response to the proposed submission, based on the statement in the notice of intent about the evaluation category the submission is likely to be in; and (ii) of the manner for paying the fee. Notification after receipt of submission in relation to which notice of intent was not required (3) If the Department receives a submission from a person in relation to which a notice of intent was not required to be given under subsection 30(1), the Secretary must, within 15 business days after the day the submission is received, notify the person in writing: (a) that the Department has received the submission; and (b) if the submission includes reasons why section 67 applies to provide a fee exemption or a request for waiver of the fee for providing submission services in response to the submission: (i) whether the fee exemption applies, or the fee is waived; and (ii) if waiver was requested and the fee is not waived—of the person’s review rights under Part 8; and (c) if the fee exemption does not apply and the fee is not waived: (i) of the amount of the fee that is payable for providing submission services in response to the submission; and (ii) of the manner for paying the fee.