National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
50Notification, including amount of fee payable
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50 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 pricing application from a person under subsection 48(1), the Secretary must, within 10 business days after the day the notice of intent is received, 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 pricing category of the proposed pricing application—of the amount of the fee that is payable for providing pricing services in response to the proposed pricing application; 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 pricing services in response to the proposed pricing application: (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, within 15 business days after the day the notice of intent is received, 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 applicant’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 pricing services in response to the proposed pricing application, based on the statement in the notice of intent about the pricing category the pricing application is likely to be in; and (ii) of the manner for paying the fee. Notification after receipt of pricing application in relation to which notice of intent was not required (3) If the Department receives a pricing application in relation to which a notice of intent was not required to be given under subsection 48(1), the Secretary must, within 15 business days after the day the pricing application is received, notify the applicant in writing: (a) that the Department has received the application; and (b) if the pricing application includes reasons why section 67 applies to provide a fee exemption or a request for waiver of the fee for providing pricing services in response to the pricing application: (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 applicant’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 pricing services in response to the pricing application; and (ii) of the manner for paying the fee.