National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
49Requirements for pricing applications
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49 Requirements for pricing applications
(1) A pricing application must: (a) be in a form approved by the Secretary; and (b) if a notice of intent in relation to the pricing application was not required to be given under subsection 48(1)—state, with reasons, why the pricing application is to be in a particular pricing category; and (c) be given to the Department in a manner approved by the Secretary.
Note 1: If the applicant considers that a fee exemption applies under section 67 and a notice of intent was not required to be given under subsection 48(1), the pricing application must include the reasons for the exemption (see subsection 67(7)).
Note 2: If the applicant wishes to request waiver of the fee that would otherwise be payable and a notice of intent was not required to be given under subsection 48(1), the request must be included in the pricing application (see subsection 68(2)).
Note 3: Information about the approved form for a pricing application and the approved manner for giving the pricing application to the Department is accessible through the Department’s website.
(2) If a notice of intent in relation to the pricing application was given under subsection 48(1), the pricing application must be given to the Department within 30 business days after the day the notice of intent was given. (3) If: (a) a notice of intent in relation to a proposed pricing application is given by a person under subsection 48(1); and (b) the proposed pricing application is not given to the Department before the end of the period referred to in subsection (2) of this section; the fee amount (if any) paid for providing pricing services in response to the proposed pricing application, except the relevant deposit referred to in subsection 41(3) included in the fee, must be refunded.
Note: If the person still seeks the pricing services, the person must give a new notice of intent in relation to a proposed new pricing application under section 48.
(4) The Secretary may, in writing, approve: (a) a form for pricing applications; and (b) a manner for giving pricing applications to the Department.