National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
48Notice of intent required for most pricing applications
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48 Notice of intent required for most pricing applications
When notice of intent is required (1) A person proposing to make a pricing application must give the Department a notice of intent in relation to the pricing application unless the Secretary has decided under subsection (3) that a notice of intent is not required. The notice of intent must: (a) be in accordance with subsection (6); and (b) be given at least 5 business days before the day the person gives the proposed pricing application to the Department.
Note 1: Requiring the notice of intent allows the Commonwealth to properly prepare for the provision of pricing services in response to the pricing application.
Note 2: The pricing application must be given to the Department within 30 business days after the notice of intent is given (see subsection 49(2)).
Exception if urgent public health need (2) If the person considers that the provision of pricing services in response to the pricing application is required to address an urgent public health need, the person may request the Secretary, in writing, to decide that a notice of intent in relation to the proposed pricing application is not required under subsection (1). (3) If the Secretary receives a request from a person under subsection (2) in relation to a proposed pricing application, the Secretary must: (a) decide that a notice of intent in relation to the proposed pricing application is not required under subsection (1), or refuse to make that decision; and (b) give the person written notice of the decision.
Note 1: If the Secretary refuses to make the decision requested, the Secretary must also comply with section 72.
Note 2: A refusal to make the decision requested is reviewable (see section 71).
(4) The Secretary may decide under subsection (3) that a notice of intent in relation to the proposed pricing application is not required if the Secretary is satisfied that the provision of pricing services in response to the pricing application is required to address an urgent public health need. Consequence if notice of intent is required but not given (5) The provision of pricing services in response to a pricing application will be delayed if a notice of intent in relation to the pricing application: (a) is required under subsection (1); and (b) is not given in accordance with that subsection. The pricing services will not begin to be provided until at least 5 business days after the day the pricing application is given to the Department. Requirements for notice of intent (6) A notice of intent in relation to a proposed pricing application under subsection (1) must: (a) be in a form approved by the Secretary; and (b) state, with reasons, why the proposed pricing application is likely to be in a particular pricing category; and (c) be given to the Department in a manner approved by the Secretary.