Commonwealth Consolidated Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES--COST RECOVERY) REGULATIONS 2022 - REG 9

When notice of intent is required

  (1)   A person proposing to make an ATAGI application must give the Department a notice of intent in relation to the 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 10 business days before the ATAGI application due day for the ATAGI application.

Note 1:   Requiring a notice of intent allows ATAGI to properly prepare for the provision of advice in response to the ATAGI application.

Note 2:   The ATAGI application must be given to the Department on or before the ATAGI application due day for the application (see paragraph   10(1)(b)).

Exception if urgent public health need

  (2)   If the person considers that the provision of advice by ATAGI in response to an ATAGI 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 ATAGI 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 ATAGI application, the Secretary must:

  (a)   decide that a notice of intent in relation to the proposed ATAGI 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 ATAGI application is not required if the Secretary is satisfied that the provision of ATAGI advice in response to the ATAGI application is required to address an urgent public health need.

Consequence if notice of intent is required but not given

  (5)   ATAGI will not provide advice in response to an ATAGI application if a notice of intent in relation to the application:

  (a)   is required under subsection   (1); and

  (b)   is not given in accordance with that subsection.

Requirements for notice of intent

  (6)   A notice of intent in relation to a proposed ATAGI application must:

  (a)   be in a form approved by the Secretary; and

  (b)   be given to the Department in a manner approved by the Secretary.

Note 1:   If the person wishes the Secretary to make a decision under subsection   8(1) in relation to the proposed ATAGI application (simple category ATAGI applications), the request and reasons for the request must be included in the notice of intent (see subsection   8(5)).

Note 2:   If the person giving the notice of intent considers that a fee exemption applies under section   67, the notice of intent must include the reasons for the exemption (see subsection   67(8)).

Note 3:   If the person giving the notice of intent wishes to request waiver of the fee that would otherwise be payable, the request must be included in the notice of intent (see subsection   68(2)).

Note 4:   Information about the approved form for a notice of intent in relation to a proposed ATAGI application and the approved manner for giving the notice of intent is accessible through the Department's website.

  (7)   The Secretary may, in writing, approve:

  (a)   a form for a notice of intent in relation to a proposed ATAGI application; and

  (b)   a manner for giving the notice of intent to the Department.