Commonwealth Consolidated Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES--COST RECOVERY) REGULATIONS 2022 - REG 30

When notice of intent is required

  (1)   A person proposing to make a submission in an evaluation category (other than the new brand or new oral form of existing pharmaceutical item category) must give the Department a notice of intent in relation to the submission 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:

  (i)   20 business days before the submission due day for the submission; or

  (ii)   if the submission is to be in the early re - entry pathway category or the early resolution pathway category--5 business days before the submission due day for the submission; or

  (iii)   if the submission is to be in the facilitated resolution pathway category because a workshop is to be held as described in subsection   29(6)--10 business days before the workshop is to be held.

Note 1:   Requiring a notice of intent allows the Commonwealth to properly prepare for the provision of submission services in response to the submission.

Note 2:   The submission must be given to the Department on or before the submission due day for the submission (see paragraph   31(1)(c)).

Exception if urgent public health need

  (2)   If the person proposing to make the submission considers that the provision of submission services in response to the submission 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 submission is not required under subsection   (1).

  (3)   If the Secretary receives a request from a person under subsection   (2) in relation to a proposed submission, the Secretary must:

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

Consequence if notice of intent is required but not given

  (5)   Submission services will not be provided in response to a submission if a notice of intent in relation to the submission:

  (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 submission must:

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

  (b)   state, with reasons, why the proposed submission is likely to be in a particular evaluation category; and

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

Note 1:   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 2:   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 3:   Information about the approved form for a notice of intent in relation to a proposed submission and the approved manner for giving the notice to the Department 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 submission; and

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