Commonwealth Consolidated Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES--COST RECOVERY) REGULATIONS 2022 - REG 8

Secretary may decide that ATAGI application is in simple category

  (1)   The Secretary may, in writing and on request, decide whether or not a person's ATAGI application is in a simple category.

Note 1:   The request must be included in the notice of intent for the ATAGI application or, if a notice of intent for the ATAGI application is not required, in the ATAGI application (see subsection   (5)).

Note 2:   A decision that the person's ATAGI application is not in a simple category is reviewable (see section   71).

Note 3:   Regardless of subsection   7(2) and this section, in some circumstances the person will be fully exempt from paying a fee in relation to the ATAGI application (see section   67).

When is ATAGI application in simple category

  (2)   The Secretary must decide under subsection   (1) that a person's ATAGI application is in a simple category if:

  (a)   the person's ATAGI application is only proposing:

  (i)   that a new brand of vaccine be determined under subsection   9B(2) of the Act to be a designated vaccine; and

  (ii)   that the proposed determination is to specify the vaccine by reference to characteristics (other than brand) that are the same as, or similar to, those specified for another vaccine that is already a designated vaccine; or

  (b)   the person's ATAGI application is only proposing:

  (i)   to vary the circumstances specified in a determination under subsection   9B(2) of the Act in which a designated vaccine may be provided; and

  (ii)   that the variation is to extend the vaccine's eligible patient population to a new group of patients who are no more vulnerable to a poor outcome from either the relevant disease or the vaccine; or

  (c)   the Secretary is satisfied that providing the ATAGI advice to the person will not involve the degree of data analysis and consideration that would justify payment of the complex category ATAGI application fee.

Note:   For examples of the characteristics referred to in subparagraph   (a)(ii), see subsection   9B(3) of the Act.

  (3)   For the purposes of paragraph   (2)(a), brand has the same meaning as in section   9B of the Act.

Reduced fee for ATAGI applications in simple category

  (4)   If the Secretary decides under subsection   (1) that a person's ATAGI application is in a simple category, the fee for providing the ATAGI advice to the person is $118,305. This fee includes a deposit of $ 455 .

Applicant who wants Secretary to decide whether ATAGI application is in simple category must include request in notice of intent or ATAGI application

  (5)   A person (the applicant ) who wants the Secretary to make a decision under subsection   (1) must:

  (a)   request this:

  (i)   in the notice of intent in relation to the proposed ATAGI application; or

  (ii)   if a notice of intent in relation to the proposed ATAGI application is not required--in the person's ATAGI application; and

  (b)   include reasons in the notice of intent or the ATAGI application (as the case may be) why the Secretary should do so.

  (6)   The Secretary may, by written notice given to the applicant, seek further information from the applicant in relation to the applicant's request.

  (7)   Giving a notice under subsection   (6) seeking further information pauses the period of 15 business days referred to in subsection   11(3) for giving the notification in relation to the ATAGI application until the further information is given in accordance with the notice.