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NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES--COST RECOVERY) REGULATIONS 2022 - REG 11

Notification, including amount of fee payable

Notification after receipt of notice of intent--no simple category request and no fee exemption or waiver sought

  (1)   If:

  (a)   the Department receives a notice of intent in relation to a proposed ATAGI application from a person under subsection   9(1); and

  (b)   the notice of intent does not include any of the following:

  (i)   a request for the Secretary to decide whether the ATAGI application is in a simple category;

  (ii)   reasons why section   67 applies to provide a fee exemption;

  (iii)   a request for waiver of the fee for providing ATAGI advice in response to the ATAGI application;

the Secretary must, within 15 business days after the day the notice is received, notify the person, in writing:

  (c)   that the Department has received the notice of intent; and

  (d)   of the amount of the fee that is payable for the provision of ATAGI advice in response to the ATAGI application; and

  (e)   of the manner for paying the fee.

Notification after receipt of notice of intent--fee exemption or waiver sought

  (2)   If:

  (a)   the Department receives a notice of intent in relation to a proposed ATAGI application from a person under subsection   9(1); and

  (b)   the notice of intent includes either of the following:

  (i)   reasons why section   67 applies to provide a fee exemption;

  (ii)   a request for waiver of the fee for providing ATAGI advice in response to the ATAGI application;

the Secretary must, within 15 business days after the day the notice of intent is received, notify the person, in writing:

  (c)   that the Department has received the notice of intent; and

  (d)   whether the fee exemption applies, or the fee is waived; and

  (e)   if the request was for waiver and the fee is not waived--of the applicant's review rights under Part   8; and

  (f)   if the fee exemption does not apply and the fee is not waived:

  (i)   of the amount of the fee that is payable for providing ATAGI advice in response to the ATAGI application; and

  (ii)   of the manner for paying the fee.

Note:   If the notice of intent in relation to the proposed ATAGI application also includes a request for the Secretary to decide whether the ATAGI application is in a simple category, the Secretary's decision in response to the request will be included in the notification given under subsection   (3) following receipt of the ATAGI application.

Notification after receipt of ATAGI application in relation to which simple category request relates or notice of intent was not required

  (3)   If the Department receives an ATAGI application, the Secretary must, within 15 business days after the day the ATAGI application is received, notify the applicant, in writing:

  (a)   that the Department has received the ATAGI application; and

  (b)   if the notice of intent in relation to the ATAGI application, or the ATAGI application (if a notice of intent in relation to the ATAGI application was not required), includes a request for the Secretary to decide whether the ATAGI application is in a simple category:

  (i)   of the Secretary's decision; and

  (ii)   if the decision is that the ATAGI application is not in a simple category--of the applicant's review rights under Part   8; and

  (c)   if a notice of intent in relation to the ATAGI application was not required and the ATAGI application includes reasons why section   67 applies to provide a fee exemption or a request for waiver of the fee for providing ATAGI advice in response to the ATAGI application:

  (i)   whether the fee exemption applies, or the fee is waived; and

  (ii)   if waiver was requested and the fee is not waived--of the applicant's review rights under Part   8; and

  (d)   if the fee exemption does not apply and the fee is not waived:

  (i)   of the amount of the fee that is payable for providing ATAGI advice in response to the ATAGI application; and

  (ii)   of the manner for paying the fee.

Note 1:   The period of 15 business days referred to in this subsection is paused if a notice is given under subsection   8(6) seeking further information in relation to a request for the Secretary to decide whether the ATAGI application is in a simple category (see subsection   8(7)).

Note 2:   The fee specified in a notification given under this section is payable to the Commonwealth (see subsection   99YBA(4) of the Act) unless the fee is waived under section   68 of this instrument.

Note 3:   If a fee exemption does not apply and the fee is not waived, and the Secretary decides that the application is in a simple category, the reduced fee prescribed by subsection   8(4) is payable. In any other case, the complex category ATAGI application fee is payable.

Note 4:   Part   6 deals with the payment of fees, including the time for payment (see paragraph   62(1)(b)).



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