National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
82ATAGI application made, but waiver of fee not requested, before commencement day
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82 ATAGI application made, but waiver of fee not requested, before commencement day
(1) This section applies if: (a) a person had made an ATAGI application under Division 1A.1 of the old Regulations for the provision of services that directly or indirectly related to a proposed Part 2 submission under the old Regulations; and (b) the person had not made the related Part 2 submission before the commencement day; and (c) the person wishes to request the Secretary to waive the fee payable by the person for the provision of services in response to the ATAGI application. (2) The person must include the request for waiver of the fee: (a) in the related submission made by the person under Part 3 of this instrument; or (b) if, under section 30 of this instrument, a notice of intent is required in relation to the proposed related submission—in the notice of intent. (3) The Secretary must notify the person, in writing, of the following: (a) whether the fee is waived; (b) if the fee is not waived: (i) the person’s review rights under Part 8 of this instrument; and (ii) the amount of the fee that is payable for the provision of services in response to the ATAGI application; and (iii) the manner for paying the fee. (4) The information required to be notified under subsection (3) must be included in the notification given under section 33 of this instrument in relation to: (a) the related submission; or (b) if applicable, the notice of intent in relation to the proposed related submission.