85Application provision for the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022

85 Application provision for the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022

(1) Subject to subsection (2), the amendments of this instrument made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022 apply in relation to the following: (a) if a notice of intent in relation to an application or a submission for the provision of services is not required—an application or a submission (including a remade application or submission) that is received by the Department on or after 1 August 2022; (b) in any other case—an application or a submission (including a remade application or submission) for the provision of services, for which a notice of intent is given on or after 1 August 2022. (2) The amendment of subsection 35(6) of this instrument made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022 applies in relation to the withdrawal of a notice of intent in relation to a proposed submission, or a submission, if: (a) the notice of intent or the submission is given on or after 1 August 2022; and (b) the notice of intent or the submission is withdrawn on or after 1 August 2022. (3) The repeal and substitution of subsection 51(4) of this instrument made by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Fees) Regulations 2022 applies in relation to the withdrawal of a notice of intent in relation to a proposed pricing application, or a pricing application, if: (a) the notice of intent or the pricing application is given on or after 1 April 2022; and (b) the notice of intent or the pricing application is withdrawn on or after 1 April 2022. (4) In this section:

services means any of the following:

(a) ATAGI advice;
(b) the service of the Department holding a pre‑submission meeting with a person;
(c) submission services;
(d) pricing services;
(e) list management services.