National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
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National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
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(1) Within 10 business days after the day the Department receives a pre‑submission meeting application for a pre‑submission meeting, the Secretary must notify the applicant in writing: (a) that the Department has received the application; and (b) whether the Secretary agrees or does not agree under section 16 to the Department holding a pre‑submission meeting with the applicant. (2) If the Secretary agrees to the Department holding a pre‑submission meeting with the applicant on a day less than 30 business days after the Secretary notifies the applicant under subsection (1), the notification under that subsection must also specify the matters referred to in subsection (4). (3) If the Secretary agrees to the Department holding a pre‑submission meeting with the applicant on a day (the meeting day) at least 30 business days after the Secretary notifies the applicant under subsection (1), the Secretary must notify the applicant in writing of the matters referred to in subsection (4) not more than 20 business days before the meeting day. (4) The matters to be specified in a notification given under subsection (1) or (3) are: (a) the category of the pre‑submission meeting (see the table in section 14); and (b) the amount of the fee that is payable for the service of holding the pre‑submission meeting (see the table in section 14); and (c) the manner for paying the fee.
Note 1: The fee specified in a notification given under this section is payable to the Commonwealth (see subsection 99YBA(4) of the Act).
Note 2: Part 6 deals with the payment of fees, including the time for payment (see paragraph 62(1)(b)).