National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
15Requirements for pre‑submission meeting applications
Start here
Get a plain-English read of 15
Turn the raw legal text into a practical explanation grounded in National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022.
15 Requirements for pre‑submission meeting applications
(1) A pre‑submission meeting application, and briefing papers for the pre‑submission meeting, must: (a) be in a form approved by the Secretary; and (b) be given to the Department in a manner approved by the Secretary.
Note 1: The briefing papers may be provided with the pre‑submission meeting application or afterwards.
Note 2: Information about the approved form for pre‑submission meeting applications and briefing papers for the meeting, and the approved manner for giving them to the Department, is accessible through the Department’s website.
(2) The Secretary may, in writing, approve: (a) a form for: (i) pre‑submission meeting applications; and (ii) briefing papers for pre‑submission meetings; and (b) a manner for giving pre‑submission meeting applications and briefing papers for pre‑submission meetings to the Department.