National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
24Submissions in Category 2
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24 Submissions in Category 2
A submission is in Category 2 if: (a) it includes a request that the Committee: (i) recommend to, or advise, the Minister to exercise a power referred to in item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 2.5, 2.6 or 2.13 of the table in Schedule 1; or (ii) advise the Minister in relation to a power referred to in item 2.15 of the table in Schedule 1; and (b) in considering the request, the Committee will need to do a cost‑effectiveness test; and (c) if the request relates to a drug or medicinal preparation—the drug or preparation is not a medicinal food the patient population for which is too small for the person making the submission to be able to provide a meaningful economic evaluation for the submission; and (d) the submission is not in Category 1.