Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A submission is in Category 3 if:
(a) subsection (2), (3), (4) or (5) applies to the submission; and
(b) the submission is not in Category 1 or Category 2.
Submissions including certain requests
(2) This subsection applies to a submission if it includes a request that the Committee recommend to, or advise, the Minister to exercise a power referred to in item 1.4, 2.4, 2.7, 2.12, 2.14, 2.15, 2.17 or 2.18 of the table in Schedule 1.
Submissions involving assessment of clinical need and effectiveness of drug, medicinal preparation or vaccine
(3) This subsection applies to a submission if:
(a) it includes a request that the Committee recommend to, or advise, the Minister to exercise a power referred to in item 1.2, 2.2 or 2.6 of the table in Schedule 1; and
(b) in considering the request, the Committee will need to assess the applicant's claim about the clinical need for, and clinical effectiveness of, the drug, medicinal preparation or vaccine to which the request relates; and
(c) the submission does not:
(i) propose any change to the unit price of a listed drug or designated vaccine; or
(ii) need the Committee to assess any implications arising from the request for the cost of supplying or providing the drug, medicinal preparation or vaccine.
Submissions for determination of brand of medicinal preparation with somatropin
(4) This subsection applies to a submission if:
(a) it is for the Minister to exercise a power referred to in item 3.1 of the table in Schedule 1 in relation to a medicinal preparation including somatropin; and
(b) it includes a claim about the therapeutic benefit derived from the relationship between ingredients in the medicinal preparation.
Submissions relating to medicinal food
(5) This subsection applies to a submission if it includes a request relating to a drug, or medicinal preparation, that is 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.