21Submissions to Committee or Minister in relation to exercise of certain powers

21 Submissions to Committee or Minister in relation to exercise of certain powers

(1) A person may prepare a submission: (a) that includes a request that the Committee recommend to, or advise, the Minister to exercise a power referred to in an item of the table in Schedule 1; or (b) for the Minister to exercise a power referred to in item 3.1 of the table in Schedule 1; or (c) to which subsection 28(3) applies.

Note 1: Subsection 28(3) applies in relation to a submission that includes a request for the Minister to exercise the power referred to in paragraph (a) of item 2.5 of the table in Schedule 1 in relation to a new form of a listed drug for oral administration in certain circumstances.

Note 2: For details about how to make a submission, see section 31.

Note 3: Submissions referred to in paragraph (a) of this subsection will be considered by the Committee.

(2) A submission referred to in paragraph (1)(a) may include more than one request relating to the exercise of a power referred to in an item of Part 1 or 2 of the table in Schedule 1 if: (a) each request relates to the same drug, medicinal preparation or vaccine; or (b) the submission proposes therapy for a disease or disorder and each request relates to the same disease or disorder that is the subject of the proposed therapy. (3) If a submission referred to in paragraph (1)(a) includes 2 or more requests, the evaluation category the submission is in depends on the request that is covered by the earliest of the following sections of this Division (unless the submission has been remade after an earlier submission was unsuccessful because it did not resolve all issues that needed to be resolved).