Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:28
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 28
Character Range: 53591–54670

28  Submissions in new brand or new oral form of existing pharmaceutical item category
 (1) A submission is in the new brand or new oral form of existing pharmaceutical item category if:
 (a) subsection (2) or (3) applies to the submission; and
 (b) the submission is not in Category 3 or the Committee Secretariat category.

New brand of existing pharmaceutical item
 (2) This subsection applies to a submission for the Minister to exercise a power referred to in item 3.1 of the table in Schedule 1.

New oral form of listed drug
 (3) This subsection applies to a submission if:
 (a) it 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; and
 (b) it seeks the same listing conditions, and contains the same active moiety in the same quantity, as an existing form of the listed drug; and
 (c) evidence of bioequivalence between the new form of the listed drug and the existing form of the listed drug is provided with the submission.