28Submissions in new brand or new oral form of existing pharmaceutical item category

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.