29Evaluation categories of certain remade submissions

29 Evaluation categories of certain remade submissions

(1) This section applies to a submission (the current submission) if: (a) the current submission is a remaking, under section 36, of an amended submission (the previous submission) that was the most recent submission made before the current submission; and (b) the previous submission was not in: (i) the Committee Secretariat category; or (ii) the new brand or new oral form of existing pharmaceutical item category; and (c) the Committee declined to take, or was of the view that the Minister should not take, the action sought by the previous submission, because of issues (the outstanding issues) arising from the previous submission. (2) This section has effect in relation to the current submission despite whichever of sections 23, 24, 25, 26, 27 and 28 applies to it. Standard re‑entry pathway category (3) The current submission is in the standard re‑entry pathway category if: (a) after considering the previous submission, the Committee either: (i) considered that the outstanding issues could not be resolved easily and identified the outstanding issues in a communication to the applicant; or (ii) made a suggestion described in paragraph (4)(a), (5)(a) or (6)(a); and (b) either: (i) the notice of intent in relation to the current submission given under section 30; or (ii) if a notice of intent in relation to the current submission was not required under that section—the current submission; states that the current submission is likely to be in the standard re‑entry pathway category. Early re‑entry pathway category (4) The current submission is in the early re‑entry pathway category if: (a) after considering the previous submission, the Committee: (i) considered that the drug, medicinal preparation or vaccine to which the previous submission related did not have high added therapeutic value; and (ii) considered that the outstanding issues could be resolved easily; and (iii) suggested to the person who made the previous submission that the person remake the submission, as a submission in the early re‑entry pathway category, to resolve the outstanding issues; and (iv) identified the outstanding issues in the suggestion; and (b) the only material differences between the current submission and the previous submission are to address the outstanding issues; and (c) the remaking of the current submission occurs after the suggestion and no later than the second submission due day after the suggestion for submissions in the early re‑entry pathway category; and (d) either: (i) the notice of intent in relation to the current submission given under section 30; or (ii) if a notice of intent in relation to the current submission was not required under that section—the current submission; states that the current submission is likely to be in the early re‑entry pathway category. Early resolution pathway category (5) The current submission is in the early resolution pathway category if: (a) after considering the previous submission, the Committee: (i) considered that the drug, medicinal preparation or vaccine, to which the previous submission related had high added therapeutic value; and (ii) considered that the outstanding issues could be resolved easily; and (iii) suggested to the person who made the previous submission that the person remake the submission, as a submission in the early resolution pathway category, to resolve the outstanding issues; and (iv) identified the outstanding issues in the suggestion; and (b) the only material differences between the current submission and the previous submission are to address the outstanding issues; and (c) the remaking of the current submission occurs after the suggestion and no later than the second submission due day after the suggestion for submissions in the early resolution pathway category; and (d) either: (i) the notice of intent in relation to the current submission given under section 30; or (ii) if a notice of intent in relation to the current submission was not required under that section—the current submission; states that the current submission is likely to be in the early resolution pathway category. Facilitated resolution pathway category (6) The current submission is in the facilitated resolution pathway category if: (a) after considering the previous submission, the Committee: (i) considered that the drug, medicinal preparation or vaccine to which the previous submission related had high added therapeutic value; and (ii) considered that a workshop involving the person who made the previous submission and one or more members of the Committee was desirable to discuss the outstanding issues; and (iii) suggested to the person who made the previous submission that the workshop be held and that the person later remake the submission, as a submission in the facilitated resolution pathway category, to resolve the outstanding issues; and (b) the workshop was held at which the outstanding issues were discussed; and (c) the remaking of the current submission occurs after the workshop and no later than the second submission due day after the workshop for submissions in the facilitated resolution pathway category; and (d) either: (i) the notice in relation to the current submission given under section 30; or (ii) if a notice of intent in relation to the current submission was not required under that section—the current submission; states that the current submission is likely to be in the facilitated resolution pathway category.