DOCUMENTS

Senator KOVACIC (New South Wales) (15:57): At the request of Senator Antic, I move: That there be laid on the table by the Minister representing the Minister for Health and Ageing, by no later than midday on Tuesday, 15 September 2026, all documents relating to the current evaluation of mFLUSIVA by the Therapeutic Goods Administration (TGA), including documents in draft, interim or preliminary form and documents generated or received to date and including the following: (a) the application dossier and all TGA evaluation reports and assessments, including drafts, preliminary, interim and first-round reports, relating to clinical, nonclinical, quality/manufacturing, statistical and pharmacovigilance matters; (b) all documents assessing or discussing safety, efficacy and the benefit-risk profile of mFLUSIVA, including known or potential risks, safety signals, uncertainties, missing information, data gaps, Risk Management Plans (RMPs), risk-minimisation measures and proposed pharmacovigilance or post-market requirements; (c) any post-market safety documentation, PSURs/PBRERs, signal assessments and RMP updates; (d) all questions, requests for information or clarification, including notices pursuant to section 31 of the Therapeutic Goods Act 1989, together with sponsor responses, supplementary information and correspondence between the TGA, sponsor, evaluators or other parties concerning the evaluation of mFLUSIVA; (e) all draft or completed Delegate's Overviews, briefing papers, internal reviews, recommendations, meeting records and expert advice, including material prepared for or received from the Advisory Committee on Medicines or other expert advisers; and (f) all documents prepared to date concerning proposed approval, rejection, indications, conditions of registration, Product Information, RMP requirements or other regulatory outcomes, including draft recommendations, proposed decisions and any draft AusPAR or decision summary.