You are here Home Guidance and resources Resources Guidance Reporting medicine shortages and discontinuations in Australia - Guidance for sponsors Guidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia Last updated 23 March 2023 Listen Print Share LinkedIn Twitter Facebook Email Loading... This guidance is for sponsors of reportable medicines, which include: Schedule 4 (Prescription Only) medicines Schedule 8 (Controlled Drug) medicines over-the-counter medicines included in the Therapeutic Goods (Reportable Medicines) Determination. ‘Reportable medicines’ are defined in the Therapeutic Goods Act 1989 (the Act), see section 30EH. This guidance describes the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia. This guidance should be read in conjunction with Medicine shortages/discontinuations – Electronic notification form: User guide. Contents About this guidance Reporting a shortage to the TGA Medicine shortages and discontinuations Mandatory reporting timeframes Impact ratings Completing the shortage notification form Submitting a shortage notification Publication of shortages on the TGA website Communication of shortages Case studies Version history Supporting documents Reporting medicine shortages and discontinuations in Australia: Guidance for sponsors [PDF, 322.24 KB] Topics Medicines Prescription medicines Shortages Featured in Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
Reporting medicine shortages and discontinuations in Australia: Guidance for sponsors [PDF, 322.24 KB]