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Reporting medicine shortages and discontinuations in Australia - Guidance for sponsors
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.
- 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
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