This user guide 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,

It describes how to complete and submit a shortage or discontinuation notice for reportable medicines, using the medicine shortages electronic notification form through the TGA Business Services (TBS) portal.

This user guide should be read in conjunction with Reporting medicines shortages and discontinuations in Australia – Guidance for sponsors

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