This user guide is for sponsors of reportable medicines, which include:
- Schedule 4 (Prescription Only) medicines
- Schedule 8 (Controlled Drug) medicines
- non-prescription 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
Contents
- About this user guide
- Medicine shortages – electronic notification form
- Steps to creating a notification
- Managing a notification form
- Accessing a notification form
Supporting documents
Page history
V3.0
Update and re-write to reflect changes to the mandatory reporting of all medicine shortages and enhances to the TBS portal and notification form.
V2.0
Revised after the introduction of legislation regarding mandatory reporting of medicine shortages
V1.1
Reflect changes in TBS notification form
V1.0
Original publication
V3.0
Update and re-write to reflect changes to the mandatory reporting of all medicine shortages and enhances to the TBS portal and notification form.
V2.0
Revised after the introduction of legislation regarding mandatory reporting of medicine shortages
V1.1
Reflect changes in TBS notification form
V1.0
Original publication