Sponsors of ‘reportable medicines’ must notify the TGA when the medicine is in shortage or being discontinued.
A medicine shortage occurs when the supply of a medicine is not likely to meet the normal or projected consumer demand within Australia at any point during the next 6 months. A discontinuation is a permanent shortage.
- PageSupplying alternative medicines during a shortageSupplying alternative medicines during a shortage - Manage a medicine shortage.
Guidance and resources
- GuidanceMedicine shortages: Information for sponsors (suppliers)We have updated guidance on how to report medicine shortages to make the process clearer and easier to understand
- DatasetMedicine shortage reports databaseSearch for medicines that are in low supply and information about alternative medicines.
- GuidancePublication of notified medicine shortages: Updated protocolFrom 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
Medicine shortages - recent amendments to the Therapeutic Goods Act 1989
- What is the patient impact of my medicine shortage and do I have to report it to the TGA?
- Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework
- Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance studies