You are here
Manage a medicine shortage
Information for sponsors and manufacturers explaining what to do if there is a medicine shortage.
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.
- PageThe TGA welcomes applications to register new generics of medicines included in the Australian Register of Therapeutic Goods (ARTG) that are in long-term shortage.
Guidance and resources
- GuidanceFrom 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
- 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