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.
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PageSupplying alternative medicines during a shortage - Manage a medicine shortage.
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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
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GuidanceGuidance and other resources for sponsors about mandatory reporting of medicine shortages in Australia.
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DatasetSearch for medicines that are in low supply and information about alternative medicines.
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User guideFrom 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
More information
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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