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Guideline on prescription medicine discontinuations

TGA and Medicines Australia conjoint best practice guidelines

17 October 2007

These guidelines have been superseded by the Medicine Shortages Information Initiative (MSII) and associated Protocol and web information. Discontinuations can be notified to the TGA using the MSII in TGA Business Services. For further information please see: Medicine Shortages Information: General Information.

Discontinuing a medicine is a decision that most pharmaceutical companies will take at some point. The Therapeutic Goods Administration (TGA) and Medicines Australia want to ensure that the impact of such a decision on patients is minimised. Therefore we have developed these best practice guidelines, which are an adaptation of the equivalent guidelines adopted by the Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health.

The guidelines are designed to ensure best practice in managing the phase out of products, especially the timing and recipients of notifications of the deletion. They make recommendations about who to tell, when and what information will be needed. The emphasis is very much on early timing and information exchange and dissemination. To help companies and health professionals further, a central contact point has been established within the TGA; the details are on the pro-forma in these guidelines.

These guidelines have been adopted jointly by the Therapeutic Goods Administration and Medicines Australia. We believe they will establish good practice across the industry and the wider health community, and allow discontinuations to be managed with as little inconvenience and worry as possible for patients.

How to access a pdf document

Ensuring best practice in the notification of prescription medical product discontinuations (pdf,122kb)