NPC Archive Item: Restrictions on the import of unlicensed melatonin products

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MHRA drug procurement advice: Restrictions on the import of unlicensed melatonin products following marketing authorisation for Circadin®▼2mg tablets. 15th August 2008.

A licensed melatonin product, (Circadin®▼ 2mg tablets) became available in the UK in June 2008 for the treatment of primary insomnia. We recently reviewed the key evidence. Until now melatonin was only available in unlicensed medicinal products, many of which were imported and of a non-pharmaceutical grade quality.

The Medicines and Healthcare products Regulatory Agency (MHRA) advises that now a licensed melatonin product is available it should be used, whenever possible, in situations where previously an unlicensed product would have been administered. This includes off-label use if the prescriber considers it to be appropriate.

When the licensed product is unsuitable e.g. an alternative dosage form, strength or immediate release product is required, then importation of unlicensed melatonin products is still possible.  Prescribers will need to provide written details of the special clinical need to the importer on each occasion that the product is ordered. Patient identification is not required. Further details can be obtained from the importer through which the order is to be processed.

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