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UK MHRA asks physicians to prescribe licensed melatonin products

This article was originally published in Scrip

Executive Summary

The UK MHRAis urging doctors and pharmacists to prescribe and supply only licensed melatonin, now that Lundbeck's modified-release product Circadin 2mg tablets are available in the UK. Before June, melatonin was only available in the UK as an unlicensed product. Many of these were non-pharmaceutical grade (non-GMP) products imported from the US, where they are classed as supplements, the MHRA points out. However, the agency recognises that there may be individuals for whom the licensed product does not meet their clinical needs, such as when alternative dosage forms are required, and licensed melatonin products can still be imported when prescribers give written details of the special clinical need to the importer, which submits this to the MRHA. Melatonin products have previously been the largest category of unlicensed products imported into the UK; the agency received 1,053 notifications of imports of these products in the six months to June.

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