Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effectiveness of the regulatory classification of melatonin in the UK compared with other countries.

The Department has not undertaken a formal assessment comparing the United Kingdom’s prescription-only classification of melatonin with its status in other countries. In the UK, melatonin is regulated as a prescription only medicine. Decisions on how medicines are classified are made by the Medicines and Healthcare products Regulatory Agency (MHRA) upon receipt of an application from a company, in accordance with the Human Medicines Regulations 2012. This process considers each medicine’s safety profile, effectiveness, and whether it can be used without medical supervision.

Other countries may allow melatonin to be sold over-the-counter or as a supplement, for example in the United States. Such differences reflect varying regulatory frameworks and healthcare contexts internationally.

The UK remains responsive to new evidence, and the MHRA will continue to consider any well-founded applications to reclassify melatonin or similar products, ensuring that patient safety and clinical benefit remain paramount.