Catherine Connolly (Galway West, Independent)
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771. To ask the Minister for Health the reason a prescription is required for melatonin; and if he will make a statement on the matter. [42944/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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Melatonin (active substance) is currently listed in Column A of the first schedule to the Prescription and Control of Supply Regulations (S.I. No. 540/2003), i.e. prescription only that cannot be renewed. In Ireland, all authorised melatonin-containing medicinal products currently authorised are subject to prescription control.

However, it should be noted that the Health Products Regulatory Agency (HPRA) is open to review any application from a Marketing Authorisation Holder to change the prescription status of melatonin to non-prescription status. This is in line with the HPRA's policy to make medicines and health products available at the most convenient point of access for people, where it is safe and appropriate to do so following evaluation of all relevant data.

Individuals or companies requiring further information on the procedures for licensing human medicines in Ireland should review the relevant documents, including guides and forms, and explanatory information provided and can also contact the HPRA for further information and guidance at info@hpra.ie.