Dáil Éireann Debate, Wednesday - 4 March 2026
257. Deputy Catherine Ardagh asked the Minister for Health the reason all melatonin products require a prescription in Ireland; if she will consider allowing availability without prescription for products with a lower dosage of the product (details supplied) in order that it could be classified as a food supplement; and if she will make a statement on the matter. [17309/26]
Amharc ar fhreagraMelatonin is a [medicinal product] most often used to treat insomnia characterised by poor quality of sleep. Melatonin is currently listed in Column A of the first schedule to the Prescription and Control of Supply Regulations ([S.I. No. 540/2003]). This means it is a prescription only medicine that cannot be renewed. In Ireland, all currently authorised melatonin-containing medicinal products are subject to prescription control.
The Health Products Regulatory Agency (HPRA) is the entity responsible for the regulation of medicines in Ireland. It should be noted that the 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.
Once a marketing authorisation has been issued it is a matter for the marketing authorisation holder to decide whether to market the medicine in Ireland.
