Medicinal Products
Seanad Éireann — 2026-03-26
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Jennifer Murnane O'Connor (FF), Carlow-Kilkenny

I am taking this on behalf of the Minister, Deputy Carroll MacNeill, who cannot be here today. I thank the Senator for highlighting a really important issue. It is good that we are talking about this and it very important that we look at the changes that can be made.
I will briefly outline some of the details on melatonin. This is most often used to treat insomnia, which is characterised by poor quality of sleep. Melatonin is currently listed in what is called column A of the First Schedule of the prescription and control of supply regulations, SI 540 of 2003. This means that it is a prescription-only medicine that cannot be renewed. In Ireland, all currently authorised melatonin-containing medical products are subject to prescription control. The Health Products Regulatory Authority is the agency in Ireland with responsibility for the regulation of medicines for the benefit of patients. The Department of Health engages closely with the HPRA on its remit. It should be noted that the HPRA is open to review any application from a marketing authorisation holder, MAH, to change the prescription status of melatonin to non-prescription status. This is in line with the HPRA 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 the evaluation of all relevant data.
The Department of Health and the HPRA are not aware of any specific MAH applications that are currently under review. Once a marketing authorisation has been issued, it is a matter for the marketing authorisation holder to decide whether to make the medicine available in Ireland. It is important to note that other policy measures have been introduced by the Department in recent years to support women through their menopause journey. I know the Senator spoke about them. It is a priority for us in government.
The Department of Health will keep the matter under review and will be happy to provide the Senator with a further update, should additional relevant information become available. I will go back to the Minister because we need to get more clarification on this. I thank the Senator again for highlighting this really important issue.

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Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/seanad/2026-03-26/debate/main
Retrieved: 2026-08-14T04:54:47+00:00
Sitting date: 2026-03-26