Dáil Éireann Debate, Tuesday - 14 October 2025
873. Deputy Michael Healy-Rae asked the Minister for Health further to Parliamentary Question No. 1161 of 17 September 2025, if Ireland has a stockpile or contingency plan for essential medicines unavailable here (details supplied); and if she will make a statement on the matter. [55111/25]
Amharc ar fhreagraThere is a legislative provision for the supply of what are known as ‘exempt medicinal products’ (EMPs), in situations where no suitable authorised medicine is available. EMPs are medicines that are not nationally authorised by the HPRA or centrally authorised by the European Commission, however, they can be supplied by pharmacists in certain circumstances.
Specifically, EMPs can be supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by their individual patients on their direct personal responsibility to fulfil the special needs of those patients. If there is no suitable authorised medicine available in Ireland and a valid prescription is issued for an EMP in line with legislative requirements, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.
The legal basis for the supply of EMPs is set out in:
• Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended, and
• Medicinal Products (Control of Wholesale Distribution) Regulations 2007, as amended.
The Health Products Regulatory Authority (HPRA) has advised that Praziquantel is not presently authorised as a medicinal product for human use in Ireland. The HPRA cannot require companies to market medicinal products in Ireland and we also have no role in relation to pricing and reimbursement. The HPRA would be willing at any stage to engage with and to provide regulatory guidance to any company who wishes to make medicinal products available in Ireland.
