Written answers

Wednesday, 17 September 2025

Department of Health

Medicinal Products

Photo of Ann GravesAnn Graves (Dublin Fingal East, Sinn Fein)
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1160. To ask the Minister for Health if she has increased the availability of naloxone-trained individuals on its use and equipped gardaí with naloxone to carry on the beat. [47836/25]

Photo of Jennifer Murnane O'ConnorJennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.

Matters relating to An Garda Siochana fall under the remit of Department of Justice, the deputy may wish to contact Department of Justice directly.

Photo of Michael Healy-RaeMichael Healy-Rae (Kerry, Independent)
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1161. To ask the Minister for Health if plans are in place to allow tapeworm infection patients to access essential medicines currently unavailable in Ireland (details supplied); and if she will make a statement on the matter. [47837/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Health Products Regulatory Authority (HPRA) can advise 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.

In situations where no suitable authorised medicine is available, there is legislative provision for the supply of what are known as ‘exempt medicinal products’ (EMPs). 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.

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