Stephen Donnelly (Wicklow, Fianna Fail)
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1162. To ask the Minister for Health further to Parliamentary Question No. 1015 of 20 June 2017, the analysis and risk assessments conducted to date in 2017; and if he will make a statement on the matter. [38131/17]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) has established an internal working group to examine all issues under its remit relating to Brexit, including the ongoing availability of medicinal products. As part of its Brexit plans, the HPRA has contacted all marketing authorisation holders and asked them to identify any issues that they anticipate in supplying medicines to Ireland after Brexit. The HPRA has also held a stakeholder meeting and publicly expressed its willingness to facilitate industry in maintaining marketing authorisations in Ireland and the rest of Europe.

In general, companies have not yet taken any firm decisions in relation to the supply of the Irish market post-Brexit, but the HPRA has indicated that it will meet with any company and take a pragmatic approach to managing the issues they might face. The HPRA is also communicating with colleagues within the UK’s regulatory authorities for human medicines and veterinary medicines to explore possible co-operation on common UK/Irish products, such as joint labeling, to minimize the impact of Brexit. Separately to these preparations for Brexit, the HPRA has commenced a project on managing medicines shortages which will help to support the availability of medicines after Brexit, but in the first instance the HPRA will seek to maintain existing authorisations on the Irish market regardless of their source.

I have also asked the HSE to reply directly to the Deputy on the issues raised that relate to the agency. Please advise my private office if you do not receive a reply within ten working days.