Dr. Lorraine Nolan:

In his opening statement Mr. Breslin mentioned the various regulatory pathways by which medicines come to the market. In the light of Brexit, changes to these regulatory pathways must take place. Where there are activities which are conducted in the United Kingdom such as manufacturing or the batch release or testing of medicines, in the light of Brexit they must be changed to another EU member state. In the case of existing licensed medicines, where there is a dependence on the United Kingdom for the activities to be conducted or where the UK agency was the lead agency in the technical evaluation of the medicines, all of these issues have to be transferred. That is one consequence of Brexit. Preparations have been under way at European level since 2016 and are advancing. The vast majority of the changes have been made, but in fairness to the committee, I note that we are aware of some companies within the United Kingdom which supply both that market and the Irish market which have not as yet made the regulatory changes. The other system is that after the United Kingdom leaves the European Union and becomes a third country, the EU 27 will continue to authorise medicines as it currently does and Ireland will continue to be part of that system. The United Kingdom will separate from that process. We are working on arrangements with the United Kingdom for things like joint packaging. Because we have a common language, for a lot of the medicines supplied here and in the United Kingdom there is joint packaging. Joint packaging with third countries will be an acceptable process. We have worked on solutions to maintain the supply of medicines to the market and ensure we will have sufficient contingency plans in place.