Dr. Lorraine Nolan:

We have. The Deputy is correct. The European Commission has given a derogation until the end of this year, so the testing that is currently performed in the UK continues to be performed there. This is a transition agreement. The industry has made very good progress on transferring regulatory activities that were conducted in the UK, which would have been the location of the marketing authorisation, the holder of the testing, and the batch released activities to the EU 27. Ireland has received many of those transfers. We have not received them all as they have also gone to other European countries. That work has been very much in train over the last number of months. There are still levels of non-compliance but the industry is continuing to work towards these and as the deadline approaches will see a big push in that direction.

There may be issues with the testing, to be honest with the committee on this point. For some complex biological medicines that are proteins etc., the relocation and the finding of a facility in Europe may not be as easy and then there is competition for contract laboratory space. It will depend on where we end up across the European system on this. A European solution will probably be determined, if necessary. If not, it can be managed on a national basis and we can work with companies towards compliance on that as well.