Dr. Lorraine Nolan:

I will start where Mr. Breslin ended, which was on ordering, and work through questions in that way. Wholesalers have a process for putting stock in allocation when there is a concern in respect of supply and availability. As we work through and identify products that could be impacted - and we are not at that stage yet because we have not identified these products - those processes can be activated. That system of controlling what is supplied to pharmacies exists and can be activated and put in place.

I will start with the TPN and compounded products. The Deputy is right in that regard. We have identified these as a category of products in respect of which particular risks will arise from Brexit because many of them have short shelf lives and some have particular storage requirements that it may not be possible to fulfil if there are delays in getting imports in through the ports. We work with three TPN compounders and suppliers in the UK. We have engaged with these and with compounding companies based in Ireland. In all cases, the companies have told us that their Brexit planning is well developed. They have increased their stocks of component parts and are looking at the logistics of getting products into Ireland. Some of this is routed through the UK but the companies are looking at flying it into Ireland directly. We are engaging with them almost weekly to get updates in real time. It is an evolving situation. If we become aware of any concerns, we will take appropriate measures to address them.

We have not been informed of any concerns relating to those supplies.

The Deputy mentioned the conduct of regulatory activities, of which there are many because of the United Kingdom's history in pharmaceutical manufacturing, etc. These include specifically mentioned activities such as QP batch release and pharmacovigilance QP residing in the United Kingdom. Over the past two years, the regulatory system across the European network has been preparing widely for this and we have also been working with the companies. It is the case that the vast majority of companies have worked to transfer those activities into the other EU 27 member states. Some of that work, specifically in the area of quality control testing, for example, has been transferred to Ireland. Similar transfers have happened with the batch release activities and the QPV. We do not necessarily have any concerns about that.

Joint labelling has been an issue that we have been working extensively on, especially as 60% of the medicines supplied in Ireland have joint labels with the UK. Ms Purcell will speak a little on that. We have been exploring the possibilities of coming up with joint labelling with other EU member states and we have had quite extensive discussions with Scandinavian countries in that regard. There are associated challenges because the look and feel of products will change very much for both healthcare professionals and patients but it is something we are developing as a contingency.