Dr. Lorraine Nolan:

Even from my opening statement, it is clear we have had a very extensive period of engagement with all the stakeholders involved. To put it in context, 7,000 medicines are authorised for supply in our market. We have contacted the marketing authorisation holders for all those products, not just once but on many occasions. We also engaged with all the wholesalers. They have reassured us that they are considering everything they need to put in place and that they are planning for Brexit. They are also examining their contingency plans, including for identifying alternative transport routes. The companies are very sophisticated and since logistics are key to their viability, they have high levels of expertise in respect of anticipation and planning in this regard.

We are doing everything we can do and anticipating everything we can. We will continue in this regard until the deadline, or until the United Kingdom exits. That said, things can happen. The co-operation arrangement developed between the HPRA, the Department and the HSE and the mechanisms we have in place through the operations group and the criticality assessment are such that, coming into the existing systems and from a regulatory viewpoint in terms of our shortages framework, we have really strengthened our intelligence capability. I am confident that we can anticipate and that we have systems in place to manage what may happen.

However, there are many unknowns with Brexit. I must be honest about that. As stated earlier, there are no guarantees, but I believe we have anticipated insofar as it is possible to do so. I also believe we have developed a good methodology to be able to manage the situations that may arise over the coming period.