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Focus on Regulation

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a potential Brexit transition period.

Speaking at the Drug Information Association (DIA) forum for EU QPPVs that took place on 4 and 5 October 2017, Ms. Saint-Raymond told industry’s representatives “to consider the changes needed and to consider implementing them”.

Ms. Saint-Raymond recalled that the UK is due become a “third country” as of 30 March 2019. The procedures that should be finalised before Brexit takes effect, assuming that no other arrangements are put in place to apply from the date of Brexit, could be time consuming. In addition, Ms. Saint-Raymond observed that if companies wait to implement such measures until the last moment, there could be related delays within EMA, due to the high amount of requests.

In these circumstances, Ms. Saint-Raymond advised companies having operations in the UK to prepare “without thinking of the transition period“, following the cautious approach already adopted by the EMA in the last months.

As discussed in our “Brexit Bulletin“, the European Commission and the EMA have already published a notice and a Q&A document concerning the steps that companies would be required to take in a Brexit “worst case scenario”, whereby EU law will no longer be applicable in the UK.

The EMA and the European Commission are preparing a series of further guidance documents which will be published on the Agency’s website.