EMA focus on Brexit preparations and EU clinical trial portal and database

The Management Board of the European Medicines Agency (EMA) was updated on the Agency’s preparation for the withdrawal of the UK from the European Union at its June meeting this week.

Further to the UK’s invocation of Article 50 on March 29 2017, the EMA needs to prepare and is working on the assumption that the UK will become a third country as of March 30, 2019. This is without prejudice to the outcome of the withdrawal negotiations. The UK fully participates in the activities of EMA; it continues to participate in all formal meetings and retains its speaking and voting rights.

The EMA is essential to the functioning of the single market for medicines in the EU. The Agency’s work is vital to provide EU citizens with effective, safe and high-quality medicines and to maintain a regulatory environment which fosters innovation and the development of new medicines. Timely preparations are necessary to ensure that EMA can continue to deliver on its mission and protect public and animal health beyond March 2019.