business & legal

18/03/02 – EU regulation

Brexit, Brugge, Botox


On 2/3/18, Theresa May proposed that, following Brexit, the UK could become an “associate member” of the European Medicines Agency (EMA) and as such continue to participate in the EU pharmaceuticals regulatory regime post Brexit. As an “associate member” the UK will have no decision making powers. Even if the UK were to accept concessions such as observer-only status to the EMA, renouncing the UK parliament’s privilege to reject EU pharmaceutical laws, and agreeing to the jurisdiction of the European Court of Justice in all EMA matters, it remains to be seen if the EU is able to agree to extend access to the EU pharma regulatory system to a country that will not be part of the single market. 82 million patient packs travel between the UK and EU each month making it essential to ensure the supply of medicines across the UK and EU is uninterrupted for patient safety. Cooperation will also safeguard the future of research into new medicines and medical technologies.

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