Brexit: EMA to focus on Medicines Evaluation and Supervision

Recommendation

7/8 May 2024

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On 24 September 2018 a meeting with industry stakeholders was held to discuss the UK's withdrawal from the European Union ("Brexit"). This meeting was organised by EMA together with the European Commission and was attended by a broad range of industry stakeholders either directly or remotely. The focus was on the possible impact on the operation of the centralised procedure for human and veterinary medicines. Now the meeting notes were published. 

At the meeting, participants were updated on EMA's Brexit preparedness plans and the relocation to Amsterdam. EMA pointed out that "with the exception of some delays in processing of EMA certificates, there should be no impact on other EMA procedures (e.g. scientific advice, orphan designation, paediatric investigation plans (PIPs), applications for marketing authorisation, post-authorisation activities)". EMA advises companies to submit applications and requests as normal and all Brexit-related variation applications before the end of 2018.