Posted by Michael Wonder on 13 Nov 2018
EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision
13 November 2018 - A report on EMA’s 24 September 2018 meeting with industry stakeholders to discuss the UK’s withdrawal from the European Union and the impact on the operation of the centralised procedure for human and veterinary medicines, published today, outlines how the European medicines regulatory network is preparing for Brexit, including EMA’s relocation and business continuity planning.
At the meeting, participants were updated on EMA’s Brexit preparedness plans, which ensure that all core activities related to the evaluation and supervision of medicines continue uninterrupted, and to the same quality and timelines during the Agency’s relocation to Amsterdam and throughout 2019.
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). Companies are advised to submit applications and requests as normal.
