EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision

News 13/11/2018

A PDF icon 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.

The Agency entered PDF icon phase 3 of its Brexit preparedness business continuity plan (BCP) on 1 October 2018, with the temporary suspension or reduction of some additional activities, including the scaling back of guideline development and revision, and the temporary putting on hold of non-product-related working parties. These steps have been taken to ensure that EMA can focus on its core business of protecting human and animal health and that freed-up resources can be redeployed to allow the Agency to safeguard its core activities related to the evaluation and supervision of medicines.

The meeting was organised by EMA together with the European Commission and was attended by a broad range of industry stakeholders. Participants were again encouraged to submit all Brexit-related variation applications before end of 2018 to ensure that their marketing authorisations are compliant with EU pharmaceutical legislation before the departure of the UK from the EU.

A further three industry stakeholder meetings on Brexit are planned for 2019.

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