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United Kingdom’s withdrawal from the European Union (‘Brexit’)

One of the consequences of Brexit is that EMA will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest.

EMA is working on the scenario that the UK will become a third countryas of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteurfor new marketing authorisation applicationsfor which the centralised procedurewould finish after 30 March 2019.

Continuity of EMA activities

EMA is essential to the functioning of the single market for medicinesin the EU. The Agency’s work is vital to providing EU citizens with effective, safe and high-quality medicines and to maintain a regulatory environment that fosters innovation and the development of new medicines.

The Agency is taking steps to ensure that it can continue to deliver on its missionand protect public and animal health while it prepares to relocate.

Business continuity plan

EMA has developed a business continuity plan to ensure operational continuitywhile the Agency prepares for its relocation and the UK’s withdrawal from the EU. It enables EMA to deliver its highest priority activities and to temporarily scale back or temporarily suspend lower priority activities if required. The plan entered its second phase in January 2018.

EMA will launch a third phaseof its business continuity plan on 1 October 2018at the latest, following implementation of the first and second phases of the plan.

Activities to be scaled back or suspendedin the third phase include:

  • collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58. In global medicine regulation, EMA will only take a reactive role. EMA’s engagement in other global public health issues such as antimicrobial resistanceor vaccines will be maintained as long as possible, but reviewed on a case-by-case basis;
  • development and revision of guidelines, which will be temporarily limited to those guidelinesthat address an urgent public or animal health need or are necessary to support and facilitate preparation for Brexit;
  • holding of non-product related working parties, which will be temporarily reduced as a consequence of the scaling back of guidelinedevelopment or revision;
  • programmes and projects, where activities in relation to project governance will be reduced in line with the reduction and suspension of projects;
  • organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions;
  • clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018. Data packages submitted for medicines until the end of July 2018 will be processed and finalised.

EMA will continuously review and adapt its business continuity plan as necessary.

For further information:

https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit

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