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

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On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), a process known as 'Brexit'. The European Medicines Agency (EMA) is making preparations to ensure that it can continue to deliver on its mission and protect public and animal health after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe provided in Article 50 of the Treaty on European Union.

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.

The Agency continues its operations in accordance with the timelines set by its rules and regulations.

EMA is working on the scenario that the UK will become a third country as of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications for which the centralised procedure would finish after 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.

No Member State has previously decided to leave the EU, so there is no precedent for this situation. 

In this section

Continuity of EMA activities

EMA is essential to the functioning of the single market for medicines in 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 mission and protect public and animal health while it prepares to relocate.

Regulatory preparedness

In April 2018, the EU27 Member States and EMA completed the redisribution of the UK's portfolio of over 370 centrally authorised products to rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway, in preparation for Brexit.

EMA informed the relevant marketing authorisation holders of the new (co)-rapporteurships at the end of April 2018.

EMA will facilitate knowledge transfer from the UK to the new rapporteurs and co-rapporteurs, who will only take full responsibility for these products as of 30 March 2019. 

Update: In September 2018, the new (co)-rapporteurs will receive a knowledge transfer package for each product, containing background knowledge on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment.

This will also help each national competent authority to forecast upcoming workload, to better support the planning of resources, particularly for complex products in the portfolio.

The redistribution plan covers the post-authorisation stage in a medicine’s lifecycle. It takes into account the diverse expertise in the European medicines regulatory network and allows Member States to participate in EMA activities according to their capacity.

The methodology draws on Member States’ expertise with a specific class of medicines and knowledge gained through prior involvement in a medicine's evaluation. For more information see: 

EMA's two working groups on committees' operational preparadness developed the methodology. For more information, see:

EMA first initiated discussions with the national competent authorities in April 2017 on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK’s withdrawal from the EU. 

Business continuity plan

EMA has developed a business continuity plan to ensure operational continuity while the Agency prepares for its relocation and the UK’s withdrawal from the EU. 

EMA published the full plan in October 2017, following endorsement by the Management Board in June 2017:

It assigns EMA activities to three categories of priority according to their impact on public health and the Agency’s ability to function. The plan enables EMA to deliver its highest priority activities and to temporarily scale back or temporarily suspend lower priority activities if required. 

The business continuity plan entered its second phase in January 2018. 

The Agency published further details of the plan in its 2018–20 multiannual work programme.

Update: In June 2018, EMA's Management Board endorsed the next phase of the business continuity plan. This will help EMA prepare for a scenario where there may be higher than anticipated staff losses. 

It will come into effect in October 2018, to enable staff to be mobilised to cover critical functions where needed.  EMA will monitor the situation and review the need for further reduction of activities on an ongoing basis. EMA will provide more information in due course.

EMA will continuously review and adapt the plan as necessary.

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Brochure: The work of EMA