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'. EMA is making preparations to ensure that the Agency 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.

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

The Agency is working closely with the EU institutions and national competent authorities in the European medicines regulatory network and will continue to share information on the latest developments with its stakeholders.

EMA's ongoing mission

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

The UK fully participates in the activities of EMA. It continues to participate in all formal meetings and retains its speaking and voting rights.

Regulatory preparedness

EMA needs to prepare in a timely manner to ensure that it can continue to deliver on its mission and protect public and animal health beyond March 2019.

The Agency is working on the assumption that the UK will become a third country as of 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations.

EMA 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. 

In June 2017, EMA's Management Board endorsed principles and a working methodology to successfully undertake a distribution of the workload on the evaluation and monitoring of medicines to ensure high quality scientific assessments and compliance with legal timelines. 

The Management Board endorsed the mandates of two working groups, one focusing on human medicines and one on veterinary medicines, that will explore options for a robust allocation of the workload across the European medicines regulatory network and ways to streamline work and further increase capacity in the network.

The Board endorsed a business continuity plan on the principles and the methodology that will help EMA prioritise its activities to make available the necessary resources to prepare for Brexit and cope with a potentially significant staff loss.

Information for companies

EMA and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the UK's withdrawal from the EU. 

This aims to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines for the benefit of patients, based on the assumption that the UK will become a third country as of 30 March 2019. 

On 31 May 2017, EMA and the European Commission published a question-and-answer (Q&A) document concerning the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies' manufacturing and batch release sites:

The Q&A provides further detail following the European Commission/EMA notice of 2 May 2017 intended to remind marketing authorisation holders of centrally authorised medicines of their legal obligations in preparation for Brexit:

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has also published information for marketing authorisation holders of nationally authorised products for human use. For more information, see the Heads of Medicines Agencies (HMA) website

Companies should check this page regularly for further guidance on the consequences of Brexit, as EMA and the European Commission are preparing a series of further guidance documents. 

Decision on EMA's location

EMA will need to move to a new location as a consequence of the UK's withdrawal from the EU. The location of the Agency after Brexit is unknown at present.

Update: The European Council will decide on the Agency's new location by common agreement, expected in November 2017. On 22 June 2017, the European Council published a document setting out the criteria and process for deciding on EMA’s new location.

The Agency is carrying out impact assessments that will help prepare for the move while retaining as many staff as possible, once the European Council has taken its decision on EMA’s new location. EMA welcomes the interest expressed by a large number of Member States in hosting the Agency. 

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The work of the European Medicines Agency - Brochure