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 to relocate to Amsterdam, the Netherlands

EMA will relocate to Amsterdam, the Netherlands, following the UK’s withdrawal from the EU.

The EU 27 Member States took this decision on 20 November in the margins of the General Affairs Council (Article 50) of the European Council

The Agency will begin working immediately with the Dutch government to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.

EMA and the Netherlands will establish a joint governance structure to steer and oversee the relocation project. 

In early December 2017, the Agency will publish a monitoring chart on its website that will allow stakeholders to track progress.

Amsterdam was one of 19 offers to host EMA submitted by the Member States at the end of July 2017. For more information, see Background to relocation decision.

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.

Continuity and prioritisation of EMA activities

EMA has developed a business continuity plan to ensure operational continuity while the Agency prepares for its relocation to Amsterdam 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:

The plan supports EMA's aim of operating for as long as possible under a 'business as usual' scenario, while preparing for the consequences of Brexit in parallel. 

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. 

EMA will continuously review and adapt the plan as necessary.

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. 

Update: In November 2017, EMA and the European Commission updated a question-and-answer (Q&A) document first published in May 2017 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.

Updates are marked ‘NEW’ and include information on how the UK’s withdrawal from the EU will affect marketing authorisation applications and the authorisations of different types of products, such as generic, hybrid and biosimilar medicines:

In November 2017, EMA also published additional practical guidance to help pharmaceutical companies make all necessary changes to their marketing authorisations by the end of March 2019, to enable the continued marketing of their medicine in the EU following Brexit:

The Q&A and practical guidance documents provide 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:

In October 2017, EMA published a report of its meeting with industry stakeholders on Brexit preparedness activities and operation of the centralised procedure for human medicines. This contains updates from EMA and EU trade industry associations on their preparations for Brexit and information on planned stakeholder engagement activities:

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. 

Background to relocation decision 

The decision taken by the EU 27 Member States on 20 November 2017 to relocate EMA to Amsterdam followed an assessment by the European Commission and EMA of the formal offers submitted by Member States to host the Agency. 

Member States had until 31 July 2017 to submit their bids to the European Council

The European Commission examined the bids based on the agreed process and criteria for deciding on EMA’s new location and submitted its assessment to the Council on 30 September 2017.

EMA published the information it submitted to support the European Commission's assessment of the 19 Member State bids to host the Agency on 3 October:

EMA made available the results of a staff retention survey carried out in September 2017 as part of business continuity planning, after staff had the opportunity to study the Member State bids. For more information, see:

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