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.

Prioritisation and delivery of EMA activities

EMA has developed a business continuity plan prioritising the Agency’s activities in order ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high quality, safe and effective medicines in the coming months and after the UK’s withdrawal from the EU.

In June 2017, EMA's Management Board endorsed the plan that makes available the necessary resources to prepare for Brexit and the move of the Agency and to cope with a potentially significant staff loss.

The plan establishes three priority levels for EMA's activities according to their impact on public health and the ability of the Agency to function properly.

The Agency will maintain the delivery of its highest and medium priority activities but has decided to scale back or temporarily suspend some of its lowest priority activities. A significant loss of staff as a consequence of the Agency’s relocation may lead to more restrictions than currently foreseen in the plan.

EMA will provide updates on the implementation of its business continuity plan as necessary.

Highest priority activities
Types of activities

Activities either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European medicines regulatory network, including for example:

  • the coordination of actions to protect the safety of patients in all EU Member States;
  • inspections across the EU;
  • maintenance of critical IT applications used by all Member States.
Current statusbusiness as usual

 

Medium priority activities
Types of activities

Strategic activities, such as:

  • the proactive publication of clinical data;
  • initiatives to promote the availability of medicines;
  • contributions to the fight against antimicrobial resistance;
  • collaboration with health technology assessment bodies.
Current statusbusiness as usual

 

Lowest priority activities
Types of activitiesGovernance and support activities
Current status

Activities temporarily suspended include:

  • the development of a new publicly available online information source on all medicines marketed in the EU (the European medicines web portal);
  • EMA’s contribution to the planning and preparation for the implementation of the Electronic Common Technical Document (eCTD) version 4.0 that will allow applicants to electronically submit documents linked to authorisation requests for human and veterinary medicines in a secure and efficient way;
  • the development of a transparency roadmap that lays out future transparency measures of the Agency;
  • participation in the benchmarking of medicines regulatory authorities in the EU as of 2018.

Activities scaled back include:

  • audits and corporate governance and support activities;
  • participation in and organisation of meetings and conferences.

 

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.

The European Council will decide on the Agency's new location by vote on 20 November 2017.

The deadline for Member States to submit formal bids to host EMA to the Council was 31 July 2017. The Council published the list of bids on 1 August 2017.  The European Commission will examine the bids based on the agreed process and criteria for deciding on EMA’s new location and submit its assessment to the Council by 30 September 2017.

The Agency is carrying out impact assessments that will help prepare for the move while retaining as many staff as possible. EMA welcomes the interest expressed by a large number of Member States in hosting the Agency. 

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Brochure: The work of EMA