Brexit: the United Kingdom's withdrawal from the European Union
On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU). Since then, the European Medicines Agency (EMA) has been making preparations to ensure that it continues to deliver on its mission and protect public and animal health after Brexit.
EMA is continuing to operate in accordance with the timelines set by its rules and regulations during its relocation and throughout the Brexit process.
For planning purposes, EMA is working on the scenario that the UK will become a third country after Brexit. As a consequence, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications via the centralised procedure. This is without prejudice to the outcome of the withdrawal negotiations.
On 29 October 2019, the European Council agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 January 2020. For more information, see:
- European Council decision taken in agreement with the United Kingdom, extending the period under Article 50(3) TEU (28/10/2019)
- European Commission: Brexit preparedness activities
The UK remains an EU Member State for the duration of the extension.
EMA calls on all pharmaceutical companies in the EU to continue their preparedness for the UK’s withdrawal.
Based on the European Council decision, and until further notice, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 January 2020.
EMA is essential to the functioning of the single market for medicines in the EU. Its 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.
EMA had developed a business continuity plan to ensure operational continuity during its physical relocation and readiness for Brexit. This enabled EMA to deliver its highest priority activities, temporarily scaling back or suspending lower priority activities as required:
- Annex 1 to EMA Brexit preparedness business continuity plan - Phase 4
- EMA Brexit preparedness business continuity plan - Phase 3 implementation plan
- EMA Brexit preparedness business continuity plan (first and second phases)
Update: In defining its work programme for 2020 and beyond, EMA will focus on the core activities identified in phase four of its business continuity plan as a baseline. It will prioritise additional tasks depending on available resources.
The Agency is still in the process of rebuilding its workforce after its relocation. It will continue to monitor staff levels and review whether it can relaunch additional activities in June 2020.
In preparation for Brexit, the EU27 Member States and EMA redistributed the UK's portfolio of medicines to other EU Member States. This involved transferring over 370 centrally authorised products to rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway.
EMA informed the relevant marketing authorisation holders of the new (co)-rapporteurships at the end of April 2018.
In September 2018, the new (co)-rapporteurs received a knowledge transfer package for each product. This contained background on the regulatory and evaluation history of each product, including the most recent benefit-risk assessment. The transfer package also helps each national competent authority forecast upcoming workload and support the planning of resources, particularly for complex products in the portfolio.
Answers to potential questions on the supply of medicines in the EU after Brexit are available in the question-and-answer document below.
The document also explains what EMA, the European Commission and national competent authorities in the Member States are doing to prevent potential medicine supply shortages due to Brexit:
In order to be best prepared to address future challenges with the existing workforce, EMA is reviewing its organisational structure. This will ensure that EMA is geared up for the future with more efficient processes firmly rooted in digital technology to keep pace with rapid advances in science.
As part of the reorganisation, EMA is looking to set up task forces that will focus on key priorities for the European medicines regulatory network. These include:
- digital business transformation;
- data analytics and methods;
- regulatory science and innovation;
- clinical trials and manufacturing strategy.
EMA also plans to integrate operations in the area of human medicines to strengthen the therapeutic focus all along a medicine’s lifecycle. This aims to assure the quality of scientific opinions and further improve support to EMA’s scientific committees.
This review followed ongoing resource constraints, with delivery of EMA’s work programme for the last quarter of 2019 being challenging.
Update: As of December 2019, EMA's total available workforce was 775. This is significantly less than in November 2017 when EMA’s relocation plans took shape.
In addition, EMA needs to implement new legislation for veterinary medicines and medical devices, which will bring additional workload. See:
EMA will share more information with stakeholders in due course.