United Kingdom's withdrawal from the European Union ('Brexit')
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.
Extension of the period under 'Article 50'
The European Council agreed to a further extension of the date for the UK’s withdrawal from the EU at its meeting on 10-11 April. The extension will last as long as necessary and, in any event, no longer than 31 October 2019. For more information, see:
The UK remains a 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 October 2019.
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 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.
No Member State has previously decided to leave the EU, so there is no precedent for this situation.
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.
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. Since 1 July 2019 the new rapporteurs and co-rapporteurs are fully responsible for these medicines.
In October 2018, EMA published the cut-off dates for UK (co)-rapporteur appointments for pre- and post-authorisation activities, based on the average duration of specific centralised procedures from submission to outcome:
- Cut-off dates for UK Rapporteurship appointments for pre and post authorisation procedures for centrally authorised products
In September 2018, the new (co)-rapporteurs received 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 working group on committees' operational preparedness for human medicines
- EMA working group on committees' operational preparedness for veterinary medicines
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.
EMA has developed a business continuity plan to ensure operational continuity during its physical relocation and readiness for the UK's withdrawal from the EU. It enables EMA to deliver its highest priority activities and to temporarily scale back or suspend lower priority activities if required.
EMA will continue to operate under business continuity conditions until at least the end of 2019, to safeguard the Agency's core activities related to the evaluation and supervision of medicines. This is necessary as EMA will need several months to rebuild its workforce.
Update: EMA has prioritised activities from its multi-annual work programme to continue in 2019, which are included in Annex 1 of the business continuity plan:
EMA is still anticipating to lose between 20% and 25% of the 901 staff members it had at the end of 2018. As of early June 2019, the Agency’s available workforce was 776. Of those, 464 staff members have relocated to the Netherlands and 312 are currently teleworking mainly from London due to their personal circumstances. A recruitment exercise is currently ongoing to make sure that staff who decide not to relocate can be replaced. However, the Agency does not anticipate reaching its previous headcount, which included a large number of staff on short-term local contracts.
Due to resource constraints, most activities temporarily suspended at the end of 2018 remain on hold. These include guideline development, most working party meetings, engagement in international activities and the proactive publication of clinical data. A further review by EMA's Management Board will take place in October 2019.
EMA will start to reinstate some activities as of June 2019. The focus will be on activities and projects that aim to increase the efficiency of EMA’s operations to ensure that the Agency is fit-for-purpose in the longer term, e.g. IT systems supporting medicines evaluation and the digitalisation of administrative processes. In addition, some of the EU network working groups directly contributing to EMA’s core activities will restart. More detail on activities to be reprioritised are outlined in the updated Annex 1 to EMA Brexit preparedness business continuity plan - Phase 4 .
EMA also faces a substantial workload stemming from new legislation for which no additional resources have been made available. These include the Regulations on medical devices and in vitro diagnostic medical devices, the EU Data Protection Regulation and the veterinary legislation, which foresees the development of major IT infrastructure and re-engineering of processes. Preparatory work on these pieces of legislation has been tentatively planned to start as of June 2019, but any work undertaken will be subject to availability of the required human and financial resources.
EMA will continuously review and adapt its business continuity plan as necessary.
EMA has published a questions-and-answers document to address potential questions from stakeholders on the supply of medicines in the EU after Brexit and what the Agency, the European Commission and national competent authorities in the Member States are doing to prevent potential medicine supply shortages due to Brexit: