As a consequence of the withdrawal from the European Union (EU), UK will become a third country by March 2019 at the latest. The European Medicines Agency (EMA) is, therefore, working to relocate its Agency from London to one of the other 27 Member States and to ensure a proper functioning of the single market for medicines in the EU and the protection of public and animal health.
Two working groups, one focusing on human medicines and one on veterinary medicines, have been established to discuss on the distribution of the workload related to the evaluation and monitoring of medicines between Member States in view of the UK decision to leave the EU.
EMA’s Management Board prepared a “business continuity plan” to ensure all the necessary resources to Brexit and to overcome problems related to potentially significant staff loss.
To guarantee undisrupted supply of medicines for the benefit of patients beyond March 2019, EMA and the European Commission are providing guidelines to help pharmaceutical companies as well as question-and-answer (Q&A) documents concerning medicinal products for human and veterinary use within the framework of the centralized procedure.
Since non-member countries cannot host EU agencies, a physical relocation of the EMA offices is needed. Some Member State have already expressed some interest in hosting the Agency, but the future location is still unknown. For now, EMA is carrying out impact assessments to prepare the move in the attempt to retain as many staff as possible. European Council’s decision on the future headquarters is expected in October 2017. These are the cities proposed to host the EMA, as of 1 August 2017: Amsterdam, Athens, Barcelona, Bonn, Bratislava, Brussels, Bucharest, Copenhagen, Dublin, Helsinki, Lille, Malta, Milan, Porto, Sofia, Stockholm, Vienna, Warsaw and Zagreb.
Updates on the consequence of Brexit on EMA activities and guidance documents are available at this link.