The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisationto allow for the continued marketing of their medicine in the European Economic Area after the UK withdraws from the EU. The guidance has been prepared on the basis that the UK will become a third country as of 30 March 2019. It should be read in conjunction with the Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the centralised procedure published in May 2017.
Marketing authorisation holders, applicants and sponsors of centrally authorised medicines for human or veterinary use should consider how Brexit will impact their medicines and which changes need to be addressed before the UK leaves the EU. They also need to ensure that the necessary changes are made by that date.
EMA is preparing a series of further Brexit-related guidance which will be published on its website in due course. Companies are advised to regularly check EMA’s dedicated webpage on the consequences of Brexit.
United Kingdom’s withdrawal from the European Union ('Brexit')
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure (28/11/2017)