The European Medicines Agency this week published additional guidance for pharmaceutical companies to help them prepare for the United Kingdom’s withdrawal from the European Union.
The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation to allow for the continued marketing of their medicine in the European Economic Area after the United Kingdom withdraws from the EU. The guidance has been prepared on the basis that the United Kingdom will become a third country as of 30 March 2019.
The newly released additional guidance, which relates to medicines for human and veterinary use, should be read in conjunction with the Q&A guidance 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 United Kingdom leaves the EU. They also need to ensure that the necessary changes are made by that date, the EMA stated.
EMA said it 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 web page on the consequences of Brexit.