The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies to prepare for Brexit.
The guidance document sets out 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 products in the European Economic Area after the UK’s European Union (EU) withdrawal.
The guidance has been prepared on the basis that the UK will become separate from the EU as of March 30, 2019.
It is recommended that the guidance be read in conjunction with the questions and answers related to the UK’s withdrawal with regard to the medicinal products for human and veterinary use within the framework of the centralised procedure, which was 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 must be addressed before Brexit occurs.
Pharmaceutical companies also need to make sure that any necessary changes are made prior to the date of withdrawal.
The EMA is now creating a further series of Brexit guidance which will be published on its website.