EMA Issues Guidance on Post-Brexit Changes for Pharma Companies

The European Medicines Agency (EMA) has issued procedural guidance to help pharmaceutical companies prepare for the UK’s 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 authorization to 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 March 30, 2019.

The EMA says the guidance should be read in conjunction with the questions and answers document, published in May 2017, related to the UK’s withdrawal from the EU with regard to the medicinal products for human and veterinary use within the framework of the centralized procedure. The EMA says marketing authorization holders, applicants, and sponsors of centrally authorized 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. The agency also said they need to ensure that the necessary changes are made by that date (March 30, 2019).

The EMA says it is preparing a series of further Brexit-related guidance, which will be published on its website.

Source: European Medicines Agency (statement) and European Medicines Agency (guidance)


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