EMA, European Commission Issue Guidance for Pharma Companies Post Brexit

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-01-2017 14:32


The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralized procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance. and companies’ manufacturing and batch release sites.

EMA is preparing a series of further guidance documents that will be published on its website in due course, said the EMA in a statement. Companies are advised to regularly check EMA’s dedicated webpage on the consequences of Brexit, which may found here.

This first questions-and-answers document follows the publication of the European Commission/EMA notice to marketing authorization holders of centrally authorized medicines for human and veterinary use on May 2, 2017.

Source: European Medicines Agency


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