FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Outlines Methods for Transferring Product Approvals Before Brexit

Dec. 1, 2017
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The European Medicines Agency published new, practical guidance for marketing authorization holders in navigating the UK’s 2019 departure from the European Union — including the procedures for classifying any Brexit-related impacts on pharmaceutical manufacturing.

The document addresses several questions for sponsors of centrally authorized products, such as how to submit now-required product variations, authorization transfers or changes in pharmacovigilance reporting, including new contact names and addresses.

Previous EMA guidance detailed how marketing authorization holders must be based in the European Economic Area after March 30, 2019 — with the UK becoming a third country for the purposes of EU regulations, and any products or ingredients manufactured there considered as imports. In addition, each drugmaker’s pharmacovigilance master files and qualified person for pharmacovigilance will have to relocate if they are based in the UK.

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