
EMA Issues Brexit Guidance
The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.
On May 31, 2017, the European Medicines Agency (EMA) and the European Commission published
Specifically, the guidance answers some of the industry’s questions regarding the implication of Brexit on marketing authorizations, orphan drug designations, and pharmacovigilance. The document address concerns regarding the location of personnel, documents, and manufacturing facilities currently located in the UK.
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.