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Glossary Terms

Pharmacovigilance System Master File

A masterfile of pharmacovigilance information made mandatory by European Union Directive 2010/84/EU. The content of the file, laid out in Article 2 of EU Reg. 520/2012, includes a curriculum vitae of the Qualified Person for Pharmacovigilance, contact details, responsibilities and back-up arrangements in the event of absence.

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