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PSMF establishment and maintenance, business as usual?

News   •   May 31, 2013 09:00 CEST

Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).