compliance
Pharmacovigilance System Master File – Emerging Requirements
It was July 2012 when the European Medicines Agency made it mandatory for all the marketing authorization holders (MAH) to maintain the Pharmacovigilance System Master File (PSMF) as per the GVP Module II. Until then, the document was a concise one and called as the detailed description of Pharmacovigilance system (DDPS). After the PSMF came […]