EN PL

EMA: Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file

28.06.2012
The pharmacovigilance system master file is a legal requirement in the EU. This guidance concerns the requirements for the pharmacovigilance system master file and is applicable for any medicinal product authorised in the EU, irrespective of the marketing authorisation procedure.