Good Pharmacovigilance Practice (GVP)
Good Pharmacovigilance Practice (GVP) is a set of measures designed to facilitate the conduct of pharmacovigilance activities in the European Union. GVP applies to holders of centralized and nationally authorized marketing authorizations for medicinal products, the European Medicines Agency (EMA), and national competent authorities for medicinal products in EU member states.
HALMED oversees the adherence to Good Pharmacovigilance Practice by marketing authorization holders in the Republic of Croatia whose qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master file (PSMF) is located in Croatia, the oversight of GVP compliance of global pharmacovigilance branches operating in Croatia, and the supervision of GVP by contractual pharmacovigilance service providers acting on behalf of marketing authorization holders in Croatia.
