Norway

Pharmacovigilance in Norway is regulated by the Norwegian Medical Products Agency (DMP) under EU pharmacovigilance legislation as incorporated through the EEA and EU GVP. The MAH must maintain an EU/EEA QPPV and PSMF and comply with EudraVigilance, PSUR, RMP, signal-management and inspection requirements. Norway does not impose a general separate national pharmacovigilance-contact requirement for human medicines. As an EU/EEA jurisdiction, the EU pharmacovigilance framework applies to the EU QPPV and Union PSMF, EudraVigilance ICSR reporting, applicable PSURs, RMPs, signal management, quality-system audits and competent-authority inspections. MAHs should also check current national submission channels, contact arrangements and language requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Difference in QPPV Nomination Between EU and KSA; PSMF Maintenance: Concept and Importance in Pharmacovigilance.