Denmark

Pharmacovigilance activities in Denmark are regulated by the Danish Medicines Agency (DKMA) under EU pharmacovigilance legislation and EU GVP. The MAH must maintain a pharmacovigilance system, appoint an EU/EEA QPPV, maintain an EU/EEA PSMF, report ICSRs through EudraVigilance and comply with applicable PSUR and RMP obligations. DKMA does not generally require a national pharmacovigilance contact, but may request one when considered necessary. The system is subject to risk-based inspection. 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.