Poland

Pharmacovigilance in Poland is regulated by the Office for Registration of Medicinal Products (URPL) under EU legislation and EU GVP. The MAH must maintain an EU/EEA QPPV and PSMF and comply with EudraVigilance, PSUR, RMP and inspection obligations. The Polish national position highly recommends a local pharmacovigilance contact when the product is marketed; the role should be organised so that national pharmacovigilance requirements and authority communication can be handled effectively. 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.