Austria

Pharmacovigilance activities in Austria are supervised by the Federal Office for Safety in Health Care (BASG) and are governed by EU pharmacovigilance legislation and EU GVP. The MAH must operate an EU-compliant pharmacovigilance system, appoint a QPPV who resides and performs the role in the EU/EEA and maintain a PSMF located in the EU/EEA. Austria does not impose a separate local pharmacovigilance contact as a universal requirement; BASG recommends a national contact and may require a locally responsible person in justified cases. EudraVigilance ICSR reporting, applicable PSURs, RMP/risk-minimisation duties and risk-based pharmacovigilance inspection apply. Where the cited public sources do not expressly define signal management, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. 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.