Andorra

Pharmacovigilance in Andorra is coordinated by the Ministry of Health through the Centre de Farmacovigilància. The national pharmacovigilance programme provides a route for reporting suspected adverse reactions. The current public official sources do not set out EU-style marketing authorisation Holder (MAH) obligations for a local QPPV, Pharmacovigilance System Master File (PSMF), Periodic Safety Update Report (PSUR/PBRER), or Risk Management Plan (RMP); these are not established as mandatory Andorran requirements without product-specific confirmation. MAHs/applicants should comply with applicable authorisation conditions and communicate safety information through the Ministry's pharmacovigilance channels. Where the cited public sources do not expressly define signal management and audit and inspection arrangements, 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): Effective Signal Management in Pharmacovigilance.