Cyprus

Pharmacovigilance activities in Cyprus are regulated by the Pharmaceutical Services of the Ministry of Health and the applicable European Union pharmacovigilance framework. MAHs must comply with EU pharmacovigilance requirements, including an EU/EEA QPPV, PSMF, EudraVigilance ICSR reporting, PSUR/PBRER obligations, risk-management requirements and pharmacovigilance inspections. In addition, Cyprus requires a local QPPV/RPPV residing in Cyprus who meets the national eligibility requirements and acts as the local pharmacovigilance contact. EU requirements are implemented in conjunction with the national Pharmaceutical Services procedures. Where the cited public sources do not expressly define risk-management plan and 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.