Malta

Pharmacovigilance in Malta is regulated by the Malta Medicines Authority within the EU pharmacovigilance framework. The Authority’s current Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations require MAHs to establish and maintain a pharmacovigilance system, have a permanently and continuously available QPPV residing and operating in the EU, and maintain a PSMF available on request. The Authority may request a national pharmacovigilance contact person reporting to the QPPV, but such a contact is not automatically mandatory unless specifically requested. Valid ICSRs follow the EU EudraVigilance framework, including 15 calendar days for serious cases and 90 calendar days for non-serious cases. The same Malta guidance covers RMPs and additional risk-minimisation measures, PSURs, PASS, safety communications, and pharmacovigilance inspections; inspections may be routine, ad hoc or requested through European procedures. MAHs remain responsible for continuously monitoring benefit-risk and implementing conditions attached to the Malta marketing authorisation. 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.