Luxembourg

Pharmacovigilance in Luxembourg is administered by the national health authorities and functions within the EU pharmacovigilance system. The official French-language government page on notification des effets indésirables des médicaments provides the national route for suspected adverse-reaction reporting and identifies the competent Luxembourg pharmacovigilance contacts. For marketing-authorisation holders, the EU framework applies: a continuously available QPPV must reside and operate in the EU/EEA, the MAH must maintain a PSMF, and valid ICSRs are submitted through the EU system within the applicable 15-day serious and 90-day non-serious reporting timelines. PSUR/PBRER obligations follow the EU reference-date and product-specific requirements, while RMPs, additional risk-minimisation measures, signal management and pharmacovigilance inspections follow EU GVP and the conditions of the authorisation. The current Luxembourg material reviewed does not establish a separate universal requirement that the EU QPPV must personally reside in Luxembourg; any national contact or local implementation requirement should be confirmed for the specific product and procedure. 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.