Lebanon

Pharmacovigilance in Lebanon is overseen by the Ministry of Public Health (MoPH) through the Lebanese National Pharmacovigilance programme. The Lebanese Good Pharmacovigilance Practices (LGVP) Modules I, II, V, VI, VII, VIII, XV and XVI were finalised on 15 January 2026, while implementation was subsequently deferred to Q3 2027. The framework provides for a Lebanese, Lebanon-resident national QPPV for national MAHs and a Lebanese, resident Local Safety Responsible for multinational MAHs. The PSMF and national PSSF requirements require the files to be supplied within 14 days when requested. Module VI sets 15 calendar days for serious valid ICSRs and 90 calendar days for non-serious valid ICSRs, using ICH E2B-compatible electronic reporting. The final modules also cover RMPs, PSURs, safety studies, communications and risk-minimisation measures. Inspection and audit modules issued for consultation in 2026 were not final at the review date, and a final Lebanese signal-management module was not identified; companies should verify later publications before implementation. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.