Lithuania

Pharmacovigilance in Lithuania is regulated by the Valstybinė vaistų kontrolės tarnyba (VVKT) and operates within the EU pharmacovigilance framework. VVKT’s Lithuanian-language information for marketing-authorisation holders confirms application of EU Good Pharmacovigilance Practice requirements and national procedures for MAHs. Accordingly, MAHs must maintain an EU-compliant pharmacovigilance system, a continuously available EU/EEA QPPV and a PSMF; a separate Lithuanian-resident QPPV is not automatically required, although the authority may require an appropriate national pharmacovigilance contact where necessary. Valid EU ICSRs are handled under the EudraVigilance framework, including 15 calendar days for serious cases and 90 calendar days for non-serious cases. PSUR/PBRER submission, RMP maintenance, signal management and additional risk-minimisation measures follow EU requirements and the conditions of the relevant marketing authorisation. VVKT also conducts pharmacovigilance inspections: its farmakologinio budrumo inspekcijos page describes planned and unplanned inspections of MAH pharmacovigilance systems. 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.