Latvia

Pharmacovigilance activities in Latvia are regulated by the State Agency of Medicines (ZVA) under EU legislation and EU GVP. The MAH must appoint an EU/EEA QPPV, maintain an EU/EEA PSMF and meet EU ICSR, PSUR and RMP obligations. Under Latvia's national pharmacovigilance requirements, when the EU QPPV does not reside and operate in Latvia, the MAH must nominate a national pharmacovigilance contact who resides and works in Latvia and provide the contact details to ZVA. 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.