Venezuela

Pharmacovigilance in Venezuela is coordinated by the National Centre for Pharmacological Surveillance (CENAVIF) within the Instituto Nacional de Higiene “Rafael Rangel” (INHRR). Under the Pharmacovigilance Guide for the Pharmaceutical Industry, effective 1 September 2025, each representative or Registration Certificate Holder must have a qualified Responsible Person for Pharmacovigilance (RFV) available in Venezuela, even when a regional responsible person exists. The RFV must be a healthcare professional with pharmacovigilance knowledge and training, must act as the principal authority contact and must keep current contact details with CENAVIF. The Guide also addresses individual safety reporting, periodic safety reports, risk-management plans, safety-related restrictions or changes, post-authorisation studies and signal evaluation. Product-specific deadlines and inspection arrangements should be checked against the current Guide and CENAVIF directions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.