El Salvador

Pharmacovigilance activities in El Salvador are regulated by the Superintendencia de Regulación Sanitaria (SRS) for regulated pharmaceutical activities and operate within the national pharmacovigilance framework of the Ministry of Health. The national framework includes the technical pharmacovigilance requirements and SRS Good Pharmacovigilance Practice guidance. MAHs and responsible regulated entities must maintain pharmacovigilance arrangements, designated pharmacovigilance responsibilities, adverse-event reporting processes and applicable periodic safety and risk-management documentation, and are subject to Good Pharmacovigilance Practice inspection. Current product-specific requirements and reporting routes should be applied in accordance with SRS and Ministry of Health instructions. Where the cited public sources do not expressly define local QPPV or responsible-person arrangement, pharmacovigilance system file, risk-management plan and signal management, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.