Bolivia

Pharmacovigilance in Bolivia is regulated by the State Agency for Medicines and Health Technologies (AGEMED). Administrative Resolution RA/AGEMED/RA/43/2024 approved the Directive for Audit and Certification in Good Pharmacovigilance Practices (BPFV), applicable from 2 January 2025 to pharmaceutical laboratories, importers and national distributors and to pharmacovigilance centres in health establishments. The audit framework requires an accredited Pharmacovigilance Responsible Person and an operational pharmacovigilance centre; the Pharmacovigilance Master File (Archivo Maestro de Farmacovigilancia) is requested before the audit and forms part of the audit documentation. The BPFV certificate is valid for three years, and regulated entities remain subject to post-certification inspections. The directive supports these organisational, master-file and inspection obligations, without converting AGEMED's national terminology into an EU-style QPPV/PSMF model. Where the cited public sources do not expressly define ICSR reporting route and timelines, periodic safety reporting, 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.