Paraguay

Pharmacovigilance in Paraguay is regulated by the National Directorate of Health Surveillance (DINAVISA), which coordinates the National Pharmacovigilance System and publishes the applicable rules, forms, and compliance materials. DINAVISA Resolution No. 340/2024 established the current national framework and provides for designation of a pharmacovigilance responsible person by holders of medicinal-product registrations. Marketing authorisation Holders (MAHs) must implement good pharmacovigilance practices, collect and evaluate safety information, report suspected adverse reactions and other relevant risks, manage signals, maintain supporting records, and comply with required periodic reporting and risk-management measures. Under Resolution No. 88/2025, holders may obtain official confirmation that good pharmacovigilance practices have been implemented, based on the applicable procedure and verification checklist. Because reporting details can depend on the type of case, product, and current DINAVISA instruction, companies should verify operative formats and timelines directly against the current resolution set and authorisation conditions and remain prepared for compliance inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.