Colombia

Pharmacovigilance in Colombia is regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), principally under Resolution 2024015321 of 2024, effective since 1 March 2025. Marketing authorisation Holders must maintain a documented pharmacovigilance programme in Spanish covering their authorised products. The programme must be overseen by a qualified physician or pharmaceutical chemist who is permanently available and must reside and operate in Colombia. Serious expected or unexpected adverse events must be reported to INVIMA within 15 calendar days, while non-serious events are reportable within 90 calendar days. MAHs must maintain PSUR/PBRERs according to the applicable EU Reference Date schedule; these reports are not routinely submitted but must remain available to INVIMA and, when formally requested, must be provided within five business days. Risk Management Plans are governed by Resolution 213 of 2022, particularly for medicinal products containing new chemical active ingredients and biological medicines. INVIMA may conduct pharmacovigilance inspection, surveillance and control visits to verify compliance. No standalone Colombian PSMF requirement was identified in current official requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.