Chile

Pharmacovigilance in Chile is regulated by the Instituto de Salud Pública de Chile (ISP), principally under Norma General Técnica N°140 on the National Pharmacovigilance System for Human Medicinal Products. Marketing authorisation Holders are required to establish and maintain an appropriate pharmacovigilance system and designate an Encargado de Farmacovigilancia responsible for pharmacovigilance activities and liaison with the ISP. Suspected adverse reactions occurring in Chile must be reported within 15 calendar days when they are serious, unexpected, or involve a recently marketed medicine that has been available in Chile for less than five years. Reports that meet none of these criteria are due within 30 calendar days; therefore, a non-serious but unexpected reaction remains subject to the 15-day timeline. Periodic Safety Reports (IPS/PSURs) are generally submitted at maximum intervals of every six months during the first two years of commercialization, annually during the following three years, and every five years thereafter, although the ISP may establish a different periodicity in specific cases. Risk Management Plans (Planes de Manejo de Riesgos) are required for specified medicinal products rather than universally for all products. The ISP also conducts pharmacovigilance inspections of marketing authorisation Holders. No standalone Chilean 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.