Peru

Pharmacovigilance in Peru is regulated by the General Directorate of Medicines, Supplies and Drugs (DIGEMID) through the Peruvian Pharmacovigilance and Technovigilance System. Holders of medicinal-product registrations and registration certificates are formal members of this national system and are expected to maintain an organized pharmacovigilance function, collect and evaluate safety information, submit suspected adverse-reaction reports, monitor signals, and support regulatory risk minimisation. Risk-management planning is addressed in the official Ministerial Resolution No. 796-2019-MINSA, which sets guidance for pharmacovigilance plans and risk-management plans. DIGEMID also publishes official reporting formats for registration holders and guidance for national electronic case management through VigiFlow. Companies should verify the current timelines and submission route applicable to each case and product, maintain complete records and quality procedures, keep the responsible safety function available to DIGEMID, and prepare for good-pharmacovigilance-practice verification. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.