Argentina

Pharmacovigilance in Argentina is regulated by the National Administration of Drugs, Foods and Medical Devices (ANMAT). Under ANMAT Disposition No. 5358/2012 (Good Pharmacovigilance Practices), the marketing authorisation Holder (TARC/MAH) must operate an appropriate pharmacovigilance organisation and designate a trained Pharmacovigilance Responsible Person (RFV), with a trained substitute for the RFV's absence. The pharmaceutical industry must report adverse reactions and other safety events within the timelines established by Disposition 5358/2012 and maintain supporting pharmacovigilance procedures, records and training for inspection. ANMAT also provides formal pathways for Periodic Safety Update Reports (IPAS/PSUR) and Risk Management Plans (PGR/RMP) where applicable. A PSMF equivalent to the EU model is not a universal Argentine requirement and applies only where a specific Argentine provision establishes it. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.