Pharmacovigilance Argentina

The GOOD PHARMACOVIGILANCE PRACTICES PROGRAM is designed as a quality system based on national and international guidelines, covering the detection, evaluation, validation, follow-up, reporting and filing of adverse events of products during their commercialization.

In Argentina, ANMAT Resolution No. 706/93 created the National Pharmacovigilance System. Through Dispositions No. 3870/99 and 2438/00 and Circular 03/08, the Pharmaceutical Industry was incorporated into the system, requiring the reporting of serious and unexpected adverse reactions, as well as non-serious ones on a defined, periodic basis. Disposition 5358/12 approved the Good Pharmacovigilance Practices. FP CLINICAL PHARMA can act before the Health Authorities as the party responsible for the safety of your company's medicines.