Proyecto de resolución "Por medio de la cual se establece el Sistema Nacional de Farmacovigilancia para medicamentos y biológicos de uso veterinario" (Draft Resolution establishing the national pharmacovigilance system for medicines and biological products for veterinary use)

The notified draft Resolution establishes the national pharmacovigilance system for medicines and biological products for veterinary use.

The text covers the following: Purpose; Scope; Definitions; General objective of the national pharmacovigilance system; Specific objectives of the national pharmacovigilance system; Components of the national pharmacovigilance system; Entities participating in the national pharmacovigilance system; Obligations of the ICA as regulatory authority; Obligations of veterinary medicine and biological product sales licence holders and importers; Obligations of reporters; Information sources for the national pharmacovigilance system; Information flow; Periodic safety report (IPS); Events to report; Report criteria; Causation analysis investigation; Causation categories; Criteria for inclusion in the various categories; Corrective actions; Post-registration studies; Communication and dissemination; Transitional provision; Penalties; and Period of validity.