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Mexico: New pharmacovigilance system for veterinary products

The Pharmacovigilance System for veterinary products is implemented to guarantee the efficacy, quality, and safety of animal medicines, contributing to the production of healthy and safe food.

2 September 2024
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The system created by the National Service for Agri-Food Health, Safety, and Quality (Senasica) seeks to identify, quantify, evaluate, and prevent the risks associated with animal drugs marketed in Mexico and, thus, contribute to their rational use.

The Pharmacovigilance System, operated by the General Directorate of Animal Health, gathers information from those who administer products for veterinary use, making it possible to identify adverse reactions to drugs and thus prevent damage to animal health.

The system involves the pharmaceutical industry, marketing companies, distributors, veterinary hospitals, pharmacies, research units, veterinarians, zootechnicians, and all professionals who directly or indirectly handle products that contribute to animal health.

The “Veterinary pharmacovigilance guidelines for reporting adverse events (REAS) and the preparation of the periodic safety report” were presented to the industry. It describes unexpected reactions that are not related to the dose and are not of allergic origin.

The document also includes follow-up events, when there is a suspected failure of a product to meet the expected efficacy as stated on the label, harmful reactions in humans after exposure to a product, suspected violation of maximum residue limits (MRLs), and potential environmental problems, or suspected transmission of an infectious agent. The System will be applied gradually, with the intent of becoming a mandatory instrument for the Mexican industry dedicated to chemical production, pharmaceuticals, biologicals, and feed for veterinary use.

August 15, 2024/ Secretariat of Agriculture and Rural Development/ Mexico.
https://www.gob.mx/

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