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Pharmacovigilance is the combination of activities of identification, assessment and prevention of the hazards derived from the use of veterinary drugs and biopharmaceuticals once commercialised, and it includes a continuous process of registration and assessment of side effects derived from the veterinary drug industry as a result of the side effects reports from marketers, associations, veterinarians, agricultural engineers, animal husbandry engineers, livestock producers, pet owners and any other end user.
According to what is established by the ICA, the National Pharmacovigilance System includes:
- The veterinary biopharmaceuticals registered in Colombia.
- The holders of sales records and the importers of veterinary drugs and biopharmaceuticals, and the departments in charge of the pharmacovigilance in every company.
- The reporters and their reports of possible side effects of veterinary drugs and biopharmaceuticals.
- The Agriculture and Livestock Institute of Colombia (ICA), as the regulating authority.
- The information from reference international organisations, equivalent entities and bibliographic sources related to side effects due to veterinary drugs and/or biopharmaceuticals.
Members of the Pharmacovigilance System:
- The Agriculture and Livestock Institute of Colombia (ICA), as the regulating authority.
- The holders of sales records and the importers of veterinary drugs and biopharmaceuticals.
- The reporters of suspected side effects.
The unfulfillment of any of the regulations established in the decisions issued by the ICA will be penalised as established in chapter 10 of title 1 of part 13 of the Decree 1071 of 2015, notwithstanding the civil or criminal actions as provided by under the law.
Wednesday, September 6th 2017/ ICA/ https://www.ica.gov.co
