It is the set of activities for the identification, evaluation and prevention of risks from the use of veterinary medicines and biologicals once they have been marketed and includes a continuous process of registration and evaluation of adverse events by the veterinary pharmaceutical industry, as a result of reports of adverse events by marketers, associations, veterinarians, veterinarians-zootechnicians, zootechnicians, producers of animals destined for public supply, pet owners and any other end user (Colombian Agricultural Institute)
Resolution No. 00010204
(08/22/2017)
“By means of which the National Pharmacovigilance System for veterinary medicines and biologicals is established”
Concepts:
Adverse event: Any event in animals, whether or not it is considered related to a product, that is unfavorable, unintended and that occurs after the use of a veterinary medicine or biological (following or not the labeling instructions). These include the suspicion of lack of efficacy according to the conditions approved in the labeling, and also harmful reactions in humans who have been exposed to veterinary medicines and biologicals. This definition includes undesirable effects, adverse effects, undesirable reactions and adverse reactions.
Adverse reaction: Harmful or unintended reaction that occurs with the usual doses used for the prophylaxis, diagnosis or treatment of diseases, or to modify physiological functions.
Lack of efficacy: Unexpected failure of a drug to produce the desired effect. Synonym of inefficacy and ineffectiveness, therapeutic failure, therapeutic failure, decreased therapeutic response, resistance and/or tolerance.
Off-label use or “non-accepted indication”: Corresponds to a use other than that officially approved by the ICA on the product label, and is only acceptable if supported by properly conducted clinical studies.
