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After the Marketing Authorization (AIM), veterinary medicinal products, including immunologicals, veterinary products and biocides for veterinary use, must continue to meet the requirements of quality, efficacy and safety and offer an acceptable balance between benefits and risks.
Pharmacovigilance is a monitoring system that aims to systematically collect information related to suspected harmful and involuntary reactions that occur in animals and, eventually, in humans, when exposed to medicines and other veterinary products used in the field of production and health animal, as well as the scientific evaluation of that information.
This system also covers other aspects of post-authorization surveillance, such as: Suspected adverse reactions associated with the use not included in the labeling; failures of the expected effectiveness and the investigation of the validity of the withdrawal period (in cases of detection of residues despite the IS having been fulfilled) and possible environmental problems.
Based on the information received from the notifier and / or the MAH, causality is attributed between the administration of the suspected product (s) and the reported reaction (s).
From this analysis and in the event of a pattern of adverse reactions that can be attributed to a given product, regulatory action can be initiated. This may consist of: adding warnings or contraindications; change in the route (s) of administration; collecting the product (or batch); suspension or revocation of the marketing authorization.
Since Pharmacovigilance is everyone’s responsibility, Campifarma has contacts where you can submit a notification, requesting the sending of the most detailed information possible and a contact to where the pharmacovigilance department can clarify doubts or obtain additional information.
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