FAQ adverse events veterinary
What should be reported?
In principle, any adverse reaction of veterinary medicinal products or of human medicinal products that have been used for the treatment of animals must be reported, such as
- adverse reactions in animals
- lack of expected effectiveness
- insufficient withdrawal period
- adverse events in humans who have had contact with the medicinal product
- environmental incidents
Who can report?
Adverse events can be reported by both animal owners and veterinarians. The report is made to the BASG or to the pharmaceutical company who is the marketing authorization holder or distributor of the medicinal product concerned. The BASG accepts the notifications online via the electronic notification form, by mail or electronically by e-mail in compliance with data protection. The pharmaceutical company is obliged to report the adverse event directly to the European Pharmacovigilance Database within 30 days.
Why should adverse reactions be reported?
The collection and evaluation of adverse event reports supports the monitoring of the quality, efficacy and safety of medicinal products. If adverse reactions occur more frequently, measures can be taken, such as the inclusion of warnings in the package leaflet, changes in the conditions of use, delimitation of sales, recall of individual batches, etc.
Adverse reactions should also be reported if a relationship with the use of a medicinal product is only suspected. Adverse events that are already known and described in the package leaflet should also be reported, since their knowledge contributes significantly to the benefit-risk assessment of the veterinary medicinal product.
