Veterinary Adverse Event Reports
Definition and goals
An adverse event is a reaction following the use of a veterinary medicinal product that is unfavourable and unintended. This adverse reaction may have occurred in the treated animal or in a human exposed to a veterinary medicinal product. Adverse reactions that occur after treatment of an animal with a human medicinal product should also be reported to the BASG.
Lack of expected effectiveness, insufficient withdrawal period, adverse events in humans who have had contact with the veterinary medicinal product, and environmental incidents after administration of a veterinary medicinal product are also important safety information and should be reported in all cases.
Reporting adverse events supports post-approval monitoring of the quality, efficacy, and safety of veterinary medicinal products.
Adverse reactions should be reported even if a relationship with the use of a medicinal product is only suspected. Adverse reactions 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.
Marketing authorization holders must report all suspected adverse events with regard to their authorised veterinary medicinal products directly to the European Pharmacovigilance Database within 30 days of receipt of the adverse event report.
Veterinarians and health care professionals (such as physicians, dentists, midwives, pharmacists, druggists) are required to report all adverse reactions occurring in Austria to the BASG.
Animal owners also have the option of voluntarily reporting suspected adverse reactions directly to the BASG.
The reports are subject to data protection and are treated confidentially. Personal data of the reporting person will only be used for queries.
Legal basis: Regulation (EU) 2019/6 of the European Parliament on veterinary medicinal products.
Reporting possibilities veterinary medicinals products
|Online form||electronic notification form veterinary|
|paper form for doctors||paper form|
|Paper form for companies||paper form company notification|
|by e-mail to:||email@example.com|
|by mail to:||BASG, 1200 Vienna, Traisengasse 5|
Your reports are subject to data protection and will be treated confidentially. The name and address of the reporting person will only be used for further inquiries.
By reporting adverse reactions, you can help provide more information about the safety of this medicinal product.
Once the Federal Office for Safety in Health Care has identified medically unacceptable risks, it can support the safe handling of medicinal products by imposing restrictions on use - possibly until the withdrawal of a marketing authorisation already granted by the authorities. The Federal Office for Safety in Health Care cooperates with the relevant authorities in other European Member States and with the European Medicines Agency.
Notification forms veterinary drugs
- Nebenwirkungsmeldekarte für Ärzte betreffend Veterinärarzneimittel24/07/2018
- Nebenwirkungsmeldekarte für Firmen betreffend Veterinärarzneimittel24/07/2018