Pharmacovigilance or drug safety embraces the detection, collection, assessment, monitoring and prevention of adverse events (side effects) associated with the use of medicinal products. In the European Community, there is a legal obligation for the Marketing Authorization Holder to detect, collect and evaluate the adverse events reports related to one of their authorized veterinary medicinal products and to inform the Competent Authority in due time and at intervals stated in the legislation. Adverse event reports increase the knowledge of the active substances and the veterinary medicinal products, which increases the safety and efficacy of our veterinary products.
What should be reported?
- Suspected adverse reactions in target animals
- Suspected adverse reactions in non-target animals (off-label use)
- Suspected lack of efficacy in target animals
- Human suspected adverse reactions (e.g. administrator of the product).
- Violation of approved withdrawal times
- Possible environmental problems
- Possible interactions with other drugs used concurrently
- Other (e.g. transmission of infectious agents by the drug itself, indirect reactions in offspring of treated animals, ...)
If you are a health professional, a veterinarian or an animal owner, please use the form to report an adverse event related to one of our veterinary drugs. Please send the contact form back to us.
IMORTANT NOTE : Please be aware that it is a legal obligation of Emdoka bvba to report all data in this form, including personal data, to the competent authorities. Emdoka bvba is legally obliged to keep all the data in its pharmacovigilance database. The data will be shared with other parties only in relation to legal pharmacovigilance duties of Emdoka bvba.