Report an adverse reaction caused by veterinary medicinal products (in animals or humans) or by human medicinal products in animals

In addition to the intended, i.e. desired effect, unintended, adverse events can also occur following the use of medicines. These "adverse events", or AEs for short, are generally referred to as "side effects".

In the event of adverse events following the use of a veterinary medicinal product or veterinary vaccine, the competent authority should be informed. This also applies if adverse events occur in an animal following the use of a medicinal product authorized for human use.

It is important to report adverse events following the use of veterinary medicinal products and veterinary vaccines, even if a connection with the use of one or more products is only suspected. Reports should be made in particular in the case of suspected

• unknown/known suspected adverse reactions
• Interactions with other medicinal products
• lack of efficacy
• reactions in persons who have had contact with the veterinary medicinal product
• transmission of infectious agents
• Negative effects on the environment
• Insufficient withdrawal period (residues in food)

The Federal Office of Consumer Protection and Food Safety (BVL) is responsible for the approval of veterinary medicinal products in Germany. The BVL is also responsible for supervising and monitoring the safety of veterinary medicinal products after authorization.

The Paul Ehrlich Institute (PEI) is responsible for the approval and post-approval monitoring of vaccines and serums for animals and immunological veterinary medicinal products in Germany.

All AE reports from Germany are collected, evaluated and sent anonymously to the pharmacovigilance database of the European Medicines Agency (EMA) by the BVL or PEI in accordance with their responsibilities. The knowledge gained is used to minimize risks, for example warnings can be included in the package leaflet. In addition, the public is informed about safety-relevant drug issues.

As a veterinarian, you should report adverse events following the use of a veterinary medicinal product to the marketing authorization holder or, alternatively, to the professional association (German Veterinary Association) or directly to the competent authority.

If you as the animal owner suspect that you or your animal are affected by an adverse event, you should have this clarified by the attending veterinarian or your family doctor. You, your veterinarian or your doctor should then inform the competent authority directly if necessary.

Based on the information available, the BVL or PEI will assess whether there is a causal link between the use of the (veterinary) medicinal product and the reported event. If an adverse reaction pattern for a (veterinary) medicinal product emerges as a result of frequent reports, measures to increase safety are initiated depending on the severity of the symptoms and the conditions under which they occurred, for example

• Inclusion of warnings in the package leaflet
• changes to the conditions of use
• ordering the suspension of the marketing authorization in particularly serious cases until the safety-relevant defects have been

have been eliminated.