Veterinarians’ reporting obligations

Veterinarians are obliged to report all serious or unexpected adverse events in the animals they are treating, or in humans who has been in contact with the medicine.

• A serious adverse event is an event that is fatal, life threatening, or causes significant disabling, reduced production or inability to work, is a congenital anomaly or birth defect, or which result in long-term or permanent symptoms in the treated animal.
• An unexpected adverse event is an adverse event that is not described in the product information.

However, veterinarians are encouraged to also report adverse events that are not covered by their obligation to report (I.e. non-serious and/or expected adverse events). These will also be processed and included in future surveillance. Reporting of events that are already known may lead to discovery of important information regarding e.g. frequency, seriousness or severity, particularly susceptible subgroups etc.

Increased reporting obligation

Veterinarians are furthermore obliged to report both known and non-serious side effects for the first two years after a new veterinary medicinal product is marketed. ‘Known adverse events’ means events that are already described in the product information.

An updated list of veterinary medicines that are under increased reporting obligation can be found