Which adverse events should be reported?

It is especially important to report a suspected adverse event if the event results in death or a life-threatening condition.

The following situations should also be reported following the use of a veterinary medicinal product (VMP):

• any observation of a lack of efficacy of a veterinary medicinal product following its administration to an animal, whether or not in accordance with the summary of product characteristics.
• any finding of a pharmacologically active substance or marker residue in a product of animal origin exceeding the maximum levels of residues established in accordance with Regulation (EC) No 470/2009 after the set withdrawal period has been respected.
• any suspected transmission of an infectious agent via a veterinary medicinal product.
• any environmental incidents observed following the administration of a veterinary medicinal product to an animal.

Furthermore, the following so-called “special situations” should be reported following the use of a veterinary medicinal product (VMP):

• deliberate misuse
• accidental exposure
• incorrect use / handling that occurred by mistake (medication error).

Suspected adverse events are sometimes easy to identify, i.e. the animal develops obvious clinical signs such as vomiting etc. However, other clinical signs can also be considered suspected adverse events and should be reported.

A high frequency of reports does not necessarily indicate that a medicinal product gives rise to many or frequent adverse events. A high reporting rate may, for example, be correlated to a newly authorised product or an extensive use of a specific medicinal product. The number of reports must be correlated to the number of doses sold in order to determine the “true” incidence of adverse events.