Reporting an adverse event

The reporting of adverse events is an important part of veterinary pharmacovigilance.  Animal owners can report adverse events or suspected adverse events after they have used the veterinary medicinal product. Marketing authorisation holders and veterinarians are obliged to report adverse events and suspected adverse events.

Before a veterinary medicinal product can be authorised and become available for use in animals, the Veterinary Medicinal Products Unit assesses whether it works effectively and can be used safely. During this assessment possible adverse events emerge before the veterinary medicinal product is authorised. These adverse events are listed in the package leaflet of the veterinary medicinal product.

However, unknown adverse events may still arise after the veterinary medicinal product has been authorised. Once the veterinary medicine has been marketed, user experiences of the veterinary medicinal products are monitored. By collecting these reports, more and more knowledge about the veterinary medicinal product becomes available. Based on this information, possible actions can be identified to prevent adverse events, or deal with them more effectively.

Animal owner Report

As an animal owner you may report an adverse effect or suspected adverse effect if you think that this occurred after the veterinary medicinal product was used in your animal(s).

You can report this:

  • To a veterinarian. This is the simplest way. The veterinarian is then obliged to report the adverse reaction or suspected adverse reaction to the supplier or to the Veterinary Medicinal Products Unit.
  • To the supplier of the veterinary medicinal product. To do this, directly contact the supplier whose name is on the label and/or the package leaflet of the veterinary medicinal product. The supplier is obliged to accept your report, to store it in a database, to investigate the report and to pass it on to the Veterinary Medicinal Products Unit.
  • To the Veterinary Medicinal Products Unit. Please send your report directly to the Veterinary Medicinal Products Unit via the Report form for (suspected) adverse events of veterinary medicinal products.

Veterinarian Report

As a veterinarian, you fulfil an important gatekeeper's function regarding the use of veterinary medicinal products. You are obliged to report suspected adverse events to the marketing authorisation holder/supplier or to the Veterinary Medicinal Products Unit.

To do this use the Report form for suspected adverse events of veterinary medicinal products.

For further information on adverse events see the website of the European Medicines Agency (EMA).

Marketing authorisation holder Report

As a marketing authorisation holder you must make individual reports of adverse events electronically.  All these reports are stored in the European adverse events database, Eudravigilance. This also applies to the reports on veterinary medicinal products for which only a national marketing authorisation has been issued.

You are obliged to report severe and suspected severe adverse events in animals and every suspected adverse reaction in humans that has occurred in the Netherlands to the Veterinary Medicinal Products Unit within 15 days.

Severe and unknown (i.e. not stated on the label or package leaflet) adverse events that are observed outside the European Union must be directly reported to the European Medicines Agency (EMA).

A complete overview of the reporting requirements of the marketing authorisation holder can be found in the EMA Guidelines.

As a marketing authorisation holder, you have two ways of following the electronic reporting procedure:

  1. Via a direct connection between the computer file of the marketing authorisation holder and EudraVigilance Veterinary. To do this, the computer system must be compatible with EudraVigilance. You should register for this via the EMA.
  2. Via an EudraVigilance internet-interface. You can register to join this system via the EMA Eudravigilance website.

Further information on EudraVigilance Veterinary can be found on the EMA website.

All reports will be sent to the Veterinary Medicinal Products Unit, where they will be verified by the Veterinary Medicinal Products Unit and entered into Eudravigilance.

In exceptional situations, adverse and suspected adverse events can be reported by submitting a report form by post or e-mail.

Definition of an adverse event

A generally used definition of an adverse reaction is:

An adverse or suspected adverse reaction of a veterinary medicinal product is a reaction that is harmful and unwanted and that occurs at doses that are normally used in the animal for prevention, the making of a diagnosis, the treatment of a disease or the changing of a physiological function.

Adverse events may occur in animals who have been treated with a veterinary medicinal product and in animals who have come into contact with a veterinary medicinal product in another way.  It is also important to report reactions that have occurred in people who have applied the veterinary medicinal products or who have been in contact with them.

Although the definition refers to ‘doses normally administered’, adverse events occurring after improper use, are also regarded as adverse events or suspected adverse events. For example, the administration of veterinary medicinal products to animals that are not mentioned in the product text that accompanies the marketing authorisation, or at non-standard doses.

Residues exceeding the set safety levels after observing the recommended waiting period as well as damaging effects on the environment also belong to this broader scope.