Reporting adverse events of veterinary medicinal products

Reporting side effects (adverse events) is an important part of veterinary pharmacovigilance. Veterinary pharmacovigilance is a joint activity by the government agency granting the marketing authorisation, the marketing authorisation holder as the supplier, and the user of veterinary medicines, primarily the veterinarian.

Animal owners can report (suspected) adverse events due to the use of veterinary medicinal products. Marketing authorisation holders and veterinarians are obliged to report (suspected) adverse events.

Reporting as animal owner

As an animal owner, you can report (suspected) adverse events if you believe that these occurred after administration of a veterinary medicine to your animal(s).

You can report this:

  • To a veterinarian. This is the easiest course of action. The veterinarians is then obliged to report the (suspected) adverse event to the supplier or to the Veterinary Medicinal Products Unit.
  • To the supplier of the veterinary medicine. You should directly contact the supplier referred to on the label/package leaflet of the veterinary medicine in question. The supplier must accept your report, save this in a file, investigate your report and notify the Veterinary Medicinal Products Unit.
  • To the Veterinary Medicinal Products Unit. You can report directly to the Veterinary Medicinal Products Unit using the EU veterinary suspected adverse reaction report form. If you would like to receive this form by post, please contact the Veterinary Medicinal Products Unit.

Reporting as veterinarian

As a veterinarian, you fulfil an important gatekeepers' function with regards to the use of veterinary medicines. You are obliged to report (suspected) adverse events to the marketing authorisation holder/supplier or to the Veterinary Medicinal Products Unit.

Reporting can be done via the EU form for reporting a suspected adverse event of a veterinary medicinal product. You can submit this form by e-mail or post.

For more information about adverse events, please see the EMA website.

Reporting as marketing authorisation holder

As a marketing authorisation holder, you must submit 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 must report serious (suspected) adverse events relating to animals and each (suspected) adverse effect relating to humans that occur in the Netherlands to the MEB Agency/VMPU within 15 days.

You should report severe and unknown (read: not stated on the labelling and/or package leaflet) adverse events that have occurred outside of the EU directly to the EMA.

For a complete overview of the reporting requirements of the marketing authorisation holder please see the EMA Guidelines.

As a marketing authorisation holder, you have 2 options with respect to the electronic reporting procedure:

  1. Via a direct link between the computer file of the marketing authorisation holder with  Eudravigilance. The computer system of the marketing authorisation holder must be compatible with Eudravigilance. The marketing authorisation holder should register  for this option via the EMA.
  2. Via an internet interface with Eudravigilance. You can register via the Eudravigilance website of the EMA for participation in this system.

More information about EudraVigilance Veterinary can be found on the EMA website.

These reports are sent to the Veterinary Medicinal Products Unit, verified and then entered into Eudravigilance by the Veterinary Medicinal Products Unit.

In exceptional situations you can report (suspected) adverse events by sending (post, e-mail) the previously standard report forms.

Definition of an adverse event

Animal owners can report (suspected) adverse events due to the use of veterinary medicinal products. Marketing authorisation holders and veterinarians are obliged to report (suspected) adverse events.

A commonly accepted definition of an adverse event is:

A (suspected) adverse event of a veterinary medicinal product is a damaging and undesirable reaction arising after doses normally administered to an animal for the prevention, diagnosis or treatment of a disease or to change a physiological function.

Adverse events can occur in animals treated with the product or in animals that came into contact with a veterinary medicinal product in another way. Reactions in humans administering the veterinary medicinal products or coming into contact with them also fall under the category of noteworthy incidents that should be reported.

Although the definition refers to ‘doses normally administered’, adverse events occurring after improper use, such as with different animals than those specified in the marketing authorisation or indications or anomalous dosages (overdoses), are also considered (suspected) adverse events.

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