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Responsible for the service Finnish Medicines Agency Fimea

Notification of suspected adverse reactions to veterinary medicinal products

  • Service
  • Nationwide
  • Public service

After the marketing authorisation has been granted, the safety of veterinary medicinal products is monitored, for example, by monitoring adverse events observed in connection with the use of the veterinary medicinal product by means of notifications of adverse reactions. The main purpose of the notification system is to detect unidentified rare adverse reactions. It is therefore hoped that adverse reactions not mentioned in the package leaflet of the medicinal product are reported in particular. The balance of benefits and adverse reactions of a medicinal product is continuously assessed as a whole, for example, in the light of information collected from adverse reaction notifications. Fimea does not confirm the receipt of the notification of adverse reactions separately or comment on it unless there is a need to request further clarifications.

Do the following

It is recommended that the notification of adverse reactions be made via the electronic service channel. The use of the service channel requires a Fimnet ID or an ID issued by Fimea, which can be retrieved from vethava[at]fimea.fi. The notification of adverse effects can also be made using a form to be completed on Fimea's website (dot form). The form will be emailed to vethava[at]fimea.fi. The form can also be printed (PDF form), completed manually and sent by post to the address indicated on the form.

To whom and on what terms

Adverse reactions may be reported by veterinarians, users of the medicinal product, marketing authorisation holders and pharmacies. The notification may be made whenever a suspected adverse reaction has arisen in connection with the use of the veterinary medicinal product, in particular where there is a suspected adverse reaction which is not indicated in the package leaflet of the veterinary medicinal product.

The service is free of charge.

Basic information

The service is provided byFimea
Responsible for the serviceFimea
Area Whole Finland
Available languagesFinnish, Swedish, English
Text edited by: Finnish Medicines Agency Fimea
Updated: 18/3/2021