Adverse effects

Before marketing authorisation is granted, pharmaceutical companies are required to present their safety studies, which have been assessed by the authorities and based on which significant adverse effects are listed in the summary of product characteristics and the package leaflet. After marketing authorisation has been granted, Fimea monitors the safety of veterinary medicines e.g. by following reported adverse reactions.

Fimea analyses all reported cases and maintains a register of adverse reactions to veterinary medicines. Information on adverse effects can be used to modify the SPC and package leaflet, if necessary, or to restrict the use of the medicine in question.

Reporting adverse reactions

Adverse reactions may be reported by veterinarians, pharmacies and general public. 
Adverse reactions should be reported preferably by using an electronic form. The use of the electronic reporting form requires identification with Suomi.fi. More information about identification can be found on Suomi.fi website. On the front page of the reporting form a choice is required whether to report on adverse reactions of a medicine used by a human or the ones related to medicines administered to animals.

Reporting form

Another way to report adverse reactions is to fill in a form on Fimea's website and send it by e-mail to [email protected] or send it by mail to the address provided on the form. Forms and return envelopes may be ordered from Fimea.
Information on reporting is also available in Fimea Guideline 1/2014 “Reporting adverse reactions to medicinal products administered to animals”.

Adverse drug reaction (ADR) report – veterinary medicines (dot)
Adverse drug reaction (ADR) report -veterinary medicines (pdf)