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 pharmacies, veterinarians, medicine users and marketing authorisation holders. More information is available in Fimea Guideline 1/2014 “Reporting adverse reactions to medicinal products administered to animals”.
Veterinarians and other health care professionals can use an electronic form to report adverse reactions to veterinary medicines. Use of the electronic form requires a user ID provided by Fimea, or a Fimnet ID. To apply for a user ID issued by Fimea, please send a request to vethava(a)fimea.fi.
Another way to report adverse reactions is to fill in an “Adverse drug reaction (ADR) report – veterinary medicines” form (dot) on Fimea's website and send it by e-mail to the address provided above. Alternatively, you can print the form (pdf) and send it by mail to the address provided on the form. Forms and return envelopes may be ordered from Fimea.
Every year, Fimea publishes a summary of the adverse reactions reported to Fimea in the previous year in the Sic! magazine.
In addition, the European Medicines Agency publishes a Veterinary Pharmacovigilance Public bulletin every year.