Submitting a report on an adverse reaction

Submitting a report on an adverse reaction

In Finland healthcare professionals and consumers can report any suspected or observed adverse reactions to Fimea. Vaccines are classified as medicines in accordance with the Finnish Medicines Act (Lääkelaki, 395/1987), so medicines also refer to vaccines in this text.

The primary purpose of the reporting system is to detect previously unknown rare adverse drug reactions. This is why Fimea would especially like to receive reports on adverse reactions that are not mentioned in the package leaflet of the medicine.

All received adverse reaction reports are entered into Fimea’s Adverse Reaction Register, and  information on received adverse reaction reports is submitted to the European Medicines Agency (EMA), which conveys the information to the marketing authorization holder of the suspected drug and to the adverse reactions register of the World Health Organization (WHO). The risk-benefit balance of a drug is continuously assessed as a whole, taking into account the reported adverse reactions among other information.

Fimea does not issue a separate confirmation on the reception of an adverse reaction report nor does Fimea comment on the report, unless further clarification is needed.

Fimea monitors and develops the pharmaceutical sector on the level of general public, and does not comment on the treatment received by an individual patient. The submission of an adverse reaction report does not substitute the assessment of the need of care or the evaluation of the medication. These questions must be resolved with your doctor or healthcare professional. Fimea cannot be consulted in problem situations arising from vaccinations or decisions to issue further vaccinations. More information about vaccine safety and adverse reactions of vaccines on THL's website.

If you suspect that you have experienced an adverse drug reaction, tell your attending physician or other health care professional about it. If necessary, the doctor or other health care professional can report the adverse reaction to Fimea, especially if it is unexpected or serious. Alternatively, you can submit the report on adverse reactions yourself or via a pharmacy.

Submitting a report on an adverse reaction

Primarily the use of the electronic reporting form for reporting adverse reactions is recommended.

The use of the electronic reporting form requires identification with More information about identification can be found on website. The electronic form can be used both by healthcare professionals and consumers. 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.

Alternatively, an adverse reaction can be reported by filling in Fimea's Adverse Reaction Reporting Form (pdf, in Finnish).  You can also send the same information to Fimea by mail without using the form. Send the report to:

Lääkealan turvallisuus- ja kehittämiskeskus Fimea
Lääkkeiden haittavaikutusrekisteri
PL 55
00034 FIMEA

The Adverse Reaction Reporting Form can also be sent with Fimea’s secure mail to [email protected]More information about Fimea’s secure mail. Fimea only accepts mails sent via the Fimea secure mail.

Fimea does not accept adverse reaction reports by telephone. If you cannot report with the electronic form or send the report by mail or e-mail, you can call Fimea and tell the address where the report form, instructions and return envelope can be sent. Alternatively, you can consult your pharmacy.

Electronic report on adverse reaction (in Finnish)

Report on adverse reaction (pdf, in Finnish) 

Instructions: report on adverse reaction (pdf)

European database of suspected adverse drug reaction reports

Reporting adverse effects of veterinary medicines

Adverse effects of veterinary medicines can be reported by veterinary surgeons, pharmacies, marketing authorisation holders and animal owners.

Further information on reporting adverse reactions to veterinary medicines