Submitting a report on an adverse reaction

In Finland, healthcare professionals and consumers can report any suspected adverse reactions to medicines and vaccines to Fimea. An adverse reaction means a harmful and unintended response to a medicine.  According to the Finnish Medicines Act (395/1987), vaccines are considered medicines, so medicines also refer to vaccines in this text.

The primary purpose of the adverse reaction reporting system is to identify previously unknown rare adverse reactions. Therefore, Fimea particularly encourages the reporting of adverse reactions not mentioned in the medicine’s package leaflet.

Fimea enters the received adverse reaction reports into its national adverse reaction register. The register of adverse reactions to medicines is governed by section 30 g of the Medicines Act (395/1987). Under section 53 of the Infectious Diseases Act (1227/2016), reports of adverse reactions to vaccines are recorded in Fimea’s adverse reaction register. Under section 52 of the Infectious Diseases Act (1227/2016), healthcare professionals are entitled to report to Fimea all diagnosed or suspected adverse reactions to a vaccine or vaccination.

Fimea submits the information of the received adverse reaction reports to the European Medicines Agency’s (EMA) EudraVigilance database, through which  the marketing authorisation holder of the suspected medicine and the World Health Organization (WHO) receive the information. Fimea submits the information in the adverse reaction register regarding vaccines also to the Finnish Institute for Health and Welfare (THL) for vaccine safety monitoring purposes. The risk-benefit balance of a medicine is continuously assessed as a whole, taking into account the reported adverse reactions along with  other information.

If you suspect that you have experienced an adverse reaction to a medicine or vaccine, tell your attending doctor or other healthcare professional about it. The doctor or other healthcare professional can report the adverse reaction to Fimea. Alternatively, you can submit the adverse reaction report yourself or via a pharmacy.

Good to know before reporting an adverse reaction

• Reporting an adverse reaction does not replace the assessment of the need for medical care or the evaluation of the medication. Any related concerns or questions should be addressed to your healthcare provider.
• 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 or provide patient-specific medical advice.
• Fimea cannot be consulted in problem situations arising from vaccinations or decisions to issue further vaccinations. Any related questions should be addressed to your vaccinating healthcare unit. You can find more information about vaccine safety and possible adverse reactions on THL's website.
• Fimea does not send a separate confirmation upon receiving  an adverse reaction report, nor does it comment on the report unless further clarification is needed.
• Fimea does not confirm a cause-and-effect relationship between the medicine and the suspected adverse reaction for an individual adverse reaction report.
• Fimea is not responsible for any possible compensation related to suspected adverse reactions. You can find more information about them on the website of the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities.
• Adverse reaction reports do not map the prevalence of adverse reactions, which can be determined through studies and healthcare registers.

How to report an adverse reaction?

To report any suspected adverse reactions to medicines or vaccines, use primarily Fimea’s electronic adverse reaction reporting form, which can be accessed via Suomi.fi identification.

Electronic adverse reaction reporting form

More information about identification can be found on Suomi.fi website.

Both healthcare professionals and consumers can use the electronic adverse reaction reporting form. On the form’s front page, select whether you are reporting an adverse reaction related to human or animal medication.

Alternatively, you can use Fimea’s adverse reaction reporting form (pdf, in Finnish). Send the completed form to Fimea via Fimea's secure email to [email protected] or by post to the address

Finnish Medicines Agency Fimea / Adverse reaction register
P.O. Box 55
FI-00034 FIMEA
FINLAND

You can also send the information about the adverse reaction to Fimea via Fimea’s secure email or by post without using the actual form.

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

More information

Fimea’s adverse reaction report section: [email protected] 
Email address format: [email protected]
Ordering of the adverse reaction reporting form: tel +358 29 522 3341 (switchboard)

Read more

Data protection (in Finnish)
EudraVigilance - European database of suspected adverse drug reaction reports (EMA, EudraVigilance)
Reporting adverse reactions to veterinary medicines