Reporting adverse reactions
Persons authorised to prescribe or dispense medication are asked to report to Fimea all diagnosed and suspected adverse reactions, particularly all serious and/or unexpected reactions as well as all adverse reactions to new medicines. Starting on 1 March 2017, all adverse reactions to vaccines are reported to Fimea. If you have submitted a report on an adverse reaction to the National Institute for Health and Welfare (THL), it will be automatically forwarded to Fimea and you do not need to submit a new report to Fimea.
An adverse reaction report may be submitted electronically (recommended) or using the Fimea form
Report on a suspected adverse drug/vaccine reaction (pdf).
Electronic reporting on adverse reactions using a Fimnet user ID will be closed from 1 March 2023. After this, electronic reporting is possible using Suomi.fi identification (the form is currently available only in Finnish).
The use of the electronic reporting form requires identification with Suomi.fi.
More information about identification can be found on Suomi.fi 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.
The electronic adverse reaction form is also available at Terveysportti’s pharmaceutical database.
Questions and comments on the electronic form may be sent by e-mail to [email protected].
Reports on adverse reactions made on paper forms should be sent to the following address: Fimea, Register for adverse drug reactions, P.O. Box 55, FI-00034 FIMEA. Report on a suspected adverse drug/vaccine reaction can also be sent with Fimea’s secure mail to [email protected].
More information about Fimea’s secure mail.
Report on adverse reaction
Electronic report on adverse reaction using Suomi.fi identification (in Finnish)
Report on a suspected adverse drug/vaccine reaction (pdf, in Finnish)
Further information:
Register for adverse drug reactions, [email protected] or tel. +358 29 522 3341 (switch)
E-mail address format: [email protected].
Inverted black triangle – a symbol in the product information documentation of medicines
Medicines described as being under 'additional monitoring' are being monitored particularly closely by pharmaceutical regulatory authorities.
Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and in the summary of product characteristics. Fimea urges healthcare professionals and patients to report any suspected adverse reactions caused particularly by medicines under additional monitoring.
Read more:
EMA List of medicines under additional monitoring (pdf)
EMA information leaflet on the black triangle (pdf)
EMA video on the black triangle (YouTube)
Reporting adverse effects of veterinary medicines
Reporting of adverse drug reactions, normative guideline 1/2017 (pdf)