Reporting adverse reactions

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 titled ‘Report on a suspected adverse drug/vaccine reaction’ (PDF). (Adverse events observed after use of a veterinary medicinal product should not be reported using this form. The correct form for these adverse events can be found here.)
 
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 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 FIMEA.EV@fimea.fi.
 
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 FIMEA.EV@fimea.fi. More information about Fimea’s secure mail.
 

Report on adverse reaction

Electronic report on adverse reaction using a Fimnet user ID (in Finnish)

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, FIMEA.EV@fimea.fi or tel. +358 29 522 3341 (switch)

E-mail address format: forename.lastname@fimea.fi.

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