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.

An adverse reaction report may be submitted electronically (recommended) or using the Fimea form titled Report of a suspected adverse drug/vaccine reaction.

Persons wishing to complete the electronic adverse reaction form should log in using a FiMnet user ID and password. A FiMnet user ID can be obtained from the FiMnet feedback page. The electronic adverse reaction form is also available at Terveysportti’s pharmaceutical database.

Instructions for completion are available at the bottom of the electronic form. The form will also prompt for any missing data or to warn about problems with the submission. 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-0034 FIMEA.

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.

Further information:

Senior Medical Officers, tel. +358 29 522 3341 ( (switch)

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

Report on adverse reaction

Electronic report on adverse reaction (in Finnish)

Report on adverse reaction (pdf) (in Finnish)

Inverted black triangle – a new symbol in the product information documentation of medicines

The European Union (EU) has introduced a new process to label medicines that are being monitored particularly closely by pharmaceutical regulatory authorities. These medicines are described as being under 'additional monitoring'.

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 in particular 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)

E­le­ct­ro­ni­c r­ep­ort on a­dverse reaction

Reporting adverse effects of veterinary medicines

Reporting of adverse drug reactions, normative guideline 1/2017