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.
An adverse reaction report may be submitted electronically (recommended) or using Fimea form number 720; Report of a suspected adverse drug 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.
Adverse reactions to vaccines should be reported to the National Institute for Health and Welfare (THL) using the form, Report of a suspected adverse reaction to a vaccine.
Senior Medical Officers, tel. +358 29 522 3341 ( (switch)
E-mail address format: firstname.lastname@example.org.
Electronic adverse reaction report(in Finnish)
Forms and form return envelopes may be ordered free of charge from Edita Prima, e-mail: email@example.com
Report of a suspected adverse reaction to a vaccine (THL, in Finnish)
Reporting adverse drug reactions, normative guideline 2/2013
Terveysportti’s pharmaceutical database (in Finnish)