Before a medicine is granted marketing authorisation, its safety is studied by the pharmaceutical company involved and assessed by the authorities.
Once the authorisation has been granted, the safety of the medicine is continually reassessed on the basis of studies and adverse reaction reports. If necessary on the basis of new data, changes may be made to the summary of product characteristics or the package information leaflet, or the use of the medicine may be restricted.
Information on adverse reactions observed in Finland is collected into Fimea register of adverse reactions.
This is a healthcare register where persons authorised to prescribe or dispense medication are asked to report all suspected adverse reactions, particularly all serious and/or unexpected reactions as well as all adverse reactions to new medicines.
For detailed instructions on adverse reaction reporting, see normative guideline 1/2017: Reporting of adverse reactions.
Fimea submits information on all received adeverse reaction reports to the European Medicines Agency (EMA), which conveys the information to the marketing authorization holder of the suspected drug and to the adverse reactions register of the World Health Organization (WHO).
European database of suspected adverse drug reaction reports
Pharmacovigilance Unit, tel. +358 29 522 3341 (tel.switch)
E-mail address format: email@example.com.