Adverse drug reactions observed in Finland are entered into Fimea's Adverse Reaction Register where healthcare professionals and consumers can report any suspected or observed adverse reactions. Vaccines are classified as medicines in accordance with the Finnish Medicines Act (Lääkelaki, 395/1987), so medicines also refer to vaccines in this text.
The primary purpose of the reporting system is to detect previously unknown rare adverse drug reactions. This is why Fimea would especially like to receive reports on adverse reactions that are not mentioned in the package leaflet of the medicine.
The risk-benefit balance of a drug is continuously assessed as a whole, taking into account the reported adverse reactions among other information. Fimea does not issue a separate confirmation on the reception of an adverse reaction report nor does Fimea comment on the report, unless further clarification is needed.
Regulatory authorities and pharmaceutical companies worldwide collect information on adverse drug reactions. This way the knowledge on the safety of a particular drug gradually increases. Authorities are particularly interested in adverse reactions of new drugs, serious adverse reactions and new, previously unknown adverse reactions.
Fimea submits information on all received adverse reaction reports to the marketing authorization holder of the suspected drug and to the adverse reactions register of the World Health Organization (WHO). In addition, any serious adverse reactions are reported also to the European Medicines Agency (EMA).
Submitting a report on an adverse reaction
To report an adverse reaction, fill in Fimea's Adverse Reaction Reporting Form and mail it to Fimea. You can also send the same information to Fimea by mail without using the form. Send the report to:
Lääkealan turvallisuus- ja kehittämiskeskus Fimea
If you suspect that you have experienced an adverse drug reaction, tell your attending physician or dentist about it. Also tell your doctor about any other drugs and dietary supplements you use, since they might interact with the suspected drug. If necessary, the doctor or dentist can report the adverse reaction to Fimea, especially if it is unexpected or serious. Alternatively, you can submit the report on adverse reactions yourself or via a pharmacy.
Starting on 1 March 2017, all suspected adverse reactions to vaccines are reported to Fimea using Fimea’s adverse reaction reporting form. Fimea monitors and develops the pharmaceutical sector on the level of general public, and does not comment on the treatment received by an individual patient. The submission of an adverse reaction report does not substitute the assessment of the need of care or the evaluation of the medication. These questions must be resolved with your doctor or healthcare professional. Fimea cannot be consulted in problem situations arising from vaccinations or decisions to issue further vaccinations. For more information in Finnish about vaccine safety and adverse reactions of vaccines, please search the THL website for `rokottaminen´.
Inverted black triangle – a new symbol in the product information of medicines
The European Union introduced a new procedure for marking medicinal products that are under special supervision by the pharmaceutical regulatory authorities. Such medicines are said to be under additional monitoring. Additional monitoring is used for medicines on which there is less information available than usual due to their novelty or limited long-term use.
These medicines are marked with an inverted black triangle in the package leaflet and summary of product characteristics. Health care professionals and patients are encouraged to actively report any suspected adverse reactions to the medicines under additional monitoring.