Safety Reporting

Reporting of Adverse Events and Reactions 

The investigator and sponsor must report the occurrence of any adverse events and reactions in a clinical trial in Finland. Fimea need not be notified of adverse reactions occurring in clinical trials not conducted in Finland. The sponsor must keep detailed records of all serious adverse events and all adverse events defined as significant in the trial protocol which are reported to him by the investigatorRegistration with EMEA’s EudraVigilance is mandatory for commercial sponsors and recommend for non-commercial sponsors as well. Registration instructions are available at the EMA EudraVigilance website. Registered sponsors must submit electronic notifications to EudraVigilance.

The sponsor must report all serious unexpected adverse reactions which are fatal or life-threatening to Fimea as quickly as possible, however, no later than within seven days of the sponsor being informed. Any additional relevant information must be reported within eight days of the submission of the first notification. Non life-threatening or non-fatal reactions must be reported as soon as possible and in any case within 15 days of the sponsor first being informed thereof. Unexpected serious adverse reactions occurring in Finland must be reported also to Fimea’s database (recipient identifier FINAM). If the sponsor is not registered with EudraVigilance, a report must be made in writing to Fimea. The report may not be submitted by fax or email. It can be made in the form of a free-form letter with the CIOMS-I form or a corresponding form.

Once a year, the sponsor must provide Fimea with a list of all suspected serious adverse reactions which have occurred during the period in question with a brief report of the safety of persons participating in the trial. The sponsor must immediately inform the investigators and Fimea of any new significant observations relating to the safety of the investigational product.