Biovigilance

Tissue establishments must record any deviations observed in their operations. If the deviation is classified as a serious adverse event or a serious adverse reaction, Fimea must be notified of them. In addition, tissue establishments report annually to Fimea a summary of the serious adverse reactions or events (Serious Adverse Reaction / Event = SAR/E) related to tissue and cell grafts they have observed. SAR/E notifications reported to Fimea that meet the criteria laid down in the Tissue Directives will be reported to the European Commission. The Commission monitors biovigilance reports throughout Europe and summarises them annually.

Notifications of serious adverse events and serious adverse reactions are sent either by e-mail or by post to the Fimea registry office.

Forms (available only in Finnish)

Notification, serious adverse reaction, tissue establishment (Part A, notification) (dot)
Notification, serious adverse reaction, tissue establishment (Part B, conclusions) (dot)
Notification, serious adverse event, tissue establishment (Part A, notification) (dot)
Notification, serious adverse event, tissue establishment (Part B, conclusions) (dot)
Template for an annual report of serious adverse reactions (dot)
Template for the annual notification of serious adverse events (dot)