Supervising blood services
- Permit or other obligation
- Public service
Fimea directs and supervises blood services in Finland and collaborates with the relevant international authorities. The Blood Establishments are regularly inspected by Fimea.
The purpose of Finland's legislation governing blood services is to ensure the quality and safety of human blood and blood components used for transfusions or other therapeutic purposes Red blood cells, platelets and plasma are used in transfusions. Plasma is also used in manufacturing medicinal products such as those containing coagulation factors and immunoglobulins.
Blood Establishments need to be authorised by Fimea and fulfill quality and safety requirements. They need to appoint a Responsible Person and employ adequate number of personnel with necessary qualifications and experience. Premises, equipment and materials need to be appropriate. Good and up-to-date documentation must be in place.
The Blood Service Act (197/2005), which entered into force in 2005, governs the donation and testing of human blood and its components used for therapeutic purposes, as well as processing, storage and distribution of blood products used in blood transfusions. Other regulations governing these activities include the Blood Service Decree of 2006 (258/2006), as well as Fimea’s administrative regulation 1/2021. The national legislation implements EC regulations concerning blood safety. On the EC level, the activities are governed by Directive 2002/98/EC of the European Parliament and of the Council (the "blood directive") and by the complementary Commission Directives 2004/33/EC, 2005/61/EC, 2005/62/EC, 2011/38/EU, 2014/110/EU and 2016/1214/EU.
The donation of blood and blood components should be voluntary. Donors must not receive financial compensation or other comparable benefits for the donation.