Supervising blood services

Supervising blood services


Fimea directs and supervises blood services in Finland and collaborates with the relevant international authorities. The Blood Service centres 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. The products used in blood transfusions include red blood cell, platelet and blood plasma products. Blood plasma is also used in manufacturing medicinal products such as those containing coagulation factors and immunoglobulins. Implementation of quality and safety requirements is ensured by subjecting blood services to licence, appointing persons in charge, employing professional personnel well-acquainted with their duties, and seeing that the facilities, devices and materials are appropriate and that comprehensive documentation is used.

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 the handling, storage and distribution of blood and blood components 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 6/2013 concerning blood service activity. The national legislation serves to implement EC regulations concerning blood services and 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 and 2005/62/EC, 2011/38/EU, 2016/1214/EU.

The donation of blood and blood components should be voluntary, and donors must not receive financial compensation or other comparable benefits for the donation.


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