Legislation on blood service activities

The purpose of the legislation is to ensure the quality and safety of human blood and its components used for transfusion or other therapeutic purposes. Compliance with the quality and safety requirements is ensured through the licencing of activities, the appointment of Responsible Persons, trained personnel, appropriate facilities, equipment and materials, and comprehensive documentation.

National legislation has implemented EU legislation on blood services and blood safety. Blood Establishments and hospital blood banks must use good practices in their quality system, i.e. the Good Practice Guidelines developed by the European Commission in co-operation with the European Directorate for the Quality of Medicines (EDQM).