Throughout the years donor blood has remained an irreplaceable and life-saving resource. Its safety and efficacy is based on principles of voluntary blood donation, good manufacturing practices and an established haemovigilance system.
According to Estonian legislation blood and blood components are defined as medicines, the production of which requires licensing (manufacturing approval) by the State Agency of Medicines. All Blood Establishments in Estonia are part of the hospitals. There are five licensed Blood Establishments which deal with blood collection; four of them also produce blood components. The license holders also have right to collect blood at the mobile sites.
During a year Blood Establishments produce more than 120,000 different blood components such as red blood cells, platelets, fresh frozen plasma and and many other blood products. European blood directives (2002/98/EC; 2004/33/EC; 2005/61/EC; 2005/62/EC) were adapted and entered into national legislation during 2005 and 2006, and since that time Blood Establishments have been regularly inspected and involved in the haemovigilance process, in accordance with the harmonized European requirements.