Legal Acts
The Blood Act governs the procedure and conditions for handling of blood and sets forth quality and safety requirements for blood components. It also sets forth oversight and liability for blood handling. The Blood Act also ensures protection of patient and donor rights.
The most important Estonian legislation, Minister of Social Affairs regulations and EU directives related to what the Blood Centre does:
- Blood Act, published in the Riigi Teataja (https://www.riigiteataja.ee/en/eli/502122013001/consolide)
- Minister of Social Affairs regulation no. 65 of 29 April 2005:
Criteria for eligibility of an individual to become donor, conditions and procedure for evaluation, list of diseases and other factors that exclude or restrict blood donations - Minister of Social Affairs regulation no. 62 of 29 April 2005:
Conditions and procedures for blood transfusions - Minister of Social Affairs regulation no. 61 of 29 April 2005:
Terms and procedure for performing immunohaematological tests - Minister of Social Affairs regulation no. 75 of 1 June 2005:
Blood component quality requirements, conditions and procedure for blood component quality testing and microbiological testing - Minister of Social Affairs regulation no. 110 of 28 October 2005:
Conditions and procedure for blood vigilance and for recalling blood components - Minister of Social Affairs regulation no. 128 of 23 December 2005:
Rules for preparation of blood components - Communicable Diseases Prevention and Control Act (adopted 12 Feb 2003)
Related to this act: Minister of Social Affairs regulation no. 121 of 31 October 2003: Procedures for testing donor, donor blood and blood product for communicable disease agents
- Medicinal Products Act (adopted 16 Dec 2004)
- Medical Devices Act (adopted 13 Oct 2004)
- Directive 2002/98/EC of the European Parliament and of the Council (setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. Quality control, blood vigilance, data protection, reporting etc)
- European Commission Directive 2004/33/EC (blood and blood components, notification of donors, eligibility; blood component storage, transport and distribution conditions etc)
- European Commission Directive 2005/61/EC (traceability requirements and notification of serious adverse reactions and events)
- European Commission Directive 2005/62/EC (standards and specifications relating to a quality system for blood establishments; organization of work; facilities; equipment and materials; blood collection, testing and processing; storage and distribution)