Directive 2002/98/EC on human blood and blood components

E617259

Directive 2002/98/EC on human blood and blood components is a European Union law that sets quality and safety standards for the collection, testing, processing, storage, and distribution of human blood and blood components for transfusion.

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Statements (48)

Predicate Object
instanceOf EU blood directive
European Union directive
adoptedBy Council of the European Union NERFINISHED
European Parliament NERFINISHED
adoptionDate 2003-01-27
aimsTo ensure a high level of human health protection
ensure quality of human blood and blood components
ensure safety of human blood and blood components
appliesTo blood establishments
collection of blood from human donors
hospital blood banks
category EU legislation on substances of human origin
excludes autologous transfusion within a single surgical procedure
followedBy Commission Directive 2004/33/EC NERFINISHED
Commission Directive 2005/61/EC NERFINISHED
Commission Directive 2005/62/EC NERFINISHED
fullName Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components NERFINISHED
implementationDeadline 2005-02-08
implementedBy Member States of the European Union NERFINISHED
jurisdiction European Union
languageOfTitle all official languages of the European Union
legalArea EU internal market law
public health law
legalBasis Article 152 of the EC Treaty
number 2002/98/EC
OJCitation OJ L 33, 8.2.2003, p. 30–40
publishedIn Official Journal of the European Union NERFINISHED
requires authorization of blood establishments
designation of competent authorities in Member States
inspection and control measures for blood establishments
notification of serious adverse reactions and events
quality management systems in blood establishments
traceability of blood and blood components
setsStandardsFor collection of human blood
collection of human blood components
distribution of human blood
distribution of human blood components
processing of human blood
processing of human blood components
storage of human blood
storage of human blood components
testing of human blood
testing of human blood components
shortName EU Blood Directive NERFINISHED
subjectMatter blood transfusion
human blood
human blood components
yearAdopted 2003

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EU Organ Donation Directive relatedTo Directive 2002/98/EC on human blood and blood components