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Key Documents
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Directive 2004/23/EC
Commission Directive 2006/17/CE – Publication of the technical requirements for the donation, procurement and testing of human tissues and cells
Commission Directive 2006/17/EC
Commission Directive 2006/86/EC – Publication of the requirements for traceability, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
Commission Directive 2006/86/EC
Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells
Commission Directive 2012/39/EU amending Directive 2006/17/EC
Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells
Commission Directive (EU) 2015/566
Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
Commission Directive (EU) 2015/565
Council of Europe – Guide to the quality and safety of tissues and cells for human application