Legal texts :

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) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.

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, OJ L 102 , 07/04/2004.

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, OJ L 38, 09/02/2006

Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, OJ L294, 25.10.2006.

Commission decision C(2009)7726 of 5.10.2009

Report from the Commission to the Council, on the basis of Member States’ reports on the implementation of the Council, Recommendation (2009/C 151/01) on patient safety, including the prevention and, control of healthcare associated infections, COM(2012) 658 final, 13.11.2012

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

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL in accordance with Article 25 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, COM(2014) 188 final, 28.03.2014


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Logo_EUCelLEXEUCelLEX acknowledged in this publication


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Others :

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Table for abbreviations