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Single European Code (SEC) for Tissues and Cells - EU Update

posted 1 Oct 2015, 10:33 by Eoin McGrath   [ updated 17 Oct 2016, 04:01 ]
Quoted from EU Document released 1 October 2015:

1. Legal requirements

The Commission Directive (EU)2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells was published on 9 April 2015 (http://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015L0565&from=EN).

The Directive introduces the obligation for tissue establishments to affix a "Single European Code” or “SEC” on tissues and cells distributed for clinical application in the EU. The Directive also sets out the requirements for its application (including exceptions) and general obligations of the tissue establishments, competent authorities and the European Commission.
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The following situations are excluded from the application of the SEC:
(a) reproductive cells from partner donation;

(b) tissues and cells distributed directly for immediate transplantation to the recipient, as referred to in Article 6(5) of Directive 2004/23/EC;

(c) tissues and cells imported into the Union in case of emergency authorised directly by the competent authority or authorities, as referred to in Article 9(3)b of Directive 2004/23/EC.