Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council 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 (Text with EEA relevance)
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type of tissues and cells, identification number or code of the tissue/cells, and lot or batch number where applicable;
identification of the tissue establishment;
expiry date;
in the case of autologous donation, this has to be specified (for autologous use only) and the donor/recipient has to be identified;
in the case of directed donations - the label must identify the intended recipient;
when tissues and cells are known to be positive for a relevant infectious disease marker, it must be marked as: BIOLOGICAL HAZARD[F1;]
[F2Single European Code as applicable to the tissues and cells being distributed for human application or the donation identification sequence as applicable to the tissues and cells released for circulation, other than distributed for human application.]
Textual Amendments
[F1If any of the information under points (d), (e) and (g) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container. This sheet must be packaged with the primary container in a manner that ensures that they remain together.]
description (definition) and, if relevant, dimensions of the tissue or cell product;
morphology and functional data where relevant;
date of distribution of the tissue/cells;
biological determinations carried out on the donor and results;
storage recommendations;
instructions for opening the container, package, and any required manipulation/reconstitution;
expiry dates after opening/manipulation;
instructions for reporting serious adverse reactions and/or events as set out in Articles 5 to 6;
presence of potential harmful residues (e.g. antibiotics, ethylene oxide etc)[F1;]
[F2for imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country).]
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