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ANNEX II U.K. Requirements for the authorisation of tissue and cell preparation processes at the tissue establishments as referred to in Article 4

E. FINAL LABELLING FOR DISTRIBUTION U.K.

1. The primary tissue/cell container must provide: U.K.

(a)

type of tissues and cells, identification number or code of the tissue/cells, and lot or batch number where applicable;

(b)

identification of the tissue establishment;

(c)

expiry date;

(d)

in the case of autologous donation, this has to be specified (for autologous use only) and the donor/recipient has to be identified;

(e)

in the case of directed donations - the label must identify the intended recipient;

(f)

when tissues and cells are known to be positive for a relevant infectious disease marker, it must be marked as: BIOLOGICAL HAZARD[F1 ;]

(g)

[F2 Single 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

F1 Substituted by Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance).

F2 Inserted by Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance).

[F1 If 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.]

2. The following information must be provided either on the label or in accompanying documentation: U.K.

(a)

description (definition) and, if relevant, dimensions of the tissue or cell product;

(b)

morphology and functional data where relevant;

(c)

date of distribution of the tissue/cells;

(d)

biological determinations carried out on the donor and results;

(e)

storage recommendations;

(f)

instructions for opening the container, package, and any required manipulation/reconstitution;

(g)

expiry dates after opening/manipulation;

(h)

instructions for reporting serious adverse reactions and/or events as set out in Articles 5 to 6;

(i)

presence of potential harmful residues (e.g. antibiotics, ethylene oxide etc)[F1 ;]

(j)

[F2 for imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country).]