Commission Directive 2006/86/ECShow full title

E. FINAL LABELLING FOR DISTRIBUTION

1. The primary tissue/cell container must provide:

(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.

If any of the information under points (d) and (e) 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:

(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).