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

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).