For the purposes of this section, the following definitions shall apply:
1° Unique European code: unique identifier applied to tissues and cells circulating in the European Union. This code is composed of two parts:
a) The donation identification sequence defined in 2° ;
b) The product identification sequence defined in 3°;
2° Donation identification sequence: this is the first part of the unique European code. It is made up of :
a) The tissue establishment code consisting, on the one hand, of the ISO code of the Member State and, on the other hand, of the number allocated to the establishments authorised by the competent authorities of each Member State of the European Union to carry out activities involving tissues and cells. The list of codes allocated to these establishments appears in a computerised register hosted by the European Commission;
b) A unique donation number allocated to each donation of tissues and cells by the establishments or organisations authorised under Article L. 1243-2, the first and second paragraphs of II of Article L. 1245-5, the first paragraph of II of Article L. 1245-5-1, and Articles L. 4211-9-1, L. 4211-9-2, L. 5124-3 and L. 5124-9-1;
3° Product identification sequence: this is the second part of the unique European code comprising :
a) The product code made up, on the one hand, of the identifier of the product coding system used by the establishments authorised in application of articles L. 1243-2 and L. 1245-5, and, on the other hand, of the tissue or cell product code as defined in the chosen coding system.
The list of these product codes appears in a computerised register hosted by the European Commission;
b) The sublot number;
c) The expiry date for the use of tissues and cells;
4° Release for circulation :
a) Either directly for grafting or administration purposes :
– the distribution defined in 2° of Article R. 1243-1, of a tissue or its derivative or a cell therapy preparation ;
– or their transfer to another Member State of the European Union or party to the Agreement on the European Economic Area;
b) Transfer to another operator for therapeutic purposes other than grafting or direct administration:
– the transfer as defined in 1° of Article R. 1243-1 of a tissue or its derivative or of cells or a cell therapy preparation ;
– or their transfer to another Member State of the European Union or party to the Agreement on the European Economic Area.