Subsection 6: Advanced therapy medicinal products prepared on an individual basis

I.-Any establishment or body referred to in Article L. 4211-9-1 or any pharmaceutical establishment referred to in Articles L. 5124-1 or L. 5124-9-1 shall set up and keep up to date a system ensuring the traceability of advanced therapy medicinal products prepared on an ad hoc basis.

II - Establishments which prepare punctually prepared advanced therapy medicinal products shall keep data enabling the identification of samples of tissues, cells, blood or its components used for the manufacture of each punctually prepared advanced therapy medicinal product. This data concerns :

1° Identification of the sampling establishment;

2° The sampling department;

3° The donation identification number;

4° The date of sampling;

5° The type of donation:

a) Whether it consists of a single tissue or several tissues;

b) Whether it comes from a living donor or a deceased donor;

6° Whether it is for autologous or allogeneic use;

7° The type of tissues or cells removed;

8° The individual results of the biological examinations carried out on the donor;

9° The medical history and, where applicable, the risk factors used as a basis for the clinical selection of the donor.

They shall also record all products or substances that come into contact with the tissues, cells or blood.

III.Establishments which distribute or transfer advanced therapy medicinal products prepared on an ad hoc basis must register :

1° The name of the individually prepared advanced therapy medicinal product;

2° The date and time of the distribution or transfer of the medicinal product;

3° The person in charge of the distribution or transfer;

4° The product code, the manufacturing batch number and, where applicable, the donation identification number;

5° The surname and first name of the patient named on the medical prescription;

6° The name and address of the health establishment in which the medicinal product is to be administered and the name of the prescriber named in the medical prescription;

7° The name and address of the establishment to which the medicinal product is transferred, where applicable.

IV.-Except in the context of the research referred to in article L. 1121-1, an advanced therapy medicinal product prepared on an ad hoc basis is distributed to the recipient health establishment accompanied by its package leaflet and labelling as provided for in the order referred to in I of article R. 5121-210.