Subsection 4a: Special provisions for the preparation, distribution and administration of advanced therapy medicinal products prepared on an ad hoc basis as part of the same medical procedure as the removal of the tissues or autologous cells used in their composition.

I.-In accordance with the provisions of II of Article L. 4211-9-1, an establishment or organisation authorised under this section may have the preparation and distribution of an individually prepared advanced therapy medicinal product as mentioned in Article R. 1124-6 and in the second paragraph of Article R. 5121-209, by the health establishment or army hospital which removes the autologous tissues or cells, i.e. from the person himself, used in its…