I.- By way of derogation from 1° and 4° of Article L. 4211-1, in the context of the research defined in Article L. 1121-1 , advanced therapy medicinal products mentioned in 17° of Article L. 5121-1 may be prepared, stored, distributed, transferred, imported and exported by establishments or organisations, including health establishments, authorised by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) after receiving the opinion of the Agence de la biomédecine.
This authorisation is issued for a period of five years. It is renewable and may be modified, suspended or withdrawn.
A Conseil d’Etat decree sets the categories of establishments that may be authorised, as well as the conditions for issuing, amending, renewing, suspending and withdrawing this authorisation.
The pharmaceutical establishments referred to in articles L. 5124-1 and L. 5124-9-1 may also carry out these activities.
II – When the preparation, distribution and administration of these medicinal products are carried out, in a health establishment or in an army hospital, as part of the same medical procedure as that for the removal of the autologous tissues or cells used in their composition, the preparation and distribution are carried out under the responsibility of an establishment or organisation mentioned in the first or last paragraphs of I of this article, in accordance with the good practices mentioned inarticle L. 5121-5 and under a written contract.
The need to administer these medicinal products as part of the same medical intervention is verified by the Agence nationale de sécurité du médicament et des produits de santé as part of the authorisation referred to in 17° of article L. 5121-1 or as part of the authorisation for research involving the human person.
A Conseil d’Etat decree specifies the conditions applicable to the preparation and the type of medicinal products concerned by this II.