Subsection 1: General provisions.

I.-Establishments or organisations which apply for or are authorised to carry out activities involving the preservation and distribution of tissues and their derivatives in accordance with Article L. 1243-2 may also apply for authorisation to enter into agreements with the health establishments mentioned in the first paragraph of Article L. 1243-6, enabling the latter to ensure, on their premises, the storage and distribution of tissues or their derivatives intended for use in the care provided in the health establishment.

The specific authorisation to enter into agreements, as provided for in the previous paragraph, is mentioned in the authorisation provided for in article L. 1243-2.

The storage and distribution provided for in these agreements are carried out under the responsibility of the establishment or organisation benefiting from the authorisation, which checks, where appropriate on site, that the health establishment with which it has entered into a contract complies with the stipulations of the agreement and the rules of good practice mentioned in article L. 1245-6.

II.-The list of tissues and their derivatives that may be the subject of the agreements mentioned in I, the maximum quantity that may be stored in a single health establishment and the conditions for their storage and, where applicable, the specific conditions for their distribution, are set by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

By way of derogation from the provisions of Article R. 1243-26, the special distribution arrangements may provide that the documents provided for in this article are drawn up after distribution, in compliance with the rules of good practice referred to in Article L. 1245-6 and under conditions which ensure the traceability and safety of these tissues and their derivatives.

III -The tissues or derivatives mentioned in the first paragraph of II may only be the subject of an agreement mentioned in I under the following conditions:

their storage must be compatible with the resources likely to be used by the health establishment in which they are stored;

-their storage and distribution must not require technical expertise beyond that of the staff of the health establishment in which they are stored;

-their storage in the health care organisation must be justified by the need to ensure that they are immediately available for the medical treatment of patients admitted to the health care organisation;

IV - The agreements mentioned in I stipulate in particular:

-the list of tissues and their derivatives concerned and their preparation process numbers;

-the corresponding therapeutic indications;

-the maximum quantity of tissues and their derivatives that may be stored;

-the premises in which storage takes place, the equipment used and the staff involved in storage and distribution activities;

-where applicable, the appropriate procedures for transmitting the documents mentioned in article R. 1243-26.