Section 9: Authorisation of health establishments carrying out activities involving advanced therapy medicinal products as part of the research referred to in the first paragraph of Article L. 1121-1

Health establishments authorised in application of this section may apply for a certificate of compliance with the good practices referred to in Article L. 5121-5. This certificate may be issued by the Agence nationale de sécurité du médicament et des produits de santé for all or part of the activities inspected to the responsible person mentioned in article R. 4211-55, within ninety days of an inspection. It may not be…

The provisions of articles R. 5124-3-1, with the exception of the last paragraph, R. 5124-4, R. 5124-48, R. 5124-57-1 to R. 5124-57-6 and R. 5124-60 are applicable to health establishments authorised in application of this section.

Health establishments authorised under this section which distribute advanced therapy medicinal products must keep at least the following information for each incoming and outgoing transaction: 1° The date of the transaction; 2° The name of the medicinal product; 3° The number and expiry date of the various batches with the quantities supplied and received per batch, in accordance with the good practices referred to in Article L. 5121-5; 4° The…