Subsection 4: Rules applicable to authorised establishments

I.-Substantial changes to the activities authorised under this section relating to … are subject to authorisation by the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° A new activity, among those mentioned in article L. 4211-9-2 ; 2° The manufacture or import of a new category of investigational advanced therapy medicinal product; 3° The manufacture or import of a new pharmaceutical form…

I.-The following changes to the authorisation are subject to declaration: 1° Change in the corporate name of the establishment or the administrative address of the authorisation holder; 2° Appointment of a new responsible person; 3° Cessation of a pharmaceutical activity or operation in the establishment. II – Within one month of their implementation, changes, with the exception of those relating to the person in charge, are declared to the Agence…

Changes other than those mentioned in articles R. 4211-58 and R. 4211-59 are declared in the annual activity report provided for in article R. 4211-62.

In the event of non-compliance with the legislative and regulatory provisions or the conditions of the authorisation, the suspension, which may not exceed one year, and the withdrawal of the authorisation are ordered by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These decisions may concern all or part of the authorised activity and may only be taken after the party concerned…

The authorised health care organisation sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Regional Health Agency an annual activity report containing, in particular, all the information necessary for the evaluation of all the activities for which it is authorised. The form and content of this report are laid down by decision of the Director General…

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…