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

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…