Subsection 2: Authorisation procedure

I.-The application for authorisation provided for in Article L. 1243-2 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the legal entity requesting the authorisation, by any means that provides a date certain of receipt. This application specifies, for each establishment or organisation and, where applicable, for each of the sites of this establishment, the activities for which…

A copy of the complete dossier is sent by the Director General of the Agence nationale de sécurité du médicament et des produits de santé to the Director General of the Agence de la biomédecine. The Director General of the Agence de la biomédecine sends his opinion to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, within two months of the date…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within four months of the date on which the application is deemed to be complete. If the Director General considers that additional information is required to enable him to reach a decision on the application, he may suspend consideration of the application until the missing information has…

I. – Substantial changes to the authorisation referred to in Article R. 1243-6 are subject to prior written authorisation by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Director General of the Agence de la biomédecine. Substantial changes are considered to be those relating to : 1° The types of activities and categories of tissues, derivatives,…

Any changes relating to : 1° The name or administrative address of the establishment or organisation, or where applicable the authorised site; 2° The appointment of a new director of the establishment or authorised body or, in the case of the Etablissement Français du Sang, the appointment of a director of a blood transfusion establishment; 3° The implementation of new technical equipment, including new medico-technical software used for the traceability…

Changes other than those mentioned in articles R. 1243-7 and R. 1243-8 are declared in the annual activity report provided for in article R. 1243-22.

The authorisations referred to in Article R. 1243-6 may be suspended or withdrawn in whole or in part, pursuant to Article L. 1245-1, and in particular in the event of danger to public health or the environment or breach of the rules of good practice provided for in Article L. 1245-6, by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, following a…

Any establishment or organisation benefiting from the authorisation referred to in Article R. 1243-6 must have put in place agreements or procedures with another establishment or other establishments or organisations authorised under this same article, guaranteeing that in the event of interruption or cessation of activity, the tissues, their derivatives, the cells or the cell therapy preparations are transferred there. By way of derogation from the first paragraph, when the…