French Public Health Code
In forceI. - The application for authorisation or renewal of authorisation of an establishment or organisation to carry out the activities referred to in Article R. 4211-32 relating to advanced therapy medicinal products prepared on an ad hoc basis is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by the legal entity applying for this authorisation, and by any means enabling receipt of this application to be dated with certainty.
This application specifies, for each establishment or organisation and, where applicable, for each of the sites of this establishment or organisation, the activities for which authorisation is sought.
This application is accompanied by a supporting file, the model for which is laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé and which includes :
1° The address of the establishment and plans of the premises, for the various activities to be carried out there;
2° A precise description of the equipment and materials used for each of the activities, including those relating to the transport of products;
3° The list and qualifications of staff, in particular those of the director and the person in charge referred to in Article R. 4211-37, and the nature of the tasks entrusted to them;
4° A list of the procedures used to carry out the various activities;
5° If certain operations are carried out by third parties:
a) The list and addresses of these third parties;
b) Agreements or draft agreements between these third parties and the legal entity applying for authorisation, specifying the responsibilities of each of the parties;
6° Where applicable, information relating to the implementation of procedures to avoid any risk of cross-contamination when therapeutic and scientific activities are carried out on the same premises;
7° For the import and export of these medicinal products as part of the research defined in Article L. 1121-1, the name and address of the suppliers and recipients and a description of the means put in place to ensure the traceability, storage methods and transport conditions for investigational advanced therapy medicinal products prepared on an ad hoc basis;
8° Where the application comes from a health establishment, a copy of the letter and the notice of receipt accompanying it, certifying that the director(s) general of the regional health agency where the establishment's sites are located have been informed of the application for authorisation to carry out the activities mentioned in this section and, where applicable, a copy of any letter indicating any observations made by the regional health agency on the implementation of these activities.
II - In the absence of a complete file, the Director General will inform the applicant, by any means that will allow this communication to be dated, of the information that is missing or incomplete, stating the deadline for providing it.
