French Public Health Code
In forceThis application specifies, for each establishment and, where applicable, for each of the sites of this establishment, the activities for which authorisation is sought.
This application is accompanied by a supporting file, the form and content of which are specified by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, published on the Agency's website, and which includes:
1° The address of the establishment and plans of the premises, for the various activities envisaged there;
2° The activity or activities requested for the establishment from among those mentioned in Article L. 4211-9-2, as well as the category of advanced therapy medicinal products to which these activities relate;
3° A precise description of the equipment and materials used for each of the activities, including those relating to the transport of products;
4° The list and qualifications of the staff, in particular those of the responsible person and the acting responsible person referred to in Article R. 4211-55, and the nature of the tasks entrusted to them;
5° A list of the procedures used to carry out the various activities;
6° If certain operations are carried out by third parties:
a) The list and addresses of these third parties;
b) The agreements or draft agreements between these third parties and the legal entity applying for authorisation, specifying the responsibilities of each of the parties;
7° Where applicable, information relating to the implementation of procedures to avoid any risk of cross-contamination between products when therapeutic and scientific activities are carried out on the same premises;
8° Where applicable, the containment measures taken in application ofArticle L. 532-3 of the Environmental Code ;
9° A copy of the letter and the notice of its receipt, 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 referred to in Article R. 4211-53 and, where applicable, a copy of any observations made by the Regional Health Agency on the implementation of these activities.
II - In the absence of a complete application, the Director General will inform the applicant, by any means that provides a date certain, of the information that is missing or incomplete, stating the deadline for providing it.
III - The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within ninety days from the date of receipt of the complete application.
The Director General may request any additional information or initiate an administrative investigation by one of his agents or an on-site investigation by an inspector mentioned in Articles L. 5313-1 and L. 5313-3 to enable him to decide on the application. The period referred to in the previous paragraph is suspended from the date on which the Director General of the Agence nationale de sécurité du médicament et des produits de santé notifies this decision until receipt of the information requested or the results of the investigation.
If no decision has been taken by the end of the period provided for in the first paragraph of this III, the application will be rejected.
Authorisations specify the name and address of the health establishment concerned, the activities and operations authorised and, where applicable, the pharmaceutical forms. A copy of the authorisation 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 regional health agency or agencies concerned.
IV -The authorisation granted is recorded in the European Union database.
