French Public Health Code
In forceI. - The application for an import authorisation for therapeutic purposes, provided for in the first paragraph of II of Article L. 1245-5, is sent by the legal entities or natural persons mentioned in the same paragraph to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by any means that enables the application to be dated with certainty.
The application for an export authorisation for therapeutic purposes, provided for in the third paragraph of II of Article L. 1245-5, is sent by the establishments or organisations authorised under Article L. 1243-2 to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by any means which allows this application to be dated with certainty.
II. - The application is accompanied by a dossier which includes :
1° The precise designation of the product ;
2° Where applicable, a copy of the authorisation issued under Article L. 1243-2 and a copy of the authorisation issued by the competent authorities of the suppliers, as well as their translation into French;
3° Any information or document making it possible to establish that the requirements mentioned in article R. 1245-4 are met by the applicant establishments;
4° The name and address of each supplier or recipient and copies of written agreements concluded with suppliers established in a State that is not a member of the European Union or a party to the Agreement on the European Economic Area;
5° A description of the means put in place to ensure product traceability, conservation methods and product transport conditions;
6° Information on the removal of tissues and cells from the human body, the preparation process used, the products and materials coming into contact with the tissue elements or products mentioned in article R. 1245-1, and, for finished products, information on the finished product;
7° pre-clinical and clinical data, including the results of clinical trials and the therapeutic indications claimed, for imports of finished products.
III. - Legal entities or natural persons submitting an application for authorisation shall make available to the Director General of the Agence nationale de sécurité du médicament et des produits de santé the other information mentioned in Annex III to Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards procedures for verifying equivalent standards of quality and safety of imported tissues and cells. They shall forward this information to the Commission at its request.
IV. - A decision 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, specifies the form and content of the dossier, as well as the list of documents and additional information required to examine the application. It is published on the website of the Agence nationale de sécurité du médicament et des produits de santé.
V. - The application is deemed to be complete if, within one month of its receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not informed the applicant, by any means capable of providing a definite date, of the information that is missing or incomplete and specifying the deadline for providing it.
