French Public Health Code
In forceI. - Applications for authorisation to import tissues, their derivatives or cells from the human body, whatever their level of processing, as provided for in the first paragraph of II of article L. 1245-5-1, are sent by pharmaceutical establishments and by establishments authorised under articles L. 4211-9-1 and L. 4211-9-2 to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by any means capable of providing a date certain for this application.
II. - The application is accompanied by a file which includes :
1° The precise designation of the tissues, their derivatives and cells from the human body intended to be imported ;
2° Any information or document making it possible to establish that the requirements mentioned in articles R. 1245-2 and R. 1245-4 are met by the applicant establishment or organisation;
3° The name and address of each supplier 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;
4° A description of the means put in place to ensure the traceability of tissues, their derivatives or cells derived from the human body, their preservation and transport;
5° Information on the conditions under which tissues and cells are removed.
III. - Establishments 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 information mentioned in Annex III of Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards procedures for verifying equivalent quality and safety standards for imported tissues and cells. They shall transmit 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 specifies the form and content of the dossier, as well as the list of documents and additional information required to examine the application. This decision 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 indicating the deadline for providing it.
