French Public Health Code
In forcePursuant to the fourth paragraph of the I of Article L. 1245-5, when the elements or products mentioned in Article R. 1245-1 do not benefit from the authorisation mentioned in Article L. 1243-2, establishments or organisations planning to supply these elements or products to a Member State of the European Union or party to the Agreement on the European Economic Area must send the Agence nationale de sécurité du médicament et des produits de santé, before they leave national territory, a dossier containing the following information:
1° The precise designation of the tissue, its derivatives, the cells derived from the human body or the cell therapy preparation and, where applicable, their trade name;
2° The country of destination and the name and address of the recipient;
3° The reasons why the element or product is not authorised;
4° Information guaranteeing the quality and safety of the elements or products with regard to the requirements of Directive 2004/23/EC, where applicable.
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 study the dossier. It is published on the website of the Agence nationale de sécurité du médicament et des produits de santé.
