Paragraph 2: Conditions for the departure from national territory of human body parts or products mentioned in Article R. 1245-1 when they do not have the authorisation mentioned in Article L. 1243-2

Pursuant 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…

The Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided. At the end of these maximum four months, when, in application of the last paragraph of I of Article L. 1245-5, the Director General of the Agence nationale de sécurité du médicament et des produits de santé is considering prohibiting the departure from national territory of an…