Subsection 1: Provisions relating to the import and export of elements or products of the human body mentioned in Article R. 1245-1, from or to countries outside the European Union and the European Economic Area

I. – 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…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will send a copy of the dossier to the Director General of the Agence de la biomédecine, who will give his opinion within one month. If no response is received within this period, this will be deemed to be a favourable opinion. The Director General of the Agence nationale de sécurité du médicament et…

In particular, the authorisations specify the type of activity authorised and the category of products imported or exported and, for imported finished products, the therapeutic indications. In the case of imports, they shall also include the information listed in Annex II to Directive (EU) 2015/566. Authorisations issued in this way may be modified, suspended or withdrawn in whole or in part by the Director General of the Agence nationale de…

Any modification of the information contained in the initial import and export authorisation application dossier, concerning the nature or origin of the products, as well as the substantial modifications mentioned in 4° of Article R. 1243-7, are subject to authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The application for modification is submitted and examined under the same conditions…

I. – Applicant establishments or organisations appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of tissues or their derivatives or cell therapy preparations, as well as one or more interim responsible persons who, for the period of replacement, are entrusted with the same powers and duties as those conferred on the responsible person and effectively exercise them for the duration of the…

I. – Natural or legal persons holding the authorisation referred to in Article R. 1245-7 inform the Agence nationale de sécurité du médicament et des produits de santé of their decision to cease all or part of their import activities. II. – Where they carry out the activity of importing, they must notify the Agence nationale de sécurité du médicament et des produits de santé without delay of any total…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorised legal entities or individuals, giving their names and addresses and the category of products that each of them is authorised to import or export. This list is accessible to the public.