French Public Health Code
In forceI. - Establishments or organisations authorised by the Agence nationale de sécurité du médicament et des produits de santé, in application of article L. 1243-2, may obtain, for therapeutic purposes, tissues, their derivatives and cells from the human body, whatever their level of preparation, as well as cell therapy preparations, prepared and stored in a Member State of the European Union or party to the agreement on the European Economic Area.
Any element or product of the human body mentioned in the first paragraph of this I which has been prepared and stored in a Member State of the European Union or party to the Agreement on the European Economic Area and which has not been the subject of an authorisation for the preparation process provided for in Article 6(2) of Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on the establishment of standards of quality and safety for donations, the procurement, testing, processing, preservation, storage and distribution of human tissues and cells is subject, prior to its entry into the customs territory, to the authorisation of the preparation process and the assessment of its therapeutic indications provided for in Article L. 1243-2. This authorisation is issued by the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Agence de la biomédecine, to the establishments or organisations mentioned in the first paragraph of this I.
Establishments or organisations authorised by the Agence nationale de sécurité du médicament et des produits de santé pursuant to Article L. 1243-2, which have authorisation for the preparation and storage process provided for in the same Article L. 1243-2, may supply the human body elements and products mentioned in the first paragraph of this I to an approved establishment in a Member State of the European Union or party to the Agreement on the European Economic Area, for therapeutic purposes.
Where these establishments or organisations do not have this process authorisation, they must inform the Agence nationale de sécurité du médicament et des produits de santé of the reasons why this authorisation has not been granted to them and, where applicable, the information relating to this process. At their request, the Agency shall communicate to the competent health authorities of the recipient country the reasons why an establishment or organisation does not have authorisation for the process.
Where the Agency has refused to issue the process authorisation referred to in the said Article L. 1243-2 or where it considers, in the light of the information transmitted, that there is a risk relating to the quality or safety of the product or that the data transmitted are insufficient, it may prohibit establishments or organisations from supplying these products.
II. - Only the establishments or organisations mentioned in the first paragraph of I of this article, health establishments carrying out the activities mentioned in the first paragraph of article L. 1243-6 and the doctors and dental surgeons mentioned in the second paragraph of the same article L. 1243-6 may import, for therapeutic purposes, from a State which is not a member of the European Union or a party to the Agreement on the European Economic Area, the elements and products of the human body mentioned in the first paragraph of I of this article. These establishments, organisations or natural persons are subject to an import authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Agence de la biomédecine.
Only establishments or organisations authorised by the Agence nationale de sécurité du médicament et des produits de santé pursuant to Article L. 1243-2 may, exceptionally, be authorised by this agency to import the elements or products mentioned in the first paragraph of I of this Article, for the personal use of one or more recipients known to these establishments or organisations and the supplier established in a State which is not a member of the European Union or a party to the Agreement on the European Economic Area. This type of import may only take place once for the same recipient.
Only establishments or organisations authorised by the Agence nationale de sécurité du médicament et des produits de santé pursuant to Article L. 1243-2 may export, for therapeutic purposes, the elements or products mentioned in the first paragraph of I of this Article, to a State that is not a member of the European Union or a party to the Agreement on the European Economic Area. These establishments or organisations are subject to an export authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Agence de la biomédecine.
The authorisations mentioned in the first and penultimate paragraphs of this II specify in particular the activity of the establishments, organisations or natural persons mentioned in the first paragraph of this II and the category of tissues and their derivatives or cell therapy preparations imported or exported as well as, where applicable, the recognised therapeutic indications. The Agence de la biomédecine is informed of the authorisations issued.
III. - By way of derogation from the first and penultimate paragraphs of II, establishments or organisations that are not authorised to carry out import or export activities may, in emergency situations, be authorised by the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the Agence de la biomédecine, to import or export, for therapeutic purposes, tissues, their derivatives and cell therapy preparations intended for a patient. The Agence de la biomédecine is informed of authorisations issued in application of this III.
