Section 5: Conditions for entry into or exit from national territory of elements or products of the human body mentioned in article R. 1245-1 intended for the manufacture of medicinal products

I. – 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…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will give his decision within three months of receipt of the complete application by his departments. If no response is received by the end of this period, the authorisation is deemed to have been refused. The Director General of the Agence nationale de sécurité du médicament et des produits de santé may request any…

The authorisations shall specify the elements listed in Annex II of 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 Authorisations issued in this way may be modified, suspended or withdrawn in whole or in part by the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions set out in Article L. 1245-1. A copy of the decisions to authorise, suspend or withdraw is sent to the…

Any modification of the elements included in the initial import authorisation application dossier, concerning the nature or origin of the tissues, their derivatives or the cells imported, the activities carried out in third countries which may have an influence on the quality and safety of the tissues and cells imported or the suppliers established in these countries, is subject to an authorisation issued by the Director General of the Agence…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall keep an up-to-date list of authorised establishments, giving the names and addresses of these establishments and the category of products that each of them is authorised to import. This list is accessible to the public on the Agency’s website. Authorised establishments shall mention this activity in the annual statement for their establishment provided…

The provisions of articles R. 1245-4 and R. 1245-9 are applicable to establishments or organisations authorised under article R. 1245-24. For the application of article R. 1245-9, the responsible person is the pharmacist in charge for pharmaceutical establishments, the responsible person mentioned in article R. 4211-37 for establishments authorised under article L. 4211-9-1 and the responsible person mentioned in article R. 4211-55 for establishments authorised under article L. 4211-9-2.