Paragraph 3: Procedure for authorising the importation of human body parts or products mentioned in Article R. 1245-1, for the personal use of one or more recipients, as provided for in the second paragraph of II of Article L. 1245-5.

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R1245-13R1245-14

Article R1245-13

French Public Health CodeIn force
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Updated 5 Nov 2023

The application for authorisation provided for in the second paragraph of II of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any means enabling its receipt to be dated, by an establishment or body already authorised under Article L. 1243-2.

This request is accompanied by a letter from the applicant justifying the need to import elements or products from the human body mentioned in article R. 1245-1, intended for the personal use of one or more recipients known to these establishments or organisations and to the supplier, in situations where the persons have had tissues or cells stored in a State which is not a member of the European Union or not part of the European Economic Area, with a view to their future use, after importation on their behalf, in particular in the case of autologous donations or donations intended for close relatives.

It must also be accompanied by a technical dossier, the content of which is set by decision of 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, published on the website of the Agence nationale de sécurité du médicament et des produits de santé.

This file includes the name and address of the supplier established in the third country, the name of the patient(s) concerned, the precise designation of the product and the number of units, and essential information on the process used and the product obtained.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall ensure that these imports do not come regularly or repeatedly from the same supplier established in a State that is not a member of the European Union or a party to the Agreement on the European Economic Area, that they are made only once for the same patient and that the imported elements or products are not intended for persons other than the intended recipients.

The provisions of V of article R. 1245-5 and the provisions of article R. 1245-6 are applicable to these requests.

The authorisation decision, taken after obtaining the opinion of the Director General of the Agence de la biomédecine, mentions the elements listed in Annex II of Directive (EU) 2015/566.

It is valid for a single operation.

Mariela Petrova

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A notary (notaire) is a public officer who authenticates specific deeds (mainly real-estate transfers and certain family-law acts). A corporate lawyer (avocat) advises on strategy, negotiates and drafts company documents, and represents you in disputes. The two roles complement rather than overlap.

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Mariela Petrova

Mariela Petrova

Avocate au Barreau de Paris

Toque #C2396

15+ Years In Corporate Practice

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