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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.

Article R1245-13 of the French Public Health Code

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…

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Article R1245-14 of the French Public Health Code

Establishments or organisations authorised to carry out imports in application of the second paragraph of II and III of article L. 1245-5 shall mention in the annual activity report provided for in article R. 1243-22 the types and quantities of tissues and cells imported as well as their origin and destination.

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