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Article R4211-51 of the French Public Health Code

An authorised establishment or organisation may transfer to another authorised establishment or organisation advanced therapy medicinal products prepared on an ad hoc basis with a view to their storage and distribution or components of these medicinal products with a view to their preparation by this second establishment or organisation. Only advanced therapy medicinal products prepared on an ad hoc basis in compliance with the health safety rules adopted in application…

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Article R4211-51-1 of the French Public Health Code

I.-In accordance with the provisions of II of Article L. 4211-9-1, an establishment or organisation authorised under this section may have the preparation and distribution of an individually prepared advanced therapy medicinal product as mentioned in Article R. 1124-6 and in the second paragraph of Article R. 5121-209, by the health establishment or army hospital which removes the autologous tissues or cells, i.e. from the person himself, used in its…

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Article R4211-52 of the French Public Health Code

For the application of the provisions of sub-sections 1 to 4a, army hospitals are considered to be health establishments and the Minister for Defence exercises, with regard to them and the army blood transfusion centre, the powers of the Director General of the regional health agency. For the application of articles R. 4211-34 and R. 4211-43 to army hospitals, the request for authorisation is sent by the Minister of Defence.

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