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Article D513-11-11 of the French Public Health Code

I. – Stools and faecal microbiota preparations may only be imported from a State in which the donor selection, tests and analyses mentioned in the rules of good practice provided for in article L. 513-11-2 are carried out in compliance with standards equivalent to these rules. II. – The establishments or organisations mentioned in article R. 513-11-10 which import faeces and preparations of faecal microbiota for therapeutic purposes including research…

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Article D513-11-12 of the French Public Health Code

In the event of infringement of the applicable legislative and regulatory provisions, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw the authorisation referred to in the second paragraph of Article L. 513-11-2.

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