Section 3: Importation of faeces and faecal microbiota preparations

I. – The importation of faeces and faecal microbiota preparations may only be authorised when these products are not available in sufficient quantities on national territory to cover patients’ needs. Only establishments or organisations holding the authorisation provided for in Article L. 513-11-1, pharmacies for internal use authorised under Article L. 5126-4 or pharmaceutical establishments authorised under Article L. 5124-3 may obtain authorisation to import faeces. Authorisation to import faecal…

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…

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.