Subsection 2: Conditions for authorisation and practice

I. – The establishments or organisations mentioned in article L. 513-11-1 shall appoint a person responsible for the collection activity, who shall ensure compliance with the regulations relating to the quality and safety of the faeces collected. They shall also appoint one or more interim responsible persons who shall be entrusted, for the replacement period, with the same powers and duties as those conferred on the responsible person and who…

Establishments or organisations applying for the authorisation referred to in Article L. 513-11-1 have premises, staff and equipment to guarantee the quality, health safety and traceability of the faeces collected, and to reduce the risks, particularly of contamination, for recipients of medicinal products containing faecal microbiota, including preparations of faecal microbiota, in accordance with the rules of good practice provided for in Article L. 513-11-2.

Establishments or organisations authorised under article L. 513-11-1 shall appoint a referral doctor responsible for selecting stool donors.

Establishments or organisations authorised under Article L. 513-11-1 shall send the Director General of the Agence nationale de sécurité du médicament et des produits de santé an annual activity report, the form and content of which shall be determined by decision of this Director. When the authorised establishment is a health establishment, it also sends a copy to the Director General of the Regional Health Agency.

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 Article L. 513-11-1.