Title III: Other regulated pharmaceutical products and substances

All stool collection activities intended for the preparation of faecal microbiota used for therapeutic purposes are carried out by establishments or organisations which are authorised by the Agence nationale de sécurité du médicament et des produits de santé, with the exception of collection carried out in the context of research involving the human person mentioned in 1° ofArticle L. 1121-1.

The collection, control, storage, traceability and transport of faeces carried out by the establishments or organisations mentioned inArticle L. 513-11-1, including in the context of research involving the human person, are carried out in accordance with the rules of good practice defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These rules of good practice include in particular the…

In the event of non-compliance with the provisions of articles L. 513-11-1 and L. 513-11-2 by an establishment or body mentioned in article L. 513-11-1 or in the event of a risk to public health, the Agence nationale de sécurité du médicament et des produits de santé may suspend or prohibit the activities mentioned in article L. 513-11-2. Except in the case of imminent risk, a decision to suspend or…

Transplantation of faecal microbiota is carried out in the interests of the recipient and is subject to the principles of donor consent and anonymity of donation. The rules of anonymity of donation do not apply in the case of intrafamilial donation.

The detailed rules for the application of this chapter shall be determined by decree.