Book I: Pharmaceutical products

For the purposes of this chapter, the following definitions shall apply 1° “Collection”: the collection of faeces as defined in 2°, under the responsibility of the establishment or body mentioned in Article L. 513-11-1 ; 2° “Stools”: stools of human origin intended for the preparation of faecal microbiota used for therapeutic purposes, collected in the context of Article L. 513-11-1, subject only to the steps necessary for their preservation and…

Prior to donation, the stool donor receives information from the establishment or organisation carrying out the collection on the conditions for : 1° Biological donor selection ; 2° Clinical selection of donors; 3° Collection of the faeces; 4° Stool storage; 5° Use of the faeces. He is also informed of the risks incurred by the recipient of the medicinal product containing faecal microbiota in the event of non-compliance with the…

Faeces are collected on the premises of the establishment or body referred to in Article L. 513-11-1. By way of derogation from the first paragraph, the collection of faeces may, in the context of research involving the human person mentioned in Title II of Book I of Part One of the Code or an authorisation for compassionate access mentioned in Article L. 5121-12-1, be carried out at the donor’s home….