French Public Health Code
In forceI. - 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 shall effectively exercise them for the duration of the replacement.
II. - The person in charge is responsible for :
1° Ensuring that faeces intended for therapeutic use are collected, checked, stored, monitored and transported in accordance with the legislative and regulatory provisions in force, in particular the rules of good practice provided for in Article L. 513-11-2 ;
2° Ensure that the quality assurance system is set up, evaluated and updated in compliance with the rules of good practice referred to in 1°;
3° Ensure that a system is put in place to ensure that any post-donation information likely to have an impact on stool quality or safety is obtained from stool donors.
III. - When an establishment or organisation is authorised under Article L. 513-11-1 to carry out its activities on different sites:
1° The responsible person mentioned in I may assume responsibility for activities on these different sites;
2° The authorised establishment or body may appoint a person to be responsible for the activities of one or more sites, who will carry out the tasks mentioned in I and II under the authority of the person in charge.
IV. - The person in charge and the interim persons in charge referred to in I must hold diplomas entitling them to practise medicine, pharmacy or a doctorate in the field of life sciences and health. They must have a total of at least two years' practical experience in the fields of activity defined by this section.
The person responsible for the site activities referred to in 2° of III must hold a diploma allowing them to practise medicine or pharmacy or a university diploma in the field of life and health sciences.
V. - The establishment or authorised body must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé a copy of any document appointing the person in charge, the interim persons in charge and, where applicable, the persons in charge of site activities mentioned in 2° of III.
