French Public Health Code
In forceI. - The application for authorisation to carry out the stool collection activity provided for in Article L. 513-11-1 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the legal entity applying for this authorisation and by any means giving a date certain for receipt of this application.
II. - This application is accompanied by a dossier, the form and content of which are laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, published on its website, and which includes :
1° Administrative information relating to the applicant establishment or organisation ;
2° Information relating to the stool collection activity, as well as any elements relating to controls aimed at ensuring the safe collection, storage, traceability and transport of the stool collected;
3° Information on the premises, equipment, staff, product routes and agreements with third parties and recipient establishments;
4° A list of products and materials that come into contact with the faeces;
5° A commitment to comply with the rules of good practice set out in Article L. 513-11-2.
III. - In the event of the submission of an incomplete dossier, the Director General of the Agence nationale de sécurité du médicament et des produits de santé will inform the applicant of the information that is missing or incomplete and specify the deadline by which it must be provided, by any means that provides a date certain of the receipt of this request.
IV. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé may request any additional information that he considers necessary for the examination of the application for authorisation and shall indicate to the applicant, by any means giving a date certain on receipt of this request, the time limit within which he must provide this information, which may not exceed four months.
V. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within four months of the date of receipt of the complete application. If no decision has been taken by the end of this period, the application will be deemed to have been accepted. This period is suspended in the event of a request for additional information as referred to in IV and resumes upon receipt of this information.
VI. - The authorisation specifies the name and address of the establishment or organisation concerned and, where the establishment or organisation has several sites, the site or sites where the activity is carried out.
VII. - Substantial changes to the authorisation referred to in VI are subject to authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, prior to their implementation. The application for authorisation, made by any means giving a date certain on receipt, is accompanied by a dossier, the form and content of which are specified by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé. Any application for a substantial amendment is submitted and examined under the same conditions as the initial application.
Substantial changes are considered to be those relating to :
1° Methods of organising the collection of faeces and which appear, as such, on a list established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, published on its website;
2° Changes to premises that have an impact on the implementation of stool collection activities;
3° The creation of new premises in which the stool collection activity is carried out.
Changes in the person in charge of the authorised establishment or organisation and, within this establishment or organisation, in the person in charge of the collection activity, are notified immediately to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
Other changes are declared in the annual activity report provided for in Article D. 513-11-8.
The Agence nationale de sécurité du médicament et des produits de santé must be notified without delay of the cessation of the stool collection activity by any means giving a certain date to this notification.
VIII. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé may refuse to authorise all or part of the activity which is the subject of the initial application for authorisation or the application for authorisation of a substantial modification, in particular when the conditions under which the stool collection activity is carried out are not such as to guarantee the quality and safety of the stool collected.
IX. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorised establishments or organisations, giving their names and addresses. This list is accessible to the public on its website.
