Section 3: Importation of faeces and faecal microbiota preparations

I. - The importation of faeces and faecal microbiota preparations may only be authorised when these products are not available in sufficient quantities on national territory to cover patients' needs.

Only establishments or organisations holding the authorisation provided for in Article L. 513-11-1, pharmacies for internal use authorised under Article L. 5126-4 or pharmaceutical establishments authorised under Article L. 5124-3 may obtain authorisation to import faeces.

Authorisation to import faecal microbiota preparations may only be obtained by pharmacies for internal use authorised to import preparations under 9° of article R. 5126-9.

The application for authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the legal entity responsible for the import and by any means that provides 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 importing establishment or organisation ;

2° Administrative information relating to the supplying establishment or organisation;

3° Administrative information relating to the establishment or collecting body if different from the establishment or supplying body;

4° Where applicable, a copy of any document valid as an authorisation issued by the competent authorities of the suppliers, together with a French translation;

5° The location(s) where the faeces are collected;

6° The requirements relating to the selection of stool donors, including their justification with regard to the specific epidemiological characteristics of the collection area;

7° The nature and results of the tests and analyses carried out on the stool donors and the stool collected;

8° Technical information describing the conditions and methods of preparation, control and storage of the imported products;

9° The nature and quantity of the imported product;

10° The intended use of the product and justification for the need to import the product;

11° Information on transport and storage to ensure the proper conservation, integrity and safety of the product concerned;

12° The batch or identification number of the product to ensure traceability;

13° An undertaking by the supplier to transmit without delay to the Agence nationale de sécurité du médicament et des produits de santé any information revealing a risk that could call into question the quality and safety of the product concerned, and in particular any information subsequent to the donation that could have an impact on the quality or safety of the faeces or faecal microbiota preparations.

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 for providing this information by any means giving a date certain to 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 to examine the application for authorisation and in particular any information concerning the selection of the donor and the performance of additional tests and analyses in relation to the geographical origin of the products collected by the supplier. It shall indicate to the applicant, by any means giving a date certain on receipt of this request, the time limit within which it 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 import authorisation is valid for a single operation within three months of issue.

VII. - The authorisation shall indicate in particular the name and address of the supplying establishment or organisation, the legal entity responsible for the import and, where applicable, the recipient establishment if the latter is not the importer. It also indicates the nature and quantity of the imported product and its intended use. It must be presented during a customs inspection.