Article D513-11-7 of the French Public Health Code
November 1, 2023
Establishments or organisations authorised under article L. 513-11-1 shall appoint a referral doctor responsible for selecting stool donors.
Establishments or organisations authorised under article L. 513-11-1 shall appoint a referral doctor responsible for selecting stool donors.
Establishments or organisations authorised under Article L. 513-11-1 shall send the Director General of the Agence nationale de sécurité du médicament et des produits de santé an annual activity report, the form and content of which shall be determined by decision of this Director. When the authorised establishment is a health establishment, it also sends a copy to the Director General of the Regional Health Agency.
In the event of infringement of the applicable legislative and regulatory provisions, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw the authorisation referred to in Article L. 513-11-1.
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…
I. – Stools and faecal microbiota preparations may only be imported from a State in which the donor selection, tests and analyses mentioned in the rules of good practice provided for in article L. 513-11-2 are carried out in compliance with standards equivalent to these rules. II. – The establishments or organisations mentioned in article R. 513-11-10 which import faeces and preparations of faecal microbiota for therapeutic purposes including research…
In the event of infringement of the applicable legislative and regulatory provisions, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw the authorisation referred to in the second paragraph of Article L. 513-11-2.
For the purposes of this chapter, the following definitions shall apply 1° Substance means any material whatever its origin, which may be : – human, such as human blood and products derived from human blood; – animal, such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, substances obtained by extraction, products derived from blood; – vegetable, such as micro-organisms, plants, parts of plants, vegetable secretions, substances obtained by…
The name of a veterinary medicinal product may be either an invented name or a common or scientific name accompanied by a trade mark or the name of the holder of the marketing authorisation or of the company operating the medicinal product. The invented name may not be confused with the common name. Without prejudice to the application of legislation relating to trademarks or service marks, the invented name shall…
Experiments on veterinary medicinal products within the meaning of article L. 5141-16 are any tests, research or experiments, hereinafter referred to as trials, which are carried out with a view to obtaining a marketing authorisation or a marketing authorisation variation. These trials include : a) For non-immunological medicinal products : -pharmaceutical tests, i.e. physico-chemical, biological or microbiological tests ; non-clinical tests, i.e. safety tests, including tests to assess the risk…
The natural or legal person who initiates a veterinary medicinal product trial as defined in article R. 5141-2 is called the sponsor. The persons who direct and supervise the performance of pharmaceutical trials and non-clinical trials are called investigators. Those who direct and supervise the performance of clinical trials are called investigators. Depending on their activity, investigators and investigators have the qualifications and experience mentioned in article R. 5141-25. The…
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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