French Public Health Code
In forceOn a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the following are set:
1° By order of the Minister for Health:
a) The maximum doses and concentrations of the micro-organisms and toxins on the list provided for in Article L. 5139-1 above which products containing them are subject to the provisions of this chapter;
b) Information appearing on the authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé, in particular information relating to the holder of the authorisation, the establishment where the authorised operations are carried out, the nature of these operations, the micro-organism or toxin used and the period of validity of the authorisation;
c) Information appearing on the annual stock statements provided for in Article R. 5139-14 ;
d) The information contained in the register or records referred to in article R. 5139-17, in particular the procedures for keeping them and the information they contain;
2° Par arrêté des ministres chargés de la recherche et de la santé, les titres de formation et l'expérience professionnelle pertinente dont le titulaire de l'autorisation justifie pour lui-même ainsi que pour les personnes qu'il habilite pour contribuer, sous sa responsabilité, aux opérations faisant l'objet de l'autorisation ;
3° By order of the ministers responsible for agriculture, industry, research, health and labour, the rules of good practice designed to guarantee biological safety and security mentioned in article R. 5139-18.
