Chapter I: General provisions

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall register the homeopathic veterinary medicinal products referred to in Article L. 5141-9, on the basis of an application accompanied by a dossier submitted and examined in accordance with the conditions laid down in this Section. When examining applications for registration, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation,…

The application for registration of a homeopathic veterinary medicinal product or a series of medicinal products mentioned in article L. 5141-9 is sent to the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. A series of medicinal products within the meaning of article L. 5141-9 liable to give rise to a single registration is understood to mean a set of medicinal products, consisting of the same…

The application for registration must be accompanied by a dossier containing : 1° The scientific name, or other name appearing in a pharmacopoeia, of the homeopathic stock or stocks, mentioning the various routes of administration, pharmaceutical forms and degrees of dilution to be registered; 2° A document describing how the stock or stocks were obtained and controlled, and justifying their homeopathic nature on the basis of an appropriate bibliography; in…

Where the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail considers that the application or the accompanying dossier is incomplete, he will invite the applicant to complete the application or dossier. The Director General will notify the applicant of his decision within two hundred and ten days of the submission of a complete application and dossier. If the Director General remains silent,…