Section 4: Registration of homeopathic medicines.

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,…

The registration includes the registration number and the data mentioned in Article R. 5141-63 as approved by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. Registration is valid for five years. It is renewable on application by the holder to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail no later than six…

The registration issued by the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail becomes null and void if it appears : 1° That it is not followed by the marketing of the homeopathic veterinary medicinal product on national territory within three years of its issue ; 2° That the homeopathic veterinary medicinal product, previously placed on the market on national territory, is no longer on the…

After registration has been granted, the manufacturing methods and control techniques set out in the dossier provided for in Article R. 5141-64 are modified in line with scientific and technical progress.

Amendments concerning the data mentioned in the application and dossier provided for in articles R. 5141-63 and R. 5141-64 are submitted for approval to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, together with the corresponding supporting documents. Silence on the part of the Director General of the Agency constitutes tacit approval of the modifications on expiry of a period of…

Any change of registration holder is subject to authorisation from the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The application must include : 1° A copy of the registration ; 2° Identification of the future holder ; 3° A document establishing that the complete and up-to-date file for the homeopathic medicinal product concerned, or a copy thereof, has been transferred to…

The registration of a homeopathic veterinary medicinal product mentioned in Article L. 5141-9 may be refused, suspended or withdrawn by the Director General of the Agency. Decisions to refuse, suspend or cancel registration are notified to the applicant. Reasons are given for the decision and the applicable appeal procedures and deadlines are indicated. A suspension decision may not be taken for more than one year. Suspension or cancellation decisions may…