Title IV: Veterinary medicinal products

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registration of a homeopathic veterinary medicinal product mentioned in Article L. 5141-9 may be refused, suspended or withdrawn by the Director General of the Agency.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…

Decisions to register homeopathic veterinary medicinal products or to suspend or cancel these registrations are made public in an extract on the website of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. Registration decisions include the information provided for in Article R. 5141-63.

The labelling and, where appropriate, the package leaflet of the homeopathic veterinary medicinal products referred to in article L. 5141-9 must bear the following information exclusively: 1° The very clear indication “homeopathic veterinary medicinal product with no approved therapeutic indication” ; 2° The scientific name of the strain(s) followed by the degree of dilution using the symbols of the European or French Pharmacopoeia; if the homeopathic veterinary medicinal product is…