Book I: Pharmaceutical products

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registration of a homeopathic veterinary medicinal product mentioned in Article L. 5141-9 may be refused, suspended or withdrawn by the Director General of the Agency.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