French Public Health Code
In forceThe 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 component or components, presented, where appropriate, in several pharmaceutical forms or different dilutions.
The application for registration must include :
1° The name and address of the applicant and of the proprietor of the medicinal product(s) and, where the latter does not manufacture the medicinal product(s), the name and address of the manufacturer and, where appropriate, the name and address of the importer ;
2° The designation of the manufacturing sites, including the packaging and inspection sites;
3° The usual common name of the homeopathic stock or stocks, with reference to the European pharmacopoeia, or the French pharmacopoeia where this is included, or, failing this, to a pharmacopoeia used officially in another Member State of the European Union or party to the Agreement on the European Economic Area;
4° Route(s) of administration;
5° Pharmaceutical form(s);
6° Degree(s) of dilution;
7° The list of presentations;
8° Animal of destination;
9° Shelf life.
