Subsection 2: Homeopathic medicinal products

The application file for registration of a medicinal product or a series of medicinal products mentioned in article L. 5121-13 is sent to the Agency. It includes the following information and documents

1° The name and address of the applicant and the operator of the medicinal product and, where the latter does not manufacture the medicinal product, the name and address of the manufacturer and, where applicable, the name and address of the importer ;

2° The common name of the homeopathic stocks, with reference to the European or French pharmacopoeia where this is included;

3° The routes of administration and pharmaceutical forms;

4° The degrees of dilution;

5° The capacity of the sales models;

6° Data relating to the quantitative and qualitative composition of the medicinal product;

7° A document describing how the strains are obtained and controlled, with reference to the monographs of the European Pharmacopoeia or, failing that, of one of the pharmacopoeias officially used in the Member States of the European Community or parties to the Agreement on the European Economic Area, and mentioning the scientific name of these strains;

8° A document justifying, on the basis of an appropriate bibliography, the homeopathic use of each strain, without proof of therapeutic effect being required, and defining the degree of dilution above which safety is guaranteed;

9° For each pharmaceutical form, a document relating to the manufacture and control of the medicinal product, describing the deconcentration methods used and referring to the monographs of the European Pharmacopoeia or, failing that, of one of the pharmacopoeias officially used in the Member States of the European Community or parties to the Agreement on the European Economic Area;

10° Data concerning the stability of the medicinal product;

11° Where appropriate, data concerning special storage precautions;

12° A copy of the authorisations to open the establishment manufacturing or importing the product;

13° A copy of any registrations or authorisations obtained for the same medicinal product in another Member State of the European Community or party to the Agreement on the European Economic Area;

14° The draft outer packaging and immediate packaging of the medicinal product and, if applicable, the draft package leaflet.