Subsection 1: Application for authorisation.

When it is informed by the holder of a marketing authorisation for a medicinal product granted under 1°, 2° or 3° of article R. 5121-28, prior to the marketing of the medicinal product or speciality concerned, of the fact that for some of the indications, pharmaceutical forms or strengths of the reference medicinal product or speciality the intellectual property rights have not expired, the Director General of the Agency shall…

For the application of 1° of Article R. 5121-26, where reference is made to published scientific literature, experts must justify the use of this bibliographical documentation and demonstrate that it meets the requirements of the protocols adopted pursuant to Article R. 5121-11, taking into account in particular the pharmaceutical form and the constituents of the excipient.

For the application of 5° of article R. 5121-28, when reference is made to published literature recognised in the tradition of homeopathic medicine practised in France, experts justify, on the basis of the documentation provided: 1° The homeopathic use of the strains used and their traditional use in the claimed indication; 2° The safety of the homeopathic medicinal product, particularly with regard to the degree of dilution of each of…