French Public Health Code
In forceA generic medicinal product may not be marketed until ten years have elapsed following the initial marketing authorisation of the reference medicinal product. However, this period is extended to eleven years if, during the first eight years following the authorisation of the reference medicinal product, the holder of the latter obtains authorisation for one or more new therapeutic indications considered, during the scientific evaluation carried out with a view to their authorisation, to provide a significant clinical advantage compared with existing therapies, without prejudice to the evaluation of the expected service by the Haute Autorité de Santé in application of the first paragraph of Article L. 161-37 of the Social Security Code.
This article also applies to similar biological medicinal products and to medicinal products with characteristics in common with a reference medicinal product but which do not meet the definition of a generic medicinal product due to differences relating to one or more elements of this definition and requiring additional data to be produced under conditions determined by regulation.
