French Public Health Code
In forceBy way of derogation from 2° of Article R. 5121-25, for the medicinal products mentioned in this Article, the dossier attached to the marketing authorisation application is compiled under the following conditions:
1° Where the application concerns a generic medicinal product of a reference medicinal product which is or has been authorised for at least eight years in France, the dossier submitted in support of the application includes, in addition to chemical, pharmaceutical and biological data, bioavailability studies demonstrating bioequivalence to the reference medicinal product.
If this medicinal product has been authorised for less than eight years in France and is or has been authorised for at least eight years in a Member State of the European Community or party to the Agreement on the European Economic Area, the procedure also applies;
2° Where the application concerns a medicinal product which does not meet the definition of a generic medicinal product because it contains, compared with a reference medicinal product which is or has been authorised for at least eight years in France, differences relating to the active substance, the therapeutic indications, the strength, the pharmaceutical form or the route of administration, or where bioequivalence with this reference medicinal product has not been demonstrated by bioavailability studies and the medicinal product does not meet the conditions laid down in Article R. 5121-29-1, the dossier submitted in support of the application shall include, in addition to the chemical, pharmaceutical and biological data, the results of appropriate pre-clinical and clinical trials determined on the basis of these differences.
If this medicinal product has been authorised for less than eight years in France and is or has been authorised for at least eight years in a Member State of the European Community or party to the Agreement on the European Economic Area, the procedure is also applicable ;
3° Where the application relates to a biological medicinal product similar to a reference biological medicinal product authorised in France for at least eight years as referred to in 14° of Article L. 5121-1 , the dossier submitted in support of the application includes, in addition to chemical, pharmaceutical and biological data, the results of appropriate pre-clinical and clinical trials relating in particular to the starting material or the manufacturing processes of the similar biological medicinal product.
If this medicinal product has been authorised for less than eight years in France and is or has been authorised for at least eight years in a Member State of the European Community or party to the Agreement on the European Economic Area, the procedure is also applicable;
4° Where the application concerns a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form as an authorised medicinal product, for which the proprietor has consented to use being made of the pharmaceutical, preclinical and clinical documentation contained in the file for this medicinal product, the file provided in support of the application includes a duplicate of the pharmaceutical file for the authorised medicinal product;
5° When the application concerns a homeopathic medicinal product subject to a marketing authorisation, the file provided in support of the application includes, in addition to the chemical, pharmaceutical and biological data, the results of the appropriate pre-clinical and clinical trials when the applicant cannot demonstrate by detailed reference to the published literature recognised in the tradition of homeopathic medicine practised in France that the homeopathic use of the medicinal product or of the homeopathic strains of which it is composed is well established and offers every guarantee of safety.
