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 applicant demonstrates, by reference to appropriate bibliographical documentation, that the application relates to a medicinal product whose active substance or substances have been in well-established medical use for at least ten years in France, in the European Community or in the European Economic Area and have recognised efficacy and an acceptable level of safety, the dossier submitted in support of the application shall include the appropriate bibliographical documentation;
2° Where the application concerns a new medicinal product containing active substances which are included in the composition of authorised medicinal products but which have not yet been combined for therapeutic purposes, the dossier submitted in support of the application includes the results of pre-clinical and clinical trials relating to the combination of these substances without it being necessary to provide pre-clinical and clinical documentation relating to each individual active substance;
3° For applications for extensions as defined in 4° of Article 2 of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, the dossier submitted in support of the application includes, in addition to chemical, pharmaceutical and biological data, the results of preclinical and clinical trials relating to the changes or additions made to the previously authorised product.
