French Public Health Code
In forceIn application of the fourth paragraph of article L. 5141-5, for the veterinary medicinal products mentioned in this article, the dossier attached to the application for marketing authorisation is compiled under the following conditions by way of derogation from the first paragraph of article R. 5141-16 :
1° Where the application concerns a generic veterinary medicinal product of a reference veterinary medicinal product which is or has been authorised for at least eight years in France, the dossier provided in support of the application includes, in addition to chemical, pharmaceutical and biological data, bioavailability studies demonstrating bioequivalence to the reference speciality as well as tests evaluating the risks that the generic veterinary medicinal product may present for the environment.
If this veterinary 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 Union, the procedure is also applicable.
2° When the application concerns a veterinary medicinal product which does not meet the definition of a generic veterinary medicinal product because it contains, in comparison with a reference veterinary 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 in relation to this reference veterinary medicinal product has not been demonstrated by bioavailability studies, the dossier provided in support of the application includes, in addition to the pharmaceutical data, the results of the appropriate non-clinical and clinical trials determined on the basis of these differences.
If this veterinary 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 Union, the procedure is also applicable.
3° When the applicant demonstrates that the application relates to a similar biological veterinary medicinal product for which the reference biological veterinary medicinal product is or has been authorised in France for at least eight years, the dossier provided in support of the application includes, in addition to the pharmaceutical data, the results of the appropriate non-clinical and clinical trials relating in particular to the raw material or the manufacturing processes of the similar biological veterinary medicinal product.
If this veterinary 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 Union, the procedure is also applicable.
4° When the application concerns a veterinary medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form as an authorised veterinary medicinal product, for which the holder has consented to the use of the pharmaceutical, non-clinical and clinical documentation contained in the file for this medicinal product, the file provided in support of the application only includes a document establishing the consent of the holder and the provision by the latter, to the applicant, of the file for the authorised veterinary medicinal product.
5° When the application concerns a homeopathic veterinary medicinal product subject to a marketing authorisation, the file provided in support of the application includes, in addition to the pharmaceutical data, the results of the appropriate non-clinical and clinical trials when the applicant cannot demonstrate by detailed reference to the published literature recognised in the tradition of homeopathic veterinary 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.
6° When the application is submitted under the provisions of 1° of article L. 5141-5-1, particularly in the event of an urgent or geographically limited health situation, the dossier provided in support of the application includes, in addition to the pharmaceutical data, the results of the appropriate clinical trials determined according to the characteristics of the veterinary medicinal product and the exceptional circumstances under consideration.
7° When the application is submitted under the provisions of 2° of Article L. 5141-5-1, in particular because of the rarity of the indications in a target species, the minor importance of the target species on national territory or the state of the art of science, the dossier submitted in support of the application includes, in addition to the pharmaceutical data, the results of the appropriate non-clinical and clinical trials determined on the basis of the characteristics of the veterinary medicinal product in question.
The concept of rare indications corresponds to indications for veterinary medicinal products used for the treatment of diseases whose prevalence or incidence is low, due in particular to natural epidemiological conditions or the consequences of health management measures.
8° When the application is for a veterinary medicinal product referred to in 3° of article L. 5141-5-1, the dossier submitted in support of the application includes, in addition to the pharmaceutical data, the results of appropriate non-clinical and clinical trials when the applicant cannot demonstrate by detailed reference to the published literature that the use of the medicinal product is well established and offers every guarantee of safety.
9° Where the application relates to an immunological veterinary medicinal product and the applicant demonstrates that, due to exceptional circumstances, certain field trials for the target species cannot be carried out for duly justified reasons, in particular due to Community provisions, the dossier submitted in support of the application does not have to include the results of the said trials;
10° Where the application concerns a medicinal product for traditional use, the active substances of which are exclusively one or more herbal substances, as defined in 1° of Article R. 5141-1, or herbal preparations or a combination of several herbal substances or herbal preparations, the dossier submitted in support of the application shall include, in addition to the pharmaceutical data, the results of appropriate non-clinical and clinical trials when the applicant cannot demonstrate by detailed reference to published literature recognised in the tradition of phytotherapeutic veterinary medicine practised in France or in the European Union that the medicinal product has been in well-established use for at least ten years in a Member State of the European Union or in another State party to the European Economic Area and that it offers every guarantee of safety.
