Chapter I: General provisions

By way of derogation from the first paragraph of Article R. 5141-16, for the veterinary 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 veterinary medicinal product the active substance or substances of which have been in well-established veterinary use for at…

The dossiers provided in support of the authorisation of the veterinary medicinal products mentioned in articles R. 5141-16 and R. 5141-18 are considered to include all the data necessary and sufficient for the evaluation of these medicinal products within the meaning of 8° of article L. 5141-2.

In 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…

When an application for authorisation concerns a generic veterinary medicinal product of a reference veterinary medicinal product which has not been authorised in France but which has been authorised in another Member State of the European Union, the applicant must indicate the Member State in which this reference veterinary medicinal product is or has been authorised. In this case, the Director General of the Agence nationale de sécurité sanitaire de…

When informed by the holder of a marketing authorisation granted under 1°, 2° or 3° of Article R. 5141-20, before the marketing of the veterinary medicinal product concerned, of the fact that for all or part of the indications, pharmaceutical forms or strengths of the reference veterinary medicinal product the intellectual property rights have not expired, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement…

I. – For the application of 1° of article R. 5141-18 , when reference is made to published scientific literature, the experts shall justify the use of this bibliographical documentation and demonstrate that it meets the requirements of the protocols adopted pursuant to article R. 5141-2 , taking into account in particular the pharmaceutical form and the constituents of the excipient. II. – For the application of 5° of article…