Book I: Pharmaceutical products

Where a veterinary medicinal product, which has already been authorised or is the subject of an application for marketing authorisation under examination in another Member State of the European Union, is the subject of an application for marketing authorisation in France without complying with the provisions of sub-section 3a of this section, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall…

The application for marketing authorisation for a veterinary medicinal product contains the following information: 1° The name or corporate name and address of the future holder of the marketing authorisation and, where appropriate, those of the company exploiting the medicinal product, as well as those of the manufacturer when neither the future holder nor the company exploiting the medicinal product ensures the manufacture; 2° The name of the veterinary medicinal…

The application for marketing authorisation is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive 2004 / 28 / EC of 31 March 2004 by order of the Ministers for Agriculture and Health on a proposal from the Director General of the National Agency for Food, Environmental and Occupational Health Safety. The drafts of the…

The application for marketing authorisation is accompanied by a dossier containing : 1° The administrative information required to examine the application ; 2° Scientific documentation demonstrating the quality, safety and efficacy of the veterinary medicinal product, in particular test or trial reports relating to pharmaceutical, non-clinical, clinical or efficacy trials, including the results obtained during these various trials and expert reports, accompanied by detailed and critical summaries; 3° A description…

The applicant for marketing authorisation is responsible for the accuracy and sincerity of the information and data provided to the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail when the application is submitted and during its examination. The applicant must inform the Agency immediately of the scope of any new data available or of which he is aware, in particular the results of studies or trials…

The expert reports provided for in article R. 5141-16 consist of a critical evaluation of the various trials carried out, taking into account the state of scientific knowledge at the time of submission of the dossier, presented in summary form and concluding with an analysis of the relationship between the benefits and the risks associated with the use of the veterinary medicinal product. Each report, dated and signed by the…

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…