Chapter I: General provisions

The specific obligations that may be imposed in application of 1° of Article L. 5141-5-1 are as follows: 1° The applicant must complete a trial programme within a period set by the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, the results of which will be used to reassess the benefit/risk balance of the veterinary medicinal product; 2° The veterinary medicinal product in question must be…

The marketing authorisation holder shall forward without delay to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, including during the examination of the dossier, indicating its scope, any new data available to him or of which he is aware, in particular the results of studies or trials carried out inside or outside the European Union, which could lead to a change…

At the request of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, the marketing authorisation holder shall examine and, where appropriate, modify the analytical methods for detecting residues in the light of technical and scientific progress. He shall provide the substances necessary and in sufficient quantity to carry out the checks to detect the presence of residues of the veterinary medicinal…

Where a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5141-5, any variation or extension, as provided for in Chapter I 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, is also subject to authorisation. All these authorisations are considered to be…

For the purposes of Article L. 5141-5, type II variations and extensions as defined in 3° and 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 are considered to be substantial variations.

In the event of a change in the classification or maximum residue limit of a pharmacologically active substance in application of Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, the marketing authorisation holder shall apply, if necessary, for the amendment of this authorisation,…

The marketing authorisation holder submits to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail any proposed amendment to the labelling or package leaflet, other than amendments to the summary of product characteristics. If the Director General of the Agency has not made a decision within thirty days of the date of submission of the application, the applicant may proceed to implement…

The marketing authorisation is renewable on application by the holder to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail no later than six months before its expiry date. The application for renewal is accompanied by a summary list of the documents submitted relating to quality, safety and efficacy, including all the changes authorised since the initial authorisation or the last renewal…

The marketing authorisation issued by the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail becomes null and void if it appears : 1° That it is not followed by the marketing of the veterinary medicinal product on national territory within three years of its issue; 2° That the veterinary medicinal product, previously placed on the market on national territory, is no longer on the market for…

Any change in the marketing authorisation holder is subject to authorisation from the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. In order to obtain this authorisation, the marketing authorisation holder submits a dossier including, in addition to the summary of product characteristics, the draft outer and primary packaging and, if applicable, the package leaflet: 1° The name of the veterinary medicinal…