Subsection 3: Authorisation procedures.

The marketing authorisation is granted by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. It is accompanied by the summary of product characteristics referred to in Article R. 5141-15 as approved by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The authorisation indicates, where applicable, whether the medicinal product is covered by…

During the examination of marketing authorisation applications, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may order any investigative measure he deems necessary and in particular: 1° Carry out any investigation relating to the manufacture of the medicinal product ; 2° Consult the experts who have been chosen to carry out the tests with a view to compiling the marketing authorisation…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail will make a decision within two hundred and ten days of the submission of a complete application. Silence on the part of the Director General will be deemed to constitute refusal of authorisation on expiry of a period of two hundred and ten days from submission of such a dossier. The Director General…

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…