Section 3: Marketing authorisation

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…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may automatically vary a marketing authorisation for a veterinary medicinal product in order to restrict the indications, limit the conditions of supply, change the dosage, add a contraindication or any other preventive measure when it appears : 1° Either, in particular following evaluation of the data mentioned in article R. 5141-90, that the…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may also suspend, for a period not exceeding one year, or revoke a marketing authorisation for a veterinary medicinal product where it appears, in particular following evaluation of the data referred to in article R. 5141-90, that the medicinal product no longer meets the conditions referred to in article L. 5141-6. In the…

The decision to suspend, revoke or vary the marketing authorisation must state the reasons on which it is based and indicate the appeal procedures and deadlines. Except in cases of urgency, the decision may only be taken after the marketing authorisation holder has been invited to present his observations. When the authorisation is suspended, withdrawn or varied automatically, the marketing authorisation holder informs the stockholders so that they can take…