Subsection 3: Authorisation procedures.

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…

Independently of decisions to suspend, modify or withdraw authorisations and as a precautionary measure, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may prohibit the supply of certain batches of authorised veterinary medicinal products that are the subject of dispute and request the authorisation holder to recall these batches.

Decisions to grant, automatically vary, refuse, renew or revoke marketing authorisations subject to the national procedure are taken in accordance with the procedures laid down in Article R. 5141-27 relating to the examination of these applications. They may only be the subject of a contentious appeal after an informal appeal has been lodged with the Director General of the Agency. Decisions to grant, automatically vary, suspend or revoke a marketing…