French Public Health Code
In forceAny 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 product concerned and its current marketing authorisation number ;
2° Identification of the future holder;
3° A document establishing that the complete and up-to-date file for the medicinal product concerned, or a copy, has been transferred to the future holder;
4° An undertaking by the pharmacist or veterinary surgeon responsible for the manufacturing company to comply with all the conditions to which the marketing authorisation was subject and, in particular, to comply with the manufacturing and control methods;
5° A description of the pharmacovigilance system that the future marketing authorisation holder intends to put in place.
In the event of a merger or partial transfer of assets, the companies concerned may submit an application for the transfer of marketing authorisations before the merger or transfer is definitively completed. In support of their application, they must provide the memorandum of understanding in principle concerning the merger or contribution. The transfer is granted subject to the condition precedent of its definitive completion, which is notified to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail will give his decision within sixty days of receipt of the complete application. Silence on the part of the Director General will be deemed to constitute authorisation on expiry of this period.
