Subsection 3a: Mutual recognition procedure and decentralised procedure.

In the event of agreement within the coordination group, referred to by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail or by another State : 1° In the case provided for in Article R. 5141-47-2, the Director General of the Agency notifies the States concerned and the holder of the agreement. In accordance with the assessment report thus approved, he will…

In the absence of agreement within the coordination group, the Community arbitration procedure provided for in Articles 36 to 38 of Directive 2001/82/EC of the European Parliament and of the Council applies. Where France is the reference State, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail is responsible for initiating this procedure by informing the European Medicines Agency of the disagreement….

On completion of the procedures provided for in this subsection, the marketing authorisation shall be granted or varied by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail within thirty days of notification of the agreement by the reference State or by the European Commission, subject to the applicant providing a French translation of the summary of product characteristics, package leaflet and…

Articles R. 5141-47-1 to R. 5141-47-5 are applicable to homeopathic veterinary medicinal products subject to the registration referred to in article L. 5141-9. This sub-section does not apply to homeopathic veterinary medicinal products intended for administration to animals whose flesh or products are not intended for human consumption and which are covered by a marketing authorisation referred to in article L. 5141-5.