Paragraph 2: Mutual recognition procedure.

In order to obtain recognition, by at least one other Member State of the European Union, of a marketing authorisation issued by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, with France then acting as reference State, the holder of this authorisation asks the latter to update or prepare the assessment report for the veterinary medicinal product; he/she sends any additions…

In order to obtain recognition in France of a marketing authorisation issued by another Member State of the European Union, known as the reference State, the holder of this authorisation must submit a marketing authorisation application to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. From receipt of the assessment report on the medicinal product, accompanied by the summary of product…