Paragraph 2: Mutual recognition procedure

In order to obtain recognition, by at least one other Member State of the European Community or party to the Agreement on the European Economic Area, of a marketing authorisation granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, with France acting as the reference State, the holder of this authorisation asks the latter to update or prepare the assessment report…

In order to obtain recognition in France of a marketing authorisation issued by another State, known as the reference State, which is a member of the European Community or a party to the Agreement on the European Economic Area, the holder of this authorisation must submit a marketing authorisation application to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. From receipt of…