Chapter I: General provisions

In the event of agreement within the coordination group, referred to by the Director General of the Agence nationale de sécurité du médicament et des produits de santé or by another State : 1° In the case provided for in Article R. 5121-51-1, the Director General of the Agency will notify the States concerned and the marketing authorisation holder of the agreement. In accordance with the assessment report thus approved,…

In the absence of agreement within the coordination group, the Community arbitration procedure provided for in articles 32 to 34 of Directive 2001/83/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 du médicament et des produits de santé is responsible for initiating this procedure by informing the European Medicines Agency of the disagreement. The…

At the end of the procedures provided for in this sub-section, the marketing authorisation is issued or varied by the Director General of the Agence nationale de sécurité du médicament et des produits de santé 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, the package leaflet and…