Section 5: Marketing authorisation

In specific cases of interest to the European Union, the Director General of the National Agency for the Safety of Medicines and Health Products or the applicant shall refer the matter to the European Medicines Agency for application of the Community arbitration procedure before a decision is taken on the granting, variation, suspension or withdrawal of the marketing authorisation. The Director General of the Agence nationale de sécurité du médicament…

At the end of the Community arbitration procedure implemented in accordance with the provisions of Articles R. 5121-51-8 and R. 5121-51-9, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall grant, vary, suspend or revoke the marketing authorisation within a period of thirty days, in accordance with the decision taken by the European Commission at the end of this procedure.