Section 3: Marketing authorisation

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail or the applicant for marketing authorisation may refer the matter to the European Medicines Agency with a view to the application of the Community arbitration procedure provided for in Articles 36 to 38 of Directive 2001/82/EC of the European Parliament and of the Council when divergent decisions have been taken by Member States…

In specific cases of Community interest, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail 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, in particular on the basis of pharmacovigilance data.

When the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail considers that the variation, suspension or withdrawal of a marketing authorisation which he has granted following a mutual recognition or decentralised procedure is necessary for the protection of human or animal health or the environment, he shall immediately inform the European Medicines Agency for the application of the Community arbitration procedure. In…

At the end of the Community arbitration procedure implemented in accordance with the provisions of Articles R. 5141-47-9 to R. 5141-47-11, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall grant, vary, suspend or withdraw 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.