French Public Health Code
In forceI.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, initiates the European Union emergency pharmacovigilance procedure under the conditions specified in II to IV of this article.
II.It informs the European Commission, the European Medicines Agency and the other Member States of the European Union of one of the following situations:
1° It is considering suspending or withdrawing a marketing authorisation;
2° It is considering prohibiting the supply of a medicinal product or a product benefiting from a marketing authorisation;
3° It is considering refusing to renew a marketing authorisation;
4° It is informed by any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150, that, due to their concerns regarding the safety of a medicinal product, the marketing of the medicinal product has been interrupted, or that measures aimed at withdrawing the marketing authorisation have been initiated, or that the company or organisation is considering taking such measures, or that renewal of the marketing authorisation has not been requested.
III - When the Director General of the Agence nationale de sécurité du médicament et des produits de santé considers it necessary to indicate a new contraindication, to reduce the recommended dosage or to restrict the indications of a medicinal product, he will inform the European Commission, the European Medicines Agency and the other Member States of the European Union. It shall specify the measures it intends to take and the reasons for them. It will initiate the European Union's emergency procedure if it considers that an urgent measure is necessary.
IV.When, in the cases provided for in II and III, the Director General of the Agence nationale de sécurité du médicament et des produits de santé decides to suspend the marketing authorisation as a matter of urgency and to prohibit the use of the medicinal product or product in order to protect public health, pending a final decision under the European Union arbitration procedure, he shall inform the European Commission, the European Medicines Agency and the other Member States of the European Union of the reasons for this measure no later than the first working day following his decision. It shall make available to the European Medicines Agency any relevant scientific information in its possession as well as any assessment carried out by the Agence nationale de sécurité du médicament et des produits de santé.
