Section 13: Pharmacovigilance

I.-The Agence nationale de sécurité du médicament et des produits de santé shall fulfil its obligations in terms of pharmacovigilance and participation in European Union activities in this field. The National Agency for the Safety of Medicines and Health Products carries out its pharmacovigilance missions under the conditions defined in Article R. 5311-2 in order to carry out a scientific assessment of all information, to examine options for preventing or…

I.-The Director General of the Agency may ask the regional pharmacovigilance centres to carry out any pharmacovigilance investigations and work. He may also ask the drug dependence and addictovigilance assessment and information centres referred to in article R. 5132-112 and the poison control centres referred to in article L. 6141-4 to provide him with any information and carry out any studies he considers useful for pharmacovigilance purposes. The Director General…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Records any adverse reaction suspected to be due to a medicinal product or to a product mentioned in Article R. 5121-150, occurring in France, which has been reported or notified to it; 2° Report electronically to the European database “Eudravigilance”: a) Any suspected serious adverse reaction occurring in France, within fifteen days of…

I.-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…