Subsection 2: Organisation and operation

The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail is responsible for implementing the national veterinary pharmacovigilance system. It leads and coordinates the actions of the various parties involved. It compiles the information collected and ensures compliance with the monitoring procedures organised by this section. It organises the dissemination of information relating to veterinary pharmacovigilance. It receives the declarations and reports sent to its Director General,…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may ask veterinary pharmacovigilance centres to carry out veterinary pharmacovigilance investigations and work. It may also ask the poison control centres mentioned in article L. 6141-4 to provide it with the information and carry out the studies it considers useful for veterinary pharmacovigilance purposes. It may also ask the Director General of the…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall inform the European Medicines Agency, the other Member States of the European Union, the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the company operating the veterinary medicinal product of any suspected serious adverse reaction and any suspected adverse reaction in humans which has…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall immediately inform the European Medicines Agency and the other Member States of the European Union of any proposal to suspend, revoke or vary ex officio a marketing authorisation based on the evaluation of pharmacovigilance data with a view to reducing the indications or availability, amending the dosage, adding a contraindication or a…