French Public Health Code
In forceA company operating a veterinary medicinal product must:
1° Keep detailed records of all suspected adverse reactions which have occurred inside or outside the European Union;
2° To record any suspected serious adverse reaction in animals and any suspected adverse reaction in humans resulting from the use of veterinary medicinal products, as well as any suspected transmission of infectious agents by veterinary medicinal products, of which he is aware or which has been brought to his attention and to report it within 15 days at the latest to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail if the reaction occurred on French territory or to the authorities of the Member State on whose territory the reaction occurred;
3° To report without delay to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail any suspected serious unexpected adverse reaction in animals, any suspected adverse reaction in humans and any suspected transmission of infectious agents by a veterinary medicinal product, occurring on the territory of a non-member State of the European Union of which it is aware, and to inform the European Medicines Agency and the competent authorities of the other Member States of the European Union in which the veterinary medicinal product is authorised within fifteen days of receipt of the information at the latest.
When France is designated as the reference Member State for the implementation of the decentralised procedure or the mutual recognition procedure provided for in articles R. 5141-47-1 et seq., any company exploiting a veterinary medicinal product authorised under one of these procedures in one or more other Member States of the European Union is required to inform the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail immediately, and no later than fifteen days following receipt of the information, of any serious adverse reactions, adverse reactions in humans or the transmission of infectious agents which may be due to this medicinal product which have occurred in this other State or these other States.
