Paragraph 4: Pharmacovigilance notification and reporting

A veterinarian who has observed, or to whom has been reported, a serious or unexpected adverse reaction which may be attributed to the use of a veterinary medicinal product, whether or not he has prescribed it, or a medicinal product for human use administered to an animal under the conditions provided for in a of 3° of article L. 5143-4, shall immediately report it to the Agence nationale de sécurité…

A 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…

Without prejudice to the conditions laid down when the marketing authorisation is granted pursuant to the provisions of the fourth paragraph of Article L. 5141-5, the company operating the veterinary medicinal product shall forward to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, in the form of a periodic safety update report, information relating to the adverse reactions which it has…

The holder of an authorisation referred to in Article L. 5141-12 must report to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, immediately after becoming aware of any suspected serious adverse reaction in animals and any suspected adverse reaction in humans which may be due to an auto-vaccine for veterinary use. It sends the Director General of the Agence nationale de…

The company exploiting a veterinary medicinal product may not communicate to the public information on this veterinary medicinal product relating to pharmacovigilance without transmitting it, beforehand or simultaneously in the event of an emergency, to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. This information must be presented in an objective and non-misleading manner.

The procedures and standard form for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail.

The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.