Paragraph 5: Other pharmacovigilance obligations.

A company operating veterinary medicinal products has at its disposal, on a permanent basis, the services of a person, pharmacist or veterinarian, responsible for veterinary pharmacovigilance residing in the European Union. The name, position and contact details of this person are communicated to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. This person is responsible for : 1° Gathering, processing and…

The principles of good veterinary pharmacovigilance practice to which veterinarians, pharmacists and members of the other health professions mentioned in 4° of article R. 5141-93 are subject are defined, on a proposal from the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, by order of the Ministers for Agriculture and Health.

The poison control centres referred to in article L. 6141-4 and the regional pharmacovigilance centres referred to in article R. 5121-167 shall transmit, without delay, to the Agence nationale de sécurité sanitaire, de l’alimentation, de l’environnement et du travail any information they have on adverse reactions in humans which may be attributed to the use of these medicinal products.