For veterinary medicinal products covered by a marketing authorisation or for homeopathic veterinary medicinal products covered by a registration, pharmacovigilance is carried out after the authorisation or registration has been issued.
For the purposes of this section, the following definitions shall apply 1° Adverse reaction: a noxious and unintended response occurring at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or for restoring, correcting or modifying physiological function; 2° Adverse reaction in humans: a noxious and unintended response in a human being following exposure to a veterinary medicinal product; 3° Serious adverse reaction: an adverse reaction…
The national veterinary pharmacovigilance system comprises : 1° The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail ; 2° (Deleted) ; 3° The veterinary pharmacovigilance centres mentioned in Article R. 5141-101; 4° Pharmacists, veterinarians and members of other health professions, as well as companies operating veterinary medicinal products.
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…
Veterinary pharmacovigilance centres are responsible for : 1° Receiving reports sent, in application of article R. 5141-103, by veterinarians, pharmacists and any member of a health profession or any person who has observed an adverse reaction in an animal; 2° Gathering information of the same nature sent to them by any member of a health profession; 3° To send a detailed quarterly report to the Director General of the Agence…
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, are the subject of agreements between the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and the national veterinary schools within which the centres…
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…
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75001, Paris France
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