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Ministerial Decree No. 9 of 11 January 2018 validating the Procedure for the implementation of pharmacovigilance for medicines for veterinary use.

Pays/Territoire
Fédération de Russie
Type du document
Règlement
Date
2018
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Évaluation/gestion des risques Collecte de données/déclarations Accès-à-l'information
Aire géographique
Arctique, Asie et Pacifique, Mer Noire, Mer Caspienne, CEI (Communauté des États indépendants), Europe de l'Est, Europe, Europe et Asie Centrale, Pacifique Nord, Pacifique Nord Occidental
Résumé

This Ministerial Decree establishes for the implementation of pharmacovigilance for medicines for veterinary use performed by Federal Service for Veterinary and Phytosanitary Surveillance and its territorial bodies by analyzing the information provided by the subjects of circulation of medicinal products for veterinary use about side effects, undesirable reactions, serious undesirable reactions, unexpected undesirable reactions to the use of medicines, individual intolerance, lack of effectiveness of medicines, as well as other facts and circumstances that pose a threat to life or health of the animal when using medicines for veterinary use identified at all stages of circulation of medicines in the Russian Federation and other countries. Pharmacovigilance shall be performed on the basis of: (a) scientific and analytical data, periodicals and network publications in the field of veterinary medicine; (b) data on the epizootic situation on the territory of the Russian Federation and the incidence of non-communicable animal diseases that cause doubts about the efficacy and safety of medicines; and (c) information obtained in the course of state control (supervision) in the field of circulation of medicines for veterinary use. Annex I contains the list of information and data related to veterinary drugs. Annex II the form of Conclusion on minimizing negative phenomena in the circulation of a medicinal product.

Texte intégral
Russe
Site web
www.fsvps.ru