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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.

Country/Territory
Russian Federation
Document type
Regulation
Date
2018
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Risk assessment/management Data collection/reporting Access-to-information
Geographical area
Arctic, Asia and the Pacific, Black Sea, Caspian Sea, CIS (Commonwealth of Independent States), Eastern Europe, Europe, Europe and Central Asia, North Pacific, North-West Pacific
Abstract

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.

Full text
Russian
Website
www.fsvps.ru