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Order No. 19 of the Ministry of Agriculture validating the list of the indicator of the risk of violation of the mandatory requirements for federal state control (supervision) in the field of circulation of medicinal products for veterinary use.

Country/Territory
Russian Federation
Document type
Regulation
Date
2022
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Risk assessment/management Authorization/permit
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

The Minister validates the following list of the indicator of the risk of violation of the mandatory requirements for federal state control (supervision) in the field of circulation of medicinal products for veterinary use: “At least three times the number of messages about confirmed cases of side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions and lack of efficacy in use of a medicinal product for veterinary use, produced by one drug manufacturer for veterinary use, during calendar year compared to the previous calendar year. An increase of at least two times in the number of one manufacturer of a series of medicinal products for veterinary applications entered into civil circulation within three months in a row, compared to the previous three months in the absence in the licensing file of this manufacturer of information confirming the possibility of such an increase in the production of medicinal products for veterinary use”.

Full text
Russian
Website
publication.pravo.gov.ru