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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.

País/Territorio
Federación de Russia
Tipo de documento
Reglamento
Fecha
2022
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Sanidad animal Medicamentos Evaluación/manejo de riesgos Autorización/permiso
Área geográphica
Ártico, Asia y Pacifico, Mar Negro, Mar Caspio, CEI (Comunidad de Estados Independientes), Europa Oriental, Europa, Europa y Central Asia, Pacífico Norte, Pacífico Nordoeste
Resumen

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”.

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publication.pravo.gov.ru