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Order No. 529 of the Ministry of Agriculture validating the Rules for the examination of medicinal products for veterinary use and the forms of conclusions of the commission of experts.

País/Territorio
Federación de Russia
Tipo de documento
Reglamento
Fecha
2022
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Sanidad animal Medicamentos Registro Evaluación/manejo de riesgos
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
Entry into force notes
This Order enters into force on 1 March 2023.
Resumen

Examination of medicinal products for veterinary use for the purpose of their state registration, confirmation of the state registration of the medicinal product, making changes to the documents contained in the registration dossier for a registered medicinal product, to include pharmaceutical substance for veterinary use, produced for sale, to the state register of medicinal products for veterinary application is based on the principles of legality, observance of human rights and freedoms of citizen, the rights of a legal entity, the independence of an expert, objectivity, comprehensiveness and completeness of research conducted using modern achievements of science and technology, responsibility of the federal state budgetary institution for the examination of medicines and experts for the conduct and quality of expertise of medicines. Examination of veterinary medicines is carried out by the federal state budgetary institution Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor). Examination of veterinary medicines is carried out in one stage and includes examination of the quality of the medicinal product and examination of the ratio of the expected benefit to the possible risk of using the medicinal product for veterinary use or examination of the quality of pharmaceutical substance.

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Página web
publication.pravo.gov.ru