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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.

Country/Territory
Russian Federation
Document type
Regulation
Date
2022
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Registration Risk assessment/management
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
Entry into force notes
This Order enters into force on 1 March 2023.
Abstract

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.

Full text
Russian
Website
publication.pravo.gov.ru