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Order No. 605 of the Federal Veterinary and Phytosanitary Supervision Service validating the Regulation on selective control of veterinary drugs.

Country/Territory
Russian Federation
Document type
Regulation
Date
2018
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Data collection/reporting Access-to-information Enforcement/compliance
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 Order establishes the procedure for implementation by the Federal Veterinary and Phytosanitary Supervision Service and its territorial bodies (territorial bodies of Rosselkhoznadzor) of selective quality control of medicinal products means for veterinary use. The subject of selective quality control of medicinal products means for veterinary use (sampling quality control of veterinary drugs) is the confirmation of compliance of medicinal products (drugs) for veterinary use and pharmaceutical substances with the requirements of a pharmacopoeial article or, in case of unavailability thereof, with regulatory document. Selective quality control of medicines includes the following procedures: (a) processing of information, provided in a mandatory manner by the subjects of circulation of medicinal products, related to series, lots of medicines for veterinary use put into civil commerce circulation in the Russian Federation; (b) selection of samples of medicinal products from subjects of circulation of medicinal products for the purpose of testing their compliance with the requirements of regulatory documents; (c) the adoption of a decision by the results of conducted tests on further civil commerce circulation of the relevant drug; (d) adoption by the authorized federal executive body of decision to transfer a medicinal product to a serial selective quality control of medicines in the case of repetitive identification of non-compliance of drug quality with the established requirements. For the purposes of performance of sampling quality control of medicinal products by the Rosselkhoznadzor (territorial bodies) tests shall be organized thereby.

Full text
Russian
Website
pravo.gov.ru