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Decree No. 39 of the Ministry of Agriculture and Food validating the Regulation on the modalities of registration of drugs.

Country/Territory
Belarus
Document type
Regulation
Date
2001 (2004)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Registration Drugs Biotechnology Animal health
Geographical area
CIS (Commonwealth of Independent States), Eastern Europe, Europe, Europe and Central Asia
Abstract

The Regulation consists of 9 Sections composed of 42 issues dealing with the following matters: 1) general provisions (sect. 1, issues 1-5); 2) the list of documents for the registration of drugs (sect. 2, issues 6-8); 3) the modalities of the examination of the application for the registration of drugs (sect. 3, issues 9-12); 4) the modalities of the registration of drugs (sect. 4, issues 13-20); 5) testing of drugs (sect. 5, issues 21-26); 6) experimental study of veterinary preparations forwarded for the registration (sect. 6, issues 27-29); 7) requirements for the application of drugs (sect. 7, issues 30-33); 8) requirements set for production and testing bacteria culture (sect. 8, issues 34-39); 9) requirements set for production and testing virus strain (sect. 9, issues 40-42). The present Regulation establishes the modalities of the registration and application of veterinary drugs. The Regulation shall be applicable to all legal and natural persons elaborating, manufacturing and trading veterinary preparations and biological substances for stockbreeding and veterinary. Application and utilization of veterinary drugs shall be authorized after the registration thereof by the Chief Veterinary Directorate and by the State Veterinary Inspection attached to the Ministry of Agriculture and Food and in the presence of the registration certificate issued thereby. The applicant must file the application form and submit the list of documentation specified in the Annex 2.

Full text
Russian
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