Governmental Decree No. 317 of 29 April 2017 “On measures to implement the Law of the Republic of Belarus "On Veterinary Activities”. País/Territorio Belarús Tipo de documento Reglamento Fecha 2017 Fuente FAO, FAOLEX Materia Ganado Palabra clave Medicamentos Alimentos para animales/piensos Registro Certificación Negocios/industria/corporaciones Investigación Transporte/depósito Recopilación de datos/informes Acceso-a-la-información Sanidad animal Área geográphica CEI (Comunidad de Estados Independientes), Europa Oriental, Europa, Europa y Central Asia Entry into force notes This Governmental Decree enters into force on 2 May 2017. Resumen This Governmental Decree validates the Regulation on the procedure for state registration of veterinary drugs, keeping the State Register of Veterinary Drugs, the procedure and the terms and conditions for issuing a veterinary medicine registration certificate and the Regulation on the procedure for state registration of feed additives, keeping State Register of Feed Additives, procedure and terms and conditions for issuing feed additive registration certificate. Regulation on the procedure for state registration of veterinary drugs, keeping the State Register of Veterinary Drugs, the procedure and the terms and conditions for issuing a veterinary medicine registration certificate establishes that issuing and certification authority shall be Department of Veterinary and Food Supervision of the Ministry of Agriculture and Food. State registration of a veterinary medicine and issuance of the veterinary drug registration certificate shall require submittal of the following documentation: (a) inventory of the documents in the registration dossier; (b) information on registration of a veterinary medicine in another country – in case of registration of veterinary drugs of foreign origin, except for veterinary drugs, manufactured in the countries of the Eurasian Economic Union (if any); (c) description of the veterinary product, including a full description of its composition and information about veterinary drugs - analogues; (d) information on the active substance, including the chemical name of the substance, the scientific name of the plant and its used parts, their physical and chemical properties; (e) updated scientific reports, articles, reports on the use of veterinary drug - for a veterinary drug of foreign origin; (f) report on experimental study of a veterinary medicine; (g) research report related to resistance for antibacterial veterinary preparations; (h) methods for detecting the residual amount active substance of pharmacological veterinary preparation; (i) draft instruction of temporary instruction for production testing of veterinary drug; (j) document setting quality requirements for veterinary drug subject to registration and control methods; (k) detailed description of control methods; (l) report related to the study on stability of veterinary drug during storage; (m) sampling report attesting quality of veterinary drugs; (n) manufacturer’s certificate, including brief description of manufacturing methods; (o) certificate of state registration of the manufacturer and license for manufacturing of veterinary drugs; (p) certificate of good practice in the process of manufacturing of veterinary drugs; (q) layout of the veterinary product packaging; and (r) layout of the veterinary product label in Russian or Belarusian. Regulation on the procedure for state registration of feed additives, keeping State Register of Feed Additives, procedure and terms and conditions for issuing feed additive registration certificate establishes that issuing and certification authority shall be Department of Veterinary and Food Supervision of the Ministry of Agriculture and Food. State registration of feed additives and issuance of registration certificate of feed additives shall require submittal of the following documentation: (a) inventory of the documents in the registration dossier; (b) characteristics of the feed additive, including a full description of its composition; (c) instructions for use of the feed additive; (d) report on the results of the safety study of the feed additive (toxicological tests on laboratory animals; tests on tolerability of the feed additive by those species of animals, which according to the instructions are authorized for use of a feed additive if the feed additive contains new components that were not previously used for feeding animals); (e) report on the stability of the feed additive during storage; and (f) information on: registration of the feed additive in another country - when registering the feed additive of foreign origin, except for feed additives manufactured in countries of Eurasian Economic Union (if any); methods of controlling the composition of the feed additive; effectiveness of the feed additive for each animal species, which according to instructions are authorized to use the feed additive; effect of the feed additive on the quality of animal products, obtained from animals that are allowed to use the feedstuffs in accordance with the instructions on additives. Texto completo Ruso Página web www.pravo.by Referencias - Legislación Implementa Law No. 438-Z “On veterinary practice”. Legislación | Belarús | 2010 (2016) Palabra clave: Legislación básica, Medicamentos, Alimentos para animales/piensos, Protección de los animales, Investigación, Negocios/industria/corporaciones, Gobierno local, Autorización/permiso, Recopilación de datos/informes, Acceso-a-la-información, Inspección, Comercio interior, Comercio internacional, Acuicultura, Enfermedades de los peces, Sanidad animal, Apicultura/sericultura, Productos pesqueros, Control de calidad de los alimentos/inocuidad de los alimentos, Higiene/procedimientos sanitarios, Carne, Leche/productos lácteos, Productos de aves caseras, Procesamiento/manipulación, Salud pública, Transporte/depósito, Plagas/enfermedades Fuente: FAO, FAOLEX