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Decision No. 1 of the Council of Eurasian Economic Commission validating the Instruction regulating circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union.

País/Territorio
Armenia
Tipo de documento
Reglamento
Fecha
2022
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Sanidad animal Medicamentos Autorización/permiso Procesamiento/manipulación Envasado/etiquetado Negocios/industria/corporaciones Límite máximo de residuos Plagas/enfermedades Normas Certificación Fraude Toxicidad/envenenamiento Investigación Registro Cumplimiento/aplicación Comercio interior Comercio internacional
Área geográphica
Asia, CEI (Comunidad de Estados Independientes), Europa, Europa y Central Asia, Naciones en desarrollo sin litoral, Asia Occidental
Entry into force notes
This Decision enters into force upon expiration of 30 calendar days from the date of its official publication, with the exception of the paragraph 1 of the Decision, which shall enter into force 24 months after the date of entry into force of this Decision.
Resumen

This Instruction regulates circulation of veterinary medicinal products in the customs territory of the Eurasian Economic Union. It shall be applicable to manufacturers of veterinary medicinal products, right holders of veterinary medicinal products (their representatives acting on the basis of a document certified in the established order), authorized bodies of the Member States in the field of circulation of veterinary medicinal products, expert institutions subordinate to these bodies of the Member States, organizations implementing veterinary medicinal products, and other subjects of circulation of veterinary medicinal means. This Instruction shall not be applicable to veterinary drugs that are intended for use in military operations, in emergency situations, for the prevention and treatment of diseases and lesions of animals caused as a result of exposure to adverse chemical, biological, radiation factors or in other situations requiring application of urgent measures in accordance with the laws of the Member States, and developed on the instructions of the public authorities of the Member States, commissioners in the field of security and defense, and whose appeal is governed by the laws of the Member States. This Instruction was adopted in order to ensure the functioning of the market of veterinary medicinal products within the Union through: (a) implementation of unified approaches to the registration of veterinary drugs; (b) ensuring the unity of mandatory requirements for quality, safety and effectiveness of veterinary medicinal products in the territories Member States and their compliance; (c) implementation of unified approaches to the creation of a quality assurance system, safety and efficacy of veterinary medicinal products; and (d) taking measures necessary to protect the consumer from the use of substandard, falsified and counterfeit veterinary drugs. Manufacturing of veterinary medicinal products in circulation in the customs territory of the Union, must comply with the Rules for the proper production practice of the Eurasian Economic Union. Manufacturing of veterinary medicinal products in the customs territory Union is carried out on the basis of: (a) license for the manufacturing of veterinary medicinal products, issued by the authorized body in accordance with the legislation of the Member State for each production site where manufacturing of veterinary medicinal products is carried out; (b) certificate of conformity for the manufacturing of veterinary medicinal products with the requirements of the Rules of Good Manufacturing Practice issued by authorized body for no more than 3 years (starting from the date of the last day of the last pharmaceutical inspection) for each production site, at which the production of a veterinary medicinal product is carried out, according to form contained in the Annex No. 1. In the customs territory of the Union, shall be prohibited manufacturing and trade of: (a) veterinary medicinal products not registered in accordance with this Instruction (with the exception of cases specified by this Instruction); and (b) falsified and counterfeit veterinary medicinal products. Manufacturers of veterinary medicinal products may carry out trade of veterinary medicinal products or transfer them, in the manner prescribed by the legislation of a Member State, to: (a) other manufacturers of veterinary medicinal products; (b) wholesalers of veterinary medicinal products; (c) veterinary pharmacies; (d) research organizations (for research work); (e) organizations of various forms of ownership, carrying out diagnostic and treatment-and-prophylactic activities in the field of veterinary medicine; and (f) organizations of various forms. Manufacturing of veterinary medicinal products is carried out according to prescription for individual animals. The following shall be prohibited: (a) manufacturing of veterinary medicinal products registered in accordance with this Instruction; (b) production of immunological (immunobiological) veterinary medicines; (c) the use of veterinary medicinal products registered in accordance with this Instruction (changes in the dosage form, their packaging or repackaging) in the process of manufacturing of veterinary medicinal products; and (d) the use of poisonous, narcotic, psychotropic and potent substances, as well as radionuclides (radioactive isotopes) in the process of the manufacturing of veterinary medicinal products. Pharmaceutical-made veterinary medicinal products are subject to intrapharmacy control. Unsold expired veterinary medicinal products are subject to destruction in accordance with the requirements stipulated in the Annex No. 3. In the customs territory of the Union, circulation of veterinary medicines on condition of: (a) their registration in accordance with this Instruction; and (b) their manufacturing at a production site that has a valid certificate. Registration in accordance with this Instruction shall be mandatory for: (a) reference veterinary medicinal products; (b) generic veterinary medicinal products (generics); (c) new combinations of previously registered veterinary medicinal products (drugs); (d) veterinary medicinal products previously registered but produced in other dosage forms and (or) in a new dosage. Registration within the Union shall not be applicable to: (a) pharmaceutical veterinary medicinal products; (b) veterinary medicinal products intended for use as exhibition samples; (c) veterinary medicinal products intended for preclinical and clinical studies (tests); (d) veterinary medicinal products imported by natural persons for the purpose of application for an animal belonging thereto (in the presence of documents, confirming the need for the use of these drugs); (e) samples of veterinary medicinal products intended for expertise for the purpose of registration of veterinary medicinal products or implementation of other procedures related to registration, and standard samples of active substances; (f) medicinal plant materials; (g) pharmaceutical substances; and (h) veterinary medicinal products not intended for sale on customs territory of the Union (export to third countries). Within the territory of the Union shall be prohibited: (a) registration under one trade name of veterinary medicinal products (drugs) that have: the same qualitative and quantitative composition of active substances; different qualitative composition of active substances; the same qualitative, but different quantitative composition of active substances; (b) registration under various trade names of veterinary drugs that have the same qualitative and quantitative composition of active substances and submitted for registration by one the right holder in the form of two or more veterinary medicinal products; (c) registration of veterinary medicinal products intended for applications for productive animals (including aquaculture species of animal origin) and containing medicinal products according to list contained in the Annex No. 4; and (d) registration of pharmaceutical veterinary medicinal products, intended for use in food-producing animals (including aquaculture species of animal origin), - in the absence in the acts, included in the legislation of the Union, of the values of the maximum allowable residue level of the amount of active ingredients (active substances) of pharmaceutical veterinary medicinal products and (or) their metabolites in the raw materials of animal origin and methods of their definition before establishing the relevant requirements (taking into account the procedure initiated by the reference registration authority). In the territory of the Union shall be prohibited trade and use of pharmaceutical substances for the treatment and prevention of animal diseases.

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