Registration of veterinary medicinal products, medicines, drugs and feed additives in Uzbekistan
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The list of components included in the composition of veterinary medicines and feed additives, their quantity. |
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Quality requirements and control methods for veterinary medicinal products and feed additives, texts of relevant international or state pharmacopoeial monographs. |
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Instructions (manuals) for use of veterinary medicinal products and feed additives. |
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Quality certificates or certificates of conformity of the veterinary medicinal products and feed additives. |
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Data on the manufacture of veterinary medicinal products and feed additives (technological instruction or regulations, manufacturing flowchart). |
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Test results for the efficacy, safety and stability of veterinary medicinal products and feed additives. |
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Substantiated information on the effectiveness, immunogenicity, virulence of veterinary biologics and microorganism strains that used in their production (viruses, bacteria, fungi, etc.). |
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Samples of veterinary medicinal products and feed additives in volumes sufficient for their technical testing specified in the documentation, and their active substances, test systems, diagnostic kits. |
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Pharmacopoeia CommitteeTasks of the Pharmacopoeia Committee:- examination of normative documents for medicines subject to registration and extension of the term of registration; - systematic revision of normative documents for medicines with a view to improving their quality and improving the methods of control; - examination and preparation for approval of additions and amendments of the... Read more |
Department of RegistrationTasks of the Registration Department:- after the adoption of the application for registration, conducts the initial (preliminary) examination of the application and attached registration documents and samples of medicines, medical devices and medical equipment; - conducts appropriate correspondence with the applicant on the... Read more |
Pharmacological CommitteeTasks of the Pharmacological Committee:- conducts examination of administrative, pharmacological, toxicological and clinical parts of registration documents of pharmacological and (or) medicinal products; - conducts examines and re-examines documents of pharmacological and (or) medicinal products with the involvement of independent experts; - decides on the use of the medicines without clinical trials in the... Read more |