{"id":1204,"date":"2025-11-11T15:05:17","date_gmt":"2025-11-11T12:05:17","guid":{"rendered":"https:\/\/kroston.by\/?page_id=1204"},"modified":"2025-11-11T15:28:10","modified_gmt":"2025-11-11T12:28:10","slug":"reg-services","status":"publish","type":"page","link":"https:\/\/kroston.by\/en\/registratsiya\/reg-services\/","title":{"rendered":"\u041f\u043e\u0440\u0442\u0444\u0435\u043b\u044c \u0443\u0441\u043b\u0443\u0433"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"1204\" class=\"elementor elementor-1204\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-41ff893 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"41ff893\" data-element_type=\"section\" 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data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u041f\u043e\u0440\u0442\u0444\u0435\u043b\u044c \u0443\u0441\u043b\u0443\u0433<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-29386da elementor-widget-divider--view-line_icon elementor-view-default elementor-widget-divider--element-align-center elementor-widget elementor-widget-divider\" data-id=\"29386da\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon elementor-divider__element\">\n\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-pills\"><\/i><\/div>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-574eb46 elementor-widget elementor-widget-text-editor\" data-id=\"574eb46\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table style=\"font-weight: 400;\"><tbody><tr><td>\u00a0<\/td><td><p><strong>\u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u0443\u0441\u043b\u0443\u0433\u0438<\/strong><\/p><p><strong>Name of Service<\/strong><\/p><\/td><\/tr><tr><td><p>1<\/p><\/td><td><p><strong>\u041d\u0430\u0446\u0438\u043e\u043d\u0430\u043b\u044c\u043d\u044b\u0435 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u044b \u0420\u0435\u0441\u043f\u0443\u0431\u043b\u0438\u043a\u0438 \u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c<\/strong><\/p><p><strong>National procedures in Belarus<\/strong><\/p><\/td><\/tr><tr><td><p>1.1<\/p><\/td><td><p>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u0441\u0442\u0440\u0430\u0442\u0435\u0433\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u041b\u041f \u043f\u043e \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u043d\u043e\u0439 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435<\/p><p>Registration of strategic drug product (standard procedure)<\/p><\/td><\/tr><tr><td><p>1.2<\/p><\/td><td><p>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u0441\u0442\u0440\u0430\u0442\u0435\u0433\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u041b\u041f \u043f\u043e \u0443\u043f\u0440\u043e\u0449\u0435\u043d\u043d\u043e\u0439 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435<\/p><p>Registration of strategic drug product (simplified procedure)<\/p><\/td><\/tr><tr><td><p>1.3<\/p><\/td><td><p>\u041f\u0435\u0440\u0435\u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f (\u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0435\u043d\u0438\u0435 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438)<\/p><p>Renewal (confirmation of registration)<\/p><\/td><\/tr><tr><td><p>1.4<\/p><\/td><td><p>\u0412\u043d\u0435\u0441\u0435\u043d\u0438\u0435 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0439<\/p><p>Variation approval**<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.1 \u0414\u043e\u0431\u0430\u0432\u043b\u0435\u043d\u0438\u0435 \u043d\u043e\u0432\u043e\u0433\u043e \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u0438\u044f \u0438\/\u0438\u043b\u0438 \u043d\u043e\u0432\u043e\u0433\u043e \u0441\u043f\u043e\u0441\u043e\u0431\u0430 \u0432\u0432\u0435\u0434\u0435\u043d\u0438\u044f \u0432 \u0418\u043d\u0441\u0442\u0440\u0443\u043a\u0446\u0438\u0438 \u043f\u043e \u043f\u0440\u0438\u043c\u0435\u043d\u0435\u043d\u0438\u044e \u0438 \u043b\u0438\u0441\u0442\u043a\u0435-\u0432\u043a\u043b\u0430\u0434\u044b\u0448\u0435<\/p><p>Addition of new indication and\/or new route of administration to SmPC and PIL<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.2 \u0418\u0441\u043a\u043b\u044e\u0447\u0435\u043d\u0438\u0435 \u0442\u0435\u043a\u0443\u0449\u0435\u0433\u043e \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u0438\u044f \u0438\/\u0438\u043b\u0438 \u0441\u043f\u043e\u0441\u043e\u0431\u0430 \u0432\u0432\u0435\u0434\u0435\u043d\u0438\u044f \u0432 \u0418\u043d\u0441\u0442\u0440\u0443\u043a\u0446\u0438\u0438 \u043f\u043e \u043f\u0440\u0438\u043c\u0435\u043d\u0435\u043d\u0438\u044e \u0438 \u043b\u0438\u0441\u0442\u043a\u0435-\u0432\u043a\u043b\u0430\u0434\u044b\u0448\u0435<\/p><p>Exception of current indication and\/or route of administration to SmPC and PIL<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.3 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u044f \u0432 \u0418\u043d\u0441\u0442\u0440\u0443\u043a\u0446\u0438\u0438 \u043f\u043e \u043f\u0440\u0438\u043c\u0435\u043d\u0435\u043d\u0438\u044e \u0438 \u043b\u0438\u0441\u0442\u043a\u0435-\u0432\u043a\u043b\u0430\u0434\u044b\u0448\u0435, \u0432\u043a\u043b\u044e\u0447\u0430\u044f \u0444\u0430\u0440\u043c\u0430\u043a\u043e\u043b\u043e\u0433\u0438\u0447\u0435\u0441\u043a\u0443\u044e \u0438 \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0443\u044e \u0438\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u044e<\/p><p>Changes in SmPC and PIL including pharmacological and clinical information<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.4 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u044f \u0432 \u0441\u043e\u0441\u0442\u0430\u0432\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 (\u0441\u043c\u0435\u043d\u0430 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044f \u0410\u0424\u0418, \u0434\u043e\u0431\u0430\u0432\u043b\u0435\u043d\u0438\u0435 \u0438\u043b\u0438 \u0438\u0441\u043a\u043b\u044e\u0447\u0435\u043d\u0438\u0435 \u0432\u0441\u043f\u043e\u043c\u043e\u0433\u0430\u0442\u0435\u043b\u044c\u043d\u044b\u0445 \u0432\u0435\u0449\u0435\u0441\u0442\u0432)<\/p><p>Changes in composition of medical product (change of API manufacturer, addition, or exception of excipients)<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.5 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u044f \u0432 \u0440\u0430\u0437\u0434\u0435\u043b\u0435 \u00ab\u0421\u043e\u0441\u0442\u0430\u0432 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u044c\u0435\u00bb (\u0435\u0441\u043b\u0438 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u044f \u043d\u0435 \u0432\u043b\u0438\u044f\u044e\u0442 \u043d\u0430 \u0444\u0430\u043a\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0439 \u0441\u043e\u0441\u0442\u0430\u0432 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430)<\/p><p>Changes in section Composition of registration dossier (if the changes do not affect the actual composition of the medicinal product<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.6 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u044f \u0432 \u041d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u043e\u0439 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430\u0446\u0438\u0438 \u0432 \u0441\u043b\u0443\u0447\u0430\u0435 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0439 \u0432 \u0441\u043f\u0435\u0446\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 \u0438 \u043c\u0435\u0442\u043e\u0434\u0430\u0445 \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044f \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430<\/p><p>Changes in Normative Documentation in case of changes in quality control specification, and methods<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.7 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u0441\u0440\u043e\u043a\u0430 \u0433\u043e\u0434\u043d\u043e\u0441\u0442\u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 \u0438\/\u0438\u043b\u0438 \u0410\u0424\u0418<\/p><p>Change of shelf-life of medical product and\/or API<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.8 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u0443\u0441\u043b\u043e\u0432\u0438\u0439 \u0445\u0440\u0430\u043d\u0435\u043d\u0438\u044f \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 \u0438\/\u0438\u043b\u0438 \u0410\u0424\u0418<\/p><p>Change of storage conditions of medical product and\/or API<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.9 \u041e\u0431\u043d\u043e\u0432\u043b\u0435\u043d\u0438\u0435 \u041d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u043e\u0439 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430\u0446\u0438\u0438<\/p><p>Update of Normative Documentation<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.10 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u0442\u0438\u043f\u0430 \u0438 \u043c\u0430\u0442\u0435\u0440\u0438\u0430\u043b\u0430 \u043f\u0435\u0440\u0432\u0438\u0447\u043d\u043e\u0439 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0438<\/p><p>Change of type, material of primary packaging<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.11 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u044f \u0432 \u043f\u0440\u043e\u0446\u0435\u0441\u0441\u0435 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 \u0438\/\u0438\u043b\u0438 \u0410\u0424\u0418<\/p><p>Changes in manufacturing process of medical product and\/or API<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.12 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u043c\u0430\u043a\u0435\u0442\u043e\u0432 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0438<\/p><p>Change of mock-ups<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.13 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u043a\u043e\u043b\u0438\u0447\u0435\u0441\u0442\u0432\u0430 \u0434\u043e\u0437 \u0432 \u043f\u0435\u0440\u0432\u0438\u0447\u043d\u043e\u0439 \u0438\u043b\u0438 \u0432\u0442\u043e\u0440\u0438\u0447\u043d\u043e\u0439 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0435<\/p><p>Change of number of doses in primary or secondary packaging<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.14 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u0442\u043e\u0440\u0433\u043e\u0432\u043e\u0433\u043e \u043d\u0430\u0438\u043c\u0435\u043d\u043e\u0432\u0430\u043d\u0438\u044f \u0438\/\u0438\u043b\u0438 \u043d\u0430\u0438\u043c\u0435\u043d\u043e\u0432\u0430\u043d\u0438\u044f \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0439 \u0444\u043e\u0440\u043c\u044b<\/p><p>Change of trade name and\/or dosage form name<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.15 \u0420\u0435\u043e\u0440\u0433\u0430\u043d\u0438\u0437\u0430\u0446\u0438\u044f \u0438\u043b\u0438 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u043d\u0430\u0437\u0432\u0430\u043d\u0438\u044f \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044f \u0438\u043b\u0438 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u0430\u0434\u0440\u0435\u0441\u0430<\/p><p>Re-organisation or manufacturer name change or address name change<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.16 \u0418\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0435 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044f \u0438\/\u0438\u043b\u0438 \u0441\u0442\u0440\u0430\u043d\u044b \u043f\u0440\u043e\u0438\u0441\u0445\u043e\u0436\u0434\u0435\u043d\u0438\u044f, \u0434\u043e\u0431\u0430\u0432\u043b\u0435\u043d\u0438\u0435 \u0438\u043b\u0438 \u0438\u0441\u043a\u043b\u044e\u0447\u0435\u043d\u0438\u0435 \u0443\u0447\u0430\u0441\u0442\u043d\u0438\u043a\u0430 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u043f\u0440\u043e\u0446\u0435\u0441\u0441\u0430 \u0434\u043b\u044f \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 \u0438\/\u0438\u043b\u0438 \u0410\u0424\u0418<\/p><p>Change of manufacturer and\/or country of origin, addition or exception of participant of manufacturer process for medical product and\/or API<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><p>1.4.17 \u0421\u043c\u0435\u043d\u0430 \u0437\u0430\u044f\u0432\u0438\u0442\u0435\u043b\u044f \u0438\/\u0438\u043b\u0438 \u0414\u0435\u0440\u0436\u0430\u0442\u0435\u043b\u044f \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u043e\u0433\u043e \u0443\u0434\u043e\u0441\u0442\u043e\u0432\u0435\u0440\u0435\u043d\u0438\u044f (\u0414\u0420\u0423)<\/p><p>Change of Applicant and\/or MAH<\/p><\/td><\/tr><tr><td><p>1.5<\/p><\/td><td><p>\u041f\u0435\u0440\u0435\u043e\u0444\u043e\u0440\u043c\u043b\u0435\u043d\u0438\u0435 \u043d\u0430\u0446\u0438\u043e\u043d\u0430\u043b\u044c\u043d\u043e\u0433\u043e \u0420\u0423 \u0432 \u0420\u0423 \u0441\u0442\u0440\u0430\u0442\u0435\u0433\u0438\u0447\u0435\u0441\u043a\u0438 \u0432\u0430\u0436\u043d\u043e\u0433\u043e \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0430<\/p><p>Change of national MA to MA of strategic drug product<\/p><\/td><\/tr><tr><td><p>2<\/p><\/td><td><p><strong>\u041f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u044b \u0415\u0410\u042d\u0421<\/strong><strong> \u0432 \u0420\u0435\u0441\u043f\u0443\u0431\u043b\u0438\u043a\u0435 \u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c\/<\/strong><\/p><p><strong>EAEU procedures in Belarus<\/strong><\/p><\/td><\/tr><tr><td><p>2.1<\/p><\/td><td><p>\u041f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0430 \u043f\u0440\u0438\u0432\u0435\u0434\u0435\u043d\u0438\u044f \u0432 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435<\/p><p>Bringing into compliance procedure<\/p><\/td><\/tr><tr><td><p>2.2<\/p><\/td><td><p>\u041f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0430 \u043f\u0440\u0438\u0432\u0435\u0434\u0435\u043d\u0438\u044f \u0432 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0432 \u0443\u043f\u0440\u043e\u0449\u0435\u043d\u043d\u043e\u043c \u043f\u043e\u0440\u044f\u0434\u043a\u0435<\/p><p>Bringing into compliance procedure (simplified submission)<\/p><\/td><\/tr><tr><td><p>2.3<\/p><\/td><td><p>\u041f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0430 \u0432\u0437\u0430\u0438\u043c\u043d\u043e\u0433\u043e \u043f\u0440\u0438\u0437\u043d\u0430\u043d\u0438\u044f<\/p><p>Mutual Recognition procedure<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><ul><li>\u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c \u2013 \u0440\u0435\u0444\u0435\u0440\u0435\u043d\u0442\u043d\u043e\u0435 \u0433\u043e\u0441\u0443\u0434\u0430\u0440\u0441\u0442\u0432\u043e\/Belarus \u2013 Reference member state<\/li><\/ul><\/td><\/tr><tr><td>\u00a0<\/td><td><ul><li>\u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c \u2013 \u0441\u0442\u0440\u0430\u043d\u0430 \u043f\u0440\u0438\u0437\u043d\u0430\u043d\u0438\u044f\/Belarus \u2013 Country of recognition<\/li><\/ul><\/td><\/tr><tr><td><p>2.4<\/p><\/td><td><p>\u0414\u0435\u0446\u0435\u043d\u0442\u0440\u0430\u043b\u0438\u0437\u043e\u0432\u0430\u043d\u043d\u0430\u044f \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0430<\/p><p>Decentralized procedure<\/p><\/td><\/tr><tr><td>\u00a0<\/td><td><ul><li>\u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c \u2013 \u0440\u0435\u0444\u0435\u0440\u0435\u043d\u0442\u043d\u043e\u0435 \u0433\u043e\u0441\u0443\u0434\u0430\u0440\u0441\u0442\u0432\u043e\/Belarus \u2013 Reference member state<\/li><\/ul><\/td><\/tr><tr><td>\u00a0<\/td><td><ul><li>\u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c \u2013 \u0441\u0442\u0440\u0430\u043d\u0430 \u043f\u0440\u0438\u0437\u043d\u0430\u043d\u0438\u044f\/Belarus \u2013 Country of recognition<\/li><\/ul><\/td><\/tr><tr><td><p>2.5<\/p><\/td><td><p>\u041f\u0440\u043e\u0432\u0435\u0440\u043a\u0430 \u0443\u0434\u043e\u0431\u043e\u0447\u0438\u0442\u0430\u0435\u043c\u043e\u0441\u0442\u0438 \u043b\u0438\u0441\u0442\u043a\u0430-\u0432\u043a\u043b\u0430\u0434\u044b\u0448\u0430 (\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u0442\u0435\u043b\u044c\u0441\u043a\u043e\u0435 \u0442\u0435\u0441\u0442\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u0435 \u041b\u0412)<\/p><p>PIL readability testing<\/p><\/td><\/tr><tr><td><p>2.6.<\/p><\/td><td><p>\u0412\u043d\u0435\u0441\u0435\u043d\u0438\u0435 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0439 \u0432 \u0434\u043e\u0441\u044c\u0435 \u041b\u041f, \u0437\u0430\u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u043e\u0433\u043e \u043f\u043e \u0415\u0410\u042d\u0421<\/p><p>Changes in registration dossier of medical product (approved in EAEU)<\/p><\/td><\/tr><tr><td><p>3<\/p><\/td><td><p><strong>\u0414\u0440\u0443\u0433\u0438\u0435 \u0443\u0441\u043b\u0443\u0433\u0438\/<\/strong><strong>Other services<\/strong><\/p><\/td><\/tr><tr><td><p>3.1<\/p><\/td><td><p>\u0421\u043e\u043f\u0440\u043e\u0432\u043e\u0436\u0434\u0435\u043d\u0438\u0435 \u0438\u043d\u0441\u043f\u0435\u043a\u0446\u0438\u0438 (\u0432\u043d\u0435 \u0420\u0435\u0441\u043f\u0443\u0431\u043b\u0438\u043a\u0438 \u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c)<\/p><p>Inspection assistance<\/p><\/td><\/tr><tr><td><p>3.2<\/p><\/td><td><p>\u0410\u043d\u0430\u043b\u0438\u0437 \u0434\u043e\u0441\u044c\u0435 \u041b\u041f \u043f\u043e \u043b\u044e\u0431\u043e\u0439 \u0438\u0437 \u0443\u043a\u0430\u0437\u0430\u043d\u043d\u044b\u0445 \u0432\u044b\u0448\u0435 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440<\/p><p>GAP analysis of drug product dossier<\/p><\/td><\/tr><tr><td><p>3.3<\/p><\/td><td><p>\u041a\u043e\u043d\u0441\u0443\u043b\u044c\u0442\u0430\u0446\u0438\u044f (\u043d\u0430\u043f\u0440\u0438\u043c\u0435\u0440, \u043e\u0442\u0447\u0435\u0442 \u043e \u0441\u0442\u0440\u0430\u0442\u0435\u0433\u0438\u0438, \u043e\u0431\u0437\u043e\u0440 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0439 \u0437\u0430\u043a\u043e\u043d\u043e\u0434\u0430\u0442\u0435\u043b\u044c\u0441\u0442\u0432\u0430 \u0438 \u0442. \u0434.)<\/p><p>Consultation (for example, strategy report, overview of legislation changes, etc)<\/p><\/td><\/tr><tr><td><p>3.4<\/p><\/td><td><p>\u0412\u0430\u043b\u0438\u0434\u0430\u0446\u0438\u044f \u043c\u0430\u043a\u0435\u0442\u0430 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u0432 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0438 \u0441 \u043d\u0430\u0446\u0438\u043e\u043d\u0430\u043b\u044c\u043d\u044b\u043c\u0438 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c\u0438<\/p><p>Validation of mock-up for medical products in accordance with national or EAEU legislation<\/p><\/td><\/tr><tr><td><p>3.5<\/p><\/td><td><p>\u0420\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u043a\u0430 \u0438\u043d\u0441\u0442\u0440\u0443\u043a\u0446\u0438\u0439 \u043f\u043e \u043f\u0440\u0438\u043c\u0435\u043d\u0435\u043d\u0438\u044e \u0438\u043b\u0438 \u043b\u0438\u0441\u0442\u043a\u043e\u0432-\u0432\u043a\u043b\u0430\u0434\u044b\u0448\u0435\u0439 \u0438\u043b\u0438 \u041d\u0414 \u0432 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0438 \u0441 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c\u0438 \u0415\u0410\u042d\u0421 (\u0420\u0435\u0448\u0435\u043d\u0438\u044f \u0415\u042d\u0421 \u2116 78 \u0438 88 \u0438 \u0434\u0440.) \u043d\u0430 \u0431\u0430\u0437\u0435 \u043e\u0440\u0438\u0433\u0438\u043d\u0430\u043b\u044c\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u044c\u0435<\/p><p>Developments of SmPC or PIL or ND in accordance with EAEU requirements (EEC Decisions N 78, N 88 and other) on the base of original dossier<\/p><\/td><\/tr><tr><td><p>3.6<\/p><\/td><td><p>\u041f\u0443\u0431\u043b\u0438\u043a\u0430\u0446\u0438\u044f \u0434\u043e\u0441\u044c\u0435 \u0432 \u0444\u043e\u0440\u043c\u0430\u0442\u0435 xml<\/p><p>ePublishing of dossier into xml<\/p><\/td><\/tr><tr><td><p>4<\/p><\/td><td><p><strong>\u0423\u0441\u043b\u0443\u0433\u0438 \u043f\u0435\u0440\u0435\u0432\u043e\u0434\u0430<\/strong><\/p><p><strong>Translation services<\/strong><\/p><\/td><\/tr><tr><td><p>4.1<\/p><\/td><td><p>\u041f\u0435\u0440\u0435\u0432\u043e\u0434 \u0441 \u0430\u043d\u0433\u043b\u0438\u0439\u0441\u043a\u043e\u0433\u043e \u043d\u0430 \u0440\u0443\u0441\u0441\u043a\u0438\u0439 (1 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u043d\u0430\u044f \u0441\u0442\u0440\u0430\u043d\u0438\u0446\u0430 = 1800 \u0441\u0438\u043c\u0432\u043e\u043b\u043e\u0432 \u0441 \u043f\u0440\u043e\u0431\u0435\u043b\u0430\u043c\u0438<\/p><p>English to Russian translation (1 standard page = 1800 characters with spaces<\/p><\/td><\/tr><tr><td><p>4.2<\/p><\/td><td><p>\u041d\u043e\u0442\u0430\u0440\u0438\u0430\u043b\u044c\u043d\u043e\u0435 \u0437\u0430\u0432\u0435\u0440\u0435\u043d\u0438\u0435 \u043f\u0435\u0440\u0435\u0432\u043e\u0434\u0430<\/p><p>Notarisation of translations<\/p><\/td><\/tr><tr><td><p>4.3<\/p><\/td><td><p>\u041d\u043e\u0442\u0430\u0440\u0438\u0430\u043b\u044c\u043d\u043e\u0435 \u0437\u0430\u0432\u0435\u0440\u0435\u043d\u0438\u0435 \u043a\u043e\u043f\u0438\u0438 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430<\/p><p>Notarising a copy of a document<\/p><\/td><\/tr><tr><td><p>4.4<\/p><\/td><td><p>\u0410\u043f\u043e\u0441\u0442\u0438\u043b\u044c<\/p><p>Apostille<\/p><\/td><\/tr><\/tbody><\/table><table style=\"font-weight: 400;\"><tbody><tr><td><p>5.<\/p><\/td><td><p><strong>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0445 \u0438\u0437\u0434\u0435\u043b\u0438\u0439 \u0432 \u0420\u0435\u0441\u043f\u0443\u0431\u043b\u0438\u043a\u0435 \u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c\/<br \/>Registration of medical devices in Belarus<\/strong><\/p><\/td><\/tr><tr><td><p>5.1<\/p><\/td><td><p>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u043e\u0433\u043e \u0438\u0437\u0434\u0435\u043b\u0438\u044f \u043a\u043b\u0430\u0441\u0441\u0430 1<\/p><p>Registration of medical device, class 1<\/p><\/td><\/tr><tr><td><p>5.2<\/p><\/td><td><p>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u043e\u0433\u043e \u0438\u0437\u0434\u0435\u043b\u0438\u044f \u043a\u043b\u0430\u0441\u0441\u0430 2\u0430<\/p><p>Registration of medical device, class 2\u0430<\/p><\/td><\/tr><tr><td><p>5.3<\/p><\/td><td><p>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u043e\u0433\u043e \u0438\u0437\u0434\u0435\u043b\u0438\u044f \u043a\u043b\u0430\u0441\u0441\u0430 2b<\/p><p>Registration of medical device, class 2b<\/p><\/td><\/tr><tr><td><p>5.4<\/p><\/td><td><p>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u043e\u0433\u043e \u0438\u0437\u0434\u0435\u043b\u0438\u044f \u043a\u043b\u0430\u0441\u0441\u0430 3<\/p><p>Registration of medical device, class 3<\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>\u00a0 \u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u0443\u0441\u043b\u0443\u0433\u0438 Name of Service 1 \u041d\u0430\u0446\u0438\u043e\u043d\u0430\u043b\u044c\u043d\u044b\u0435 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u044b \u0420\u0435\u0441\u043f\u0443\u0431\u043b\u0438\u043a\u0438 \u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c National procedures in Belarus 1.1 \u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u0441\u0442\u0440\u0430\u0442\u0435\u0433\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u041b\u041f \u043f\u043e \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u043d\u043e\u0439 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435 Registration of strategic drug product (standard procedure) 1.2 \u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u0441\u0442\u0440\u0430\u0442\u0435\u0433\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u041b\u041f \u043f\u043e \u0443\u043f\u0440\u043e\u0449\u0435\u043d\u043d\u043e\u0439 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435 Registration of strategic drug product (simplified procedure) 1.3 \u041f\u0435\u0440\u0435\u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f (\u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0435\u043d\u0438\u0435 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438) Renewal (confirmation of registration) 1.4 \u0412\u043d\u0435\u0441\u0435\u043d\u0438\u0435 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0439 Variation&hellip;<\/p>","protected":false},"author":1,"featured_media":0,"parent":850,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1204","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.3 (Yoast SEO v22.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u041f\u043e\u0440\u0442\u0444\u0435\u043b\u044c \u0443\u0441\u043b\u0443\u0433 - \u041a\u0440\u043e\u0441\u0442\u043e\u043d \u0422\u0440\u0435\u0439\u0434<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kroston.by\/en\/registratsiya\/reg-services\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u041f\u043e\u0440\u0442\u0444\u0435\u043b\u044c \u0443\u0441\u043b\u0443\u0433\" \/>\n<meta property=\"og:description\" content=\"\u00a0 \u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u0443\u0441\u043b\u0443\u0433\u0438 Name of Service 1 \u041d\u0430\u0446\u0438\u043e\u043d\u0430\u043b\u044c\u043d\u044b\u0435 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u044b \u0420\u0435\u0441\u043f\u0443\u0431\u043b\u0438\u043a\u0438 \u0411\u0435\u043b\u0430\u0440\u0443\u0441\u044c National procedures in Belarus 1.1 \u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f 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\u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u043d\u043e\u0439 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435 Registration of strategic drug product (standard procedure) 1.2 \u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u0441\u0442\u0440\u0430\u0442\u0435\u0433\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u041b\u041f \u043f\u043e \u0443\u043f\u0440\u043e\u0449\u0435\u043d\u043d\u043e\u0439 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435 Registration of strategic drug product (simplified procedure) 1.3 \u041f\u0435\u0440\u0435\u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f (\u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0435\u043d\u0438\u0435 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438) Renewal (confirmation of registration) 1.4 \u0412\u043d\u0435\u0441\u0435\u043d\u0438\u0435 \u0438\u0437\u043c\u0435\u043d\u0435\u043d\u0438\u0439 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