{"id":316,"date":"2022-01-17T21:36:59","date_gmt":"2022-01-17T20:36:59","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=316"},"modified":"2022-01-17T21:37:00","modified_gmt":"2022-01-17T20:37:00","slug":"marketing-medicinal-products","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/medicinal-products\/marketing-medicinal-products\/","title":{"rendered":"Marketing Medicinal Products"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:16px;--awb-text-transform:none;--awb-text-color:var(--awb-color1);--awb-text-font-family:&quot;Source Sans Pro&quot;;--awb-text-font-style:normal;--awb-text-font-weight:700;\" id=\"navigacija_naslov\"><p>Medicinal Products<\/p>\n<\/div><nav class=\"awb-menu awb-menu_column awb-menu_em-hover mobile-mode-collapse-to-button awb-menu_icons-left awb-menu_dc-yes mobile-trigger-fullwidth-off awb-menu_mobile-toggle awb-menu_indent-left mobile-size-full-absolute loading mega-menu-loading awb-menu_desktop awb-menu_dropdown awb-menu_expand-right awb-menu_transition-fade\" style=\"--awb-font-size:14px;--awb-items-padding-bottom:0.5em;--awb-color:#0d4873;--awb-active-color:#0d4873;--awb-main-justify-content:flex-start;--awb-mobile-justify:flex-start;--awb-mobile-caret-left:auto;--awb-mobile-caret-right:0;--awb-fusion-font-family-typography:&quot;Source Sans Pro&quot;;--awb-fusion-font-style-typography:normal;--awb-fusion-font-weight-typography:700;--awb-fusion-font-family-submenu-typography:inherit;--awb-fusion-font-style-submenu-typography:normal;--awb-fusion-font-weight-submenu-typography:400;--awb-fusion-font-family-mobile-typography:inherit;--awb-fusion-font-style-mobile-typography:normal;--awb-fusion-font-weight-mobile-typography:400;\" aria-label=\"meni_humani\" data-breakpoint=\"1024\" data-count=\"0\" data-transition-type=\"fade\" data-transition-time=\"300\"><button type=\"button\" class=\"awb-menu__m-toggle awb-menu__m-toggle_no-text\" aria-expanded=\"false\" aria-controls=\"menu-meni_humani\"><span class=\"awb-menu__m-toggle-inner\"><span class=\"collapsed-nav-text\"><span class=\"screen-reader-text\">Toggle Navigation<\/span><\/span><span class=\"awb-menu__m-collapse-icon awb-menu__m-collapse-icon_no-text\"><span class=\"awb-menu__m-collapse-icon-open awb-menu__m-collapse-icon-open_no-text fa-bars fas\"><\/span><span class=\"awb-menu__m-collapse-icon-close awb-menu__m-collapse-icon-close_no-text fa-times fas\"><\/span><\/span><\/span><\/button><ul id=\"menu-meni_humani\" class=\"fusion-menu awb-menu__main-ul awb-menu__main-ul_column\"><li  id=\"menu-item-312\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-312 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  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awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"334\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medicinal-products\/advertising-of-medicines\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Advertising of medicines<\/span><\/a><\/li><li  id=\"menu-item-337\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-337 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"337\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medicinal-products\/marketing-and-consumption-of-medicinal-products\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Marketing and consumption of medicinal products<\/span><\/a><\/li><li  id=\"menu-item-342\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-342 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"342\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medicinal-products\/clinical-trials\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Clinical Trials<\/span><\/a><\/li><li  id=\"menu-item-983\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-983 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"983\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/good-clinical-practice-gcp\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Good Clinical Practice (GCP)<\/span><span 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trials<\/span><\/a><\/li><li  id=\"menu-item-357\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-357 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"357\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medicinal-products\/search-for-import-licenses\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for import licenses<\/span><\/a><\/li><\/ul><\/nav><\/div><\/div>\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-flex-column\" 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class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h5>Marketing Medicinal Products<\/h5><\/h5><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>In the activities regarding the marketing of a medicinal product, issuing a marketing authorization and authorization renewal and variations, the Agency cooperates with manufacturers of medicinal products and their agencies, expert committees and experts cooperators of the Agency.<\/p>\n<div class=\"entry-content\">\n<div id=\"sadrzaj\">\n<p>In accordance with Law, marketing authorizations are granted based on the supervision of the complete CTD or the European dossier within the time limits and in the manner prescribed in line with the EU directives. Experts employed in the Agency, as well as the expert cooperators of the Agency participate in the evaluation of pharmaceutical and pharmacological-toxicological and clinical documentation on quality, safety and efficiency of a medicinal product.<\/p>\n<p>Particular expert interviews about the quality of a medicinal product, its components, efficiency, range of indiciations, adverse reactions, pharamcoeconomic parametars, etc., are carried out with the applicants for marketing authorizations, especially when there are innovative medicinal products, or products which have not been marketed in Serbia before.<\/p>\n<p>The procedure of granting a marketing authorization of a medicinal product have been harmonized with the EU directives and guidelines for Good Regulatory Practice. Documentation, regarding the security of data, is particularly kept in the manner set forth by the EU. National marketing authorizations for medicinal products are issued in Serbia.<\/p>\n<p>Since Serbia is not a member of the EU, in this phase of the development of pharmaceutical regulatory system for granting centralized authorization or marketing authorization based on mutual reckognition is not yet possible. Although Serbia is not yet a member of the EU, when marketing medicinal products, there is a possibility of reckognizing and accepting expert oppinions and performed clinical trials, in line with the Declaration of Helsinki, as well as the study on bioequivalence and bioavailability, with the applications processed in accordance with the internationally reckognized standards, and with medicinal products that have already been marketed.<\/p>\n<p>When granting the marketing authorization for a medicinal product, the Medicines and Medical Devices Agency of Serbia keeps in sight the provisions of international agreements on the obligation of marketing good quality, safe and efficient medicinal products, the increase of marketed false medicinal products in the world and the need for cessation thereof, as well as the illegal marketing of the unregistered medicial products. In order to ensure the best possible conditions for prevention, diagnosing, treatment and rehabilitation to Serbian citizens and medical workers during the provision of medical services, it is neccessary that the widest possible asortment of good quality, safe and efficient medicinal products is present on the Serbian market.<\/p>\n<p>The Agency issues the approval for marketing authorizations for unregistered medicinal products when it is medically indicated and legally permitted.<\/p>\n<p>The Agency publishes LISTS OF MEDICINAL PRODUCTS for which marketing authorizations were granted and decisions on the termination of their marketing authorizations was passed, in \u201cThe Official Gazette of the Republic of Serbia\u201d.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":308,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-316","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/316","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/comments?post=316"}],"version-history":[{"count":1,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/316\/revisions"}],"predecessor-version":[{"id":318,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/316\/revisions\/318"}],"up":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/308"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=316"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}