{"id":75,"date":"2022-01-16T12:10:13","date_gmt":"2022-01-16T11:10:13","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=75"},"modified":"2023-06-23T14:01:11","modified_gmt":"2023-06-23T13:01:11","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"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>Pharmacovigilance<\/p>\n<\/div><nav class=\"awb-menu awb-menu_row 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_farmakovigilanca\" 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_farmakovigilanca\"><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_farmakovigilanca\" class=\"fusion-menu awb-menu__main-ul awb-menu__main-ul_row\"><li  id=\"menu-item-81\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-81 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"81\"><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\/pharmacovigilance\/\" 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\">Pharmacovigilance<\/span><\/a><\/li><li  id=\"menu-item-116\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-116 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"116\"><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\/pharmacovigilance\/how-we-monitor-the-safety\/\" 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\">How we monitor the safety?<\/span><\/a><\/li><li  id=\"menu-item-841\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-841 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"841\"><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\/security-information\/\" 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\">Safety information<\/span><\/a><\/li><li  id=\"menu-item-127\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-127 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"127\"><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\/pharmacovigilance\/reporting-of-adverse-drug-reactions\/\" 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\">Reporting of Adverse Drug Reactions<\/span><\/a><\/li><li  id=\"menu-item-135\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-135 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"135\"><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\/pharmacovigilance\/medicines-under-intensive-monitoring\/\" 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\">List of medicines under additional monitoring<\/span><\/a><\/li><li  id=\"menu-item-146\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-146 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"146\"><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\/pharmacovigilance\/meddra-and-ime-lists\/\" 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\">MedDRA and IME lists<\/span><\/a><\/li><li  id=\"menu-item-842\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-842 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"842\"><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\/drug-license-holders\/\" 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 authorisation holders<\/span><\/a><\/li><li  id=\"menu-item-161\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-161 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"161\"><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\/pharmacovigilance\/annual-report\/\" 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\">Annual reports<\/span><\/a><\/li><li  id=\"menu-item-861\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-861 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"861\"><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\/questions-and-answers\/\" 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\">Questions and answers<\/span><\/a><\/li><li  id=\"menu-item-862\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-862 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"862\"><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\/medsafetyweek\/\" 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\">MedSafetyWeek<\/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\" style=\"--awb-padding-right:50px;--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.56%;--awb-width-medium:75%;--awb-order-medium:0;--awb-spacing-right-medium:2.56%;--awb-spacing-left-medium:2.56%;--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\"><nav class=\"fusion-breadcrumbs fusion-breadcrumbs-1\" style=\"--awb-breadcrumb-sep:&#039;\/&#039;;\" aria-label=\"Breadcrumb\"><ol class=\"awb-breadcrumb-list\"><li class=\"fusion-breadcrumb-item awb-breadcrumb-sep\" ><a href=\"https:\/\/www.alims.gov.rs\/english\" class=\"fusion-breadcrumb-link\"><span >Home<\/span><\/a><\/li><\/ol><\/nav><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\"><h1 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h5>Pharmacovigilance<\/h5><\/h1><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>Welcome to the PHARMACOVIGILANCE section of the website of the Medicines and Medical Devices Agency of Serbia (ALIMS).<\/p>\n<p>No medicine is entirely safe. In other words, no medicine is risk free. Although many of the risks are known at the time of licensing a medicine, some information on its safety profile comes to light later, after marketing a medicine, as medicine usage increase.<\/p>\n<p>Before a medicine is marketed, information on its safety is limited to its use in clinical trials under specific, ideal circumstances that do not necessarily reflect the way the medicines are used in daily routine health practice, once they are marketed. Despite the extensive pre-marketing research, non-clinical trials in animals and clinical trials in humans, some adverse reactions may not be seen until a very large number of people have received the medicine.<\/p>\n<p>Therefore it is very important that the safety of all medicines is monitored throughout their marketed life \u2013 known as pharmacovigilance.<\/p>\n<p>The ultimate goal of pharmacovigilance is to protect public health by putting patient safety first. Therefore, pharmacovigilance is considered an essential part of medicines regulation.<br \/>\nOne of the assigned affairs performed by the ALIMS is the establishment, continuous maintenance and improvement of the national pharmacovigilance system in Serbia. The system should enable safety signal detection, risk identification, characterization, assessment, minimization, communication and prevention in order to provide the best possible benefit\/risk ratio of medicines in daily practice and promote rational and safe use of medicines. Those pharmacovigilance activities ALIMS conducts through its National Pharmacovigilance Centre (NPC).<\/p>\n<p>As crucial a element of public health protection, pharmacovigilance represents the most important aspect of ALIMS`s\u00a0 for the current and future periods. Working together with all parties in the field of pharmacovigilance, the ALIMS wants to contribute to the strengthening a responsible, authoritative and confident pharmacovigilance system and medicine regulatory system, in order to improve patient safety.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-75","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/75","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=75"}],"version-history":[{"count":25,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/75\/revisions"}],"predecessor-version":[{"id":376,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/75\/revisions\/376"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=75"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}