{"id":856,"date":"2023-07-05T12:11:30","date_gmt":"2023-07-05T11:11:30","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=856"},"modified":"2023-07-05T12:42:06","modified_gmt":"2023-07-05T11:42:06","slug":"questions-and-answers","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/questions-and-answers\/","title":{"rendered":"Questions and answers"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background 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\"><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-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:inherit;--awb-fusion-font-style-typography:normal;--awb-fusion-font-weight-typography:400;--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><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--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;\">Questions and answers<\/h1><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;width:100%;\"><div class=\"fusion-separator-border sep-double\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;border-bottom-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-2\"><p>&#8211; I have an adverse reaction to a medicine, what should I do?<\/p>\n<p>You can report this reaction to your doctor or pharmacist who will report it to the Agency\u2019s National Center for Monitoring Adverse Drug Reactions (pharmacovigilance)<\/p>\n<p>&#8211; What is pharmacovigilance?<\/p>\n<p>Pharmacovigilance is the process of monitoring, reporting, evaluating, and responding to adverse drug reactions.<\/p>\n<p>&#8211; Why are adverse drug reactions monitored?<\/p>\n<p>At the end of a clinical trial of a medicine, frequent adverse reactions are known. After registration, the medicine is marketed when it begins to be used in routine clinical practice on a large number of patients, under far less strict conditions. At that time, we still do not know the overall safety profile of the medicine, that is, information is incomplete or not available at all regarding rare adverse reactions and reactions after long-term exposure, interactions, resistance, potential for medical errors, unapproved use of the medicine, abuse and misuse, use of the medicine in specific categories of patients (children, the elderly, pregnant women, nursing mothers, patients with accompanying diseases: liver, kidney, heart failure, etc.). For the above reasons and as there is a difference between a very precise and organized way of conducting clinical trials and everyday routine clinical practice, knowledge about the safety profile of the medicine is limited and must be expanded. That is why it is of great importance to monitor the safety of all medicines from the moment they are marketed &#8211; or pharmacovigilance.<\/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-856","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/856","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=856"}],"version-history":[{"count":3,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/856\/revisions"}],"predecessor-version":[{"id":867,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/856\/revisions\/867"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}