{"id":144,"date":"2022-01-16T21:12:00","date_gmt":"2022-01-16T20:12:00","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=144"},"modified":"2023-06-23T14:52:43","modified_gmt":"2023-06-23T13:52:43","slug":"meddra-and-ime-lists","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/meddra-and-ime-lists\/","title":{"rendered":"MedDRA and IME lists"},"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\" 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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>MedDRA and IME lists<\/h5><\/h1><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>The Medical Dictionary for Regulatory Activities \u2013 MedDRA is a clinically validated medical terminology dictionary used by regulatory authorities and the pharmaceutical industry. It was developed due to the need for standardization of terminology between regulatory authorities and multinational pharmaceutical companies, as well as the need to minimize errors in the translation of terms, for electronic data transfer.<\/p>\n<p>MSSO (Maintenance and Support Services Organization) is an organization that provides support to MedDRA, which includes maintenance, distribution, implementation and development of MedDRA in accordance with the needs of users. The MedDRA structure is organized in hierarchical levels of which the highest level is System Organ Class (SOC), followed by High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT) and Lowest Level Term (LLT). A characteristic of MedDRA is multiaxiality which is characterized by the concept of multiple organ systems. Namely, one PT can be connected to one or more organ systems. MedDRA may manifest multiaxiality on PT, HLT or HLGT levels.<\/p>\n<\/div><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1024\" height=\"976\" title=\"slika-e11\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/slika-e11-1024x976.jpg\" alt class=\"img-responsive wp-image-151\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/slika-e11-200x191.jpg 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/slika-e11-400x381.jpg 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/slika-e11-600x572.jpg 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/slika-e11-800x762.jpg 800w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/slika-e11.jpg 1172w\" sizes=\"(max-width: 640px) 100vw, 1024px\" \/><\/span><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-transform:none;\"><p>According to the Rulebook on the method of reporting, collecting and monitoring adverse reactions to medicines (\u201cOfficial Gazette of RS,\u201d No. 64\/2011), the marketing authorization holder or the person responsible for pharmacovigilance shall code all ICSR adverse reactions by using the MedDRA system.<\/p>\n<p>The expert working group in the European Medicines Agency (EudraVigilance Expert Working Group) has initiated the development of the important medical event (IME) terms list in order to facilitate the classification, analysis and assessment of collected data by the marketing authorization holders\/persons responsible for pharmacovigilance in day-to-day pharmacovigilance activities.<\/p>\n<p>The IME list is based on PT level coding in MedDRA. This level is mostly used for database searches and data analysis. If an adverse reaction is encoded in LLT based on verbatim, parent categories shall be automatically added to it based on the hierarchical system, hence the severity of LLT should be checked by the associated PT.<\/p>\n<p>Example:<\/p>\n<\/div><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-2 hover-type-none\"><img decoding=\"async\" width=\"150\" height=\"150\" title=\"Slika2-Medra-150&#215;150\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/Slika2-Medra-150x150-1.jpg\" alt class=\"img-responsive wp-image-156\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/Slika2-Medra-150x150-1-66x66.jpg 66w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/Slika2-Medra-150x150-1.jpg 150w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/span><\/div><div class=\"fusion-text fusion-text-4\" style=\"--awb-text-transform:none;\"><p align=\"justify\">Every adverse reaction on the PT level in the IME list has one designation: <strong> CS <\/strong>(core serious) or <strong>ES<\/strong> (extended serious).<\/p>\n<p>Every adverse reaction on the IME list shall be considered\u00a0 an important medical event and shall always be coded as serious.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":75,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-144","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/144","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=144"}],"version-history":[{"count":8,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/144\/revisions"}],"predecessor-version":[{"id":155,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/144\/revisions\/155"}],"up":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/75"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=144"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}