{"id":132,"date":"2022-01-16T20:36:21","date_gmt":"2022-01-16T19:36:21","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=132"},"modified":"2023-07-05T11:28:52","modified_gmt":"2023-07-05T10:28:52","slug":"medicines-under-intensive-monitoring","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/medicines-under-intensive-monitoring\/","title":{"rendered":"Medicines under intensive monitoring"},"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 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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  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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 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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;\"><h4>List of medicines under intensive monitoring<\/h4><\/h1><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>Medicines under additional monitoring have a black inverted tringle displayed in their Summary of product characteristics (SPC) and the package leaflet (PIL), with the appropriate sentence:<\/p>\n<p>\u25bcThis medicine is under additional monitoring.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4>What is the meaning of the inverted black triangle symbol?<\/h4><\/h4><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-transform:none;\"><p>After a marketing authorization is obtained for a medicinal product, it continues to be carefully monitored within the so-called post-market surveillance. However, if a medicine has the inverted black triangle symbol, it means that it is monitored more intensively than other medicines. The most common reason for additional monitoring of medicines is that less information is available about it compared to other medicines, e.g. because the medicine is new on the market or because there are limited data on its long-term use. If a medicine is marked with an inverted black triangle, it does not mean that the medicine is not safe.<br \/>\nThe symbol of the inverted black triangle indicated at the very beginning of SPC\/PIL should increase the attention of healthcare professionals and\/or patients or users of such medicine, when monitoring the therapeutic use of the medicine. When they see an inverted black triangle, healthcare professionals and patients should know that it is extremely important to report any suspected adverse reactions to that medicine. For more detailed information on how to report a suspected adverse drug reaction click <a href=\"#\" target=\"_blank\" rel=\"noopener\">here.<\/a><\/p>\n<\/div><div class=\"fusion-text fusion-text-4\" style=\"--awb-text-transform:none;\"><h4>What medicines are additionally monitored?<\/h4>\n<\/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-5\"><p>In accordance with the EU principles, the status of additional monitoring in the Republic of Serbia is always assigned to the following categories of medicines:<\/p>\n<ul>\n<li>medicines containing a new active substance that was approved in the EU after 01\/01.\/2011;<\/li>\n<li>biological medicines, such as vaccines or drugs from human plasma (blood), approved after 01\/01\/2011;<\/li>\n<li>medicines for which the marketing authorization holder is obliged to conduct post-authorization safety studies (PASS), e.g. in order to provide more data on long-term use of the medicine or on rare side effects observed during clinical studies;<\/li>\n<li>medicines that received a conditional marketing authorization (when the marketing authorization holder must provide more data on the medicine over a certain period of time) or medicines approved under special circumstances (when there are specific reasons why the marketing authorization holder cannot provide comprehensive data on the medicine).<\/li>\n<\/ul>\n<p>Other medicines can also receive additional monitoring status based on the decision of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).<br \/>\nAlso, the Medicines and Medical Devices Agency of Serbia (ALIMS) can determine the status of additional monitoring of a medicine in accordance with an expert assessment of its safety profile.<br \/>\nMedicines that are additionally monitored in the Republic of Serbia are all medicines approved by ALIMS with an active substance that is in the <a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/document_listing\/document_listing_000366.jsp&amp;mid=WC0b01ac058067c852\" target=\"_blank\" rel=\"noopener\">EU List of Medicines under Additional Monitoring<\/a> (updated every month after the PRAC meeting), as well as <a href=\"https:\/\/www.alims.gov.rs\/wp-content\/uploads\/2022\/01\/l-eu.pdf\" target=\"_blank\" rel=\"noopener\">Medicines outside the EU List<\/a> for which the expert ALIMS assessment determined the status of additional monitoring in the Republic of Serbia.<\/p>\n<\/div><div class=\"fusion-text fusion-text-6\"><h4>When does a medicine get additional monitoring status?<\/h4>\n<\/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-7\"><p>A medicine can be included in the list of medicines under additional monitoring during its first registration, but also at any other stage of its lifecycle. Once included in the list, the medicine usually retains the additional monitoring status for five years or until the decision of the relevant regulatory authorities (EMA, ALIMS) is changed.<\/p>\n<p>The release of the packaging of a medicine with the updated PIL text may be delayed in relation to the decision to add the medicine to the list for additional monitoring or to delete it from the list. This can happen because it takes a certain amount of time (prescribed by the applicable regulations) to replace the existing inventory of the packaging of medicines with the new one.<\/p>\n<\/div><div class=\"fusion-text fusion-text-8\"><h4>What are the obligations of the marketing authorization holder?<\/h4>\n<\/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-9\"><p>Marketing authorization holders in the Republic of Serbia should implement the decision by which their medicine is included in the list of medicines under additional monitoring by indicating the symbol of the inverted black triangle and the corresponding information in the draft SPC and PIL, or more specifically:<\/p>\n<ol>\n<li>attached to the the marketing authorization application;<\/li>\n<li>for medicines that already have a marketing authorization issued in the Republic of Serbia with a corresponding request for a variation that changes the SPC\/PIL. If the marking of information on additional monitoring of medicines is the only change to SPC\/PIL, a request for approval of variation C.I z) type IA is submitted;<\/li>\n<li>attached to the marketing authorization renewal application.<\/li>\n<\/ol>\n<p>You can download the method of specifying information about additional monitoring of medicines and reporting suspected adverse drug reactions in the information about medicines <a href=\"https:\/\/www.alims.gov.rs\/wp-content\/uploads\/2022\/01\/nr-SmPC-PIL.pdf\" target=\"_blank\" rel=\"noopener\"><i class=\"fas fa-file-word\"><\/i>HERE<\/a>.<\/p>\n<\/div><div class=\"fusion-text fusion-text-10\"><h4>Why is a list of medicines under intensive monitoring required?<\/h4>\n<\/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-11\"><p>Issuance of a marketing authorization is based on a positive assessment of the benefit-risk ratio in its therapeutic application for a clearly defined indication area. However, at the time of submitting a request for registration of a new medicine, not all possible risks of a new therapy are known, that is, information on the safety of a specific medicine is relatively limited. This is conditioned by numerous factors, which are the consequences of the usual way of conducting clinical trials, such as: small number of subjects, insufficient diversity of the studied population (in terms of age, gender and ethnicity), limited representation of comorbidities and concomitant therapy in the studied population, relatively short study duration, statistical flaws. In order to identify possible rare adverse reactions and complete the information on the safety profile of the medicine, it is very important to continue monitoring the medicine once it is marketed and to report suspicions of its adverse reactions. The information collected in this way is regularly evaluated by regulatory agencies that try to determine whether new data change the benefit-risk ratio of the medicine, that is, whether it is still positive.<\/p>\n<\/div><div class=\"fusion-text fusion-text-12\"><h4>Regulatory framework for additional monitoring of medicines<\/h4>\n<\/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-13\"><p>The list of medicines under additional monitoring is defined in accordance with Article 38 of the Rulebook on the manner of reporting, collecting and monitoring adverse reactions to medicines (Official Gazette of RS No. 64\/2011), which stipulates that the Medicines and Medical Devices Agency of Serbia (ALIMS) determines the list of medicines that are marked with special labels for intensive monitoring of their safety profile.<\/p>\n<p><a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/special_topics\/general\/general_content_000491.jsp&amp;mid=WC0b01ac058058f32d\" target=\"_blank\" rel=\"noopener\">EU legislation<\/a> related to pharmacovigilance (Directive 2010\/84\/EU, Regulation (EU) No 1235\/2010) defines the concept of \u201cmedicines under additional monitoring\u201d which refers to medicines that are intensively monitored due to their safety profile, which is additionally regulated by the guidelines of Good Pharmacovigilance Practice (GVP) &#8211; Module X &#8211; Additional monitoring.<\/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-132","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/132","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=132"}],"version-history":[{"count":9,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/132\/revisions"}],"predecessor-version":[{"id":776,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/132\/revisions\/776"}],"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=132"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}