{"id":488,"date":"2022-01-19T19:53:38","date_gmt":"2022-01-19T18:53:38","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=488"},"modified":"2022-01-19T20:21:36","modified_gmt":"2022-01-19T19:21:36","slug":"function-and-activities","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/about-agency\/function-and-activities\/","title":{"rendered":"Function and activities"},"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>About the Agency<\/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-right: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: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_o_agenciji\" 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_o_agenciji\"><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_o_agenciji\" class=\"fusion-menu awb-menu__main-ul awb-menu__main-ul_column\"><li  id=\"menu-item-472\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-472 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"472\"><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\/about-agency\/\" 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\">About Agency<\/span><\/a><\/li><li  id=\"menu-item-491\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-491 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"491\"><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\/about-agency\/function-and-activities\/\" 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\">Function and activities<\/span><\/a><\/li><li  id=\"menu-item-500\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-500 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"500\"><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\/about-agency\/organization-and-resources\/\" 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\">Organization and resources<\/span><\/a><\/li><li  id=\"menu-item-504\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-504 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"504\"><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\/about-agency\/tradition\/\" 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\">Tradition<\/span><\/a><\/li><li  id=\"menu-item-507\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-507 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"507\"><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\/about-agency\/location\/\" 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\">Location<\/span><\/a><\/li><li  id=\"menu-item-557\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-557 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"557\"><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\/about-agency\/quality-management\/\" 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\">Quality Management<\/span><\/a><\/li><li  id=\"menu-item-562\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-562 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"562\"><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\/about-agency\/information-technology\/\" 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\">Information Technology<\/span><\/a><\/li><li  id=\"menu-item-590\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-590 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"590\"><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\/about-agency\/publications\/\" 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\">Publications<\/span><\/a><\/li><li  id=\"menu-item-892\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-892 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"892\"><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\/documents-reports\/\" 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\">Documents- Reports<\/span><\/a><\/li><li  id=\"menu-item-616\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-616 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"616\"><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\/about-agency\/expert-meetings\/\" 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\">Expert meetings<\/span><\/a><\/li><li  id=\"menu-item-611\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-611 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"611\"><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\/about-agency\/presentation\/\" 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\">Presentation<\/span><\/a><\/li><li  id=\"menu-item-585\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-585 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"585\"><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\/about-agency\/cooperation-agreements\/\" 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\">Cooperation Agreements<\/span><\/a><\/li><li  id=\"menu-item-568\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-568 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"568\"><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\/about-agency\/links\/\" 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\">Links<\/span><\/a><\/li><li  id=\"menu-item-904\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-904 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"904\"><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\/competitions-and-public-procurement\/\" 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\">Competitions and public procurement<\/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-five\"><h5 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h5>Function and activities<\/h5><\/h5><\/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 id=\"id61e85d84bbf95\" class=\"collapseomatic colomat-visited colomat-close\" tabindex=\"0\" title=\"Function\">Function<\/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-2\" style=\"--awb-text-transform:none;\"><p>The Agency shall be in charge of:<\/p>\n<ul type=\"disc\">\n<li>issuing marketing authorizations for medicinal products and medical devices;<\/li>\n<li>performing laboratory quality control of medicinal products and medical devices;<\/li>\n<li>issuing authorizations for clinical trials of medicinal products and medical devices and controlling the conduct of clinical trials;<\/li>\n<li>monitoring adverse reactions of medicinal products and medical devices;<\/li>\n<li>issuing certificates on compliance with guidelines on Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice in clinical trials of medicinal products and medical devices;<\/li>\n<li>authorizing the import of non-registered medicinal products and medical devices for the treatment of a particular patient or group of patients and medicinal products and medical devices for scientific research;<\/li>\n<li>classification of medicinal products and medical devices;<\/li>\n<li>collecting and processing statistical data on trade and consumption of medicinal products and medical devices;<\/li>\n<li>providing information and promotion of rational use of medicinal products and medical devices;<\/li>\n<li>integration into international networks of information on medicinal products and medical devices and integration into international agencies associations;<\/li>\n<li>other tasks in accordance with this Law;<\/li>\n<\/ul>\n<\/div><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4 id=\"id61e85d84bbfda\" class=\"collapseomatic colomat-visited\" tabindex=\"0\" title=\"Activities\">Activities<\/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>Activities performed in the ALIMS refer to the issues before issuing permits for the drug or medical device registration in the Register of medical devices and activities that are performed after the marketing of drugs and medical devices.<\/p>\n<p><a href=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat.jpg\"><img decoding=\"async\" class=\"alignleft size-large wp-image-493\" src=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-1024x284.jpg\" alt=\"\" width=\"1024\" height=\"284\" srcset=\"https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-200x55.jpg 200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-300x83.jpg 300w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-400x111.jpg 400w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-600x166.jpg 600w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-768x213.jpg 768w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-800x222.jpg 800w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-1024x284.jpg 1024w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat-1200x333.jpg 1200w, https:\/\/www.alims.gov.rs\/english\/wp-content\/uploads\/2022\/01\/k-lat.jpg 1425w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/p>\n<p>Activities performed in the ALIMS:<\/p>\n<\/div><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4>Premarketing activities<\/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-4\" style=\"--awb-text-transform:none;\"><p>Experts employed in the Agency, as well as the expert cooperators of the Agency participate in the evaluation of pharmaceutical, pharmacological-toxicological and clinical documentation on quality, safety and efficiency of medicinal products.<\/p>\n<p>Evaluation of documentation is performed in accordance with the Law on Medicinal Products and Medical Devices, and based on the insight into complete Common Technical Dossier \u2013 CTD or European Dossier, presented by the client during the submission of application.<\/p>\n<p>In order to provide the citizens of Serbia and health-care workers with the best possible conditions for prevention, diagnostics, treatment and rehabilitation, it is necessary to make a wide range of high-quality, safe and efficient medicinal products and medical devices available on the Serbian market, which is the obligation of the Agency.<\/p>\n<p>The Medicines and Medical Devices Agency of Serbia also receives applications from the manufacturers of innovative medicinal products that have their registered offices outside Serbia, for the performance of IIIa and b and IV phase of clinical trials of medicinal products, i.e. medicinal products in the phase of development and those already marketed. The applications are processed by the Agency experts in cooperation with the experts from the Commission for Clinical Trials of Medicinal Products. The consent is given in line with Directive 2001\/20 EC, and the certificate on compliance with Good Clinical Practice in line with ICH guidelines (International Conference on Harmonization \u2013 ICH).<\/p>\n<p>Pursuant to the Law on Medicinal Products and Medical Devices, the issuance of marketing authorizations, as well the renewals and amendments thereto, are carried out in the Medicines and Medical Devices Agency of Serbia. Procedures for the issuance of marketing authorizations for medical devices are harmonized with the guidelines on Good Regulatory Practice and the Law on Medicinal Products and Medical Devices.)<\/p>\n<\/div><div class=\"fusion-title title fusion-title-5 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4>Postmarketing activities<\/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-5\" style=\"--awb-text-transform:none;\"><p>The Medicines and Medical Devices Agency of Serbia, performs the activities of organized and continual monitoring of adverse reactions to medicinal products, by applying the latest international standards:<\/p>\n<ul type=\"disc\">\n<li>spontaneous reports on adverse reactions to medicinal products<\/li>\n<li>gathering and evaluating reports made by health-care workers on adverse reactions during the treatment of patients<\/li>\n<li>reports on adverse reactions during clinical trials and<\/li>\n<li>evaluation of periodic reports on adverse reactions to medicinal products in postmarketing period (Periodic Safety Update Reports \u2013 PSURs).<\/li>\n<\/ul>\n<p>Due to the access to current data bases, the Agency experts provide reliable information on medicinal products and medical devices, as well as advices to patients and health-care professionals regarding the rational and economical use thereof. For the purpose of pharmacoepidemiologic and pharmacoeconomic researches, the Agency monitors the distribution and consumption of medicinal products and medical devices. Within the National Centre for Information on Medicines and Medical Devices there is the Library of the Agency with the current web-site presentation of the Agency performances and information on medicinal products and medical devices.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":469,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-488","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/488","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=488"}],"version-history":[{"count":5,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/488\/revisions"}],"predecessor-version":[{"id":492,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/488\/revisions\/492"}],"up":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/469"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=488"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}