{"id":260,"date":"2022-01-17T11:26:41","date_gmt":"2022-01-17T10:26:41","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=260"},"modified":"2022-01-17T11:28:03","modified_gmt":"2022-01-17T10:28:03","slug":"vigilance","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/veterinary-medicines\/vigilance\/","title":{"rendered":"Vigilance"},"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>Veterinary Medicines<\/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-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: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_veterina\" 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_veterina\"><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_veterina\" class=\"fusion-menu awb-menu__main-ul awb-menu__main-ul_column\"><li  id=\"menu-item-177\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-177 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"177\"><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\/veterinary-medicines\/\" 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\">Veterinary Medicines<\/span><\/a><\/li><li  id=\"menu-item-196\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-196 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"196\"><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\/veterinary-medicines\/quality-control\/\" 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 Control<\/span><\/a><\/li><li  id=\"menu-item-206\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-206 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"206\"><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\/veterinary-medicines\/information-on-medicines\/\" 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 on medicines<\/span><\/a><\/li><li  id=\"menu-item-216\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-216 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"216\"><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\/veterinary-medicines\/advertising-of-medicines\/\" 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\">Advertising of medicines<\/span><\/a><\/li><li  id=\"menu-item-228\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-228 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"228\"><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\/veterinary-medicines\/marketing-and-consumption-of-medicinal-products\/\" 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 and consumption of medicinal products<\/span><\/a><\/li><li  id=\"menu-item-233\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-233 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"233\"><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\/veterinary-medicines\/clinical-trials\/\" 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\">Clinical Trials<\/span><\/a><\/li><li  id=\"menu-item-238\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-238 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"238\"><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\/veterinary-medicines\/expert-opinions\/\" 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 opinions<\/span><\/a><\/li><li  id=\"menu-item-263\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-263 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"263\"><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\/veterinary-medicines\/vigilance\/\" 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\">Vigilance<\/span><\/a><\/li><li  id=\"menu-item-266\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-266 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"266\"><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\/veterinary-medicines\/complaints\/\" 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\">Complaints<\/span><\/a><\/li><li  id=\"menu-item-269\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-269 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"269\"><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\/veterinary-medicines\/search-for-veterinary-medicines\/\" 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\">Search for veterinary medicines<\/span><\/a><\/li><li  id=\"menu-item-271\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-271 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"271\"><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\/veterinary-medicines\/search-for-veterinary-certificates\/\" 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\">Search for veterinary certificates<\/span><\/a><\/li><li  id=\"menu-item-877\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-877 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"877\"><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\/reporting-adverse-reactions-to-veterinary-medical-product\/\" 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 adverse reactions to veterinary medical product<\/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>Vigilance<\/h5><\/h5><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>Agency of Medicines and Medical Devices of Serbia, according to the Law on Medicines and Medical Devices (OG 30\/10) undertake the survelillance of veterinary medicinal products, processing and the assessment of the adverse reactions in animals and humans.<\/p>\n<p>Activities performed by the Agency in this regard include:<\/p>\n<p>-collection, processing and evaluation of data on adverse drug reactions related to the use of drugs for which MA has been granted, or during clinical trials;<br \/>\n-processing and evaluating periodic reports on drug safety (PSURs), which the Agency receives from the marketing authorization holders<br \/>\n-notification the holder of the marketing authorization of serious adverse reactions to the drug immediately and not later than 15 days from the date of receipt of such information<br \/>\n-inform the competent institution of the EU on the record of serious adverse reactions on the territory of the Republic of Serbia.<br \/>\n-notification the Ministry in charge of veterinary matters as well as veterinarians of serious adverse reactions to the drug and the significant changes in the safety of the medicine immediately, and no later than 15 days from the date of receipt of such information<br \/>\n-encouraging veterinarians to report adverse drug reactions, or suspected adverse reactions<br \/>\n-making a database of information collected in pharmacovigilance system available to the public and the authorities at home and abroad in accordance with the internationally accepted standard terminology (VEDDRA)<br \/>\n-exchange of information collected in pharmacovigilance system with the authorities for pharmacovigilance in other countries.<\/p>\n<p>Mandatory reporting means the reporting of serious adverse reactions to the drug, manifested during clinical trials or in the period after obtaining the marketing authorisation. Mandatory reporting, for the purposes hereof, is done by the producer, the sponsor of the clinical trial, the investigator or the contracting organization that performs certain tasks in the implementation of clinical trials, as well as the MA holder;<br \/>\nSpontaneous reporting of adverse reactions to the drug involves voluntary reporting of adverse effects on the market, which appeared during the treatment of patients. Reporting is performed by veterinary institutions, veterinarians or animal owners (reporters).<br \/>\nAll suspected adverse drug reactions are reported on Form for reporting adverse reactions to veterinary medicine.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":172,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-260","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/260","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=260"}],"version-history":[{"count":2,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/260\/revisions"}],"predecessor-version":[{"id":262,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/260\/revisions\/262"}],"up":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/172"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=260"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}