{"id":7487,"date":"2022-11-04T13:08:41","date_gmt":"2022-11-04T13:08:41","guid":{"rendered":"https:\/\/cinmed.me\/farmakovigilanca\/uputstva-za-nosioca-dozvole-za-lijek\/"},"modified":"2026-03-02T10:14:22","modified_gmt":"2026-03-02T09:14:22","slug":"instructions-for-marketing-authorisation-holders","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/pharmacovigilance\/instructions-for-marketing-authorisation-holders\/","title":{"rendered":"Instructions for marketing authorisation holders"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7487\" class=\"elementor elementor-7487 elementor-665\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-668816e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"668816e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b031b8f\" data-id=\"b031b8f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e3486b7 elementor-widget elementor-widget-image\" data-id=\"e3486b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"915\" height=\"477\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika.png\" class=\"attachment-large size-large wp-image-8805\" alt=\"uputstva za nosioca dozvole - Rules\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika.png 915w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika-300x156.png 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika-768x400.png 768w\" sizes=\"(max-width: 915px) 100vw, 915px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb5dca3 elementor-widget elementor-widget-text-editor\" data-id=\"cb5dca3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Responsibilities of marketing authorization holders in the area of pharmacovigilance are defined by the <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/Law-on-medicinal-products_-eng.pdf\"><u>Law on Medicinal Products<\/u><\/a>\u00a0and <a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Rulebook_on_pharmacovigilance_oct-2014.pdf\" target=\"_blank\" rel=\"noopener\"><u>Rulebook on the manner of collecting of data and reporting and monitoring adverse reactions to medicines for use in human medicine<\/u><\/a>. In line with the Law on medicines, <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/good-pharmacovigilance-practices\">Guidelines on Good Pharmacovigilance Practice<\/a> are applied in this area and they are available on the website of the European Medicines Agency (EMA).<\/p><p>Additionally, responsibilities of marketing authorization holders are more closely defined by the following instructions:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-966e376 elementor-widget elementor-widget-text-editor\" data-id=\"966e376\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/Instruction-on-the-manner-of-submitting-the-summary-of-PSMF.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting the summary of PSMF\u00a0<\/a><i>(updated 4.2.2022.)<\/i><\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/Instruction-on-the-manner-of-submitting-ADR-report.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting ADR report <\/a> (<i>updated <\/i> 13.12.2021.)<\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/Instruction-on-the-manner-of-sending-letters-to-health-professionals.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of sending letters to health professionals <\/a> (<i>updated<\/i> 13.12.2021.)<\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/Instruction-on-the-manner-of-submitting-periodic-safety-update-report.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting periodic safety update report <\/a>\u00a0 (<i>updated<\/i> 13.12.2021.)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/06\/Instruction-on-the-manner-of-submitting-RMP-june-2025.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting risk management plan (RMP)\u00a0<\/a> (<i>updated<\/i> 16.6.2025.)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-09c494f\" data-id=\"09c494f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a168863 elementor-widget elementor-widget-shortcode\" data-id=\"a168863\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t    <div class=\"sidebar-menu-wrapper\">\r\n        <div class=\"sidebar-menu-header\">\r\n            <img decoding=\"async\" class=\"sidebar-menu-header-icon\" src=\"\/wp-content\/uploads\/2022\/11\/4.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Pharmacovigilance<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-farmakovigilanca-container\"><ul id=\"menu-farmakovigilanca\" class=\"list-none\t\"><li id=\"menu-item-7342\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7342 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/osnovni-pojmovi\/\">General information<\/a><\/li>\n<li id=\"menu-item-7343\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7343 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/prijava-nezeljenog-dejstva-lijeka\/\">Adverse reactions to medicines reporting<\/a><\/li>\n<li id=\"menu-item-7344\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7344 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/uputstva-za-nosioca-dozvole-za-lijek\/\">Instructions for marketing authorisation holders<\/a><\/li>\n<li id=\"menu-item-7345\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7345 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/pisma-zdravstvenim-radnicima\/\">Direct Healthcare Professional Communication<\/a><\/li>\n<li id=\"menu-item-7346\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7346 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/mjere-minimizacije-rizika\/\">Risk minimisation measures<\/a><\/li>\n<li id=\"menu-item-7348\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7348 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/lista-ozbiljnih-nezeljenih-dejstava\/\">List of serious adverse reactions<\/a><\/li>\n<li id=\"menu-item-7349\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7349 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/lista-ljekova-pod-dodatnim-pracenjem\/\">List of medicines under additional monitoring<\/a><\/li>\n<li id=\"menu-item-7350\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7350 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/godisnji-izvjestaji\/\">Annual reports<\/a><\/li>\n<\/ul><\/div>            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n\t\t<div class=\"elementor-shortcode\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5bf21fb elementor-widget elementor-widget-shortcode\" data-id=\"5bf21fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"relative pt-10 rounded bg-primary pb-72\">\n\t<h1 class=\"ml-10 text-4xl text-white \">Search <span class=\"font-bold\">register<\/span><\/h1>\n\t<div class=\"mt-8 \">\n\t\t<h3 class=\"mb-4 ml-10 text-secondary text-medium \">Here you can search for medicines in our register<\/h3>\n\t\t<div class=\"relative inline-block w-4\/5 ml-10 text-left\" style=\"width:80%\">\n\t\t\t<div>\n\t\t\t\t<select onchange=\"javascript:handleSelect(this)\" class=\"block h-[52px] text-[18px] text-light appearance-none w-full bg-white py-3 px-4 pr-8 rounded leading-tight focus:outline-none focus:bg-white focus:border-none\">\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\">Choose register<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-medicines-for-human-use\/\">Register of medicines for human use<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-veterinary-medicines\/\">Register of veterinary medicines<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/medical-devices\/register-of-medical-devices\/\">Register of medical devices<\/option>\n\t\t\t\t<\/select>\n\n\t\t\t\t<script type=\"text\/javascript\">\n\t\t\t\t\tfunction handleSelect(elm) {\n\t\t\t\t\t\twindow.location = elm.value;\n\t\t\t\t\t}\n\t\t\t\t<\/script>\n\t\t\t\t<img decoding=\"async\" style=\"top:22px;\" class=\"absolute right-[15px] top-[22px] \" src=\"\/wp-content\/uploads\/2022\/11\/strelca-copy-8.png\" \/>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-[30px] w-[380px]\" src=\"\/wp-content\/uploads\/2022\/11\/nele.png\" \/>\n<\/div>\n\n\n<div class=\"relative px-10 pt-10 mt-10 rounded pb-72 bg-light-yellow\">\n\t<div class=\"mt-8 md:mt-0\">\n\t\t<h1 class=\"text-3xl text-primary \">Sign up for<\/h1>\n\t\t<h1 class=\"mb-5 text-3xl font-bold text-primary\">Newsletter<\/h1>\n\t\t  \n  \n  <div class=\"\n    mailpoet_form_popup_overlay\n      \"><\/div>\n  <div\n    id=\"mailpoet_form_1\"\n    class=\"\n      mailpoet_form\n      mailpoet_form_shortcode\n      mailpoet_form_position_\n      mailpoet_form_animation_\n    \"\n      >\n\n    <style type=\"text\/css\">\n     #mailpoet_form_1 .mailpoet_form {  }\n#mailpoet_form_1 .mailpoet_column_with_background { padding: 10px; }\n#mailpoet_form_1 .mailpoet_form_column:not(:first-child) { 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class=\"mailpoet_validate_error\"\n                style=\"display:none;\"\n                >        <\/p>\n      <\/div>\n    <\/form>\n\n      <\/div>\n\n  \t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-0 left-0 w-[380px] \" src=\"\/wp-content\/uploads\/2022\/11\/newsletter.png\" \/>\n<\/div>\t\t<div class=\"elementor-shortcode\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Responsibilities of marketing authorization holders in the area of pharmacovigilance are defined by the Law on Medicinal Products\u00a0and Rulebook on the manner of collecting of data and reporting and monitoring adverse reactions to medicines for use in human medicine. In line with the Law on medicines, Guidelines on Good Pharmacovigilance Practice are applied in this [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7479,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"cinmed-template-custom.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-7487","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Instructions for marketing authorisation holders - Cinmed<\/title>\n<meta name=\"description\" content=\"Instructions for marketing authorisation holdersGuidelines on Good Pharmacovigilance Practice EMA\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cinmed.me\/farmakovigilanca\/uputstva-za-nosioca-dozvole-za-lijek\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Instructions for marketing authorisation holders - 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