{"id":7490,"date":"2022-11-24T14:25:46","date_gmt":"2022-11-24T14:25:46","guid":{"rendered":"https:\/\/cinmed.me\/humani-lijekovi\/klinicka-ispitivanja-2\/"},"modified":"2026-07-07T08:53:55","modified_gmt":"2026-07-07T06:53:55","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/humane-medicines\/clinical-trials\/","title":{"rendered":"Clinical trials"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7490\" class=\"elementor elementor-7490 elementor-1622\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b1cc3b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1cc3b4\" 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-b11a068\" data-id=\"b11a068\" 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-ce4b035 elementor-widget elementor-widget-image\" data-id=\"ce4b035\" 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=\"840\" height=\"318\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x318-1.jpg\" class=\"attachment-large size-large wp-image-4551\" alt=\"\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x318-1.jpg 840w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x318-1-300x114.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x318-1-768x291.jpg 768w\" sizes=\"(max-width: 840px) 100vw, 840px\" \/>\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-8ab3f95 elementor-widget elementor-widget-text-editor\" data-id=\"8ab3f95\" 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>\u00a0<\/p><p>In accordance with the Law on Medicinal Products, the Institute for Medicines and Medical Devices of Montenegro is responsible for issuing clinical trials authorizations, approving substantial modifications, registering non-interventional studies, trial inspecions, and monitoring the safety of investigational medicinal products.<\/p><p>Clinical trials in Montenegro are conducted in accordance with the Law on Medicinal Products, the Rulebook on Detailed Requirements and Documentation Necessary for the Approval and Conduct of Clinical Trials of Medicinal Products for Human Use, the Guideline for Good Clinical Practice (harmonized with ICH E6(R3)), and the <a href=\"https:\/\/www.ema.europa.eu\/en\/ich-e11r1-guideline-clinical-investigation-medicinal-products-pediatric-population-scientific-guideline\">Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population (ICH E11(R1))<\/a>, while respecting the principles of medical ethics set out in the <a href=\"https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects\/\">Declaration of Helsinki<\/a>.<\/p><p>Medicinal products used in clinical trials must be manufactured in compliance with Good Manufacturing Practice (GMP) and must be labelled in accordance with the Rulebook. Where a medicinal product has a marketing authorization, it must also be labelled in accordance with the applicable regulations governing the labelling of medicinal products.<\/p><p>Within the Institute\u2019s development policy, particular emphasis is placed on establishing the necessary infrastructure for conducting clinical trials in Montenegro, thereby increasing patients\u2019 access to modern diagnostic methods and therapies. At the same time, the Institute devotes special attention to educating healthcare professionals and the general public in this field in order to reduce risks associated with the conduct of clinical trials in Montenegro.<\/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-4fb82c9 elementor-widget__width-initial elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"4fb82c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-4fb82c9\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"4fb82c9\" data-accordion-type=\"toggle\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"general-information\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-8351\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><span class=\"eael-accordion-tab-title\">General Information<\/span><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><\/div><div id=\"elementor-tab-content-8351\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"general-information\"><p>A <strong>clinical study<\/strong> is any investigation involving human subjects conducted for the purpose of determining the safety and\/or efficacy of medicinal products and intended to:<\/p><ul><li>discover or verify the clinical, pharmacological, or other pharmacodynamic effects of one or more medicinal products;<\/li><li>identify any adverse reactions to one or more medicinal products; or<\/li><li>study the absorption, distribution, metabolism, and excretion of one or more medicinal products.<\/li><\/ul><p>A <strong>clinical trial<\/strong> is a clinical study that meets any of the following conditions:<\/p><ul><li>the assignment of subjects to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice in Montenegro or the concerned Member State of the European Union;<\/li><li>the decision to prescribe the investigational medicinal product is taken together with the decision to include the subject in the clinical study; or<\/li><li>diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.<\/li><\/ul><p>A <strong>low-intervention clinical trial<\/strong> is a clinical trial that fulfils all of the following conditions:<\/p><ul><li>the investigational medicinal products, excluding placebos, are authorized medicinal products;<\/li><li>according to the clinical trial protocol:<\/li><\/ul><ol><li>a) the investigational medicinal products are used in accordance with the terms of their marketing authorization; or<\/li><li>b) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those medicinal products in any of the competent Member States of the European Union; and<\/li><\/ol><ul><li>the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared with normal clinical practice in any of the competent Member States of the European Union.<\/li><\/ul><p>A <strong>non-interventional study<\/strong> is a clinical study that does not constitute a clinical trial.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"submission-of-applications-and-reports\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-8352\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><span class=\"eael-accordion-tab-title\">Submission of Applications and Reports<\/span><i aria-hidden=\"true\" class=\"fa-toggle fas fa-angle-right\"><\/i><\/div><div id=\"elementor-tab-content-8352\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"submission-of-applications-and-reports\"><ul><li><p>In accordance with the Law on Medicinal Products, the following applications shall be submitted to the Institute:<\/p><ul><li>Application for Clinical Trial Authorisation<\/li><li>Application for Approval of Substantial Modifications<\/li><li>Application for Registration of a Non-Interventional Study.<\/li><\/ul><p>The documentation to be submitted with the above applications is specified in the annexes to the Rulebook.<\/p><p>The relevant application forms can be downloaded here:<\/p><ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/06\/Zahtjev-za-izdavanje-dozvole-za-KI-Za851.71-03.docx\">Application Form for Clinical Trial Authorization<\/a> (<em>updated <\/em><em>6.2026.<\/em>)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/06\/Zahtjev-za-odobrenje-izmjena-i-dopuna-klinickog-ispitivanja-Za851.73-03.docx\">Application Form for Approval of Substantial Modifications<\/a> (<em>updated <\/em><em>6.2026.<\/em>)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/06\/Zahtjev-za-evidentiranje-neintervencijske-studije-Za851.72-04.docx\">Application Form for Registration of a Non-Interventional Study<\/a> (<em>updated <\/em><em>6.2026.<\/em>)<\/li><\/ul><p>Reporting on the safety of investigational medicinal products is regulated by the Rulebook.<\/p><p>The content of the Clinical Trial End-of-Study Report must comply with the <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e-3-structure-and-content-clinical-study-reports-step-5_en.pdf\">ICH Guideline Structure and Content of Clinical Study Reports (E3)<\/a>.<\/p><p>The Register of Authorized Clinical Trials is available <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/07\/Registar-odobrenih-klinickih-ispitivanja-06072026.pdf\">here<\/a>. (<em>updated <\/em><em>6.7.2026.<\/em>)<\/p><p>The Register of Registered Non-Interventional Studies is available <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/07\/Registar-evidentiranih-neintervencijskih-studija-06072026.pdf\">here<\/a>. (<em>updated <\/em><em>6.7.2026.<\/em>)<\/p><\/li><\/ul><\/div>\n\t\t\t\t\t<\/div><\/div>\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-c99dd92\" data-id=\"c99dd92\" 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-351ab63 elementor-widget elementor-widget-shortcode\" data-id=\"351ab63\" 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\/1.png\" \/>\r\n            <p><a class=\"sidebar-menu-header-title\" href=\"\">Human 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class=\"mailpoet_bounce1\"><\/span><span class=\"mailpoet_bounce2\"><\/span><span class=\"mailpoet_bounce3\"><\/span><\/span><\/div>\n\n      <div class=\"mailpoet_message\">\n        <p class=\"mailpoet_validate_success\"\n                style=\"display:none;\"\n                >Thank you for subscribing!\n        <\/p>\n        <p 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>\u00a0 In accordance with the Law on Medicinal Products, the Institute for Medicines and Medical Devices of Montenegro is responsible for issuing clinical trials authorizations, approving substantial modifications, registering non-interventional studies, trial inspecions, and monitoring the safety of investigational medicinal products. Clinical trials in Montenegro are conducted in accordance with the Law on Medicinal Products, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7488,"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-7490","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical trials - Cinmed<\/title>\n<meta name=\"description\" content=\"Clinical trials\" \/>\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\/humani-lijekovi\/klinicka-ispitivanja-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical trials - 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