{"id":14224,"date":"2023-07-07T13:13:25","date_gmt":"2023-07-07T13:13:25","guid":{"rendered":"https:\/\/cinmed.me\/humane-medicines\/defekti-kvaliteta-ljekova\/"},"modified":"2026-07-10T13:27:21","modified_gmt":"2026-07-10T11:27:21","slug":"medicines-quality-defects","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/humane-medicines\/medicines-quality-defects\/","title":{"rendered":"Medicines quality defects"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"14224\" class=\"elementor elementor-14224 elementor-12667\" 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=\"810\" height=\"528\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Ljekovi-810x528-1.jpg\" class=\"attachment-large size-large wp-image-4521\" alt=\"Potrosnja ljekova\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Ljekovi-810x528-1.jpg 810w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Ljekovi-810x528-1-300x196.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Ljekovi-810x528-1-768x501.jpg 768w\" sizes=\"(max-width: 810px) 100vw, 810px\" \/>\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-c369fd8 elementor-widget elementor-widget-text-editor\" data-id=\"c369fd8\" 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><strong>Reporting a suspected quality defect of a medicinal product<\/strong><\/p><p><strong>\u00a0<\/strong><\/p><p>CInMED must be notified without delay of any suspected deviation from the quality standards of a medicinal product (quality defect), as well as of any suspicion of the presence of falsified medicines on the Montenegrin market, in the manner described below.<\/p><p>\u00a0<\/p><p><strong>Who should report a suspected quality defect?<\/strong><\/p><p>Reports on suspected quality defects may be submitted to CInMED by:<\/p><ul><li>Marketing authorization holders;<\/li><li>Manufacturers of medicinal products;<\/li><li>Wholesalers;<\/li><li>Healthcare professionals;<\/li><li>Veterinary professionals;<\/li><li>Sponsors of clinical trials;<\/li><li>The Ministry of Health, the competent Veterinary Authority, the Customs Administration, the Ministry of Interior, or other state institutions;<\/li><li>Whistleblowers \u2013 usually employees involved in the manufacture of medicinal products or in the manufacturer\u2019s quality control laboratories;<\/li><li>Employees of CInMED;<\/li><li>Patient or user of medicinal product.<\/li><\/ul><p>If a patient or user of medicines product suspects or notices deficiencies in the quality or packaging of a medicine, they should report the suspected defect to the pharmacist who dispensed the medicine or to the physician who prescribed it, or to the Institute through any of the reporting methods described below.<\/p><p><strong>\u00a0<\/strong><\/p><p><strong>How to submit a report of a suspected quality defect?<\/strong><\/p><p><strong>\u00a0<\/strong><\/p><ul><li><strong>In person or by post<\/strong> to the following address:<br \/>Institute for Medicines and Medical Devices<br \/>Bulevar Ivana Crnojevi\u0107a 64a<br \/>81000 Podgorica<br \/>Montenegro<\/li><li><strong>By e-mail<\/strong> to: <a href=\"mailto:defekti.kvaliteta@cinmed.me\">defekti.kvaliteta@cinmed.me<\/a><br \/>If you do not receive confirmation of receipt within 24 hours after submitting a report by e-mail, please contact CInMED by telephone at the numbers listed below.<\/li><li><strong>By telephone<\/strong>:<br \/>+382 20 310 280 (working days, 07:00\u201315:00)<br \/>+382 69 512 779 (emergency mobile phone for urgent reports outside working hours, weekends, and public holidays).<\/li><\/ul><p><strong>\u00a0<\/strong><\/p><p><strong>What should be submitted?<\/strong><\/p><p>When submitting a report of a suspected quality defect, the completed <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/07\/Za851.85-03-IMS-Prijava-sumnje-u-kvalitet-odnosno-odstupanja-od-standarda-kvaliteta-lijeka.docx\"><em>Reporting Form for Suspected Quality Defects or Deviations from Quality Standards<\/em><\/a> must be provided, together with supporting documentation, where applicable.<\/p><p>\u00a0<\/p><p><strong>More information<\/strong><\/p><p>Detailed information on the procedure for reporting suspected quality defects, as well as on the measures and activities undertaken depending on the defect classification, can be found in the <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/07\/Pg851.62-03-IMS-Instruction-for-Reporting-a-Suspected-Quality-Defect-of-a-Medicinal-Product.docx\"><em>Instruction for Reporting a Suspected Quality Defect of a Medicinal<\/em><\/a><em> Product.<\/em><\/p>\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-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-70df5f8 elementor-widget elementor-widget-shortcode\" data-id=\"70df5f8\" 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 medicines<\/a><\/p>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-humani-ljekovi-container\"><ul id=\"menu-humani-ljekovi\" class=\"list-none\t\"><li id=\"menu-item-7168\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7168 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\/humani-lijekovi\/izdavanje-dozvole-za-lijek\/\">Placing a medicine on the market<\/a><\/li>\n<li id=\"menu-item-7195\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7195 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\/humani-lijekovi\/uvoz-i-izvoz-ljekova\/\">Import and export of medicines<\/a><\/li>\n<li id=\"menu-item-7228\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7228 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\/humani-lijekovi\/kontrolisane-supstance\/\">Controlled substances<\/a><\/li>\n<li id=\"menu-item-7173\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7173 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\/humani-lijekovi\/klinicka-ispitivanja-2\/\">Clinical trials<\/a><\/li>\n<li id=\"menu-item-7172\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7172 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\/humani-lijekovi\/potrosnja-ljekova\/\">Consumption of medicines<\/a><\/li>\n<li id=\"menu-item-7174\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7174 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\/humani-lijekovi\/maksimalne-cijene-ljekova\/\">Maximum prices of medicines<\/a><\/li>\n<li id=\"menu-item-12824\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-12824 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\/humani-lijekovi\/defekti-kvaliteta-ljekova\/\">Medicines quality defects<\/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-d1b992c elementor-widget elementor-widget-shortcode\" data-id=\"d1b992c\" 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      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product (quality defect), as well as of any suspicion of the presence of falsified medicines on the Montenegrin market, in the manner described below. \u00a0 Who should report [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4519,"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-14224","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medicines quality defects - Cinmed<\/title>\n<meta name=\"description\" content=\"Defekti kvaliteta ljekova\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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