{"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":"2025-09-10T10:36:32","modified_gmt":"2025-09-10T08:36:32","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>\u00a0<\/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><\/ul><p>If a patient 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.<\/p><p><strong>\u00a0<\/strong><\/p><p><strong>How to submit a report of a suspected quality defect?<\/strong><\/p><p>\u00a0<\/p><ol><li>\u00a0 <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>\u00a0 <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 12 hours after submitting a report by e-mail, please contact CInMED by telephone at the numbers listed below.<\/li><li>\u00a0 <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><\/ol><p>\u00a0<\/p><p><strong>What should be submitted?<\/strong><\/p><p><strong>\u00a0<\/strong><\/p><p>When submitting a report of a suspected quality defect, the completed <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/09\/Za851.85-02-IMS-Prijava-sumnje-u-kvalitet-odnosno-odstupanja-od-standarda-kvaliteta-lijeka.docx\" target=\"_blank\" rel=\"noopener\"><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><strong>\u00a0<\/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\/2025\/09\/Pg851.62-02-IMS-Guideline-for-reporting-suspected-QD.pdf\" target=\"_blank\" rel=\"noopener\"><em>Guideline for Reporting a Suspected Quality Defect of a Medicinal Product<\/em>.<\/a><\/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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<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>Reporting a suspected quality defect of a medicinal product \u00a0 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. \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 v27.0 - 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\" href=\"https:\/\/cinmed.me\/humani-lijekovi\/defekti-kvaliteta-ljekova\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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