{"id":7496,"date":"2022-11-18T12:09:12","date_gmt":"2022-11-18T12:09:12","guid":{"rendered":"https:\/\/cinmed.me\/humani-lijekovi\/uvoz-i-izvoz-ljekova\/"},"modified":"2026-02-27T09:05:19","modified_gmt":"2026-02-27T08:05:19","slug":"import-and-export-of-medicines","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/humane-medicines\/import-and-export-of-medicines\/","title":{"rendered":"Import and export of medicines"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7496\" class=\"elementor elementor-7496 elementor-1056\" 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=\"539\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-810x539-1.jpg\" class=\"attachment-large size-large wp-image-4535\" alt=\"\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-810x539-1.jpg 810w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-810x539-1-300x200.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-810x539-1-768x511.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-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>In accordance with <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/Law-on-medicinal-products_-eng.pdf\">Law on Medicinal Products<\/a>\u00a0the Institute for medicines and medical devices shall:<\/p><ul><li>issue a consent for import of unauthorised medicinal products in the following cases:<p>1) the medicinal product \u00a0is intended for a specific patient or group of patients,<\/p><p>2)\u00a0 medically justified needs for the protection of public health, based on the request of a health institution<\/p><p>3)\u00a0 in the event of an epidemic, epizootic, natural disaster or other emergency situations in accordance with this law<\/p><p>4) the import of a donation or humanitarian aid medicinal product, including. a donation program in the EU,<\/p><p>5) a medicinal product for scientific research,<\/p><p>6) for compassionate use.\u00a0<\/p><\/li><li>issue approval for import and export of immunological medicinal products and medicinal products from the blood and plasma.<\/li><\/ul><p>In accordance with Article 114 of the<a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/Law-on-medicinal-products_-eng.pdf\"> Law on Medicinal Products<\/a>, the import and export of medicine falls within the wholesale of medicines. Wholesale of medicines may be performed by:<\/p><p>1) wholesalers which have the wholesale authorisation issued by the Institute for medicinal products for human use or the competent authority for veterinary affairs for medicinal products for veterinary use; and<\/p><p>2) manufacturers established and authorised in Montenegro, for medicinal products covered by the manufacturing authorisation.\u00a0<\/p><p>Documentation required for issuance of the consent for import of unauthorised medicinal products, as well as issuance of the approval for import and export of immunological medicinal products and medicinal products from the blood and plasma shall be submitted to the Institute in accordance with <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2024\/04\/Rulebook-on-more-detailed-conditions-for-the-issuance-of-import-authorisation-for-a-medicine-that-does-not-have-marketing-authorisation.pdf\" target=\"_blank\" rel=\"noopener\">Rulebook on more detailed conditions for the issuance of import authorization for a medicine that does not have marketing authorisation <\/a> <i>(\u201cOfficial Gazette of Montenegro\u201d No 19\/24 and 34\/24) <\/i>and the instruction Required documentation for issuance of import authorisation for medicines that do not have marketing authorisation and import-export of blood products and immunological products.<\/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-ae34a96 elementor-widget elementor-widget-text-editor\" data-id=\"ae34a96\" 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>Instructions and Forms<br \/><\/strong><\/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-639a17f elementor-widget elementor-widget-text-editor\" data-id=\"639a17f\" 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=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/10\/Required-documentation-for-issuance-of-import-authorisation-for-medicine_15_10.pdf\" target=\"_blank\" rel=\"noopener\">Required documentation for issuance of import authorisation for medicines that do not have marketing authorisation and import-export of blood products and immunological products<\/a> <em>(updated 15.10.2025.)<\/em><\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/02\/Instruction-for-using-excel-table-for-import-of-medicines-that-do-not-ha.pdf\" target=\"_blank\" rel=\"noopener\">Instruction for using excel table for import of medicines that do not have marketing authorisation<\/a> <em>(updated 6.6.2023.)<\/em><\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/06\/Za851.57-01-IMS-Obrazac-zahtjeva-za-izdavanje-saglasnosti-za-uvoz-ljekov.docx\" target=\"_blank\" rel=\"noopener\">Application form for the issuance of import authorisation for medicines for human use that do not have marketing authorisation<\/a> <em>(updated 6.6.2023.) &#8211; document in Montenegrin<\/em><\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/10\/Za851.58-02-IMS-Obrazlozen-zahtjev-predlagaca-uvoza-lijeka-za-humanu_15_10.docx\" target=\"_blank\" rel=\"noopener\">Justified application of the proposer of import of a medicine for human use that does not have marketing authorisation<\/a> <em>(updated 15.10.2025.) &#8211; document in Montenegrin<\/em><\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/09\/Za851.59-01-IMS-Obrazac-zahtjeva-za-izdavanje-odobrenja-za-uvoz-imunol._.docx\" target=\"_blank\" rel=\"noopener\">Application form for the issuance of a permit for the import of an immunological medicinal product or a medicinal product derived from blood and plasma, for use in human medicine, which has a marketing authorization<\/a> <em>(updated 30.9.2025.) \u2013 document in Montenegrin<\/em><\/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-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-c5f6c44 elementor-widget elementor-widget-shortcode\" data-id=\"c5f6c44\" 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      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following cases: 1) the medicinal product \u00a0is intended for a specific patient or group of patients, 2)\u00a0 medically justified needs for the protection of public health, based on the request [&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-7496","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>Import and export of medicines - Cinmed<\/title>\n<meta name=\"description\" content=\"Import and export of medicines Instruction for using excel table for import of medicines that do not have marketing authorisation Required documentation for issuance of import authorisation for medicines that do not have marketing 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