{"id":7502,"date":"2022-11-18T13:51:55","date_gmt":"2022-11-18T13:51:55","guid":{"rendered":"https:\/\/cinmed.me\/inspektorat\/promet-na-veliko-dobra-distributivna-praksa\/"},"modified":"2026-04-08T10:49:53","modified_gmt":"2026-04-08T08:49:53","slug":"wholesale-good-distribution-practice","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/inspectorate\/wholesale-good-distribution-practice\/","title":{"rendered":"Wholesale\/Good Distribution Practice"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7502\" class=\"elementor elementor-7502 elementor-1092\" 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=\"504\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-840x504-1.jpg\" class=\"attachment-large size-large wp-image-4541\" alt=\"promet na veliko ljekova\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-840x504-1.jpg 840w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-840x504-1-300x180.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Medicines-840x504-1-768x461.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-81f4de1 elementor-widget elementor-widget-text-editor\" data-id=\"81f4de1\" 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 the <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/Law-on-medicinal-products_-eng.pdf\">Law on Medicinal Products<\/a>, wholesalers are legal persons seated in Montenegro that have a wholesale authorisation for medicines.<\/p><p>\u00a0<\/p><p>Wholesale shall include all activities consisting of procuring, holding, supplying or exporting medicines apart from supplying medicines to the public.<\/p><p>\u00a0<\/p><p>Wholesale distribution is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid, and it may be performed by:<\/p><ul><li>legal or natural persons established in Montenegro who hold a wholesale distribution authorisation (wholesalers);<\/li><li>manufacturers established and authorised in Montenegro, for medicinal products covered by the manufacturing\u00a0<\/li><\/ul><p>\u00a0<\/p><p>Wholesale is carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public.<\/p><p>\u00a0<\/p><p>Only medicinal products that have been granted a marketing authorisation or registered in accordance with this Law, as well as medicinal products referred to in Article 30 of this Law, may be included in wholesale distribution in Montenegro.<\/p><p>\u00a0<\/p><p>The wholesale distribution of donated or humanitarian aid medicinal products is also considered wholesale distribution.<\/p><p>\u00a0<\/p><p>Retail distribution includes dispensing and sale of medicinal products directly to public.<\/p><p>Retail distribution shall be conducted in accordance with special legislation.<\/p><p>\u00a0<\/p><p>Wholesale authorisation for medicines for human use is issued by the Institute, while wholesale authorisation for veterinary medicines is issued by the Directorate for Foodsafety, Veterinary and Phytosanitary Affairs.<\/p><p>\u00a0<\/p><p>Wholesale authorisation is issued for an indefinite period, except for medicines containing drugs.<\/p><p>Wholesale authorisation for medicines containing drugs is in accordance with the Law about preventing drugs abuse issued for 5 years.\u00a0<\/p><p>Legal or physical person performing wholesale of medicines shall act in accordance with <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:52013XC1123(01)&amp;from=EN\" target=\"_blank\" rel=\"noopener\">Guidelines of Good Distribution Practice for medicines for human use<\/a> (published 12.10.2020.).<\/p><p>\u00a0<\/p><p>Institute shall issue a certificate on the application of Guidelines of Good Distribution Practice (GDP certificate) based on verification of the fulfillment of conditions in accordance with this Law and secondary legislation before commencing wholesale for a period of up to 5 years from the control of fulfillment of conditions and at the request of the wholesaler.<\/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-6d50258 elementor-widget elementor-widget-text-editor\" data-id=\"6d50258\" 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>Register of wholesalers is available <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/04\/Za851.126-01-IMS-Register-of-wholesalers_08_04_2026-1.xlsx\" target=\"_blank\" rel=\"noopener\">here<\/a>. The register is updated in accordance with amendments of its content (<em>last update 8.4<\/em>.2026).<\/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-2592d47 elementor-widget elementor-widget-heading\" data-id=\"2592d47\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Instructions and forms <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21b6ea2 elementor-widget elementor-widget-text-editor\" data-id=\"21b6ea2\" 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><ul><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/06\/Instruction-for-applicants-for-obtaining_amending_cessation-of-validity-of-wholesale-authorisation.pdf\" target=\"_blank\" rel=\"noopener\">Instruction for applicants for obtaining\/amending\/cessation of validity of wholesale authorisation for medicines<\/a> <em>(updated 1.6.2023.)<\/em><\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/06\/Instruction-for-applicants-for-obtaining_amending_extension_cessation-of-validity-of-wholesale-authorisation-for-medicines-containing-narcotic-drugs.pdf\" target=\"_blank\" rel=\"noopener\">Instruction for applicants for obtaining\/amending\/extension\/cessation of validity of wholesale authorisation for narcotic drugs<\/a> <em>(updated\u00a0 1.6.2023.)<\/em><\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/05\/Zahtjev-za-dobijanje_izmjenu_dopunu_prestanak_vazenja_dozvole-za-promet-ljekova-za-humanu-upotrebu-na-veliko.pdf\" target=\"_blank\" rel=\"noopener\">Application form for obtaining\/amending\/cessation of validity of wholesale authorisation for medicines <\/a><em>(updated 29.5.2023.)<\/em><\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/05\/Zahtjev-za-dobijanje_izmjenu_dopunu_produzenje_prestanak_vazenja_dozvole-za-promet-na-veliko-ljekova-koji-sadrze-droge.pdf\" target=\"_blank\" rel=\"noopener\">Application form for obtaining\/amending\/extension\/cessation of validity of wholesale authorisation for narcotic drugs<\/a>\u00a0<em>(updated 29.5.2023.)<\/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-38b1b40 elementor-widget elementor-widget-shortcode\" data-id=\"38b1b40\" 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\/5.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Inspectorate<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-inspektorat-container\"><ul id=\"menu-inspektorat\" class=\"list-none\t\"><li id=\"menu-item-14222\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-14222 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\/inspektorat\/opste-informacije\/\">General information<\/a><\/li>\n<li id=\"menu-item-7408\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7408 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\/inspektorat\/proizvodnja-dobra-proizvodacka-praksa\/\">Manufacturing\/GoodManufacturing Practice<\/a><\/li>\n<li id=\"menu-item-7409\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7409 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\/inspektorat\/promet-na-veliko-dobra-distributivna-praksa\/\">Wholesale\/Good Distribution Practice<\/a><\/li>\n<li id=\"menu-item-7410\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7410 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\/inspektorat\/dobra-praksa-u-farmakovigilanci\/\">Good Pharmacovigilance Practice<\/a><\/li>\n<li id=\"menu-item-7411\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7411 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\/inspektorat\/dobra-klinicka-praksa\/\">Good Clinical Practice<\/a><\/li>\n<li id=\"menu-item-19604\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-19604 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\/inspektorat\/proizvodnja-uvoz-i-distribucija-aktivnih-supstanci\/\">Manufacture\/import and distribution of active substances<\/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 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{margin: 0; padding: 0 20px;}#mailpoet_form_1 .mailpoet_paragraph.last {margin-bottom: 0} @media (max-width: 500px) {#mailpoet_form_1 {background-image: none;}} @media (min-width: 500px) {#mailpoet_form_1 .last .mailpoet_paragraph:last-child {margin-bottom: 0}}  @media (max-width: 500px) {#mailpoet_form_1 .mailpoet_form_column:last-child .mailpoet_paragraph:last-child {margin-bottom: 0}} \n    <\/style>\n\n    <form\n      target=\"_self\"\n      method=\"post\"\n      action=\"https:\/\/cinmed.me\/wp-admin\/admin-post.php?action=mailpoet_subscription_form\"\n      class=\"mailpoet_form mailpoet_form_form mailpoet_form_shortcode\"\n      novalidate\n      data-delay=\"\"\n      data-exit-intent-enabled=\"\"\n      data-font-family=\"\"\n      data-cookie-expiration-time=\"\"\n    >\n      <input type=\"hidden\" name=\"data[form_id]\" value=\"1\" \/>\n      <input type=\"hidden\" name=\"token\" value=\"4c898e438e\" \/>\n      <input type=\"hidden\" name=\"api_version\" value=\"v1\" 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class=\"mailpoet_submit\" value=\"Subscribe!\" data-automation-id=\"subscribe-submit-button\" style=\"width:100%;box-sizing:border-box;padding:5px;margin: 0 auto 0 0;border-color:transparent;\" \/><span class=\"mailpoet_form_loading\"><span 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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ecbcaa2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ecbcaa2\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3f27751\" data-id=\"3f27751\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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>In accordance with the Law on Medicinal Products, wholesalers are legal persons seated in Montenegro that have a wholesale authorisation for medicines. \u00a0 Wholesale shall include all activities consisting of procuring, holding, supplying or exporting medicines apart from supplying medicines to the public. \u00a0 Wholesale distribution is subject to the possession of an authorisation to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7497,"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-7502","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>Wholesale\/Good Distribution Practice - Cinmed<\/title>\n<meta name=\"description\" content=\"Wholesale\/Good Distribution Practice Guidelines of Good Distribution Practice for medicines for human use\" \/>\n<meta name=\"robots\" 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