{"id":7501,"date":"2022-11-18T13:38:51","date_gmt":"2022-11-18T13:38:51","guid":{"rendered":"https:\/\/cinmed.me\/inspektorat\/proizvodnja-dobra-proizvodacka-praksa\/"},"modified":"2026-08-03T13:19:56","modified_gmt":"2026-08-03T11:19:56","slug":"manufacturing-goodmanufacturing-practice","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/inspectorate\/manufacturing-goodmanufacturing-practice\/","title":{"rendered":"Manufacturing\/GoodManufacturing Practice"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7501\" class=\"elementor elementor-7501 elementor-1086\" 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=\"669\" height=\"438\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Proizvodnja-inspektorat.jpg\" class=\"attachment-large size-large wp-image-6251\" alt=\"proizvodnja ljekova\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Proizvodnja-inspektorat.jpg 669w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Proizvodnja-inspektorat-300x196.jpg 300w\" sizes=\"(max-width: 669px) 100vw, 669px\" \/>\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>Manufacturing of medicines may only be performed by legal persons having a manufacturing authorization issued by the Institute 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>.<\/p><p>\u00a0<\/p><p>Manufacturing of medicines containing drugs may only be performed by legal persons having a manufacturing authorization issued by the Institute 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> and <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Law-about-preventing-drugs-abuse-2011-1.pdf\">Law on preventing drugs abuse<\/a>.<\/p><p>\u00a0<\/p><p>Manufacturer of medicines performing the manufacturing is responsible for the quality, safety and efficacy of the medicine it manufactures. Medicinal products manufacturer that manufactures medicines derived from blood, radiopharmaceuticals and biotechnological medicines shall meet special conditions regarding premises, equipment and personnel.\u00a0<\/p><p>\u00a0<\/p><p>Manufacturing authorizations for medicines, except for medicines containing drugs and psychotropic substances shall be issued for an indefinite period.<\/p><p>\u00a0<\/p><p>Manufacturing authorizations for medicines containing drugs and psychotropic substances shall be issued for a period of 5 years.<\/p><p>\u00a0<\/p><p>Manufacturing authorization shall be issued for a specific manufacturing site, pharmaceutical form and a specific finished medicine and may relate to the whole process, or parts of the process of a medicine manufacturing.<\/p><p>\u00a0<\/p><p>Legal or physical persons that manufacture medicines shall act in accordance with the manufacturing authorization issued by the Institute, Good manufacturing practice and Good distribution practice.<\/p><p>\u00a0<\/p><p>Institute shall issue a certificate on the application of <a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\">Good Manufacturing Practice guidelines<\/a> on the basis of the verification of the fulfillment of conditions, for a period of up to 3 years from the control of fulfillment of conditions and at the request of the Institute.<\/p><p>\u00a0<\/p><p>Manufacture of active substances used as starting materials shall include both total and partial manufacture, import and processes of dividing up, packaging, or presentation prior to its incorporation into a medicinal product. Manufacture of active substances shall be carried out in accordance with Good Manufacturing Practice for active substances.<\/p><p>\u00a0<\/p><p>Legal or physical persons seated in Montenegro performing the activities of manufacture, import and distribution of active substances shall enroll in the Register of manufacturers, importers, or wholesalers of active substances.<\/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-4883215 elementor-widget elementor-widget-text-editor\" data-id=\"4883215\" 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>Register of manufacturers of medicines\u00a0<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-ee4e4bc elementor-widget elementor-widget-text-editor\" data-id=\"ee4e4bc\" 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 manufacturers of medicines is available <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/08\/Za851.92-05-IMS-Registar-proizvodaca-ljekova-03.08.2026.xlsx\" target=\"_blank\" rel=\"noopener\">here<\/a>. The register is updated in accordance with amendments of its content (last update 3.8.2026).<\/p><p>\u00a0<\/p><p><em>Register of foreign manufacturers who have been issued a GMP certificate <\/em>is available <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/07\/Za851.112-02-IMS-Registar-stranih-proizvodaca-kojima-je-izdat-GMP-sertifikat-27.07.2026.xlsx\" target=\"_blank\" rel=\"noopener\">here<\/a>. The register is updated in accordance with amendments of its content (last update 27.7.2026).<\/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-cf8584b elementor-widget elementor-widget-text-editor\" data-id=\"cf8584b\" 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-56b031a elementor-widget elementor-widget-text-editor\" data-id=\"56b031a\" 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\/2026\/07\/Pg851.91-01-IMS_eng-Instruction-for-obtaining_amending_cessation-of-validity-of-the-manufacturing-authorization-for-medicines.pdf\">Instruction for applicants for obtaining,\u00a0 amending, cessation of validity of the manufacturing authorization for medicines<\/a> (update 03.07.2026)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/07\/Za851.156-01-IMS-Zahtjev-za-dobijanje_izmjenu_dopunu_prestanak-vazenja-Dozvole-za-proizvodnju-ljekova.docx\">Application form for obtaining, amending, cessation of validity of the manufacturing authorization (on Montenegrin language<\/a> (updated 3.7.2026)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/06\/Instructions-for-submission-of-an-application-for-the-issuance-of-a-GMP-certificate.pdf\">Instructions for submission of an application for the issuance of a GMP certificate<\/a> (published 12.06.2026)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/06\/Application-for-the-issuance-of-GMP-certificate.docx\">Application for the issuance of GMP certificate<\/a> (published 12.06.2026)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/06\/Pg851.39-01-IMS_eng-Instructions-for-manufacturers-regarding-situations-that-must-be-reported-without-delay-to-CInMED_z.pdf\">Instructions for manufacturers regarding situations that must be reported without delay to CInMED<\/a> (published on 17.06.2026)<\/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-6106fbc elementor-widget elementor-widget-shortcode\" data-id=\"6106fbc\" 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\n<div class=\"overflow-hidden relative p-6 text-white rounded-2xl shadow-md bg-primary\">\n\t<div class=\"mb-5\">\n\t\t<div class=\"flex gap-3 justify-between items-center mb-2\">\n\t\t\t<h2 class=\"text-2xl font-bold tracking-tight leading-tight text-white\">\n\t\t\t\tFind medicines <span class=\"font-normal text-[#fbf2db]\"> and medical devices<\/span>\t\t\t<\/h2>\n\t\t\t<div class=\"flex relative z-20 flex-shrink-0 gap-1.5 items-center\">\n\t\t\t\t<button type=\"button\" class=\"flex relative z-10 justify-center items-center w-8 h-8 text-white rounded-full transition-all duration-200 cursor-pointer sidebar-register-prev bg-white\/20 hover:bg-white hover:text-primary shadow-xs focus:outline-none\" aria-label=\"Previous register\">\n\t\t\t\t\t<svg class=\"w-4 h-4 pointer-events-none\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" viewBox=\"0 0 24 24\"><path stroke-linecap=\"round\" stroke-linejoin=\"round\" d=\"M15 19l-7-7 7-7\"\/><\/svg>\n\t\t\t\t<\/button>\n\t\t\t\t<button type=\"button\" class=\"flex relative z-10 justify-center items-center w-8 h-8 text-white rounded-full transition-all duration-200 cursor-pointer sidebar-register-next bg-white\/20 hover:bg-white hover:text-primary shadow-xs focus:outline-none\" aria-label=\"Next register\">\n\t\t\t\t\t<svg class=\"w-4 h-4 pointer-events-none\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" viewBox=\"0 0 24 24\"><path stroke-linecap=\"round\" stroke-linejoin=\"round\" d=\"M9 5l7 7-7 7\"\/><\/svg>\n\t\t\t\t<\/button>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<p class=\"text-sm leading-relaxed text-white\/90\">\n\t\t\tQuick and easy access to databases of approved medicines and medical devices.\t\t<\/p>\n\t<\/div>\n\n\t<!-- Swiper Slider -->\n\t<div class=\"overflow-hidden relative z-10 w-full swiper sidebarRegisterSwiper\">\n\t\t<div class=\"flex items-stretch swiper-wrapper\">\n\t\t\t\t\t\t\t<div class=\"flex flex-col h-auto swiper-slide\">\n\t\t\t\t\t<div class=\"flex flex-col flex-1 p-6 h-full text-left bg-white rounded-xl border shadow-sm transition-shadow duration-300 border-surface-variant hover:shadow-md\">\n\t\t\t\t\t\t<div class=\"w-14 h-14 bg-[#FDF5E6] rounded-xl flex items-center justify-center mb-4 flex-shrink-0\">\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-7 h-7\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/medical_services.png\" alt=\"Database of medicines for human use\">\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h3 class=\"mb-2 text-xl font-bold leading-snug\" style=\"color: rgb(221, 111, 16);\">\n\t\t\t\t\t\t\t<a class=\"relative z-20 transition-colors duration-200 hover:!text-[#c25e1a] !no-underline hover:!no-underline\" style=\"color: inherit;\" href=\"\/en\/register-of-medicines-for-human-use\/\">\n\t\t\t\t\t\t\t\tHuman medicines database\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<p class=\"flex-grow mb-6 text-sm leading-relaxed text-gray-600\">Search authorised human medicines<\/p>\n\t\t\t\t\t\t<a class=\"relative z-20 inline-flex items-center gap-2 mt-auto font-semibold text-sm !text-[#E37222] hover:!text-[#c25e1a] !cursor-pointer transition-colors duration-200 !no-underline hover:!no-underline group\" href=\"\/en\/register-of-medicines-for-human-use\/\">\n\t\t\t\t\t\t\t<span>Search database<\/span>\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-4 h-4 transition-transform duration-200 group-hover:translate-x-1\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/arrow_forward.png\" alt=\"Arrow forward\">\n\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"flex flex-col h-auto swiper-slide\">\n\t\t\t\t\t<div class=\"flex flex-col flex-1 p-6 h-full text-left bg-white rounded-xl border shadow-sm transition-shadow duration-300 border-surface-variant hover:shadow-md\">\n\t\t\t\t\t\t<div class=\"w-14 h-14 bg-[#FDF5E6] rounded-xl flex items-center justify-center mb-4 flex-shrink-0\">\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-7 h-7\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/pets.png\" alt=\"Database of veterinary medicines\">\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h3 class=\"mb-2 text-xl font-bold leading-snug\" style=\"color: rgb(221, 111, 16);\">\n\t\t\t\t\t\t\t<a class=\"relative z-20 transition-colors duration-200 hover:!text-[#c25e1a] !no-underline hover:!no-underline\" style=\"color: inherit;\" href=\"\/en\/register-of-veterinary-medicines\/\">\n\t\t\t\t\t\t\t\tVeterinary medicines database\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<p class=\"flex-grow mb-6 text-sm leading-relaxed text-gray-600\">Search authorised veterinary medicines<\/p>\n\t\t\t\t\t\t<a class=\"relative z-20 inline-flex items-center gap-2 mt-auto font-semibold text-sm !text-[#E37222] hover:!text-[#c25e1a] !cursor-pointer transition-colors duration-200 !no-underline hover:!no-underline group\" href=\"\/en\/register-of-veterinary-medicines\/\">\n\t\t\t\t\t\t\t<span>Search database<\/span>\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-4 h-4 transition-transform duration-200 group-hover:translate-x-1\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/arrow_forward.png\" alt=\"Arrow forward\">\n\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"flex flex-col h-auto swiper-slide\">\n\t\t\t\t\t<div class=\"flex flex-col flex-1 p-6 h-full text-left bg-white rounded-xl border shadow-sm transition-shadow duration-300 border-surface-variant hover:shadow-md\">\n\t\t\t\t\t\t<div class=\"w-14 h-14 bg-[#FDF5E6] rounded-xl flex items-center justify-center mb-4 flex-shrink-0\">\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-7 h-7\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/science.png\" alt=\"Register of medical devices\">\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h3 class=\"mb-2 text-xl font-bold leading-snug\" style=\"color: rgb(221, 111, 16);\">\n\t\t\t\t\t\t\t<a class=\"relative z-20 transition-colors duration-200 hover:!text-[#c25e1a] !no-underline hover:!no-underline\" style=\"color: inherit;\" href=\"\/en\/medical-devices\/register-of-medical-devices\/\">\n\t\t\t\t\t\t\t\tRegister of medical devices\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<p class=\"flex-grow mb-6 text-sm leading-relaxed text-gray-600\">Search medical devices registered with CInMED<\/p>\n\t\t\t\t\t\t<a class=\"relative z-20 inline-flex items-center gap-2 mt-auto font-semibold text-sm !text-[#E37222] hover:!text-[#c25e1a] !cursor-pointer transition-colors duration-200 !no-underline hover:!no-underline group\" 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legal persons having a manufacturing authorization issued by the Institute in accordance with the Law on Medicinal Products [&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-7501","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Manufacturing\/GoodManufacturing Practice - Cinmed<\/title>\n<meta name=\"description\" content=\"Manufacturing\/GoodManufacturing Practice\" \/>\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\/inspektorat\/proizvodnja-dobra-proizvodacka-praksa\/\" \/>\n<meta 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