{"id":11201,"date":"2023-03-22T13:18:45","date_gmt":"2023-03-22T13:18:45","guid":{"rendered":"https:\/\/cinmed.me\/obavjestenje-o-povlacenju-vakcine-bcg-sa-trzista-crne-gore\/"},"modified":"2023-03-23T12:55:16","modified_gmt":"2023-03-23T12:55:16","slug":"notice-on-the-withdrawal-of-the-bcg-vaccine-from-the-market-of-montenegro","status":"publish","type":"post","link":"https:\/\/cinmed.me\/en\/notice-on-the-withdrawal-of-the-bcg-vaccine-from-the-market-of-montenegro\/","title":{"rendered":"Notice on the withdrawal of the BCG vaccine from the market of Montenegro"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"11201\" class=\"elementor elementor-11201 elementor-11180\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8d6dc83 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8d6dc83\" 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-2f32ca0\" data-id=\"2f32ca0\" 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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b9640a0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b9640a0\" 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-905ba6f\" data-id=\"905ba6f\" 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-ded7703 elementor-widget elementor-widget-text-editor\" data-id=\"ded7703\" 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 relation to the withdrawal of the BCG vaccine produced by the Institute of Virology, Vaccines and Serums &#8220;Torlak&#8221;, Republic of Serbia, from the market of Montenegro, the Institute for Medicines and Medical Devices would like to inform the expert and general public on the following:<\/p><p>\u00a0<\/p><p>In January of this year, the Institute for Medicines and Medical Devices, in accordance with the Law on Medicines, approved the import of this vaccine through the so-called emergency import, based on the assessment of submitted documentation which proved that the vaccine met the prescribed standards in terms of quality, safety and efficacy. The aforementioned documentation, among other things, includes two quality control certificates \u2013 Certificate of Analysis of the manufacturer of the medicine and the Certificate of Analysis issued by the National Control Laboratory of the Agency for Medicines and Medical Devices of Serbia, which is a member of the European Network of Official Medicines Control Laboratories.<\/p><p>\u00a0<\/p><p>Subsequent routine control carried out by the manufacturer determined that there was a possibility of a potential deviation of the number of live, attenuated Bacillus Calmette-Guerin (<em>Mycobacterium bovis BCG<\/em>) bacteria, compared to the number that had been declared. Therefore, expected immune response might be incomplete in an extremely small number of patients (newborns, children and adults at an increased risk for developing a tuberculosis). Due to this matter, mentioned batch of the vaccine has been withdrawn, bearing in mind that the manufacturer is obliged to withdraw a medicine from the market, even though a suspected defect that cannot cause serious consequences for human health is in question.<\/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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>In relation to the withdrawal of the BCG vaccine produced by the Institute of Virology, Vaccines and Serums &#8220;Torlak&#8221;, Republic of Serbia, from the market of Montenegro, the Institute for Medicines and Medical Devices would like to inform the expert and general public on the following: \u00a0 In January of this year, the Institute for [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":16679,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11201","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - 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