{"id":25795,"date":"2026-10-22T11:40:08","date_gmt":"2026-10-22T09:40:08","guid":{"rendered":"https:\/\/cinmed.me\/obavjestenje-nosiocima-dozvola-za-ljekove-procjena-rizika-od-prisustva-nitrozaminskih-necistoca\/"},"modified":"2026-10-22T11:43:44","modified_gmt":"2026-10-22T09:43:44","slug":"obavjestenje-nosiocima-dozvola-za-ljekove-procjena-rizika-od-prisustva-nitrozaminskih-necistoca","status":"publish","type":"post","link":"https:\/\/cinmed.me\/en\/obavjestenje-nosiocima-dozvola-za-ljekove-procjena-rizika-od-prisustva-nitrozaminskih-necistoca\/","title":{"rendered":"Notice to MAHs \u2013 Risk Assessment for the presence of nitrosamine impurities"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"25795\" class=\"elementor elementor-25795 elementor-25790\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6a788cb0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6a788cb0\" 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-4a205130\" data-id=\"4a205130\" 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-7c8fb51d elementor-widget elementor-widget-text-editor\" data-id=\"7c8fb51d\" 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>The Institute for Medicines and Medical Devices (CInMED) reminds marketing authorisation holders of medicinal products for human use of their obligation to conduct and regularly update risk assessments for the presence of nitrosamine impurities, in accordance with Article 63 of the Law on Medicines (\u201cOfficial Gazette of Montenegro\u201d, Nos. 14\/26 and 94\/26) and the relevant guidelines of the European Medicines Agency (EMA).<\/p>\n<p>\u00a0<\/p>\n<p>In this regard, all marketing authorisation holders are requested to submit to CInMED, within 90 days of the publication of this notice, information on the status of the risk assessments conducted for all medicinal products for which they hold a valid marketing authorisation in Montenegro, together with the relevant documentation, if such documentation has not been previously submitted or has since been updated.<\/p>\n<p>\u00a0<\/p>\n<p>If the documentation has already been submitted and no new relevant information or changes have arisen, an appropriate confirmation should be provided.<\/p>\n<p>\u00a0<\/p>\n<p>The requested information and documentation should be submitted by email to <a href=\"mailto:nitrozamini@cinmed.me\"><strong>nitrozamini@cinmed.me<\/strong><\/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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The Institute for Medicines and Medical Devices (CInMED) reminds marketing authorisation holders of medicinal products for human use of their obligation to conduct and regularly update risk assessments for the presence of nitrosamine impurities, in accordance with Article 63 of the Law on Medicines (\u201cOfficial Gazette of Montenegro\u201d, Nos. 14\/26 and 94\/26) and the relevant [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":23845,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-25795","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 v28.6 - 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