{"id":1851,"date":"2025-02-10T15:29:10","date_gmt":"2025-02-10T15:29:10","guid":{"rendered":"https:\/\/www.nmvoitalia.it\/?p=1851"},"modified":"2025-06-25T10:24:48","modified_gmt":"2025-06-25T10:24:48","slug":"decreto-legislativo-serializzazione","status":"publish","type":"post","link":"https:\/\/www.nmvoitalia.it\/en\/2025\/02\/10\/decreto-legislativo-serializzazione\/","title":{"rendered":"Legislative Decree on Serialization Published"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1851\" class=\"elementor elementor-1851\">\n\t\t\t\t<div class=\"elementor-element elementor-element-07cc866 e-flex e-con-boxed e-con e-parent\" data-id=\"07cc866\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:1742,&quot;url&quot;:&quot;https:\\\/\\\/www.nmvoitalia.it\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/News.png&quot;}],&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d532c66 entry-title elementor-widget elementor-widget-shortcode\" data-id=\"d532c66\" 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\t\t<div class=\"elementor-shortcode\"><div style=\"max-width: 650px; color: white\">Pubblicato in Gazzetta Ufficiale il Decreto Legislativo &#8220;Serializzazione&#8221;<\/div><\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-69a177d2 e-flex e-con-boxed e-con e-parent\" data-id=\"69a177d2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc8edc5 elementor-widget elementor-widget-text-editor\" data-id=\"dc8edc5\" 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>Pubblicato in Gazzetta Ufficiale il D.Lgs. 6.2.2025, n. 10 che adegua la normativa nazionale al sistema europeo di serializzazione dei farmaci. Di seguito la sintesi delle disposizioni principali:<\/p>\n<ol>\n<li>\ud835\udc0b\ud835\udc28\ud835\udc2d\ud835\udc2d\ud835\udc22 \ud835\udc2b\ud835\udc22\ud835\udc25\ud835\udc1a\ud835\udc2c\ud835\udc1c\ud835\udc22\ud835\udc1a\ud835\udc2d\ud835\udc22 \ud835\udc1f\ud835\udc22\ud835\udc27\ud835\udc28 \ud835\udc1a\ud835\udc25\u20198 \ud835\udc1f\ud835\udc1e\ud835\udc1b\ud835\udc1b\ud835\udc2b\ud835\udc1a\ud835\udc22\ud835\udc28 2025: i lotti di tutti i farmaci (A, compresa H, C e SOP\/OTC) rilasciati fino all\u20198 febbraio 2025 potranno essere immessi in commercio con l\u2019attuale bollino autoadesivo, fino a scadenza;<\/li>\n<li>\ud835\udc0f\ud835\udc1e\ud835\udc2b\ud835\udc22\ud835\udc28\ud835\udc1d\ud835\udc28 \ud835\udc1d\ud835\udc22 \ud835\udc2c\ud835\udc2d\ud835\udc1a\ud835\udc1b\ud835\udc22\ud835\udc25\ud835\udc22\ud835\udc33\ud835\udc33\ud835\udc1a\ud835\udc33\ud835\udc22\ud835\udc28\ud835\udc27\ud835\udc1e: dal 9 febbraio 2025 all\u20198 febbraio 2027 le QP potranno rilasciare, per tutti i medicinali destinati al mercato italiano, sia dentro che fuori il campo di applicazione della FMD (Falsified Medicines Directive):\n<ul>\n<li>\ud835\udc0b\ud835\udc28\ud835\udc2d\ud835\udc2d\ud835\udc22 \ud835\udc1d\ud835\udc28\ud835\udc2d\ud835\udc1a\ud835\udc2d\ud835\udc22 \ud835\udc1d\ud835\udc1e\ud835\udc25 \ud835\udc2c\ud835\udc28\ud835\udc25\ud835\udc28 \ud835\udc1b\ud835\udc28\ud835\udc25\ud835\udc25\ud835\udc22\ud835\udc27\ud835\udc28 \ud835\udc2f\ud835\udc22\ud835\udc20\ud835\udc1e\ud835\udc27\ud835\udc2d\ud835\udc1e (A, compresa H, C e SOP\/OTC);<\/li>\n<li>\ud835\udc0b\ud835\udc28\ud835\udc2d\ud835\udc2d\ud835\udc22 \ud835\udc1d\ud835\udc28\ud835\udc2d\ud835\udc1a\ud835\udc2d\ud835\udc22 \ud835\udc1d\ud835\udc22 \ud835\udc03\ud835\udc1a\ud835\udc2d\ud835\udc1a\ud835\udc26\ud835\udc1a\ud835\udc2d\ud835\udc2b\ud835\udc22\ud835\udc31 + \ud835\udc1a\ud835\udc27\ud835\udc2d\ud835\udc22-\ud835\udc2d\ud835\udc1a\ud835\udc26\ud835\udc29\ud835\udc1e\ud835\udc2b\ud835\udc22\ud835\udc27\ud835\udc20 (\ud835\udc00\ud835\udc13\ud835\udc03) + \ud835\udc1d\ud835\udc22\ud835\udc2c\ud835\udc29\ud835\udc28\ud835\udc2c\ud835\udc22\ud835\udc2d\ud835\udc22\ud835\udc2f\ud835\udc28 \ud835\udc2b\ud835\udc1e\ud835\udc1a\ud835\udc25\ud835\udc22\ud835\udc33\ud835\udc33\ud835\udc1a\ud835\udc2d\ud835\udc28 \ud835\udc2c\ud835\udc2e \ud835\udc2c\ud835\udc2e\ud835\udc29\ud835\udc29\ud835\udc28\ud835\udc2b\ud835\udc2d\ud835\udc28 \ud835\udc1d\ud835\udc22 \ud835\udc2c\ud835\udc22\ud835\udc1c\ud835\udc2e\ud835\udc2b\ud835\udc1e\ud835\udc33\ud835\udc33\ud835\udc1a (\ud835\udc1c\ud835\udc1a\ud835\udc2b\ud835\udc2d\ud835\udc1a \ud835\udc2f\ud835\udc1a\ud835\udc25\ud835\udc28\ud835\udc2b\ud835\udc22) prodotto dall\u2019Istituto Poligrafico (A, compresa H, C). Le caratteristiche del Datamatrix e del dispositivo realizzato su supporto di sicurezza (carta valori) dovranno essere individuate tramite due distinti decreti del Ministero della Salute.<\/li>\n<\/ul>\n<\/li>\n<li>\ud835\udc12\ud835\udc0e\ud835\udc0f\/\ud835\udc0e\ud835\udc13\ud835\udc02: sui prodotti SOP\/OTC oltre al bollino farmaceutico, che in questo periodo di stabilizzazione pu\u00f2 assolvere anche la funzione di prevenzione delle manomissioni, potr\u00e0 essere apposto (o continuare ad essere utilizzato) anche l\u2019elemento di sicurezza (anti-tampering) da regolamento UE.<\/li>\n<li>\ud835\udc12\ud835\udc1a\ud835\udc27\ud835\udc33\ud835\udc22\ud835\udc28\ud835\udc27\ud835\udc22: Le sanzioni per la mancata apposizione e attivazione del Datamatrix, dell\u2019anti-tampering (ATD) e del dispositivo realizzato su supporto di sicurezza (carta valori) sui lotti immessi in commercio dopo il 9 febbraio 2025 non sono applicabili fino al termine del periodo di stabilizzazione (8 febbraio 2027).<\/li>\n<\/ol>\n<div>\u00a0<\/div>\n<div>\n<div><span style=\"font-size: 17.6px;\">In allegato il testo pubblicato in Gazzetta Ufficiale<\/span><\/div>\n<div><span style=\"font-size: 17.6px;\">\u00a0<\/span><\/div>\n<div><span style=\"font-size: 17.6px;\">\u00a0<\/span><\/div>\n<div><span style=\"font-size: 17.6px;\">\u00a0<\/span><a style=\"font-size: 1.1rem; letter-spacing: 1.1px; background-color: #ffffff;\" href=\"https:\/\/www.nmvoitalia.it\/wp-content\/uploads\/2025\/04\/Dlgs-10-06_02_2024_Gazzetta-Ufficiale.pdf\" target=\"_blank\" rel=\"noopener\">Dlgs 10-06_02_2024_Gazzetta Ufficiale<\/a><\/div>\n<\/div>\n<p><!-- \/wp:paragraph --><!-- wp:paragraph --><\/p>\n<p><!-- \/wp:paragraph --><\/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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Pubblicato in Gazzetta Ufficiale il D.Lgs. 6.2.2025, n. 10 che adegua la normativa nazionale al sistema europeo di serializzazione dei farmaci. Di seguito la sintesi delle disposizioni principali: \ud835\udc0b\ud835\udc28\ud835\udc2d\ud835\udc2d\ud835\udc22 \ud835\udc2b\ud835\udc22\ud835\udc25\ud835\udc1a\ud835\udc2c\ud835\udc1c\ud835\udc22\ud835\udc1a\ud835\udc2d\ud835\udc22 \ud835\udc1f\ud835\udc22\ud835\udc27\ud835\udc28 \ud835\udc1a\ud835\udc25\u20198 \ud835\udc1f\ud835\udc1e\ud835\udc1b\ud835\udc1b\ud835\udc2b\ud835\udc1a\ud835\udc22\ud835\udc28 2025: i lotti di tutti i farmaci (A, compresa H, C e SOP\/OTC) rilasciati fino all\u20198 febbraio 2025 potranno essere immessi in [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":205,"comment_status":"closed","ping_status":"open","sticky":false,"template":"elementor_theme","format":"standard","meta":{"_eb_attr":"","footnotes":""},"categories":[10],"tags":[],"class_list":["post-1851","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"gutentor_comment":0,"_links":{"self":[{"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/posts\/1851","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/comments?post=1851"}],"version-history":[{"count":46,"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/posts\/1851\/revisions"}],"predecessor-version":[{"id":2496,"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/posts\/1851\/revisions\/2496"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/media\/205"}],"wp:attachment":[{"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/media?parent=1851"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/categories?post=1851"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nmvoitalia.it\/en\/wp-json\/wp\/v2\/tags?post=1851"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}