{"id":288,"date":"2026-07-29T14:56:45","date_gmt":"2026-07-29T12:56:45","guid":{"rendered":"https:\/\/www.pqra.gr\/serialisation-and-the-falsified-medicines-directive-keeping-the-supply-chain-safe\/"},"modified":"2026-08-27T11:39:21","modified_gmt":"2026-08-27T09:39:21","slug":"serialisation-and-the-falsified-medicines-directive-keeping-the-supply-chain-safe","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/serialisation-and-the-falsified-medicines-directive-keeping-the-supply-chain-safe\/","title":{"rendered":"Serialisation \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u039f\u03b4\u03b7\u03b3\u03af\u03b1 \u03b3\u03b9\u03b1 \u03c4\u03b1 \u03a8\u03b5\u03c5\u03b4\u03b5\u03c0\u03af\u03b3\u03c1\u03b1\u03c6\u03b1 \u03a6\u03ac\u03c1\u03bc\u03b1\u03ba\u03b1: \u039a\u03c1\u03b1\u03c4\u03ce\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b7\u03bd \u0391\u03bb\u03c5\u03c3\u03af\u03b4\u03b1 \u0395\u03c6\u03bf\u03b4\u03b9\u03b1\u03c3\u03bc\u03bf\u03cd \u0391\u03c3\u03c6\u03b1\u03bb\u03ae\u03c2"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Since February 2019, almost every prescription medicine pack in the EU has carried two safety features &mdash; a unique 2D barcode and an anti-tampering device &mdash; designed to keep falsified medicines out of the legal supply chain. Compliance is not a one-off packaging change but an ongoing obligation that touches manufacturing, data management and the wider distribution network.<\/strong><\/p>\n\n<h2>The legal framework<\/h2>\n<p>The Falsified Medicines Directive (2011\/62\/EU) introduced harmonised measures across the EU to protect patients from falsified medicines. Its detailed rules on safety features are set out in Commission Delegated Regulation (EU) 2016\/161, which has applied since 9 February 2019. Together they require two safety features on the packaging of most prescription medicines:<\/p>\n<ul>\n<li>a <strong>unique identifier<\/strong> &mdash; a 2D data-matrix barcode carrying a product code, a randomised serial number, batch number and expiry date; and<\/li>\n<li>an <strong>anti-tampering device<\/strong> that shows whether a pack has been opened.<\/li>\n<\/ul>\n\n<h2>How verification works<\/h2>\n<p>The system is built on an end-to-end verification model. Manufacturers upload the unique identifiers to a shared repository &mdash; the European Medicines Verification System (EMVS) &mdash; which connects to national verification systems. At the point of dispensing, a pharmacy scans the barcode, checks it against the database and decommissions it, so the same identifier cannot be reused. A now well-established European network links thousands of manufacturers, wholesalers and pharmacies to this system.<\/p>\n\n<h2>What it means for marketing-authorisation holders<\/h2>\n<p>Responsibility for the data underpinning the system rests largely with the marketing-authorisation holder:<\/p>\n<ul>\n<li>generating compliant unique identifiers and applying them at the point of manufacture;<\/li>\n<li>uploading and maintaining accurate product master data in the EMVS;<\/li>\n<li>managing alerts when a pack fails verification, which must be investigated;<\/li>\n<li>coordinating with contract manufacturers and packaging sites to ensure serialisation is applied correctly.<\/li>\n<\/ul>\n\n<h2>Common compliance gaps<\/h2>\n<ul>\n<li>Inaccurate or incomplete master data, which generates false alerts and disrupts dispensing.<\/li>\n<li>Weak processes for investigating and resolving alerts, which can be an early signal of falsification.<\/li>\n<li>Poorly defined responsibilities between the MAH, contract manufacturers and on-boarding partners.<\/li>\n<li>Overlooking national variations in scope and implementation across member states.<\/li>\n<\/ul>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA helps marketing-authorisation holders and manufacturers meet their obligations under the Falsified Medicines Directive &mdash; from serialisation and EMVS on-boarding to master-data management, alert handling and the technical agreements that keep contract sites compliant. We help you treat safety-feature compliance as an ongoing quality process rather than a one-off project.<\/p>\n<p><a href=\"\/el\/contact\/\">Contact PQRA<\/a> for support with serialisation and FMD compliance.<\/p>","protected":false},"excerpt":{"rendered":"<p>Since February 2019, almost every prescription medicine pack in the EU has carried two safety features &mdash; a unique 2D barcode and an anti-tampering device &mdash; designed to keep falsified medicines out of the legal supply chain. Compliance is not a one-off packaging change but an ongoing obligation that touches manufacturing, data management and the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":289,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,11],"tags":[],"class_list":["post-288","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-quality-assurance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Serialisation and the Falsified Medicines Directive: Keeping the Supply Chain Safe - PQRA<\/title>\n<meta name=\"description\" content=\"Since February 2019, almost every prescription medicine pack in the EU has carried two safety features \u2014 a unique 2D barcode and an anti-tampering\u2026\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/serialisation-and-the-falsified-medicines-directive-keeping-the-supply-chain-safe\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Serialisation and the Falsified Medicines Directive: Keeping the Supply Chain Safe - 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