What EU FMD Delegated Regulation 2016/161 - Safety Features and Unique Identifier for Medicinal Products requires
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC, applicable from 9 February 2019 in most EU/EEA Member States (with derogations for Greece and Italy until February 2025), establishes the detailed technical and operational requirements for the safety features on medicinal product packaging within the Falsified Medicines Directive (FMD) framework. The Regulation mandates two safety features on the outer packaging of prescription medicinal products: (1) a unique identifier (UI) - a 2D data matrix code containing the product code, serial number, batch number, expiry date, and optionally a national reimbursement number - and (2) a tamper-evident device (TED) on the packaging. The Regulation establishes the European Medicines Verification System (EMVS) through a network of national medicines verification organisations (NMVOs) connected to the European hub, and defines the obligations of manufacturers, wholesale distributors, pharmacists, dispensers, and parallel importers for uploading, verifying, and decommissioning the unique identifier along the pharmaceutical supply chain.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission - Commission Delegated Regulation (EU) 2016/161 of 2 October 2015; Directive 2001/83/EC Article 54a; Directive 2011/62/EU (Falsified Medicines Directive); European Medicines Verification Organisation (EMVO); European Medicines Agency (EMA) · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0161
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