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
SHA-256 integrity: ab46dfb31729957004b895177caf88280cfd7ce13a42eafd2d6331265e2bdcf1
Primary Citations — 6 traced to source
- {"source":"Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC - Safety Features on Medicinal Products","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0161","relevant_sections":"Article 3 (tamper-evident device requirements); Article 4 (unique identifier data elements: product code, serial number, batch number, expiry date); Article 5 (2D data matrix carrier); Article 10 (wholesale distributor verification obligations); Article 25 (dispenser decommission obligation); Articles 33-40 (repositories: European Hub and NMVO system architecture and upload obligations); Annex I (exempt prescription products); Annex II (OTC products subject to safety features); Articles 47a-47b (parallel import re-serialisation)"}
- {"source":"European Medicines Verification Organisation (EMVO) - EMVS Architecture and Connectivity","url":"https://emvo-medicines.eu/","relevant_sections":"EMVO role as European Hub operator under Delegated Regulation 2016/161; NMVO connectivity requirements for manufacturers, wholesalers, and pharmacies; GS1 EPCIS message format for UI data uploads; EMVS alert management procedures; business continuity requirements for EMVS operations; EMVO onboarding process for new manufacturers connecting to the European Hub"}
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