What EU Falsified Medicines Directive 2011/62/EU - Serialisation and Track-and-Trace Requirements requires
Directive 2011/62/EU and Commission Delegated Regulation (EU) 2016/161 require manufacturers, importers, and distributors of prescription medicines in the EU to implement a two-component safety feature system: a unique identifier (2D barcode containing product code, serial number, batch number, and expiry date) and an anti-tampering device. The European Medicines Verification System (EMVS) enables pharmacies to verify authenticity at point of dispensing.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0062
SHA-256 integrity: af4647b5b0705c257bf8dc76451928b24daab69d3395fb883f1f51f320c8f34d
Primary Citations — 5 traced to source
- {"title":"Directive 2011/62/EU - Falsified Medicines Directive","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011L0062","section":"Article 54a (safety features), Article 85c (notification of falsified medicines)"}
- {"title":"Commission Delegated Regulation (EU) 2016/161 - Safety Features","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0161","section":"Article 10 (unique identifier), Article 25 (anti-tampering device), Article 30 (verification)"}
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/eu-falsified-medicines-directive-2011-62-eu-serialisation-track-trace.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-falsified-medicines-directive-2011-62-eu-serialisation-track-trace.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-falsified-medicines-directive-2011-62-eu-serialisation-track-trace
- Back to registry: Browse all 10,090 compliance nodes