Commonly used terms and their definitions
EU legislation (Directive 2011/62/EU) to prevent falsified medicines from entering the legal supply chain. Introduced safety features and verification requirements.
The organisation responsible for implementing and managing the European Medicines Verification System (EMVS) at a pan‑European level.
The system enabling verification of the unique identifier and decommissioning at the point of dispensing, supported by national systems (NMVS).
A country-level organisation operating the National Medicines Verification System (NMVS) and collaborating with EMVO.
The national verification system operated by the NMVO in each participating country, integrated with the European Hub.
A GS1-standardised 2D barcode symbology used to encode the unique identifier on medicine packs, including GTIN, serial, expiry, and batch.
A globally unique identifier for trade items, encoded using AI (01) in GS1 barcodes. In EU pharma, GTIN-14 is commonly used.
A GS1 prefix that defines the meaning, format, and length of the data element that follows, e.g. (01) GTIN, (21) Serial, (17) Expiry, (10) Batch.
The set of data elements required by FMD: product code (GTIN), serial number, batch/lot, and expiry date, encoded in a GS1 DataMatrix.
A unique alphanumeric value assigned to each individual pack, encoded using AI (21).
Identifies the manufacturing batch for traceability and quality control, encoded using AI (10).
The date until which the product can be used safely, encoded using AI (17) in YYMMDD format.
Country‑specific reimbursement code optionally encoded using AI 71x where x indicates the country.
Changing a pack’s state in the EMVS (e.g., supplied, exported). Some states are reversible within time limits, others are irreversible.
A security feature on packaging that provides visible evidence of tampering attempts; required by FMD on prescription medicines.
Processes and tooling used by EMVO/NMVOs and stakeholders to triage, investigate, and resolve verification alerts generated by the EMVS.
Information may be outdated. Always consult official documentation from EMVO, EMA, GS1, and national regulatory bodies for current requirements.