GS1 Data Matrix the pack → ePI bridge.
A 2D GS1 DataMatrix on the secondary pack is now a regulatory expectation across most major markets (EU FMD, US DSCSA, Saudi NUPCO, Russia Chestny Znak, Turkey ITS). Alnexia designs and verifies the artwork — and links the same code to the patient-facing electronic Product Information.
What we deliver
GS1 application identifiers
GTIN, batch, expiry and serial number encoded per GS1 General Specifications.
EU FMD safety features
Unique identifier plus anti-tampering device design per Delegated Regulation 2016/161.
US DSCSA alignment
Product identifier (sNDC), serial, lot and expiry layout for US distribution.
Print quality (ISO/IEC 15415)
Symbol grade target, X-dimension and quiet zone calculated for substrate and press.
ePI URL resolver
DataMatrix resolves to the current authorised ePI for the SKU — one scan, current label.
Verification testing
Sample reads at multiple resolutions and lighting conditions, with a verification report.
Artefacts you receive
- DataMatrix print artwork
- Symbol grade verification report
- GS1 AI content sheet
- ePI resolver mapping
Sourced from regulators and industry leaders
- EU FMD — Delegated Regulation 2016/161 — EUR-Lex
- GS1 Healthcare — GS1
- FDA — DSCSA — U.S. FDA
Ready to scope this work?
Talk to an Alnexia specialist about timelines, deliverables and pricing — no obligation.
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