The HL7 standard that turns the paper package leaflet into structured, interoperable healthcare data — the format regulators are converging on for ePI.
Electronic product information (ePI) replaces the folded paper leaflet with authoritative digital product information. HL7 FHIR gives it a structured clinical format, so the leaflet becomes data that health systems, apps, and regulators can consume — not a PDF.
EMA and FDA pilots have both converged on FHIR-based ePI, with GS1 identifiers connecting the regulated document to the physical pack.
Structured ePI means a clinical system can surface the warnings section, in the patient's language, for the exact batch dispensed — impossible with paper or PDF.
Label changes reach patients when the regulator approves them, not when old stock exhausts. That is the core patient-safety argument for ePI.
Screen readers, larger type, and 29 languages from the same source document — paper can't do that.
AstraLabel manages the ePI lifecycle — conversion, review, approval, publication — and serves it via GS1 Digital Link scan from the pack.
ePI by PharmaLedger delivers approved product information in 29 languages, running on this platform.
Aggregate-only scan analytics show engagement without collecting any personal data.
30-minute implementation-readiness consultation with a PLA platform specialist. No procurement, no NDA.
