Digital product information · ePI and eIFU
Regulated product information, live behind every pack.
PILs, SmPCs and eIFUs turned into structured, source-linked records your reviewers approve — delivered through the GS1 code already on your pack.
- No artwork change
- GS1 Digital Link
- HL7 FHIR ePI
- EU ePI Common Standard
- UK data residency
- Part 11 & Annex 11 by design
A patient scans the pack
GS1 DataMatrix
The code already printed on your carton. Unchanged.
GTIN
The product number that code already carries.
Resolver
Yours, GS1's, or one we run on your domain.
Approved ePI
The current version for that product, market and language.
The most regulated document you own is the one you can't update.
A safety variation is approved. The wording now has to reach the local label in every market where you hold an authorisation — through the national annex, the linguistic review, the artwork proof, the reprint and the submission.
Your batch records went digital. Your submissions went digital. The one artefact that actually reaches the patient did not.
Once a pack has left the line, there is no way to correct what it says.
Today — the paper chain
per change · per market- Artwork revision, proofing, approval loopsweeks
- Print run — new leaflets, new cartons££
- Line stoppage and repackaging£££
- Obsolete stock write-off££££
- Old leaflets still in patients' handsmonths
With ePIL
all markets · same day- Update the structured record onceminutes
- Medical, regulatory and QA reviewsame day
- Live behind the code already on the packinstant
- Stock on shelves stays sellable£0 waste
- Superseded versions stay addressableaudited
The code is already on your carton.
No new code, no artwork change, no variation to file, no reprint. The GS1 DataMatrix mandated for verification is already carrying everything needed to reach the right leaflet.
Already on GS1
Nothing on the carton changes
Most prescription packs in the UK and EU already carry a GS1 DataMatrix for verification, and it already encodes the GTIN. We register as a target for the identifier you are printing today. Nothing new goes on the artwork.
Not on GS1 yet
Live first, on the carton later
Your approved content is reachable from day one through the portal and the API — no code required. The mark joins the carton at your next scheduled artwork revision, as part of work you had already planned rather than a change raised for this.
We're the destination, not the resolver
We don't own your routing. Whatever resolves your scans today points at us as a registered target — your resolver, GS1's canonical one, or one we run on your domain.
The binding sits inside the approval
Which GTIN resolves to which version is part of the approved, hashed record — not an editable redirect someone can change afterwards.
Old batches still resolve
Superseded versions stay addressable, so a pack from last year reaches the leaflet that was approved for it.
Identifiers and routing records stay yours — point them elsewhere at any time. Serial numbers are read past, never stored. The printed leaflet stays in the pack: it is still statutory, and this complements it.
Three document types in. One approved record out.
Send the PDF you already hold. Nothing retyped, no template to populate first.
- PIL
Patient leaflet
Becomes patient-facing ePI, readable on a phone.
- SmPC
Prescribing information
Becomes HCP-facing ePI, queryable section by section.
- eIFU
Device instructions for use
Same pipeline, under device rules rather than medicines rules.
Structured content
Every section, warning and product attribute, broken out at component level.
A source link on every value
Page, paragraph and quotation. Nothing your reviewers have to take on trust.
A sign-off trail
Medical, regulatory and QA gates. Attributable throughout, locked on approval.
A FHIR ePI bundle
Aligned to the EU Common Standard, bound to the GTINs on your packs.
Click any value. See where it came from.
The link your reviewers follow inside the product — and the one you follow when an inspector asks where a statement came from.
page 1
page 2
page 3
page 4
Structured record
“4.1 Therapeutic indications” draws on 2 passages of the leaflet, highlighted alongside it.
A worked example on a real molecule, using illustrative wording. Your own documents behave the same way.
One approved record. Three different pay-offs.
Every variation is a race between the approval letter and the stock already in the channel — and you carry the gap.
The approved wording goes live behind the pack the day it clears review, in every market at once, without an artwork cycle standing between approval and the patient.
Inspection view
- ePI v14 approved — medical, regulatory, QA14:02
- Bound to 27 GTINs across 9 marketssame day
- Every value linked to its source paragraphtraceable
- v13 retained and still resolvablearchived
Not a trend to watch. A schedule to meet.
European Union
The Common Standard is adopted
The revised legislation agreed in December 2025 carries provision for electronic leaflets, phased after adoption.
QRD template
The leaflet itself is being rewritten
Working through consultation now. When it lands, every leaflet you hold is a change-control item.
United Kingdom
The MHRA is in delivery
Improving Patient Information runs across 2026–27, on a timeline diverging from the EU.
What each chair needs to sign this off.
Regulatory
Version control, binding records, inspection view.
QA
Validation approach, audit trail specification, GxP posture.
IT & Security
Architecture, UK data residency, SSO, tenant isolation.
Procurement
Deployment model, pricing, supplier qualification pack.
Legal
Data processing, IP in your content, exit and export.
Answers before your supplier qualification asks.
Quality
Segregation of duties
Whoever made the change cannot be the only person who approves it.
ALCOA+ audit trail
Every edit appended against a person and a time, never overwritten.
Approved versions locked
Checksum and e-signature manifest. Designed to support 21 CFR Part 11 and EU Annex 11.
Validation documentation
To support your qualification. We don't claim your validated state on your behalf.
Security
UK data residency
Processed and stored in a London region.
Tenant isolation
Rows are refused at the database, not filtered by the application.
Your identity provider
Single sign-on per organisation.
Not used to train models
Your content produces your structured content, and nothing else.
09Next step
Put one of your own documents through it.
Upload a PIL, an SmPC or an eIFU and see the structured content, the source links and the ePI mapping it produces. No procurement process required to start.
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