The ePI workflow layer
From Word PILs to compliant, submitted ePI — in one place.
Change #1 of 10 — RA / Labelling
Your PILs are in Word. The EU wants them in FHIR.
Article 63 mandates electronic Product Information for all medicines. Voluntary rollout starts Q3 2026 for vaccines and oncology. Mandatory for new MAs from mid-2028. Most teams don't yet know what they have — let alone how to convert it.
Art. 63 — Electronic PI
By 2028From a Word file to structured ePI
Today
PIL.docx · free text
New ePIFHIR · structured data
Indications
Posology
Side effects
Storage
Same leaflet content — but every section becomes a coded, machine-readable element that regulators, pharmacies and patients can query electronically.
The scale of the problem
Bigger than most teams realise
The scope isn't one conversion — it's your entire product information estate across every product, document type, and EU language.
10k+
Document conversions for a typical 50-product portfolio across 4 document types and 25–50 languages
SourceGlemser Technologies, 2024
4–5h
To convert a single label to FHIR with specialist tooling — 10–12 hours manually
SourceGlemser Technologies, 2024
24
Official EU languages every ePI must eventually support with translation workflows
SourceEMA ePI Common Standard
What's actually changing
From paper PIL to living ePI
This isn't a formatting update — it's a fundamental shift in how product information is authored, stored, updated and delivered.
Workbench
+ New TaskQuick Tasks/ePI transition — current vs new directive
We have 140 product information documents in Word. How do we get to FHIR-structured ePI by 2028?
RegIntel12:39
118.00s288 sources91% confidence2 warnings
2 warnings
Here's the obligation delta for ePI transition. The new EU Pharmaceutical Directive replaces Directive 2001/83/EC[1][2] — below is what changes, row by row.
Current vs. new directive4 rows
Change area
Current — 2001/83/EC
New directive — from ~mid-2028
Format
Current
Paper PIL in every pack. SmPC and PIL as Word or PDF. No structured data format.
Storage & access
Current
Documents in company systems with inconsistent versioning. No central EU repository.
New directive
ePI hosted on EMA's European Medicines Web Portal. Publicly accessible via API. Always current.[5]
Updating content
Current
PIL changes require variation then reprinting millions of leaflets. Outdated info circulates for months.
New directive
Once approved, ePI updates digitally. Patients scanning the QR code see current information immediately.[6]
⚠Dates reflect the political agreement text; final deadlines depend on entry into force and the transition period for each obligation.
Synthesised from 18 citations across 288 regulatory sources.
Book a 15-minute live walkthrough of the Workbench
Why existing tools don't solve this
The missing layer
There are tools for parts of the problem. None give your regulatory team a complete operating system for the transition.
EM
EMA PLM Portal
The submission endpoint
EN
Enterprise RIM (e.g. Veeva)
The heavyweight platform
How Regunaut solves it
Five modules. One complete transition.
Each module maps to a real step — from initial audit through keeping ePI current after submission.
Centralises every PIL, SmPC, labelling document and CCDS equivalent — tagged by product, country, language and version. Gap identification and FHIR-readiness scoring per document.
- Automated ingestion from file stores and regulatory systems
- Tagging by product, country, language and document type
- Gap identification for missing market documents
- FHIR-readiness scoring per document
Industry evidence
The industry is already moving — is your team?
ePI pilots have run for years. The EMA roadmap is published. The question is whether you're ahead or behind.
14
EU countries with active ePI pilots as of February 2026
EFPIA joint survey, Feb 2026
4M+
Packs with ePI in Belgium/Luxembourg pilot — 97% of hospital pharmacists reported no issues
EFPIA joint survey, Feb 2026
6–12mo
Typical packaging validation cycle — packaging decisions need to happen now
Industry standard, 2026
“Manufacturers that treat this as a 2028 problem will retrofit packaging under regulatory pressure. Those that act now will deliver compliant ePI before the deadline.”
Common questions
What teams are asking about ePI
Know exactly where your PIL portfolio stands
We map your product information estate against ePI requirements and show you the gaps, timeline, and workload — in 30 minutes.
ePI readiness assessment
30-minute session auditing your PIL portfolio and mapping transition requirements. Free, no commitment.
Book assessment