EMA ePI MANDATE · 2026
Electronic Product Information · Action Required
The clock started. Has your team?
Q4 2026 is the first voluntary ePI milestone. Every week without a plan is a week your competitors use to pull ahead.
Q4 2026
Voluntary ePI go-live begins for vaccines (ATC J07)
H1 2027
Expansion to oncology products (ATC L01, L04)
H2 2027
Progressive rollout to all Centrally Authorised Products (CAPs)
2027–2028
National implementation planning and rollout for non-CAPs by NCAs
DOES THIS SOUND LIKE YOUR TEAM?
ONE PARTNER. EVERY STAGE.
Find your gaps
ePI Readiness & Strategy · Readiness Assessment · ePI Pathfinder · Migration Roadmap · Architecture & Advisory
Convert, author & submit
FHIR-Native Platform · Smart Conversion · Guided Authoring · Built-In Validation · Product Catalogue
Standardise & automate
Pharma Labelling & GS1 Compliance · Digital Labelling Management · Barcode GS1 Validator · Regulatory AI Agents
WHY DEEVITA
We wrote the standard
Active HL7 Vulcan ePI Working Group member.
FHIR-native from day one
Built for EMA from day one.
Proven in regulated production
Delivered pharma labelling and AI systems globally.
ePI Strategy · FHIR-Native Platform · Pharma Labelling & GS1 · One partner. Every stage.