EU ePI Common Standard (hl7.eu.fhir.epil v1.0.0).
The EU ePI Common Standard is the EMA, Heads of Medicines Agencies (HMA) and European Commission's shared technical baseline for electronic Product Information — built on HL7 FHIR. It defines a Bundle of FHIR resources (Composition, MedicinalProductDefinition, RegulatedAuthorization, Organization, references to SPOR/IDMP) that together replace the paper SmPC and PIL with structured, machine-readable content.
What we deliver
hl7.eu.fhir.epil conformance
Bundles produced against v1.0.0 of the EU Implementation Guide and validated with HL7 validator_cli.jar.
Composition by QRD section
Section-by-section mapping from Annex I/IIIA/IIIB to FHIR Composition.section entries.
SPOR / IDMP references
Substance, product, organisation and referential data resolved against EMA SPOR.
Multi-language packaging
One ePI bundle carrying all 24 EU languages, indexable by language code.
Versioning & supersedence
Provenance, document version, supersedes and effectivePeriod handled per IG.
GS1 Data Matrix linkage
Pack-level 2D code resolving to the current ePI for the SKU.
What is in scope today
The current EMA programme covers centrally authorised products (CAPs) with phased onboarding by therapeutic area. The Common Standard supports human medicinal product information and is extensible for veterinary use.
Alnexia produces conformant ePI bundles today for vaccines, oncology and biosimilars, parallel-run against the QRD PDF, ready for PLM Portal submission as each phase opens.
How Alnexia compares to existing platforms
We benchmark every output against industry references such as ArisGlobal LifeSphere Regulatory, Docuvera (READY! for ePI) and myHealthbox eLeaflet — focusing on structural fidelity, language coverage, validator cleanliness and time-to-publish. Our delivery is platform-agnostic: we can hand you the bundle, push to PLM Portal directly, or sit inside your existing RIM.
Artefacts you receive
- FHIR Bundle (JSON + XML)
- validator_cli evidence pack
- SPOR/IDMP reference list
- Parallel-run fidelity scorecard vs source SmPC/PIL
- PLM Portal submission package
Sourced from regulators and industry leaders
- EMA — Electronic product information (ePI) — European Medicines Agency
- EU ePI Common Standard (hl7.eu.fhir.epil) — HL7 Europe
- PLM Portal — ePI module — EMA key milestones
- ArisGlobal LifeSphere Regulatory — Vendor reference
- Docuvera — READY! for ePI — Vendor reference
- myHealthbox eLeaflet — Vendor reference
Ready to scope this work?
Talk to an Alnexia specialist about timelines, deliverables and pricing — no obligation.
Discuss your project