Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Vulcan eMedicinal Product Information IG › ePI List HL7 FHIR R5
FHIR R5 · List Resource

ePI List Use Cases

The FHIR List resource is incredibly versatile. In the ePI ecosystem, it serves two primary tracking paradigms: monitoring various products across different jurisdictions, and managing all language instances for a single product within one jurisdiction.

USE CASE 1

Multi-Language Single Product Tracker

Tracking all 4 language instances (SmPC and PIL) for a centrally authorized product within the EU.

8
Total ePIs
4
SmPCs
4
PILs
4
Languages
1
Jurisdiction
epi-list-fictionalmed-a-ema
current
FictionalMed A ePI Language Tracker — EU
European Union 🇪🇺
EMA
1.0
Tracks all approved language instances (SmPC & PIL) for FictionalMed A within the EU Centralised Procedure.
🌍

Selected Language Entries (8 of 48)

1
FictionalMed A 50mg/200mg/25mg (Summary of Product Characteristics)
current
urn:uuid:9c552d9b-10db-409a-9929-75bb53380fce
2026-03-27
en (English)
SmPC
2
FictionalMed A 50mg/200mg/25mg (Patient Information Leaflet)
current
urn:uuid:7f68d8b3-3d47-420e-8af4-b6a439192c2b
2026-03-27
en (English)
PIL
3
FictionalMed A 50mg/200mg/25mg (Résumé des Caractéristiques du Produit)
current
urn:uuid:b958951c-7b9a-41d4-89fd-fa1b73b32992
2026-03-27
fr (French)
SmPC
4
FictionalMed A 50mg/200mg/25mg (Notice Patient)
current
urn:uuid:3efd996a-6795-4036-ad2e-6e8207f41c82
2026-03-27
fr (French)
PIL
5
FictionalMed A 50mg/200mg/25mg (Zusammenfassung der Merkmale)
current
urn:uuid:f18cdff1-8577-4ed1-a299-a7bc937e186e
2026-03-27
de (German)
SmPC
6
FictionalMed A 50mg/200mg/25mg (Packungsbeilage)
current
urn:uuid:a97d2af7-e2e1-43ee-8599-e861704519b4
2026-03-27
de (German)
PIL
7
FictionalMed A 50mg/200mg/25mg (Ficha Técnica)
current
urn:uuid:e89079a6-925f-4a0f-9ca6-0bf25df222ac
2026-03-27
es (Spanish)
SmPC
8
FictionalMed A 50mg/200mg/25mg (Prospecto)
current
urn:uuid:65e21916-cddd-49d6-afca-971177392fde
2026-03-27
es (Spanish)
PIL
View List/epi-list-fictionalmed-a-ema (FHIR JSON) ▼ 
{
  "resourceType": "List",
  "id":           "epi-list-fictionalmed-a-ema",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/epi/StructureDefinition/List-uv-epi"
    ]
  },
  "status": "current",
  "mode":   "working",
  "title":  "FictionalMed A ePI Language Tracker — EU",
  "code": {
    "coding": [{
      "system":  "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-list-type-cs",
      "code":    "medicinal-product",
      "display": "Medicinal Product"
    }]
  },
  "subject": { "reference": "Organization/acme" },
  "date": "2025-06-15",
  "note": [{
    "text": "Tracks all 24 approved language instances (SmPC & PIL) for FictionalMed A within the EU Centralised Procedure."
  }],
  "entry": [
    {
      "flag": { "text": "Master" },
      "item": { "reference": "Bundle/fictionalmed-a-smpc-en",
                "display":   "FictionalMed A SmPC (English)" }
    },
    {
      "flag": { "text": "Translation" },
      "item": { "reference": "Bundle/fictionalmed-a-smpc-fr",
                "display":   "FictionalMed A SmPC (French)" }
    }
    // ... 46 more instances for DE, ES, IT, NL, etc.
  ]
}