Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. 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
Up to 14 FHIR resources can be used to create an ePI. However, not all 14 resources are needed to support all use cases. Different resources can be combined to support various scenarios.
To assist implementers in selecting the appropriate resources for their preferred use cases, ePI are arranged into four types (ePI Type 1, 2, 3 and 4). See the table below for an overview of the four types and typical use case examples.
ePI Type 2 is the recommended starting point for most implementers since it enables the most common use cases.
| ePI Type | Core FHIR Resources Used | Primary Regulatory / Industry Value & Most Relevant Use Cases |
|---|---|---|
| Type 1 Digital Label Reproduction |
• Bundle • Composition • Binary/images |
Faithful digital version of approved labeling (SmPC, PIL, carton) that regulators accept as the legal document of record. • Publish dynamic content on regulator / company websites • Auto-generate printing-ready artwork • Flag differences between submitted ePI versions • Auto-generate comparison tables |
| Type 2a Product Identification and Advanced Search |
• MedicinalProductDefinition • RegulatedAuthorization • Organization • PackagedProductDefinition • ManufacturedItemDefinition • AdministrableProductDefinition • Ingredient |
Enables fast, accurate lookup in regulatory databases, national catalogues and hospital formularies. |
| Type 2b Drug Shortages |
• Organization • MedicinalProductDefinition • RegulatedAuthorization • ManufacturedItemDefinition • PackagedProductDefinition |
Rapid identification of therapeutic/pharmaceutical equivalents during supply disruptions. Find alternative products by company, active substance, strength, form and pack size to manage shortages and authorise substitutions. |
| Type 2c Cross-border Travel |
• Organization • MedicinalProductDefinition • PharmaceuticalProductDefinition • ManufacturedItemDefinition |
Allows recognition of medicines carried by travelling patients in another jurisdiction. |
| Type 2d Distribution |
• Organization • MedicinalProductDefinition • RegulatedAuthorization • PackagedProductDefinition |
Full end-to-end supply-chain traceability using global identifiers (GTIN, PhPID, PCID). |
| Type 2e Allergens |
• ManufacturedItemDefinition • Ingredient |
Identify and flag allergens or excipients of interest (e.g., lactose, gluten, aspartame, parabens). |
| Type 2f Digital Health |
• Organization • MedicinalProductDefinition • RegulatedAuthorization • ManufacturedItemDefinition • AdministrableProductDefinition • Ingredient |
Unique, persistent product linking across clinical and regulatory systems to support ePrescribing and EMR medication lists. |
| Type 3 Clinical Guidance |
• ClinicalUseDefinition (Indication, Contraindication, Interaction, Undesirable Effect) • MedicationKnowledge |
Structured clinical details and controlled terminology (SNOMED, ICD, MedDRA) to facilitate interoperability with digital health. • Interaction alerts (Drug–drug, drug-device, drug-food) • Personalised patient counselling material • Structured dose details |
| Type 4 Computable & Granular Components |
All resources above except for the Composition. | Transition to a fully component-based structure to maximize content reuse, web-publishing, and digital health interoperability. All narrative content moved from the Composition to its corresponding structured Resource. E.g., SMPC's MAH section moves to Organization resource; Indication moves to Clinical Use Definition resource • Auto-generate batch specific label variations from content components • Auto-generate personalized label variations • Dynamic content tailored to comorbidities, contraindications, indications, or allergens |
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-01-02
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