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
This guide describes how to create an ePI Type 1 document.
ePI Type 1 is a structured, FHIR-based version of the regulator's label template (e.g., Summary of Product Characteristics, Patient Information Leaflet, Packaging Artwork). This replaces the traditional DOCX or PDF version of the label template.
For a list of all ePI components, see the ePI components page or the Artifacts/Profiles.
ePI Type 1 uses the following FHIR resources:
The following figure shows how the ePI Type 1 resources relate to each other:
The table below describes each resource’s purpose, key fields, and role in ePI Type 1:
| Resource | Purpose | Key Fields | Role in ePI Type 1 |
|---|---|---|---|
| Bundle | Container for the SmPC, grouping all resources. |
- type: Set to document.- entry: References to Composition and Binary.- identifier: Unique ID for the SmPC.
|
Packages all components into a single, interoperable document. |
| Composition | Organizes the narrative content of the SmPC. |
- language: Language code (e.g., en).- section: Structured sections (e.g., indications, dosage, contraindications).- title: SmPC title.- author: Reference to authoring entity.
|
Provides the main narrative content (e.g., paragraphs, tables, bulleted lists) and section headings. |
| Binary | Stores media, such as images, in Base64 format. |
- contentType: MIME type (e.g., image/png).- data: Base64-encoded content.
|
Includes images (e.g., product images, pack artwork) referenced in the SmPC. |
The following table provides step-by-step instructions to create an ePI Type 1 document:
| Step | Description | Actions |
|---|---|---|
| Step 1: Start with the Base ePI Profile | Use the Base ePI Profile as the foundation. |
- Review the [Base ePI Profile](./profiles.md) for mandatory elements. - Ensure compliance with regional labeling requirements. |
| Step 2: Create SmPC Content | Develop the narrative content of the SmPC. |
- Create a Composition resource.- Set language (e.g., en).- Structure content in section elements using XHTML or Markdown.- Use section codes from the [ePI section code value set](./section-codes.md) (e.g., indications, dosage, contraindications). - Include product details (e.g., name, ingredients) within the narrative. |
| Step 3: Include Media | Add images or other media to the SmPC. |
- Convert images to Base64 format. - Create a Binary resource with contentType (e.g., image/png) and data.- Reference the Binary in the relevant Composition section.
|
| Step 4: Bundle the Resources | Combine all resources into a single document. |
- Create a Bundle resource with type set to document.- Add entry elements for the Composition and Binary.- Assign a unique identifier to the Bundle.
|
| Step 5: Validate and Test | Ensure the SmPC is compliant and functional. |
- Validate the Bundle using the FHIR Validator against the Base ePI Profile. - Test with a FHIR server (e.g., HAPI FHIR) to confirm storage and retrieval. - Verify API compatibility (e.g., POST, GET operations). - Check content for regulatory compliance (e.g., EMA SmPC guidelines). |