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

Build ePI Type 1

This guide describes how to create an ePI Type 1 document.

What is ePI Type 1?

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.

Overview of Resources Involved

ePI Type 1 uses the following FHIR resources:

• Bundle: The container for the ePI document.
• Composition: Organizes the narrative content (e.g., SmPC section headings and sub-headings).
• Binary: Stores images in Base64 format.

The following figure shows how the ePI Type 1 resources relate to each other:

Detailed Component Descriptions

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.

Steps to Build an ePI Type 1 Document

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).

Additional Resources

• ​ePI Profile: Refer to the Profiles page for details on FHIR resources.
• ​Technical Style Guide: Follow the style guide for structuring narrative content (e.g., paragraphs, tables, bullets) in XHTML.