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 3

This guide describes how to create an ePI Type 3 document.

What is ePI Type 3?

ePI Type 3 adds clinical details and structured dose to the ePI.

​For a list of all ePI components, see the ePI components page or the Artifacts/Profiles.

Overview of Resources Involved

ePI Type 3 uses the following FHIR resources to structure the clinical use document:

• Bundle: The container for the ePI document.
• Composition: Organizes the narrative content (e.g., clinical use sections).
• Binary: Stores media (e.g., Base64-encoded images).
• Product Details: Refer to Build ePI Type 2
• ClinicalUseDefinition: Specifies clinical details (e.g., indications, contraindications).
• MedicationKnowledge: Structures dosage information.

The following figure shows how the ePI Type 3 resources relate to each other:

Detailed Component Descriptions

The table below describes each resource’s purpose, key fields, and role in ePI Type 3:

Resource	Purpose	Key Fields	Role in ePI Type 3
Bundle	Container for the clinical use document, grouping all resources.	- type: Set to document. - entry: References to Composition, ClinicalUseDefinition, etc. - identifier: Unique ID for the document.	Packages all components into a single, interoperable document.
Composition	Organizes the narrative content of the clinical use document.	- language: Language code (e.g., en). - section: Structured sections (e.g., clinical use overview). - title: Document title. - author: Reference to authoring entity from ePI Type 2.	Provides a narrative summary of clinical use, complementing structured data.
ClinicalUseDefinition	Specifies clinical details, such as indications and warnings.	- type: Type of use (e.g., indication, contraindication). - indication: Disease or condition. - contraindication: Conditions where use is restricted. - interaction: Drug interactions. - undesirableEffect: Side effects. - warning: Safety warnings.	Provides structured clinical data for indications, contraindications, interactions, effects, and warnings.
MedicationKnowledge	Structures dosage information for the product.	- doseForm: Dosage form (e.g., tablet). - amount: Dosage quantity. - administrationGuidelines: Dosage instructions. - medicineClassification: Classification (e.g., ATC code).	Defines structured dosage instructions for clinical use.
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 document.

Steps to Build an ePI Type 3 Document

The following table provides step-by-step instructions to create an ePI Type 3 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 clinical use requirements (e.g., EMA guidelines).
Step 2: Define the Product Details	Reference the product details from ePI Type 2.	- Refer to the [ePI Type 2 page](./build-epi2.md) for the product’s MedicinalProductDefinition. - Ensure the product details align with clinical use information.
Step 3: Define Clinical Uses	Specify clinical details for the product.	- Create ClinicalUseDefinition resources for indications, contraindications, interactions, undesirable effects, and warnings. - Set type (e.g., indication, contraindication) and relevant details. - Reference the product details from ePI Type 2.
Step 4: Structure Dosage Information	Define structured dosage instructions.	- Create a MedicationKnowledge resource. - Set doseForm, amount, and administrationGuidelines. - Reference the product details from ePI Type 2.
Step 5: Create Narrative Content	Develop the narrative content summarizing clinical use.	- 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., clinical particulars, warnings). - Reference the authoring entity from ePI Type 2 and ClinicalUseDefinition.
Step 6: Include Media	Add images or other media to the document.	- 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 7: Bundle the Resources	Combine all resources into a single document.	- Create a Bundle resource with type set to document. - Add entry elements for Composition, ClinicalUseDefinition, MedicationKnowledge, and Binary. - Assign a unique identifier to the Bundle.
Step 8: Validate and Test	Ensure the clinical use document 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 clinical data and dosage for accuracy and regulatory compliance (e.g., EMA 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.