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 2

This page describes how to create an ePI Type 2 document.

What is ePI Type 2?

ePI Type 2 adds product and organizational details 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 2 uses the following FHIR resources:

• Bundle: The container for the ePI document.
• Composition: Organizes the narrative content (e.g., ePI sections).
• Binary: Stores media (e.g., Base64-encoded images).
• MedicinalProductDefinition: Describes the medicinal product.
• Organization: Details entities involved (e.g., manufacturer, regulator).
• RegulatedAuthorization: Specifies regulatory approvals.
• ManufacturedItemDefinition: Describes the manufactured product form.
• AdministrableProductDefinition: Details the administrable form of the product.
• PackagedProductDefinition: Describes the packaging details.
• Ingredient: Specifies the product’s ingredients.
• Substance: Details substances in the product.

The following figure shows how the ePI Type 2 resources relate to each other:

Detailed Component Descriptions

The table below describes each resource’s purpose, key fields, and role in ePI Type 2:

Resource	Purpose	Key Fields	Role in ePI Type 2
Bundle	Container for the ePI, grouping all resources.	- type: Set to document. - entry: References to Composition, MedicinalProductDefinition, etc. - identifier: Unique ID for the ePI.	Packages all components into a single, interoperable document.
Composition	Organizes the narrative content of the ePI.	- language: Language code (e.g., en). - section: Structured sections (e.g., usage instructions, side effects). - title: ePI title. - author: Reference to Organization.	Provides the main narrative content (e.g., paragraphs, tables, bulleted lists) and section headings.
MedicinalProductDefinition	Describes the medicinal product.	- name: Product name. - ingredient: Active ingredients. - indication: Approved uses. - identifier: Product ID.	Defines the product the ePI describes, ensuring accurate referencing.
Organization	Details entities involved with the product.	- name: Organization name. - contact: Contact details. - identifier: Unique ID (e.g., DUNS number).	Identifies the manufacturer, regulator, or other entities for compliance.
RegulatedAuthorization	Specifies regulatory approvals for the product.	- identifier: Authorization ID. - subject: Reference to MedicinalProductDefinition. - holder: Reference to Organization. - status: Approval status (e.g., active).	Documents regulatory approval details, critical for patient trust.
ManufacturedItemDefinition	Describes the manufactured form of the product.	- manufacturedDoseForm: Form (e.g., tablet, liquid). - unitOfPresentation: Presentation unit (e.g., tablet). - manufacturer: Reference to Organization.	Details the physical product form, relevant for patient instructions.
AdministrableProductDefinition	Details the administrable form of the product.	- administrableDoseForm: Form (e.g., oral solution). - routeOfAdministration: Administration route (e.g., oral). - ingredient: Reference to Ingredient.	Specifies how the product is administered, guiding patient usage.
PackagedProductDefinition	Describes the product’s packaging.	- package: Packaging details (e.g., blister pack). - quantity: Number of units. - containedItem: Reference to ManufacturedItemDefinition.	Provides packaging information for patient reference.
Ingredient	Specifies the product’s ingredients.	- substance: Reference to Substance. - role: Role (e.g., active ingredient). - strength: Ingredient strength.	Lists ingredients for patient awareness (e.g., allergens).
Substance	Details substances in the product.	- code: Substance code (e.g., from SNOMED CT). - description: Substance description.	Provides detailed substance information, linked to Ingredient.
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 ePI.

Steps to Build an ePI Type 2 Document

The following table provides step-by-step instructions to create an ePI Type 2 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 ePI requirements (e.g., EMA guidelines).
Step 2: Define the Medicinal Product	Create a resource for the product details.	- Create a MedicinalProductDefinition resource. - Populate fields like name, ingredient, and indication. - Assign a unique identifier.
Step 3: Add Organizations	Document involved entities.	- Create an Organization resource for each entity (e.g., manufacturer, regulator). - Include name, contact, and identifier.
Step 4: Specify Regulatory Authorization	Document the product’s regulatory approvals.	- Create a RegulatedAuthorization resource. - Set identifier, subject (reference to MedicinalProductDefinition), and holder (reference to Organization). - Include status (e.g., active).
Step 5: Define Manufactured Item	Describe the manufactured product form.	- Create a ManufacturedItemDefinition resource. - Set manufacturedDoseForm and unitOfPresentation. - Reference the manufacturer (Organization).
Step 6: Define Administrable Product	Detail the administrable form of the product.	- Create an AdministrableProductDefinition resource. - Set administrableDoseForm and routeOfAdministration. - Reference ingredient (Ingredient resource).
Step 7: Define Packaging	Describe the product’s packaging.	- Create a PackagedProductDefinition resource. - Set package and quantity. - Reference containedItem (ManufacturedItemDefinition).
Step 8: Specify Ingredients and Substances	Document the product’s ingredients and substances.	- Create an Ingredient resource for each ingredient. - Set substance (reference to Substance) and strength. - Create a Substance resource with code and description.
Step 9: Create ePI Content	Develop the patient-focused content of the ePI.	- 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., usage instructions, side effects). - Reference the MedicinalProductDefinition and Organization.
Step 10: Include Media	Add images or other media to the ePI.	- 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 11: Bundle the Resources	Combine all resources into a single document.	- Create a Bundle resource with type set to document. - Add entry elements for Composition, MedicinalProductDefinition, Organization, RegulatedAuthorization, ManufacturedItemDefinition, AdministrableProductDefinition, PackagedProductDefinition, Ingredient, Substance, and Binary. - Assign a unique identifier to the Bundle.
Step 12: Validate and Test	Ensure the ePI 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.

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.