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 3 document.
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.
ePI Type 3 uses the following FHIR resources to structure the clinical use document:
The following figure shows how the ePI Type 3 resources relate to each other:
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. |
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). |