Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. 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

Page standards status: Informative

Highlight text changes?

ePI Type 3 focusess on Clinical Guidance. It builds upon the product identification of Type 2 by adding structured clinical data—such as indications, contraindications, and interaction alerts. This type enables Clinical Decision Support (CDS) in EMRs and mobile apps.

Structural Outline

The ePI Type 3 document is a FHIR Bundle containing the narrative, product resources (from Type 2), and a set of ClinicalUseDefinition resources.

graph TD
B[Bundle: document] --> C[Composition]
B --> MPD[MedicinalProductDefinition]
B --> CUD1[ClinicalUseDefinition: Indication]
B --> CUD2[ClinicalUseDefinition: Contraindication]
B --> MK[MedicationKnowledge: Dose Form]

subgraph "Composition Resource"
C --> S1["Section: Clinical Particulars"]
C -. "contained" .-> BI["Binary: Side Effect Image"]
end

CUD1 --> MPD
CUD2 --> MPD
MK --> MPD

Key Elements Checklist

• [Bundle]
  • id: Unique logical ID for the resource.
  • meta: Must include versionId, lastUpdated, and profile (e.g., bundle-epi-type3).
  • type: Must be set to document.
  • entry: Must include all narrative, product (Type 2), and clinical (Type 3) resources.
• [Composition]
  • section: Narrative sections should cross-reference the structured clinical definitions where appropriate.
• [ClinicalUseDefinition]
  • type: Specifies the clinical category (e.g., indication, contraindication, interaction).
  • subject: Reference to the MedicinalProductDefinition.
  • category: Clinical categorization of the use (e.g., Pregnancy, Pediatrics).
  • interaction: Details specific drug-drug or drug-food interactions.
• [MedicationKnowledge]
  • clinicalGuideline: Machine-readable dosing and usage guidelines.
  • medicineClassification: Therapeutic classification (e.g., ATC codes).

Resource & Element Details

The following table maps the additional clinical resources required for Type 3.

Resource	Purpose	Key Elements & Implementation
ClinicalUseDefinition	Direct capture of safety and usage data.	Use multiple instances for different types (Indication, Contraindication, Interaction). Link each to the MedicinalProductDefinition.
MedicationKnowledge	Computable dosing and therapeutic info.	Optional but recommended for precise dosing logic and drug classification mappings.

Conceptual Workflow

Moving to Type 3 requires clinical data extraction and alignment:

1. Clinical Coding: Identify and code indications (e.g., SNOMED CT) and contraindications.
2. Define Clinical Definitions: Create a ClinicalUseDefinition for each clinical scenario described in the narrative.
3. Link to Product: Associate all clinical resources with the MedicinalProductDefinition via the subject field.
4. Align Narrative: Ensure the Composition sections (e.g., Section 4.1) align with the structured data in the ClinicalUseDefinition resources.
5. Validate: Verify against the Type 3 Profile.

Implementation Examples

Refer to the following examples for a technical starting point:

• JSON Example: SmPC Type 3 (Clinical) (Source)
• JSON Example: PIL Type 3 (Clinical) (Source)