German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide
0.1.0 - ci-build

German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Data Structure Overview

This page gives a visual and textual summary of the FHIR resources used to structure an electronic Package Leaflet (ePI) document.

Visual Overview

Data Structure Diagram

📦 Key Resources

📚 Bundle

A container for all included resources that together form the electronic Package Leaflet. It wraps the entire document and links all related definitions.

🏢 Organisation

Represents the manufacturer or marketing authorisation holder, providing details such as name, address, and identifiers.

💊 MedicinalProductDefinition

Describes the conceptual product, including its name, identifiers, classification, and pharmaceutical aspects.

📦 PackagedProductDefinition

Defines packaging details, such as physical container types and product identifiers (e.g., GTIN or PPN).

🧾 Composition

​The central resource that defines the document structure and section layout using SPOR-coded headings. It acts as the main entry point for the ePI content. For details on the section structure and headings used in the Composition resource, see the Section Structure page.

This resource model is designed to ensure traceability and structure throughout the ePI lifecycle, while maintaining alignment with regulatory requirements and the HL7 FHIR standard. It leverages base resources and patterns from the Vulcan (Vulcan ePI IG) and EMA (EMA ePI IG) implementation guides, but further details and adapts them for the specific requirements of the German context and the digital pilot use case.