German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
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German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide - Local Development build (v0.7.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Product Information Leaflet Composition Sections (QRD/SPOR-aligned)

This document describes the overall section architecture of the Product Information Leaflet Composition, including the two root sections and the diGItal extension codes. For detailed SPOR code listings per QRD chapter, see QRD 10.4 Section Structure and QRD 11 Section Structure.

General Composition Requirements

Profile Inheritance Architecture

The FHIR Composition resource representing the Product Information Leaflet uses a profile inheritance architecture to ensure both structural flexibility and strict regulatory compliance:

Abstract Profiles (not used directly):

  1. DEU-ePIL-Composition — Base: two root sections (QRD + Localized Sections), MAH extension, metadata. Direct parent for eAAPI input profiles.
  2. DEU-ePIL-Composition-eCAPI — Output: adds section-level change marking extension, relatesTo version tracking with bidirectional invariant. Parent for eCAPI output profiles.

Concrete Profiles (eAAPI — Input, parent: DEU-ePIL-Composition):

  1. DEU-ePIL-Extended-QRD-10-4-template-de-eAAPI — QRD 10.4, strict chapter validation. All mandatory subsections enforced (1..1).
  2. DEU-ePIL-Extended-QRD-11-template-de-eAAPI — QRD 11 (Draft), strict chapter validation. Structural changes vs 10.4.

Concrete Profiles (eCAPI — Output, parent: DEU-ePIL-Composition-eCAPI):

  1. DEU-ePIL-Extended-QRD-10-4-template-de-eCAPI — QRD 10.4, relaxed subsections. Chapters 1-6 required, subsections optional (0..1). Change detection enabled.
  2. DEU-ePIL-Extended-QRD-11-template-de-eCAPI — QRD 11 (Draft), relaxed subsections. Change detection enabled.
DEU-ePIL-Composition (abstract base)
├── Two root sections: QRD (mandatory) + Localized Sections (optional)
├── MAH Organization extension (mandatory)
│
├── DEU-ePIL-Extended-QRD-10-4-template-de-eAAPI (concrete, input)
│   ├── Chapters 1-6 with mandatory subsections
│   └── ACS: instructions-for-use, information-for-hcp
│
├── DEU-ePIL-Extended-QRD-11-template-de-eAAPI (concrete, input)
│   ├── Chapters 1-6 with QRD 11 structure + mandatory subsections
│   └── ACS: instructions-for-use, information-for-hcp
│
└── DEU-ePIL-Composition-eCAPI (abstract, output)
    ├── Change detection (sectionChange extension + relatesTo)
    │
    ├── DEU-ePIL-Extended-QRD-10-4-template-de-eCAPI (concrete)
    │   ├── Chapters 1-6 required, subsections optional (0..1)
    │   └── ACS: instructions-for-use, information-for-hcp
    │
    └── DEU-ePIL-Extended-QRD-11-template-de-eCAPI (concrete)
        ├── Chapters 1-6 required, subsections optional (0..1)
        └── ACS: instructions-for-use, information-for-hcp

Section Depth

The section depth describes how many levels of section nesting exist within the Composition. Depth is counted from the QRD root section:

Composition
└── QRD Root Section (200000029894)        ← Level 1
    └── Chapter (e.g., Chapter 2)          ← Level 2
        └── Subsection (e.g., Warnings)    ← Level 3
Profile Section Depth Meaning
eAAPI (Input) 3 QRD root → chapters → subsections. All three levels are always present.
eCAPI (Output) 2 or 3 Per chapter: either chapters with full text (depth 2) or chapters with subsections (depth 3). See eCAPI Output Delivery for details.

eAAPI always require depth 3

eAAPI vs eCAPI Profile Differences

Aspect eAAPI (Input) eCAPI (Output)
Purpose Submission via electronic Author API Retrieval via electronic Consumer API
Chapters 1-6 Required (1..1) Required (1..1)
Chapter subsections Mandatory per QRD template (1..1) All optional (0..1)
Change detection Not defined sectionChange extension (0..1) at all levels
relatesTo Not defined Version replacement tracking (0..*) with bidirectional invariant
Localized Sections Optional (inherited) Optional (inherited)

Profile Usage: Instances must reference the API- and QRD-version-specific concrete profile in meta.profile:

<meta>
    <!-- eAAPI Input, QRD 10.4 -->
    <profile value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Extended-QRD-10-4-template-de-eAAPI"/>
</meta>

<meta>
    <!-- eCAPI Output, QRD 10.4 -->
    <profile value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Extended-QRD-10-4-template-de-eCAPI"/>
</meta>

The Localized Sections root section and its subsections (general-notification, education-material, additional-chapter) are defined in the abstract base and inherited by all concrete profiles.

Images in the Package Leaflet

To include images (such as pictograms or logos) in the package leaflet, use the epi-image-reference extension. Images must be added as contained Binary resources within the Bundle. Reference these images in the appropriate section(s) of the Composition using the epi-image-reference extension, which links to the contained Binary. This approach enables images to be rendered in the correct context within the electronic leaflet.

Two Root Sections

The Composition contains two root sections at the top level:

Composition
├── Section 1: QRD Section (SPOR Code: 200000029894)
│   ├── text: Header as narrative (black triangle, introductory text, table of contents)
│   ├── Chapters 1-6: EMA QRD chapters (SPOR codes)
│   ├── instructions-for-use (0..1)
│   ├── information-for-hcp (0..1)
│   └── unclassified-approved-chapter (0..*)
│
└── Section 2: Localized Sections (ACS Code: localized-sections)
    ├── general-notification (0..1)
    ├── education-material (0..1)
    └── additional-chapter (0..*)

Root Section 1: QRD Section

SPOR Code: 200000029894

The QRD root section contains all regulatory content aligned with the EMA QRD template. It includes EMA chapters 1-6 with their subsections (using SPOR codes), plus approved additional chapters specific to QRD Rev. 11.

QRD-specific Additional Chapters

These chapters extend the QRD section beyond the standard chapters 1-6 and use the DEU-ePIL-Extended-Section-CodeSystem:

Instructions for Use (Anwendungshinweise)

  • Code: instructions-for-use
  • Cardinality: 0..1
  • Note: Temporary ACS code — will be replaced by an official SPOR code once QRD Rev. 11 is released. Remains as ACS code for QRD 10.4.

Information for Healthcare Professionals (Informationen für Fachpersonal)

  • Code: information-for-hcp
  • Cardinality: 0..1
  • Note: Temporary ACS code — will be replaced by an official SPOR code once QRD Rev. 11 is released. Remains as ACS code for QRD 10.4.

Unclassified Approved Chapter (Nicht klassifiziertes genehmigtes Kapitel)

  • Code: unclassified-approved-chapter
  • Cardinality: 0..*
  • Purpose: Approved content from the PIL that is not assignable to a specific QRD section and does not fit the instructions-for-use or information-for-hcp categories.

All chapter types support subsection (0..*) for further structuring.

Root Section 2: Localized Sections

ACS Code: localized-sections

The Localized Sections root contains optional, country- and project-specific content that extends the standard QRD template. Content in this section has no rendering obligation — display proposals are documented below for renderers that choose to present this content.

Available Chapter Types

General Notification (Allgemeiner Hinweis)

  • Code: general-notification
  • Cardinality: 0..1
  • Purpose: General hint or notice from the Marketing Authorization Holder (MAH)
  • Display Proposal: Render between header and first QRD chapter

Education Material (Schulungsmaterial)

  • Code: education-material
  • Cardinality: 0..1
  • Purpose: List of educational materials provided for the medicinal product
  • Display Proposal: Render after the last QRD chapter

Additional Chapters (Weitere Kapitel)

  • Code: additional-chapter
  • Cardinality: 0..*
  • Purpose: Generic additional chapters for any content beyond standard requirements
  • Display Proposal: Render after the last QRD chapter

All chapter types support subsection (0..*) for further structuring.

CodeSystem: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem

Example: Localized Sections

<!-- Root Section 2: Localized Sections -->
<section>
    <title value="Lokalisierte Abschnitte"/>
    <code>
        <coding>
            <system value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"/>
            <code value="localized-sections"/>
        </coding>
    </code>

    <!-- General Notification -->
    <section>
        <title value="Allgemeiner Hinweis"/>
        <code>
            <coding>
                <system value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"/>
                <code value="general-notification"/>
            </coding>
        </code>
        <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">
                <p>Hinweis des pharmazeutischen Unternehmers...</p>
            </div>
        </text>
    </section>

    <!-- Education Material -->
    <section>
        <title value="Schulungsmaterial"/>
        <code>
            <coding>
                <system value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"/>
                <code value="education-material"/>
            </coding>
        </code>
        <section>
            <title value="Patientenhandbuch"/>
            <code>
                <coding>
                    <system value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"/>
                    <code value="subsection"/>
                </coding>
            </code>
        </section>
    </section>

    <!-- Additional Chapter -->
    <section>
        <title value="Weitere Informationen"/>
        <code>
            <coding>
                <system value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"/>
                <code value="additional-chapter"/>
            </coding>
        </code>
        <section>
            <title value="Kontaktinformationen"/>
            <code>
                <coding>
                    <system value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"/>
                    <code value="subsection"/>
                </coding>
            </code>
        </section>
    </section>
</section>

Implementation Notes

  • EMA Chapters 1-6: Use standard SPOR codes — see QRD 10.4 and QRD 11 for details
  • Localized Sections: Use DEU-ePIL-Extended-Section-CodeSystem with general-notification, education-material, additional-chapter, and subsection codes
  • No Rendering Obligation: Localized Sections content is entirely optional for renderers — display proposals are suggestions, not requirements
  • Profile Inheritance: Concrete profiles inherit from API-specific abstract (eAAPI/eCAPI), which inherits from DEU-ePIL-Composition base
  • Bundle References: Bundles reference the abstract base profile (DEU-ePIL-Composition), instances must use a concrete eAAPI or eCAPI profile
  • All custom subsections are optional and can be repeated as needed
  • Titles may be adapted per product, especially where placeholders like X appear