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

Package Leaflet Composition Sections (QRD/SPOR-aligned)

This document outlines the hierarchical section structure of the PACKAGE LEAFLET in alignment with SPOR codes. It includes all known headings, nested subsections, and indication of optional segments.

General Composition Requirements

Dependencies

The FHIR Composition resource representing the package leaflet must conform to the DEUePIPLCompositionPackageLeaflet profile. In addition, it is required to declare conformance to the following profiles in its meta.profile array:

This ensures alignment with both the German and EU regulatory requirements for electronic package leaflets.

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.

Sections

Root section PACKAGE LEAFLET

SPOR Code: 200000029894

Description: The root section represents the entire package leaflet document. It serves as the container for all QRD chapters and their subsections. This section may contain:

  • The full narrative content of the leaflet
  • Heading content of the package leaflet (such as product name, pharmaceutical form, strength, etc.) that appears before the first QRD chapter
  • All required and optional QRD chapters (sections 1–6)
  • Any additional regulatory or product-specific information
  • Custom subsections as needed for product-specific adaptations

All content below is structured as child sections of this root.

QRD Chapters with subsections

1. What X is and what it is used for

SPOR Code: 200000029895

  • Level=H3 PL custom subsection (Optional)
2. What you need to know before you [take] [use] X

SPOR Code: 200000029896

  • Do not [take] [use] X — 200000029897
  • Warnings and precautions — 200000029898
  • Children [and adolescents] — 200000029899
  • Other medicines and X — 200000029900
  • X with [food] [and] [,] [drink] [and] [alcohol] — 200000029901 (Optional)
  • Pregnancy [and] [,] breast-feeding [and fertility] — 200000029902
  • Driving and using machines — 200000029903
  • X contains {name the excipient(s)} — 200000029904
  • Level=H3 PL custom subsection (Optional)
3. How to [take] [use] X

SPOR Code: 200000029905

  • Use in children [and adolescents] — 200000029906 (Optional)
  • If you [take] [use] more X than you should — 200000029907
  • If you forget to [take] [use] X — 200000029908
  • If you stop [taking] [using] X — 200000029909 (Optional)
  • Level=H3 PL custom subsection (Optional)
4. Possible side effects

SPOR Code: 200000029910

  • Additional side effects in children [and adolescents] — 200000029911 (Optional)
  • Reporting of side effects — 200000029912 (Optional)
  • Level=H3 PL custom subsection (Optional)
5. How to store X

SPOR Code: 200000029913

  • Level=H3 PL custom subsection (Optional)
6. Contents of the pack and other information

SPOR Code: 200000029914

  • What X contains — 200000029915
  • What X looks like and contents of the pack — 200000029916
  • Marketing Authorisation Holder and Manufacturer — 200000029917
  • This medicine is authorised in the Member States… — 200000029918 (Optional)
  • This leaflet was last revised in… — 200000029919 (Optional)
  • Other sources of information — 200000029920 (Optional)
  • The following information is intended for healthcare professionals only — 200000029921 (Optional)
  • Level=H3 PL custom subsection (Optional)

Notes

  • All H3 "custom subsections" are optional and can be repeated as needed.
  • Titles may be adapted per product, especially where placeholders like X appear.
  • Use the appropriate SPOR code when defining Composition.section.code in FHIR.