German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
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Section Structure QRD 11

Disclaimer: This document is based on the QRD Annotated Template v11 — Draft for Public Consultation (April 2025). QRD Rev. 11 has not yet been officially released. Section ordering and structural details documented here are preliminary and may change in the final version. Existing SPOR codes may or may not change; at minimum, new SPOR codes are expected to be added (e.g. for chapter 7 "Instructions for use" and "Information for healthcare professionals"). This page will be updated once the official template is published by EMA.

This document outlines the hierarchical section structure of the Package Leaflet based on QRD Template Revision 11 (Draft), including structural changes compared to QRD 10.4.

For general composition requirements, profile architecture, and diGItal extension chapters, see Composition Sections.

Key Structural Changes vs QRD 10.4

# Change Impact
1 Revision date + EMA ref moved from chapter 6 to header 200000029919, 200000029920 removed from chapter 6
2 Introductory bullet block entirely deleted "Do not pass it on" relocated to chapter 1
3 Table of contents now optional Was standard in 10.4
4 New optional "How X works" sub-heading Chapter 1
5 During-treatment warnings moved from chapter 2 to chapter 4 Chapters 2 and 4
6 Food & drink sub-section deleted from chapter 2, moved to chapter 3 200000029901 relocated
7 Contraception added to pregnancy sub-heading Chapter 2
8 Children-specific driving/machines advice expanded Chapter 2
9 Biological medicines batch traceability statement added Chapter 4
10 Chapter 6 heading updated to include "contact details" Chapter 6
11 New optional Chapter 7: Instructions for use After chapter 6
12 New optional Information for healthcare professionals section After chapter 7
13 Key Information Section under separate consultation Potential new section before chapter 1

Root Section: PACKAGE LEAFLET

SPOR Code: 200000029894

Header (root section narrative text)

The text element of this root section contains introductory content before the numbered chapters. In QRD 11, the header structure has changed significantly:

  • Product name, strength, pharmaceutical form, active substance(s)
  • Black triangle warning (conditional — additional monitoring only)
  • This leaflet was last revised in <{MM/YYYY}><{month YYYY}>. ← MOVED here from chapter 6
  • References to alternative formats (braille, audio, large print) and EMA website ← MOVED here from chapter 6
  • Electronic leaflet / QR code availability statement ← NEW
  • "Read all of this leaflet carefully…" ← ENTIRELY DELETED in QRD 11
  • "What is in this leaflet" — table of contents listing chapters 1-7 — now optional (was standard in 10.4)

QRD Chapters

1. Was ist X und wofür wird es angewendet? (What X is and what it is used for)

SPOR Code: 200000029895

Changes in QRD 11:

  • "Do not pass it on to others" statement relocated here from deleted introductory block (Rx only)
  • New optional "How X works" sub-heading for patient-friendly benefit summary

Subsections:

  • 200000044346 — Ebene=H3 PL benutzerdefinierter unterabschnitt (Level=H3 PL custom subsection) — Optional

2. Was sollten Sie vor der [Einnahme] [Anwendung] von X beachten? (What you need to know before you [take] [use] X)

SPOR Code: 200000029896

Changes in QRD 11:

  • Warnings now split by timing: only pre-treatment warnings remain here; during-treatment warnings moved to chapter 4
  • Food & drink sub-section (200000029901) deleted from this chapter — content moved to chapter 3
  • Pregnancy sub-heading now includes "contraception": Schwangerschaft, Stillzeit, Fortpflanzungsfähigkeit und Empfängnisverhütung
  • Children-specific driving/machines advice expanded (cycling, walking unaccompanied, concentration)

Subsections:

  • 200000029897 — X darf nicht [eingenommen] [angewendet] werden[,] (Do not [take] [use] X)
  • 200000029898 — Warnhinweise und Vorsichtsmaßnahmen (Warnings and precautions) — pre-treatment only
  • 200000029899 — Kinder [und Jugendliche] (Children [and adolescents]) — Optional
  • 200000029900 — Andere Arzneimittel und X (Other medicines and X)
  • 200000029901 — X mit Nahrungsmitteln, Getränken und Alkohol — DELETED, moved to chapter 3
  • 200000029902 — Schwangerschaft [und] [,] Stillzeit [und Fortpflanzungsfähigkeit] [und Empfängnisverhütung] (Pregnancy, breast-feeding, fertility [and contraception])
  • 200000029903 — Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen (Driving and using machines)
  • 200000029904 — X enthält {Bezeichnung [des] [der] sonstigen Bestandteil(s)(e)} (X contains {name the excipient(s)})
  • 200000044346 — Ebene=H3 PL benutzerdefinierter unterabschnitt (Level=H3 PL custom subsection) — Optional

3. Wie ist X [einzunehmen] [anzuwenden]? (How to [take] [use] X)

SPOR Code: 200000029905

Changes in QRD 11:

  • Food & drink interactions moved here from chapter 2

Subsections:

  • 200000029901 — X mit [Nahrungsmitteln], [Getränken] [und] [Alkohol] (X with food, drink and alcohol) — MOVED here from chapter 2
  • 200000029906 — Anwendung bei Kindern [und Jugendlichen] (Use in children [and adolescents]) — Optional
  • 200000029907 — Wenn Sie eine größere Menge von X [eingenommen] [angewendet] haben, als Sie sollten (If you [take] [use] more X than you should) — Optional
  • 200000029908 — Wenn Sie die [Einnahme] [Anwendung] von X vergessen haben (If you forget to [take] [use] X) — Optional
  • 200000029909 — Wenn Sie die [Einnahme] [Anwendung] von X abbrechen (If you stop [taking] [using] X) — Optional
  • 200000044346 — Ebene=H3 PL benutzerdefinierter unterabschnitt (Level=H3 PL custom subsection) — Optional

4. Welche Nebenwirkungen sind möglich? (Possible side effects)

SPOR Code: 200000029910

Changes in QRD 11:

  • Side effects now explicitly split: (1) most serious first with frequency, (2) then all others by frequency
  • During-treatment warnings relocated here from chapter 2 (with cross-reference back)
  • New optional batch traceability statement for self-administered biological medicines
  • Reporting of side effects now must appear (was "should" in 10.4)

Subsections:

  • 200000029911 — Zusätzliche Nebenwirkungen bei Kindern [und Jugendlichen] (Additional side effects in children [and adolescents]) — Optional
  • 200000029912 — Meldung von Nebenwirkungen (Reporting of side effects) — mandatory
  • 200000044346 — Ebene=H3 PL benutzerdefinierter unterabschnitt (Level=H3 PL custom subsection) — Optional

5. Wie ist X aufzubewahren? (How to store X)

SPOR Code: 200000029913

Subsections:

  • 200000044346 — Ebene=H3 PL benutzerdefinierter unterabschnitt (Level=H3 PL custom subsection) — Optional

6. Inhalt der Packung, Kontaktdaten und weitere Informationen (Contents of the pack, contact details and other information)

SPOR Code: 200000029914

Changes in QRD 11:

  • Heading updated: now includes "contact details" (Kontaktdaten)
  • 200000029919 (revision date) removed — moved to header
  • 200000029920 (other sources) removed — moved to header
  • 200000029921 (HCP info) removed — moved to separate section after chapter 7

Subsections:

  • 200000029915 — Was X enthält (What X contains)
  • 200000029916 — Wie X aussieht und Inhalt der Packung (What X looks like and contents of the pack)
  • 200000029917 — Pharmazeutischer Unternehmer und Hersteller (Marketing Authorisation Holder and Manufacturer)
  • 200000029918 — Dieses Arzneimittel ist in den Mitgliedsstaaten des EWR unter den folgenden Bezeichnungen zugelassen — Optional, NAP only
  • 200000044346 — Ebene=H3 PL benutzerdefinierter unterabschnitt (Level=H3 PL custom subsection) — Optional

7. Anwendungshinweise (Instructions for use) — NEW, optional

SPOR Code: pending (currently using ACS code instructions-for-use)

New optional chapter for two specific situations:

  1. Administration instructions are too long to fit in chapter 3
  2. Instructions relate to a medical device accompanying the medicine (e.g. auto-injector, pre-filled pen, inhaler)

Informationen für Fachpersonal (Information for healthcare professionals) — NEW, optional, separate section

SPOR Code: pending (currently using ACS code information-for-hcp)

A separate section (not a numbered chapter) after chapter 7, for:

  • Preparation, handling, posology for healthcare professionals
  • Parenteral products, hospital medicines, extemporaneous preparations
  • Two accepted approaches for SmPC inclusion: as separate document or as tear-off section

Additional Chapters (diGItal extensions, ACS codes)

In QRD 11, chapters 7 (Instructions for use) and Information for HCP are now part of the QRD template itself. The ACS codes instructions-for-use and information-for-hcp will be replaced by official SPOR codes once QRD Rev. 11 is officially released.

Until then, these ACS codes remain in use. See Composition Sections for the complete diGItal extension chapter documentation.

Unclassified Approved Chapter (Nicht klassifiziertes genehmigtes Kapitel)

Code: unclassified-approved-chapter

  • Cardinality: 0..*
  • 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