German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
0.7.0 - ci-build

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

: Project specific Product Information Leaflet Section Code System - TTL Representation

Draft as of 2026-05-04

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "DEU-ePIL-Extended-Section-CodeSystem"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem DEU-ePIL-Extended-Section-CodeSystem</b></p><a name=\"DEU-ePIL-Extended-Section-CodeSystem\"> </a><a name=\"hcDEU-ePIL-Extended-Section-CodeSystem\"> </a><p>This case-sensitive code system <code>http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem</code> provides <b>a fragment</b> that includes following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">instructions-for-use<a name=\"DEU-ePIL-Extended-Section-CodeSystem-instructions-for-use\"> </a></td><td>Anwendungshinweise</td><td>Instructions for Use section for diGItal Product Information Leaflets. Temporary code until official QRD Rev. 11 SPOR code is available; remains as ACS code for QRD 10.4.</td></tr><tr><td style=\"white-space:nowrap\">information-for-hcp<a name=\"DEU-ePIL-Extended-Section-CodeSystem-information-for-hcp\"> </a></td><td>Informationen für Fachpersonal</td><td>Information for healthcare professionals section for diGItal Product Information Leaflets. Temporary code until official QRD Rev. 11 SPOR code is available; remains as ACS code for QRD 10.4.</td></tr><tr><td style=\"white-space:nowrap\">unclassified-approved-chapter<a name=\"DEU-ePIL-Extended-Section-CodeSystem-unclassified-approved-chapter\"> </a></td><td>Nicht klassifiziertes genehmigtes Kapitel</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">localized-sections<a name=\"DEU-ePIL-Extended-Section-CodeSystem-localized-sections\"> </a></td><td>Lokalisierte Abschnitte</td><td>Root section for optional, country- and project-specific content that extends the standard QRD template. Content in this section has no rendering obligation — display proposals are documented in the IG.</td></tr><tr><td style=\"white-space:nowrap\">general-notification<a name=\"DEU-ePIL-Extended-Section-CodeSystem-general-notification\"> </a></td><td>Allgemeiner Hinweis</td><td>General hint or notice from the Marketing Authorization Holder (MAH). Display proposal: render between header and first QRD chapter.</td></tr><tr><td style=\"white-space:nowrap\">education-material<a name=\"DEU-ePIL-Extended-Section-CodeSystem-education-material\"> </a></td><td>Schulungsmaterial</td><td>List of educational materials provided for the medicinal product. Display proposal: render after the last chapter.</td></tr><tr><td style=\"white-space:nowrap\">additional-chapter<a name=\"DEU-ePIL-Extended-Section-CodeSystem-additional-chapter\"> </a></td><td>Weitere Kapitel</td><td>Generic additional chapter code for any additional sections beyond standard QRD and EMA chapters.</td></tr><tr><td style=\"white-space:nowrap\">subsection<a name=\"DEU-ePIL-Extended-Section-CodeSystem-subsection\"> </a></td><td>Unterabschnitt</td><td>Generic subsection (can be used multiple times in any chapter)</td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"^^xsd:anyURI ;
fhir:l <http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem>
  ] ; # 
  fhir:version [ fhir:v "0.7.0"] ; # 
  fhir:name [ fhir:v "DEU_ePIL_Extended_Section_CodeSystem"] ; # 
  fhir:title [ fhir:v "Project specific Product Information Leaflet Section Code System"] ; # 
  fhir:status [ fhir:v "draft"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2026-05-04T08:58:29+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "ACS PharmaProtect GmbH"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "ACS PharmaProtect GmbH" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://www.pharmaprotect.de" ]     ] [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "andreas.schaefer@wambo.com" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Extensible section codes for diGItal Product Information Leaflet documents, organized by root section (QRD and Localized Sections)."] ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "fragment"] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "instructions-for-use" ] ;
fhir:display [ fhir:v "Anwendungshinweise" ] ;
fhir:definition [ fhir:v "Instructions for Use section for diGItal Product Information Leaflets. Temporary code until official QRD Rev. 11 SPOR code is available; remains as ACS code for QRD 10.4." ]
  ] [
fhir:code [ fhir:v "information-for-hcp" ] ;
fhir:display [ fhir:v "Informationen für Fachpersonal" ] ;
fhir:definition [ fhir:v "Information for healthcare professionals section for diGItal Product Information Leaflets. Temporary code until official QRD Rev. 11 SPOR code is available; remains as ACS code for QRD 10.4." ]
  ] [
fhir:code [ fhir:v "unclassified-approved-chapter" ] ;
fhir:display [ fhir:v "Nicht klassifiziertes genehmigtes Kapitel" ] ;
fhir:definition [ fhir:v "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." ]
  ] [
fhir:code [ fhir:v "localized-sections" ] ;
fhir:display [ fhir:v "Lokalisierte Abschnitte" ] ;
fhir:definition [ fhir:v "Root section for optional, country- and project-specific content that extends the standard QRD template. Content in this section has no rendering obligation — display proposals are documented in the IG." ]
  ] [
fhir:code [ fhir:v "general-notification" ] ;
fhir:display [ fhir:v "Allgemeiner Hinweis" ] ;
fhir:definition [ fhir:v "General hint or notice from the Marketing Authorization Holder (MAH). Display proposal: render between header and first QRD chapter." ]
  ] [
fhir:code [ fhir:v "education-material" ] ;
fhir:display [ fhir:v "Schulungsmaterial" ] ;
fhir:definition [ fhir:v "List of educational materials provided for the medicinal product. Display proposal: render after the last chapter." ]
  ] [
fhir:code [ fhir:v "additional-chapter" ] ;
fhir:display [ fhir:v "Weitere Kapitel" ] ;
fhir:definition [ fhir:v "Generic additional chapter code for any additional sections beyond standard QRD and EMA chapters." ]
  ] [
fhir:code [ fhir:v "subsection" ] ;
fhir:display [ fhir:v "Unterabschnitt" ] ;
fhir:definition [ fhir:v "Generic subsection (can be used multiple times in any chapter)" ]
  ] ) . #