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 - XML Representation

Draft as of 2026-05-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="DEU-ePIL-Extended-Section-CodeSystem"/>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <url
       value="http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"/>
  <version value="0.7.0"/>
  <name value="DEU_ePIL_Extended_Section_CodeSystem"/>
  <title
         value="Project specific Product Information Leaflet Section Code System"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2026-05-04T08:58:29+00:00"/>
  <publisher value="ACS PharmaProtect GmbH"/>
  <contact>
    <name value="ACS PharmaProtect GmbH"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.pharmaprotect.de"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="andreas.schaefer@wambo.com"/>
    </telecom>
  </contact>
  <description
               value="Extensible section codes for diGItal Product Information Leaflet documents, organized by root section (QRD and Localized Sections)."/>
  <caseSensitive value="true"/>
  <content value="fragment"/>
  <concept>
    <code value="instructions-for-use"/>
    <display value="Anwendungshinweise"/>
    <definition
                value="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."/>
  </concept>
  <concept>
    <code value="information-for-hcp"/>
    <display value="Informationen für Fachpersonal"/>
    <definition
                value="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."/>
  </concept>
  <concept>
    <code value="unclassified-approved-chapter"/>
    <display value="Nicht klassifiziertes genehmigtes Kapitel"/>
    <definition
                value="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."/>
  </concept>
  <concept>
    <code value="localized-sections"/>
    <display value="Lokalisierte Abschnitte"/>
    <definition
                value="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."/>
  </concept>
  <concept>
    <code value="general-notification"/>
    <display value="Allgemeiner Hinweis"/>
    <definition
                value="General hint or notice from the Marketing Authorization Holder (MAH). Display proposal: render between header and first QRD chapter."/>
  </concept>
  <concept>
    <code value="education-material"/>
    <display value="Schulungsmaterial"/>
    <definition
                value="List of educational materials provided for the medicinal product. Display proposal: render after the last chapter."/>
  </concept>
  <concept>
    <code value="additional-chapter"/>
    <display value="Weitere Kapitel"/>
    <definition
                value="Generic additional chapter code for any additional sections beyond standard QRD and EMA chapters."/>
  </concept>
  <concept>
    <code value="subsection"/>
    <display value="Unterabschnitt"/>
    <definition
                value="Generic subsection (can be used multiple times in any chapter)"/>
  </concept>
</CodeSystem>