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Narrative

Note: links and images are rebased to the (stated) source

Source1

{
  "resourceType": "CodeSystem",
  "id": "DEU-ePIL-Extended-Section-CodeSystem",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem",
  "version": "0.7.0",
  "name": "DEU_ePIL_Extended_Section_CodeSystem",
  "title": "Project specific Product Information Leaflet Section Code System",
  "status": "draft",
  "experimental": false,
  "date": "2026-05-04T10:57:06+02:00",
  "publisher": "ACS PharmaProtect GmbH",
  "contact": [
    {
      "name": "ACS PharmaProtect GmbH",
      "telecom": [
        {
          "system": "url",
          "value": "https://www.pharmaprotect.de"
        },
        {
          "system": "email",
          "value": "andreas.schaefer@wambo.com"
        }
      ]
    }
  ],
  "description": "Extensible section codes for diGItal Product Information Leaflet documents, organized by root section (QRD and Localized Sections).",
  "caseSensitive": true,
  "content": "fragment",
  "concept": [
    {
      "code": "instructions-for-use",
      "display": "Anwendungshinweise",
      "definition": "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."
    },
    {
      "code": "information-for-hcp",
      "display": "Informationen für Fachpersonal",
      "definition": "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."
    },
    {
      "code": "unclassified-approved-chapter",
      "display": "Nicht klassifiziertes genehmigtes Kapitel",
      "definition": "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."
    },
    {
      "code": "localized-sections",
      "display": "Lokalisierte Abschnitte",
      "definition": "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."
    },
    {
      "code": "general-notification",
      "display": "Allgemeiner Hinweis",
      "definition": "General hint or notice from the Marketing Authorization Holder (MAH). Display proposal: render between header and first QRD chapter."
    },
    {
      "code": "education-material",
      "display": "Schulungsmaterial",
      "definition": "List of educational materials provided for the medicinal product. Display proposal: render after the last chapter."
    },
    {
      "code": "additional-chapter",
      "display": "Weitere Kapitel",
      "definition": "Generic additional chapter code for any additional sections beyond standard QRD and EMA chapters."
    },
    {
      "code": "subsection",
      "display": "Unterabschnitt",
      "definition": "Generic subsection (can be used multiple times in any chapter)"
    }
  ]
}