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Packageacs.ig.epi.pl.deu
Resource TypeImplementationGuide
IdImplementationGuide-DEU-ePIL.json
FHIR VersionR5
Sourcehttps://simplifier.net/resolve?scope=acs.ig.epi.pl.deu@0.3.1&canonical=http://fhir.pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEU-ePIL
URLhttp://fhir.pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEU-ePIL
Version0.3.0
Statusdraft
Date2025-10-22T09:19:06+02:00
NameDEU_ePIl_ImplementationGuide
TitleGerman (DEU) electroinic Product Information Leaflet (ePIL) Implementation Guide
DescriptionGerman (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide

Resources that use this resource

No resources found


Resources that this resource uses

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Narrative

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

Generated Narrative: ImplementationGuide DEU-ePIL

DEU_ePIl_ImplementationGuide

The official URL for this implementation guide is:

http://fhir.pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEU-ePIL

German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide


Source1

{
  "resourceType": "ImplementationGuide",
  "id": "DEU-ePIL",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "url": "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEU-ePIL",
  "version": "0.3.0",
  "name": "DEU_ePIl_ImplementationGuide",
  "title": "German (DEU) electroinic Product Information Leaflet (ePIL) Implementation Guide",
  "status": "draft",
  "date": "2025-10-22T09:19:06+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": "German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide",
  "packageId": "DEU-ePIL",
  "license": "CC0-1.0",
  "fhirVersion": [
    "5.0.0"
  ],
  "dependsOn": [
    {
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      "extension": [
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          "valueMarkdown": "Automatically added as a dependency - all IGs depend on HL7 Terminology"
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      "uri": "http://terminology.hl7.org/ImplementationGuide/hl7.terminology",
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      "version": "5.2.0"
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      "uri": "http://hl7.org/fhir/uv/emedicinal-product-info/ImplementationGuide/hl7.fhir.uv.emedicinal-product-info",
      "packageId": "hl7.fhir.uv.emedicinal-product-info",
      "version": "1.0.0"
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      "packageId": "eu.epi.february2025b",
      "version": "1.0.0"
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  "definition": {
    "extension": [
      {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
        "valueCode": "hl7.fhir.uv.tools.r5#0.7.1"
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    "resource": [
      {
        "extension": [
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            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/DEU-ePIL-Bundle"
        },
        "name": "01 - DEU ePIL Bundle",
        "description": "This profile defines constraints on the EUEpiBundle to ensure a unique identifier across all Implementation Guides (GIs). All new versions of a GI must retain the same Bundle ID.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/DEU-ePIL-Organization"
        },
        "name": "02 - DEU ePIL Organization",
        "description": "Defines the Organization resource for the Marketing Authorization Holder (MAH) including identifier, name, and contact information.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/DEU-ePIL-MedicinalProductDefinition"
        },
        "name": "03 - DEU ePIL Medicinal Product Definition",
        "description": "Defines the MedicinalProductDefinition resource, including the product name, active ingredients, classification, and dose form, based on the specified SPOR coding system.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/DEU-ePIL-PackagedProductDefinition"
        },
        "name": "04 - DEU ePIL Packaged Product Definition",
        "description": "Defines the PackagedProductDefinition resource, including packaging identifiers (GTIN, PZN), name, and quantity of contained items.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource:abstract"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/DEU-ePIL-Composition"
        },
        "name": "05 - DEU ePIL Composition (Product Information Leaflet)",
        "description": "Abstract base profile for Product Information Leaflet (PIL) documents. Defines the foundational 3-level section hierarchy with flexible constraints. Cannot be used directly in instances - use concrete child profiles such as DEU_ePIL_Extended_QRD_template_de.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "StructureDefinition:resource"
          }
        ],
        "reference": {
          "reference": "StructureDefinition/DEU-ePIL-Extended-QRD-template-de"
        },
        "name": "06 - DEU ePIL Extended QRD Template (German)",
        "description": "This profile extends DEU_ePIL_Composition with detailed QRD validation rules and diGItal project-specific chapter extensions. It provides strict validation for EMA chapters 1-6 plus extensible additional chapters.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "CodeSystem"
          }
        ],
        "reference": {
          "reference": "CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"
        },
        "name": "Project specific Product Information Leaflet Section Code System",
        "description": "Extensible section codes for diGItal Product Information Leaflet documents, supporting chapters 7 through N with flexible subsection structure.",
        "isExample": false
      },
      {
        "extension": [
          {
            "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
            "valueString": "Bundle"
          }
        ],
        "reference": {
          "reference": "Bundle/21792f15-0c33-4764-aa6f-7945c986241c"
        },
        "name": "Tripapolon ePIL Example (JSON)",
        "description": "Example electronic Product Information Leaflet Bundle for Tripapolon product in JSON format",
        "isExample": true,
        "profile": [
          "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Bundle"
        ]
      },
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        ],
        "reference": {
          "reference": "Bundle/dc2f861c-d1d1-420b-a171-dba26086cb58"
        },
        "name": "Tripapolon ePIL Example (XML)",
        "description": "Example electronic Product Information Leaflet Bundle for Tripapolon product in XML format",
        "isExample": true,
        "profile": [
          "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Bundle"
        ]
      }
    ],
    "page": {
      "sourceUrl": "toc.html",
      "name": "toc.html",
      "title": "Table of Contents",
      "generation": "html",
      "page": [
        {
          "sourceUrl": "index.html",
          "name": "index.html",
          "title": "Home",
          "generation": "markdown"
        },
        {
          "sourceUrl": "data-structure.html",
          "name": "data-structure.html",
          "title": "Data Structure Overview",
          "generation": "markdown"
        },
        {
          "sourceUrl": "package-leaflet-composition.html",
          "name": "package-leaflet-composition.html",
          "title": "Product Information Leaflet Composition Sections (QRD/SPOR-aligned)",
          "generation": "markdown"
        }
      ]
    },
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          "code": "copyrightyear"
        },
        "value": "2025+"
      },
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          "code": "releaselabel"
        },
        "value": "ci-build"
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