{
  "description": "German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide",
  "_filename": "ImplementationGuide-DEU-ePIL.json",
  "package_name": "acs.ig.epi.pl.deu",
  "definition": {
    "page": {
      "name": "toc.html",
      "page": [ {
        "name": "index.html",
        "title": "Home",
        "sourceUrl": "index.html",
        "generation": "markdown"
      }, {
        "name": "data-structure.html",
        "title": "Data Structure Overview",
        "sourceUrl": "data-structure.html",
        "generation": "markdown"
      }, {
        "name": "package-leaflet-composition.html",
        "title": "Product Information Leaflet Composition Sections (QRD/SPOR-aligned)",
        "sourceUrl": "package-leaflet-composition.html",
        "generation": "markdown"
      } ],
      "title": "Table of Contents",
      "sourceUrl": "toc.html",
      "generation": "html"
    },
    "resource": [ {
      "name": "01 - DEU ePIL Bundle",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/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."
    }, {
      "name": "02 - DEU ePIL Organization",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/DEU-ePIL-Organization"
      },
      "description": "Defines the Organization resource for the Marketing Authorization Holder (MAH) including identifier, name, and contact information."
    }, {
      "name": "03 - DEU ePIL Medicinal Product Definition",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/DEU-ePIL-MedicinalProductDefinition"
      },
      "description": "Defines the MedicinalProductDefinition resource, including the product name, active ingredients, classification, and dose form, based on the specified SPOR coding system."
    }, {
      "name": "04 - DEU ePIL Packaged Product Definition",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/DEU-ePIL-PackagedProductDefinition"
      },
      "description": "Defines the PackagedProductDefinition resource, including packaging identifiers (GTIN, PZN), name, and quantity of contained items."
    }, {
      "name": "05 - DEU ePIL Composition (Product Information Leaflet)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource:abstract"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/DEU-ePIL-Composition"
      },
      "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."
    }, {
      "name": "06 - DEU ePIL Extended QRD Template (German)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/DEU-ePIL-Extended-QRD-template-de"
      },
      "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."
    }, {
      "name": "Project specific Product Information Leaflet Section Code System",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "CodeSystem"
      } ],
      "isExample": false,
      "reference": {
        "reference": "CodeSystem/DEU-ePIL-Extended-Section-CodeSystem"
      },
      "description": "Extensible section codes for diGItal Product Information Leaflet documents, supporting chapters 7 through N with flexible subsection structure."
    }, {
      "name": "Tripapolon ePIL Example (JSON)",
      "profile": [ "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Bundle" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Bundle"
      } ],
      "isExample": true,
      "reference": {
        "reference": "Bundle/21792f15-0c33-4764-aa6f-7945c986241c"
      },
      "description": "Example electronic Product Information Leaflet Bundle for Tripapolon product in JSON format"
    }, {
      "name": "Tripapolon ePIL Example (XML)",
      "profile": [ "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Bundle" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Bundle"
      } ],
      "isExample": true,
      "reference": {
        "reference": "Bundle/dc2f861c-d1d1-420b-a171-dba26086cb58"
      },
      "description": "Example electronic Product Information Leaflet Bundle for Tripapolon product in XML format"
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
      "valueCode": "hl7.fhir.uv.tools.r5#0.7.1"
    } ],
    "parameter": [ {
      "code": {
        "code": "copyrightyear",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "2025+"
    }, {
      "code": {
        "code": "releaselabel",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "ci-build"
    }, {
      "code": {
        "code": "validation",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "allow-any-extensions"
    }, {
      "code": {
        "code": "autoload-resources",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/capabilities"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/examples"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/extensions"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/models"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/operations"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/profiles"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/resources"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/vocabulary"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/maps"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/testing"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/history"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "fsh-generated/resources"
    }, {
      "code": {
        "code": "path-pages",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "template/config"
    }, {
      "code": {
        "code": "path-pages",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input/images"
    }, {
      "code": {
        "code": "path-liquid",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "template/liquid"
    }, {
      "code": {
        "code": "path-liquid",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "input/liquid"
    }, {
      "code": {
        "code": "path-qa",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "temp/qa"
    }, {
      "code": {
        "code": "path-temp",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "temp/pages"
    }, {
      "code": {
        "code": "path-output",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "output"
    }, {
      "code": {
        "code": "path-tx-cache",
        "system": "http://hl7.org/fhir/guide-parameter-code"
      },
      "value": "input-cache/txcache"
    }, {
      "code": {
        "code": "path-suppressed-warnings",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "input/ignoreWarnings.txt"
    }, {
      "code": {
        "code": "path-history",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/history.html"
    }, {
      "code": {
        "code": "template-html",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "template-page.html"
    }, {
      "code": {
        "code": "template-md",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "template-page-md.html"
    }, {
      "code": {
        "code": "apply-contact",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "apply-context",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
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      "code": {
        "code": "apply-copyright",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "apply-jurisdiction",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
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      "code": {
        "code": "apply-license",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "apply-publisher",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "apply-version",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "apply-wg",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "active-tables",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "fmm-definition",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "http://hl7.org/fhir/versions.html#maturity"
    }, {
      "code": {
        "code": "propagate-status",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "excludelogbinaryformat",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "tabbed-snapshots",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    } ]
  },
  "date": "2025-10-22T09:19:06+02:00",
  "publisher": "ACS PharmaProtect GmbH",
  "fhirVersion": [ "5.0.0" ],
  "license": "CC0-1.0",
  "dependsOn": [ {
    "id": "hl7tx",
    "uri": "http://terminology.hl7.org/ImplementationGuide/hl7.terminology",
    "version": "6.5.0",
    "extension": [ {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
      "valueMarkdown": "Automatically added as a dependency - all IGs depend on HL7 Terminology"
    } ],
    "packageId": "hl7.terminology.r5"
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    "id": "hl7ext",
    "uri": "http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions",
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      "url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
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    } ],
    "packageId": "hl7.fhir.uv.extensions.r5"
  }, {
    "id": "hl7_fhir_uv_emedicinal_product_info",
    "uri": "http://hl7.org/fhir/uv/emedicinal-product-info/ImplementationGuide/hl7.fhir.uv.emedicinal-product-info",
    "version": "1.0.0",
    "packageId": "hl7.fhir.uv.emedicinal-product-info"
  }, {
    "id": "eu_epi_february2025b",
    "uri": "http://fhir.org/packages/eu.epi.february2025b/ImplementationGuide/eu.epi.february2025b",
    "version": "1.0.0",
    "packageId": "eu.epi.february2025b"
  } ],
  "name": "DEU_ePIl_ImplementationGuide",
  "type": null,
  "experimental": null,
  "resourceType": "ImplementationGuide",
  "title": "German (DEU) electroinic Product Information Leaflet (ePIL) Implementation Guide",
  "package_version": "0.3.1",
  "status": "draft",
  "id": "61628393-308a-45ed-af02-dc3200d34664",
  "kind": null,
  "url": "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEU-ePIL",
  "version": "0.3.0",
  "packageId": "DEU-ePIL",
  "contact": [ {
    "name": "ACS PharmaProtect GmbH",
    "telecom": [ {
      "value": "https://www.pharmaprotect.de",
      "system": "url"
    }, {
      "value": "andreas.schaefer@wambo.com",
      "system": "email"
    } ]
  } ]
}