{
  "description": "German (DEU) Electronic Product Information (ePI) Product Information Leaflet (PIL) Implementation Guide",
  "_filename": "ImplementationGuide-DEU-ePI-PIL.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 LeafletComposition 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, ENR_ID), 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"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/DEU-ePIL-Composition"
      },
      "description": "This profile represents the constraints applied to Product Information Leaflet (PIL) documents."
    }, {
      "name": "06 - DEU ePIL Extended QRD CAP Template (German)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/DEU-ePIL-Extendend-QRD-CAP-template-de"
      },
      "description": "This profile represents the constraints from QRD rules applied to the Composition resource used in ePILs extended by custom chapter sections."
    }, {
      "name": "21792f15-0c33-4764-aa6f-7945c986241c",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Bundle"
      } ],
      "isExample": true,
      "reference": {
        "reference": "Bundle/21792f15-0c33-4764-aa6f-7945c986241c"
      }
    }, {
      "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": "WINREVAIR 45 mg/-60 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Datenpumpe (Bundle)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Bundle"
      } ],
      "reference": {
        "reference": "Bundle/TmpGI"
      }
    }, {
      "name": "Gebrauchsinformation: Informationen für Anwender (Bundle)",
      "profile": [ "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-PackagedProductDefinition", "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Bundle", "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePI-PIL-Composition", "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-MedicinalProductDefinition", "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Extended-QRD-CAP-template-de", "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Organization" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Bundle"
      } ],
      "reference": {
        "reference": "Bundle/dc2f861c-d1d1-420b-a171-dba26086cb58"
      }
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
      "valueCode": "hl7.fhir.uv.tools.r5#0.5.0"
    } ],
    "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": "jira-code",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "none"
    }, {
      "code": {
        "code": "validation",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "allow-any-extensions"
    }, {
      "code": {
        "code": "tx-server",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "https://tx.fhir.org"
    }, {
      "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"
      },
      "value": "true"
    }, {
      "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"
    }, {
      "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": "2025-09-05T15:36:41+02:00",
  "publisher": "ACS PharmaProtect GmbH",
  "fhirVersion": [ "5.0.0" ],
  "license": "CC0-1.0",
  "dependsOn": [ {
    "id": "hl7ext",
    "uri": "http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions",
    "version": "5.3.0-ballot-tc1",
    "extension": [ {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
      "valueMarkdown": "Automatically added as a dependency - all IGs depend on the HL7 Extension Pack"
    } ],
    "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"
  }, {
    "id": "hl7_terminology_r5",
    "uri": "http://terminology.hl7.org",
    "version": "6.3.0",
    "packageId": "hl7.terminology.r5"
  } ],
  "name": "DEU_ePI_PIl_ImplementationGuide",
  "type": null,
  "experimental": null,
  "resourceType": "ImplementationGuide",
  "title": "German (DEU) Electronic Product Information (ePI) Product Information Leaflet (PIL) Implementation Guide",
  "package_version": "0.2.0",
  "status": "draft",
  "id": "04030a2a-531e-43a9-9780-78c46213932a",
  "kind": null,
  "url": "http://fhir.pharmaprotect.de/digital/epil-fhir-ig/ImplementationGuide/DEU-ePI-PIL",
  "version": "0.2.0",
  "packageId": "DEU-ePI-PIL",
  "contact": [ {
    "name": "ACS PharmaProtect GmbH",
    "telecom": [ {
      "value": "https://www.pharmaprotect.de",
      "system": "url"
    }, {
      "value": "andreas.schaefer@wambo.com",
      "system": "email"
    } ]
  } ]
}