{
  "description": "EMRN Electronic Product Information Implementation Guide",
  "_filename": "ImplementationGuide-EUePI.json",
  "package_name": "eu.epi.february2025b",
  "definition": {
    "page": {
      "name": "toc.html",
      "page": [ {
        "name": "index.html",
        "title": "Home",
        "sourceUrl": "index.html",
        "generation": "markdown"
      } ],
      "title": "Table of Contents",
      "sourceUrl": "toc.html",
      "generation": "html"
    },
    "resource": [ {
      "name": "01 Document Type Code System",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "CodeSystem"
      } ],
      "isExample": false,
      "reference": {
        "reference": "CodeSystem/100000155531"
      },
      "description": "EU EPI document type code system, defined in EMA's Referentials Management Service."
    }, {
      "name": "01 Document Type Value Set",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ValueSet"
      } ],
      "isExample": false,
      "reference": {
        "reference": "ValueSet/EUepidocumenttypesVs"
      },
      "description": "EU EPI document type value set, defined in EMA's Referentials Management Service."
    }, {
      "name": "01 EU EPI Bundle",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiBundle"
      },
      "description": "This profile represents the constraints applied to the Bundle resource used in ePI, as defined by the EU ePI Common Standard. ePI is composed of multiple documents (summary of product characteristics, package leaflet, etc.). Each document is represented by a Bundle with type=document."
    }, {
      "name": "02 EU EPI Composition (General)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiComposition"
      },
      "description": "This profile represents the constraints applied to the Composition resource used in ePI, as defined by the EU ePI Common Standard. The Composition captures the section headings, sub-section headings, and narrative text (For example, paragraphs, bulleted lists, tables) in an ePI document."
    }, {
      "name": "02 Section Code System",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "CodeSystem"
      } ],
      "isExample": false,
      "reference": {
        "reference": "CodeSystem/200000029659"
      },
      "description": "Section codes allowed in EU EPI document compositions, defined in EMA's Referentials Management Service."
    }, {
      "name": "02 SmPC Code Value Set",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ValueSet"
      } ],
      "isExample": false,
      "reference": {
        "reference": "ValueSet/EUepismpcqrdcodesVs"
      },
      "description": "List of section codes allowed in SmPC documents, defined in EMA's Referentials Management Service."
    }, {
      "name": "03 Annex II Code Value Set",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ValueSet"
      } ],
      "isExample": false,
      "reference": {
        "reference": "ValueSet/EUepiannexqrdcodesVs"
      },
      "description": "List of section codes allowed in Annex II documents, defined in EMA's Referentials Management Service."
    }, {
      "name": "03 EU EPI Composition (SmPC documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiCompositionSmPC"
      },
      "description": "This profile represents the constraints applied to SmPC documents."
    }, {
      "name": "04 EU EPI Composition (Annex II documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiCompositionAnnexII"
      },
      "description": "This profile represents the constraints applied to Annex II documents."
    }, {
      "name": "04 Labelling Code Value Set",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ValueSet"
      } ],
      "isExample": false,
      "reference": {
        "reference": "ValueSet/EUepilabellingcodesVs"
      },
      "description": "List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service."
    }, {
      "name": "05 EU EPI Composition (Labelling documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiCompositionLabeling"
      },
      "description": "This profile represents the constraints applied to Labelling documents."
    }, {
      "name": "05 PL Code Value Set",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ValueSet"
      } ],
      "isExample": false,
      "reference": {
        "reference": "ValueSet/EUepiplqrdcodesVs"
      },
      "description": "List of section codes allowed in Package Leaflet documents, defined in EMA's Referentials Management Service."
    }, {
      "name": "06 CAP Code Value Set",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ValueSet"
      } ],
      "isExample": false,
      "reference": {
        "reference": "ValueSet/EUepicapqrdcodesVs"
      },
      "description": "List of section codes allowed in Centrally Authorised Product (CAP) medicine documents, defined in EMA's Referentials Management Service."
    }, {
      "name": "06 EU EPI Composition (PL documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiCompositionPackageLeaflet"
      },
      "description": "This profile represents the constraints applied to Package Leaflet (PL) documents."
    }, {
      "name": "07 EU EPI Composition (CAP authorised medicines)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiCompositionCAP"
      },
      "description": "This profile represents the constraints applied to Centrally Authorised Products (CAP) Composition resources."
    }, {
      "name": "07 NAP-MRP-DCP Code Value Set",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ValueSet"
      } ],
      "isExample": false,
      "reference": {
        "reference": "ValueSet/EUepinapmrpdcpqrdcodesVs"
      },
      "description": "List of section codes allowed in Nationally Authorised Product (NAP) medicine documents, defined in EMA's Referentials Management Service."
    }, {
      "name": "08 EU EPI Composition (NAP authorised medicines)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiCompositionNAPMRPDCP"
      },
      "description": "This profile represents the constraints applied to Nationally Authorised Products (NAP) Composition resources."
    }, {
      "name": "09 EU EPI Composition (CAP SmPC documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUQRD-CAP-template-new-SmPC-en"
      },
      "description": "Profile for QRD validations of CAP SmPC EPI documents"
    }, {
      "name": "10 EU EPI Composition (CAP Annex II documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUQRD-CAP-template-new-Annex-II-en"
      },
      "description": "Profile for QRD validations of CAP Annex II EPI documents"
    }, {
      "name": "11 EU EPI Composition (CAP Labelling documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUQRD-CAP-template-new-Labeling-en"
      },
      "description": "Profile for QRD validations of CAP Labelling EPI documents."
    }, {
      "name": "12 EU EPI Composition (CAP PL documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUQRD-CAP-template-new-Package-Leaflet-en"
      },
      "description": "Profile for QRD validations of CAP Package Leaflet EPI documents."
    }, {
      "name": "13 EU EPI Composition (NAP SmPC documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUQRD-NAP-template-new-Common-SmPC-en"
      },
      "description": "Profile for QRD validations of NAP SmPC EPI documents."
    }, {
      "name": "14 EU EPI Composition (NAP Labelling documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUQRD-NAP-template-new-Common-Labeling-en"
      },
      "description": "Profile for QRD validations of NAP Labelling EPI documents."
    }, {
      "name": "15 EU EPI Composition (NAP PL documents)",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUQRD-NAP-template-new-Common-Package-Leaflet-en"
      },
      "description": "Profile for QRD validations of NAP Package Leaflet EPI documents"
    }, {
      "name": "16 EU EPI List",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:resource"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/EUEpiList"
      },
      "description": "This profile represents the constraints applied to the List resource used in ePI, as defined by the EU ePI Common Standard."
    }, {
      "name": "Authorization type extension used in List resource.",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:extension"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/ext-epi-authorization-type"
      },
      "description": "Authorization type extension used in List resource."
    }, {
      "name": "ePI Bundle example 1",
      "profile": [ "http://ema.europa.eu/fhir/StructureDefinition/EUEpiBundle" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Bundle"
      } ],
      "isExample": true,
      "reference": {
        "reference": "Bundle/b99c95f8-bb0b-ef11-9f8a-000d3aa845fb"
      },
      "description": "Example of the use of the resource"
    }, {
      "name": "ePI Composition example 1",
      "profile": [ "http://ema.europa.eu/fhir/StructureDefinition/EUEpiComposition" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Composition"
      } ],
      "isExample": true,
      "reference": {
        "reference": "Composition/fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"
      },
      "description": "Example of the use of the resource"
    }, {
      "name": "ePI List example 1",
      "profile": [ "http://ema.europa.eu/fhir/StructureDefinition/EUEpiList" ],
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "List"
      } ],
      "isExample": true,
      "reference": {
        "reference": "List/36ce77ef-bb0b-ef11-a81c-000d3aaa7e62"
      },
      "description": "Example of the use of the resource"
    }, {
      "name": "Image reference extension used in Composition resource.",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:extension"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/ext-epi-image-reference"
      },
      "description": "Image reference extension used in Composition resource."
    }, {
      "name": "Image SMPC example 1",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Binary"
      } ],
      "isExample": true,
      "reference": {
        "reference": "Binary/d15f2fb1-ca0b-ef11-9f89-7c1e5212dc19"
      },
      "description": "Example of the use of the Binary resource to store document images"
    }, {
      "name": "Image SMPC example 2",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Binary"
      } ],
      "isExample": true,
      "reference": {
        "reference": "Binary/d15f2fb1-ca0b-ef11-9f89-7c1e5212dc20"
      },
      "description": "Example of the use of the Binary resource to store document images"
    }, {
      "name": "Version number extension used in List resource.",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "StructureDefinition:extension"
      } ],
      "isExample": false,
      "reference": {
        "reference": "StructureDefinition/ext-epi-version-number"
      },
      "description": "Version number extension used in List resource."
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
      "valueCode": "hl7.fhir.uv.tools.r5#0.3.0"
    } ],
    "parameter": [ {
      "code": {
        "code": "copyrightyear",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "2024+"
    }, {
      "code": {
        "code": "releaselabel",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "ci-build"
    }, {
      "code": {
        "code": "apply-publisher",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "apply-contact",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "true"
    }, {
      "code": {
        "code": "show-inherited-invariants",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
      },
      "value": "false"
    }, {
      "code": {
        "code": "autoload-resources",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
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      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
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      "value": "input/capabilities"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
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      "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"
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        "code": "path-resource",
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      "value": "input/resources"
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      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
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      "value": "input/vocabulary"
    }, {
      "code": {
        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
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      "value": "input/maps"
    }, {
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        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
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      "value": "input/testing"
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        "code": "path-resource",
        "system": "http://hl7.org/fhir/guide-parameter-code"
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      "value": "input/history"
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        "code": "path-resource",
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      "value": "fsh-generated/resources"
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        "code": "path-pages",
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      "value": "template/config"
    }, {
      "code": {
        "code": "path-pages",
        "system": "http://hl7.org/fhir/guide-parameter-code"
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      "value": "input/images"
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        "code": "path-liquid",
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      },
      "value": "template/liquid"
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        "code": "path-liquid",
        "system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
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      "value": "input/liquid"
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        "code": "path-qa",
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        "code": "path-temp",
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      "code": {
        "code": "path-history",
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      },
      "value": "http://ema.europa.eu/fhir/history.html"
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      },
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        "code": "tabbed-snapshots",
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      "value": "true"
    } ]
  },
  "date": "2025-02-24T17:39:56+00:00",
  "publisher": "European Medicines Agency",
  "fhirVersion": [ "5.0.0" ],
  "license": "CC0-1.0",
  "dependsOn": [ {
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    "uri": "http://terminology.hl7.org/ImplementationGuide/hl7.terminology",
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    "packageId": "hl7.fhir.uv.extensions.r5"
  } ],
  "name": "EUePIImplementationGuide",
  "type": null,
  "experimental": null,
  "resourceType": "ImplementationGuide",
  "title": "European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide",
  "package_version": "1.0.0",
  "status": "active",
  "id": "4eb1b75f-e5b3-4512-999a-befe46854fff",
  "kind": null,
  "url": "http://ema.europa.eu/fhir/ImplementationGuide/EUePI",
  "version": "1.0.0",
  "packageId": "EUePI",
  "contact": [ {
    "name": "European Medicines Agency",
    "telecom": [ {
      "value": "https://ema.europa.eu/fhir",
      "system": "url"
    } ]
  }, {
    "name": "FHIR at EMA",
    "telecom": [ {
      "value": "http://ema.europa.eu/fhir",
      "system": "url"
    } ]
  } ]
}