Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

: bundle-epi-type1-example

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{
  "resourceType" : "Bundle",
  "id" : "bundle-epi-type1-example",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type1"
    ]
  },
  "language" : "en",
  "identifier" : {
    "system" : "http://ema.europa.eu/fhir/epiDocument",
    "value" : "b99c95f8-bb0b-ef11-9f8a-000d3aa845fb"
  },
  "type" : "document",
  "timestamp" : "2024-05-08T09:21:26.034+00:00",
  "entry" : [
    {
      "fullUrl" : "urn:uuid:fe63fd6a-afe8-4b61-a203-0cf4a69ffb60",
      "resource" : {
        "resourceType" : "Composition",
        "id" : "fe63fd6a-afe8-4b61-a203-0cf4a69ffb60",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
          ]
        },
        "language" : "en",
        "text" : {
          "status" : "additional",
          "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><a name=\"Composition_fe63fd6a-afe8-4b61-a203-0cf4a69ffb60\"> </a>electronic Product Information (ePI) document</div>"
        },
        "contained" : [
          {
            "resourceType" : "Binary",
            "id" : "d15f2fb1-ca0b-ef11-9f89-7c1e5212dc19",
            "contentType" : "image/png",
            "data" : "iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg=="
          }
        ],
        "identifier" : [
          {
            "system" : "http://ema.europa.eu/fhir/epiComposition",
            "value" : "fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"
          }
        ],
        "status" : "final",
        "type" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/v1/lists/100000155531",
              "code" : "100000155538",
              "display" : "B. PACKAGE LEAFLET"
            }
          ]
        },
        "subject" : [
          {
            "reference" : "MedicinalProductDefinition/medprod-example"
          }
        ],
        "date" : "2024-05-08T09:21:26.034+00:00",
        "author" : [
          {
            "reference" : "Organization/mah-example"
          }
        ],
        "title" : "Humira 20 mg solution for injection in pre-filled syringe (market authorization)",
        "section" : [
          {
            "title" : "B. PACKAGE LEAFLET",
            "code" : {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/v1/lists/100000155531",
                  "code" : "100000155538",
                  "display" : "B. PACKAGE LEAFLET"
                }
              ]
            },
            "text" : {
              "status" : "additional",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Package Leaflet Text</div>"
            }
          }
        ]
      }
    }
  ]
}