Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

• Narrative Content
• XML
• JSON
• TTL

: Annotated ePI v1 (proposal)

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{
  "resourceType" : "DocumentReference",
  "id" : "docref-epi-annotated-v1",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference docref-epi-annotated-v1</b></p><a name=\"docref-epi-annotated-v1\"> </a><a name=\"hcdocref-epi-annotated-v1\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-apix-documentreference.html\">APIX Regulatory DocumentReference</a></p></div><p><b>identifier</b>: Document Set Identifier/urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc, Document Version Number Identifier/urn:uuid:8ee1964d-f23e-5dc2-8f64-7fbbc2e94416</p><p><b>version</b>: 1</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type proposed-labelling}\">Proposed Labelling</span></p><p><b>date</b>: 2027-01-11 10:00:00+0100</p><p><b>author</b>: <a href=\"Organization-org-synthpharma-ag.html\">SynthPharma AG</a></p><p><b>description</b>: </p><div><p>Proposed product information as annotated ePI, version 1: adds nausea (uncommon) to SmPC 4.8 and leaflet section 4.</p>\n</div><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style=\"display: none\">*</td><td>application/fhir+xml</td><td><a href=\"Binary-binary-epi-annotated-v1.html\">Binary: application/fhir+xml (5736 bytes base64)</a></td><td>4301</td><td><code>6cPKZV1qBKdpZA1grvBEOzE+VqA=</code></td><td>epi-annotated-v1.xml</td><td>2027-01-11 10:00:00+0100</td></tr></table></blockquote></div>"
  },
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo",
            "code" : "docsetid",
            "display" : "Document Set Identifier"
          }
        ]
      },
      "system" : "http://example.org/synthpharma/document-set-id",
      "value" : "urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc"
    },
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo",
            "code" : "docverid",
            "display" : "Document Version Number Identifier"
          }
        ]
      },
      "system" : "http://example.org/synthpharma/document-version-id",
      "value" : "urn:uuid:8ee1964d-f23e-5dc2-8f64-7fbbc2e94416"
    }
  ],
  "version" : "1",
  "status" : "current",
  "docStatus" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
        "code" : "proposed-labelling",
        "display" : "Proposed Labelling"
      }
    ]
  },
  "date" : "2027-01-11T10:00:00+01:00",
  "author" : [
    {
      🔗 "reference" : "Organization/org-synthpharma-ag",
      "display" : "SynthPharma AG"
    }
  ],
  "description" : "Proposed product information as annotated ePI, version 1: adds nausea (uncommon) to SmPC 4.8 and leaflet section 4.",
  "content" : [
    {
      "attachment" : {
        "contentType" : "application/fhir+xml",
        "url" : "Binary/binary-epi-annotated-v1",
        "size" : "4301",
        "hash" : "6cPKZV1qBKdpZA1grvBEOzE+VqA=",
        "title" : "epi-annotated-v1.xml",
        "creation" : "2027-01-11T10:00:00+01:00"
      }
    }
  ]
}