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 v2 (regulator comments, round 1)

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{
  "resourceType" : "DocumentReference",
  "id" : "docref-epi-annotated-v2",
  "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-v2</b></p><a name=\"docref-epi-annotated-v2\"> </a><a name=\"hcdocref-epi-annotated-v2\"> </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:888a24fe-5349-56ad-bcd4-d5181ab7dc71</p><p><b>version</b>: 2</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 labelling-comments}\">Labelling Comments</span></p><p><b>date</b>: 2027-02-22 10:00:00+0100</p><p><b>author</b>: <a href=\"Organization-org-ema-srm-hmed.html\">Health Authority – Regulatory Review Division</a></p><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Target</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/document-relationship-type replaces}\">Replaces</span></td><td><a href=\"DocumentReference-docref-epi-annotated-v1.html\">DocumentReference: identifier = Document Set Identifier: urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc,Document Version Number Identifier: urn:uuid:8ee1964d-f23e-5dc2-8f64-7fbbc2e94416; version = 1; status = current; docStatus = final; type = Proposed Labelling; date = 2027-01-11 10:00:00+0100; description = Proposed product information as annotated ePI, version 1: adds nausea (uncommon) to SmPC 4.8 and leaflet section 4.</a></td></tr></table><p><b>description</b>: </p><div><p>Regulator's tracked changes on v1: nausea frequency raised to common; intake with food required (SmPC 4.2, leaflet section 3).</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-v2.html\">Binary: application/fhir+xml (6404 bytes base64)</a></td><td>4802</td><td><code>8jcYmg+KSvZyKEK5Kw4HBKCUVRQ=</code></td><td>epi-annotated-v2.xml</td><td>2027-02-22 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/health-authority/document-version-id",
      "value" : "urn:uuid:888a24fe-5349-56ad-bcd4-d5181ab7dc71"
    }
  ],
  "version" : "2",
  "status" : "current",
  "docStatus" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type",
        "code" : "labelling-comments",
        "display" : "Labelling Comments"
      }
    ]
  },
  "date" : "2027-02-22T10:00:00+01:00",
  "author" : [
    {
      🔗 "reference" : "Organization/org-ema-srm-hmed",
      "display" : "Health Authority – Regulatory Review Division"
    }
  ],
  "relatesTo" : [
    {
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/document-relationship-type",
            "code" : "replaces",
            "display" : "Replaces"
          }
        ]
      },
      "target" : {
        🔗 "reference" : "DocumentReference/docref-epi-annotated-v1"
      }
    }
  ],
  "description" : "Regulator's tracked changes on v1: nausea frequency raised to common; intake with food required (SmPC 4.2, leaflet section 3).",
  "content" : [
    {
      "attachment" : {
        "contentType" : "application/fhir+xml",
        "url" : "Binary/binary-epi-annotated-v2",
        "size" : "4802",
        "hash" : "8jcYmg+KSvZyKEK5Kw4HBKCUVRQ=",
        "title" : "epi-annotated-v2.xml",
        "creation" : "2027-02-22T10:00:00+01:00"
      }
    }
  ]
}