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
: Annotated ePI v2 (regulator comments, round 1)
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
<http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v2> a fhir:DocumentReference ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "docref-epi-annotated-v2"] ; #
fhir:meta [
fhir:profile ( [
fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference>
] )
] ; #
fhir:language [ fhir:v "en"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
] ; #
fhir:identifier ( [
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"^^xsd:anyURI ] ;
fhir:code [ fhir:v "docsetid" ] ;
fhir:display [ fhir:v "Document Set Identifier" ]
] )
] ;
fhir:system [ fhir:v "http://example.org/synthpharma/document-set-id"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc" ]
] [
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"^^xsd:anyURI ] ;
fhir:code [ fhir:v "docverid" ] ;
fhir:display [ fhir:v "Document Version Number Identifier" ]
] )
] ;
fhir:system [ fhir:v "http://example.org/health-authority/document-version-id"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:uuid:888a24fe-5349-56ad-bcd4-d5181ab7dc71" ]
] ) ; #
fhir:version [ fhir:v "2"] ; #
fhir:status [ fhir:v "current"] ; #
fhir:docStatus [ fhir:v "final"] ; #
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "labelling-comments" ] ;
fhir:display [ fhir:v "Labelling Comments" ]
] )
] ; #
fhir:date [ fhir:v "2027-02-22T10:00:00+01:00"^^xsd:dateTime] ; #
fhir:author ( [
fhir:link <http://hl7.org/fhir/Organization/org-ema-srm-hmed> ;
fhir:reference [ fhir:v "Organization/org-ema-srm-hmed" ] ;
fhir:display [ fhir:v "Health Authority – Regulatory Review Division" ]
] ) ; #
fhir:relatesTo ( [
fhir:code [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/document-relationship-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "replaces" ] ;
fhir:display [ fhir:v "Replaces" ]
] )
] ;
fhir:target [
fhir:link <http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v1> ;
fhir:reference [ fhir:v "DocumentReference/docref-epi-annotated-v1" ]
]
] ) ; #
fhir:description [ fhir:v "Regulator's tracked changes on v1: nausea frequency raised to common; intake with food required (SmPC 4.2, leaflet section 3)."] ; #
fhir:content ( [
fhir:attachment [
fhir:contentType [ fhir:v "application/fhir+xml" ] ;
fhir:url [ fhir:v "Binary/binary-epi-annotated-v2"^^xsd:anyURI ] ;
fhir:size [ fhir:v "4802"^^xsd:long ] ;
fhir:hash [ fhir:v "8jcYmg+KSvZyKEK5Kw4HBKCUVRQ="^^xsd:base64Binary ] ;
fhir:title [ fhir:v "epi-annotated-v2.xml" ] ;
fhir:creation [ fhir:v "2027-02-22T10:00:00+01:00"^^xsd:dateTime ]
]
] ) . #
<http://hl7.org/fhir/Organization/org-ema-srm-hmed> a fhir:Organization .
<http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v1> a fhir:DocumentReference .
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