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
: scenario4 06 labelling comments round 2 issued
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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/Task/scenario4-06-labelling-comments-round2> a fhir:Task ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "scenario4-06-labelling-comments-round2"] ; #
fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2027-03-08T10:00:00+01:00"^^xsd:dateTime ] ;
fhir:profile ( [
fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task>
] )
] ; #
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><b>Labelling comments issued (round 2)</b></p><table class=\"grid\"><tr><th>Task</th><td>Labelling Comments (<code>labelling-comments</code>)</td></tr><tr><th>Procedure number</th><td>VAR-II-2027-0012</td></tr><tr><th>Version</th><td>1</td></tr><tr><th>Status</th><td>requested</td></tr><tr><th>Business status</th><td>Labelling Comments Issued (<code>labelling-comments-issued</code>)</td></tr><tr><th>Requester</th><td>Health Authority – Regulatory Review Division</td></tr><tr><th>Owner</th><td>SynthPharma AG</td></tr><tr><th>Group identifier</th><td>urn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be</td></tr><tr><th>Authored</th><td>2027-03-08T10:00:00+01:00</td></tr><tr><th>Last modified</th><td>2027-03-08T10:00:00+01:00</td></tr><tr><th>Based on</th><td><a href=\"Task-scenario4-01-variation-submitted.html\">scenario4-01-variation-submitted</a></td></tr><tr><th>Response due</th><td>2027-03-18T23:59:59+01:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-epi-annotated-v4.html\">Annotated ePI v4 (regulator comments, round 2)</a> <code>labelling-comments</code></li></ul><p><b>Outputs (from the owner)</b></p><p>None</p></div>"^^rdf:XMLLiteral ]
] ; #
fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"^^xsd:anyURI ] ;
fhir:code [ fhir:v "apixtaskinstance" ] ;
fhir:display [ fhir:v "APIX Task Instance ID" ]
] )
] ;
fhir:system [ fhir:v "http://example.org/health-authority/task-id"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:uuid:8a3d95f3-0eec-5411-bed1-b117622746a7" ]
] [
fhir:use [ fhir:v "official" ] ;
fhir:type [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"^^xsd:anyURI ] ;
fhir:code [ fhir:v "apixregulatorprocedureno" ] ;
fhir:display [ fhir:v "APIX Regulator Procedure Number" ]
] )
] ;
fhir:system [ fhir:v "http://example.org/health-authority/procedure-number"^^xsd:anyURI ] ;
fhir:value [ fhir:v "VAR-II-2027-0012" ]
] ) ; #
fhir:basedOn ( [
fhir:link <http://hl7.org/fhir/Task/scenario4-01-variation-submitted> ;
fhir:reference [ fhir:v "Task/scenario4-01-variation-submitted" ]
] ) ; #
fhir:groupIdentifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "http://example.org/health-authority/work-flow-group-id"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be" ]
] ; #
fhir:status [ fhir:v "requested"] ; #
fhir:businessStatus [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "labelling-comments-issued" ] ;
fhir:display [ fhir:v "Labelling Comments Issued" ]
] )
] ; #
fhir:intent [ fhir:v "proposal"] ; #
fhir:priority [ fhir:v "routine"] ; #
fhir:code [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"^^xsd:anyURI ] ;
fhir:code [ fhir:v "labelling-comments" ] ;
fhir:display [ fhir:v "Labelling Comments" ]
] )
] ; #
fhir:requestedPeriod [
fhir:start [ fhir:v "2027-03-08T10:00:00+01:00"^^xsd:dateTime ] ;
fhir:end [ fhir:v "2027-03-18T23:59:59+01:00"^^xsd:dateTime ]
] ; #
fhir:authoredOn [ fhir:v "2027-03-08T10:00:00+01:00"^^xsd:dateTime] ; #
fhir:lastModified [ fhir:v "2027-03-08T10:00:00+01:00"^^xsd:dateTime] ; #
fhir:requester [
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:owner [
fhir:link <http://hl7.org/fhir/Organization/org-synthpharma-ag> ;
fhir:reference [ fhir:v "Organization/org-synthpharma-ag" ] ;
fhir:display [ fhir:v "SynthPharma AG" ]
] ; #
fhir:input ( [
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:value [
a fhir:Reference ;
fhir:link <http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v4> ;
fhir:reference [ fhir:v "DocumentReference/docref-epi-annotated-v4" ] ;
fhir:display [ fhir:v "Annotated ePI v4 (regulator comments, round 2)" ]
]
] ) . #
<http://hl7.org/fhir/Task/scenario4-01-variation-submitted> a fhir:Task .
<http://hl7.org/fhir/Organization/org-ema-srm-hmed> a fhir:Organization .
<http://hl7.org/fhir/Organization/org-synthpharma-ag> a fhir:Organization .
<http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v4> a fhir:DocumentReference .
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