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 05 labelling comments round 1 answered with a counter-proposal
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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/scenario4-05-labelling-comments-round1-response> a fhir:Task ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "scenario4-05-labelling-comments-round1-response"] ; #
fhir:meta [
fhir:versionId [ fhir:v "2" ] ;
fhir:lastUpdated [ fhir:v "2027-03-01T16:30:00+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>Counter-proposal received (round 1)</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>2</td></tr><tr><th>Status</th><td>completed</td></tr><tr><th>Business status</th><td>Counter-Proposal Received (<code>counter-proposal-received</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>2027-02-22T10:00:00+01:00</td></tr><tr><th>Last modified</th><td>2027-03-01T16:30:00+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>2027-03-04T23:59:59+01:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-epi-annotated-v2.html\">Annotated ePI v2 (regulator comments, round 1)</a> <code>labelling-comments</code></li></ul><p><b>Outputs (from the owner)</b></p><ul><li><a href=\"DocumentReference-docref-epi-annotated-v3.html\">Annotated ePI v3 (counter-proposal, round 1)</a> <code>proposed-labelling</code></li><li><a href=\"DocumentReference-docref-epi-clean-v3.html\">Clean ePI v3 (counter-proposal, round 1)</a> <code>epi-bundle</code></li></ul></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:8d04eb3f-cad1-5a30-aa90-894f6ea36577" ]
] [
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 "completed"] ; #
fhir:businessStatus [
fhir:coding ( [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "counter-proposal-received" ] ;
fhir:display [ fhir:v "Counter-Proposal Received" ]
] )
] ; #
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 "2027-02-22T10:00:00+01:00"^^xsd:dateTime ] ;
fhir:end [ fhir:v "2027-03-04T23:59:59+01:00"^^xsd:dateTime ]
] ; #
fhir:executionPeriod [
fhir:start [ fhir:v "2027-02-22T10:20:00+01:00"^^xsd:dateTime ] ;
fhir:end [ fhir:v "2027-03-01T16:30:00+01:00"^^xsd:dateTime ]
] ; #
fhir:authoredOn [ fhir:v "2027-02-22T10:00:00+01:00"^^xsd:dateTime] ; #
fhir:lastModified [ fhir:v "2027-03-01T16:30:00+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-v2> ;
fhir:reference [ fhir:v "DocumentReference/docref-epi-annotated-v2" ] ;
fhir:display [ fhir:v "Annotated ePI v2 (regulator comments, round 1)" ]
]
] ) ; #
fhir:output ( [
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 "proposed-labelling" ] ;
fhir:display [ fhir:v "Proposed Labelling" ]
] )
] ;
fhir:value [
a fhir:Reference ;
fhir:link <http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v3> ;
fhir:reference [ fhir:v "DocumentReference/docref-epi-annotated-v3" ] ;
fhir:display [ fhir:v "Annotated ePI v3 (counter-proposal, round 1)" ]
]
] [
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 "epi-bundle" ] ;
fhir:display [ fhir:v "ePI Bundle" ]
] )
] ;
fhir:value [
a fhir:Reference ;
fhir:link <http://hl7.org/fhir/DocumentReference/docref-epi-clean-v3> ;
fhir:reference [ fhir:v "DocumentReference/docref-epi-clean-v3" ] ;
fhir:display [ fhir:v "Clean ePI v3 (counter-proposal, round 1)" ]
]
] ) . #
<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-v2> a fhir:DocumentReference .
<http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v3> a fhir:DocumentReference .
<http://hl7.org/fhir/DocumentReference/docref-epi-clean-v3> a fhir:DocumentReference .
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