API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build

API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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/cander2/apix-ig/ and changes regularly. See the Directory of published versions

: List-Of-Questions - TTL Representation

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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 -------------------------------------------------------------------

 a fhir:Bundle ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "List-Of-Questions"] ; # 
  fhir:type [ fhir:v "transaction"] ; # 
  fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:task-002"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:task-002> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Task"^^xsd:anyURI ]     ]
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:loq-bundle-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:loq-bundle-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Bundle"^^xsd:anyURI ]     ]
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:provenance-002"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:provenance-002> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Provenance"^^xsd:anyURI ]     ]
  ] ) . # 

<urn:uuid:task-002> a fhir:Task ;
  fhir:id [ fhir:v "task-002"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Task_task-002\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Task task-002</b></p><a name=\"task-002\"> </a><a name=\"hctask-002\"> </a><p><b>status</b>: Requested</p><p><b>intent</b>: order</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/task-code respond-to-questions}\">Respond to List of Questions</span></p><p><b>description</b>: Provide responses to the List of Questions for Type II variation (shelf life extension)</p><p><b>for</b>: <a href=\"MedicinalProductDefinition/mpd-001\">MedicinalProductDefinition/mpd-001</a></p><p><b>authoredOn</b>: 2025-06-29 17:56:00-0400</p><p><b>requester</b>: <a href=\"Organization/ema\">Organization/ema</a></p><p><b>owner</b>: <a href=\"Organization/pharma-inc\">Organization/pharma-inc</a></p></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:status [ fhir:v "requested"] ; # 
  fhir:intent [ fhir:v "order"] ; # 
  fhir:code [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/task-code"^^xsd:anyURI ] ;
fhir:code [ fhir:v "respond-to-questions" ] ;
fhir:display [ fhir:v "Respond to List of Questions" ]     ] )
  ] ; # 
  fhir:description [ fhir:v "Provide responses to the List of Questions for Type II variation (shelf life extension)"] ; # 
  fhir:for [
fhir:reference [ fhir:v "MedicinalProductDefinition/mpd-001" ]
  ] ; # 
  fhir:authoredOn [ fhir:v "2025-06-29T17:56:00-04:00"^^xsd:dateTime] ; # 
  fhir:requester [
fhir:reference [ fhir:v "Organization/ema" ]
  ] ; # 
  fhir:owner [
fhir:reference [ fhir:v "Organization/pharma-inc" ]
  ] . # 

<urn:uuid:loq-bundle-001> a fhir:Bundle ;
  fhir:id [ fhir:v "loq-bundle-001"] ; # 
  fhir:type [ fhir:v "collection"] ; # 
  fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:questionnaire-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:questionnaire-001> )
  ] ) . # 

<urn:uuid:questionnaire-001> a fhir:Questionnaire ;
  fhir:id [ fhir:v "questionnaire-001"] ; # 
  fhir:title [ fhir:v "List of Questions for Type II Variation (Shelf Life Extension)"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:item ( [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "administrative" ]       ]     ] ) ;
fhir:linkId [ fhir:v "admin-1" ] ;
fhir:text [ fhir:v "Is the fee for the Type II variation fully paid and documented?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "administrative" ]       ]     ] ) ;
fhir:linkId [ fhir:v "admin-2" ] ;
fhir:text [ fhir:v "Are all required metadata fields in the application form complete?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "labeling-storage" ]       ]     ] ) ;
fhir:linkId [ fhir:v "labeling-1" ] ;
fhir:text [ fhir:v "Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "labeling-patient-info" ]       ]     ] ) ;
fhir:linkId [ fhir:v "labeling-2" ] ;
fhir:text [ fhir:v "Is the patient leaflet revised to clarify the extended shelf life?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "labeling-clarity" ]       ]     ] ) ;
fhir:linkId [ fhir:v "labeling-3" ] ;
fhir:text [ fhir:v "Is the updated ePI text sufficiently clear for all EU languages?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "cmc-stability" ]       ]     ] ) ;
fhir:linkId [ fhir:v "cmc-1" ] ;
fhir:text [ fhir:v "Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "cmc-analytical" ]       ]     ] ) ;
fhir:linkId [ fhir:v "cmc-2" ] ;
fhir:text [ fhir:v "Are there any new stability studies conducted, or the submission includes only the data available from additional timepoints from previously submitted studies?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "cmc-impurities" ]       ]     ] ) ;
fhir:linkId [ fhir:v "cmc-3" ] ;
fhir:text [ fhir:v "Are the test methods used the same as in the previously submitted stability information?" ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "cmc-container" ]       ]     ] ) ;
fhir:linkId [ fhir:v "cmc-4" ] ;
fhir:text [ fhir:v " Are there any new degradation products identified within the newly submitted data? " ] ;
fhir:type [ fhir:v "string" ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/StructureDefinition/question-category"^^xsd:anyURI ] ;
fhir:value [
a fhir:Coding ;
fhir:system [ fhir:v "http://example.org/codes"^^xsd:anyURI ] ;
fhir:code [ fhir:v "cmc-degradation" ]       ]     ] ) ;
fhir:linkId [ fhir:v "cmc-5" ] ;
fhir:text [ fhir:v "Any changes in the packaging configuration and/or storage of the samples during stability?" ] ;
fhir:type [ fhir:v "string" ]
  ] ) . # 

<urn:uuid:provenance-002> a fhir:Provenance ;
  fhir:id [ fhir:v "provenance-002"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Provenance_provenance-002\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Provenance provenance-002</b></p><a name=\"provenance-002\"> </a><a name=\"hcprovenance-002\"> </a><p>Provenance for <a href=\"Bundle-List-Of-Questions.html#Bundle_loq-bundle-001\">Bundle: type = transaction</a></p><p>Summary</p><table class=\"grid\"><tr><td>Recorded</td><td>2025-06-29 17:56:00-0400</td></tr></table><p><b>Agents</b></p><table class=\"grid\"><tr><td><b>Type</b></td><td><b>who</b></td></tr><tr><td><span title=\"Codes:{http://hl7.org/fhir/provenance-participant-type author}\">author</span></td><td><a href=\"Organization/ema\">Organization/ema</a></td></tr></table></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:target ( [
fhir:reference [ fhir:v "Bundle/loq-bundle-001" ]
  ] ) ; # 
  fhir:recorded [ fhir:v "2025-06-29T17:56:00-04:00"^^xsd:dateTime] ; # 
  fhir:agent ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/provenance-participant-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "author" ]       ] )     ] ;
fhir:who [
fhir:reference [ fhir:v "Organization/ema" ]     ]
  ] ) ; # 
  fhir:signature ( [
    ( fhir:type [
fhir:system [ fhir:v "urn:iso-astm:E1762-95:2013"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1.2.840.10065.1.12.1.1" ]     ] ) ;
fhir:when [ fhir:v "2025-06-29T17:56:00-04:00"^^xsd:dateTime ] ;
fhir:who [
fhir:reference [ fhir:v "Organization/ema" ]     ]
  ] ) . #