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
@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-Response"] ; #
fhir:type [ fhir:v "transaction"] ; #
fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:task-003"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:task-003> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Task"^^xsd:anyURI ] ]
] [
fhir:fullUrl [ fhir:v "urn:uuid:response-bundle-001"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:response-bundle-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Bundle"^^xsd:anyURI ] ]
] [
fhir:fullUrl [ fhir:v "urn:uuid:provenance-003"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:provenance-003> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Provenance"^^xsd:anyURI ] ]
] ) . #
<urn:uuid:task-003> a fhir:Task ;
fhir:id [ fhir:v "task-003"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Task_task-003\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Task task-003</b></p><a name=\"task-003\"> </a><a name=\"hctask-003\"> </a><p><b>status</b>: Completed</p><p><b>intent</b>: order</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/task-code submit-response}\">Submit Response to List of Questions</span></p><p><b>description</b>: Submission of 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 18:15:00-0400</p><p><b>requester</b>: <a href=\"Organization/pharma-inc\">Organization/pharma-inc</a></p><p><b>owner</b>: <a href=\"Organization/ema\">Organization/ema</a></p></div>"^^rdf:XMLLiteral
] ; #
fhir:status [ fhir:v "completed"] ; #
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 "submit-response" ] ;
fhir:display [ fhir:v "Submit Response to List of Questions" ] ] )
] ; #
fhir:description [ fhir:v "Submission of 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 "2025-06-29T18:15:00-04:00"^^xsd:dateTime] ; #
fhir:requester [
fhir:reference [ fhir:v "Organization/pharma-inc" ]
] ; #
fhir:owner [
fhir:reference [ fhir:v "Organization/ema" ]
] . #
<urn:uuid:response-bundle-001> a fhir:Bundle ;
fhir:id [ fhir:v "response-bundle-001"] ; #
fhir:type [ fhir:v "collection"] ; #
fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:questionnaire-response-001"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:questionnaire-response-001> )
] ) . #
<urn:uuid:questionnaire-response-001> a fhir:QuestionnaireResponse ;
fhir:id [ fhir:v "questionnaire-response-001"] ; #
fhir:questionnaire [ fhir:v "Questionnaire/questionnaire-001"^^xsd:anyURI] ; #
fhir:status [ fhir:v "completed"] ; #
fhir:authored [ fhir:v "2025-06-29T18:15:00-04:00"^^xsd:dateTime] ; #
fhir:item ( [
fhir:linkId [ fhir:v "admin-1" ] ;
fhir:text [ fhir:v "Is the fee for the Type II variation fully paid and documented?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "Yes, the fee was paid on June 25, 2025, with documentation included in the application form." ] ] )
] [
fhir:linkId [ fhir:v "admin-2" ] ;
fhir:text [ fhir:v "Are all required metadata fields in the application form complete?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "All metadata fields are complete, as verified against EMA guidelines." ] ] )
] [
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:answer [
fhir:value [
a fhir:string ;
fhir:v "No additional guidance is needed; the ePI clearly states storage at 2-8°C for 36 months." ] ] )
] [
fhir:linkId [ fhir:v "labeling-2" ] ;
fhir:text [ fhir:v "Is the patient leaflet revised to clarify the extended shelf life?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "Yes, the patient leaflet has been updated to reflect the 36-month shelf life." ] ] )
] [
fhir:linkId [ fhir:v "labeling-3" ] ;
fhir:text [ fhir:v "Is the updated ePI text sufficiently clear for all EU languages?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "The ePI text has been translated and reviewed for clarity in all EU languages." ] ] )
] [
fhir:linkId [ fhir:v "cmc-1" ] ;
fhir:text [ fhir:v "Do stability studies cover all required environmental conditions for 36 months?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "Yes, stability studies include temperature, humidity, and light conditions for 36 months, per ICH guidelines." ] ] )
] [
fhir:linkId [ fhir:v "cmc-2" ] ;
fhir:text [ fhir:v "Are analytical methods validated for detecting degradation over 36 months?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "Analytical methods are fully validated, with results included in the PQI submission." ] ] )
] [
fhir:linkId [ fhir:v "cmc-3" ] ;
fhir:text [ fhir:v "Are new impurities identified in extended stability studies?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "No new impurities were identified; all impurities are within acceptable limits." ] ] )
] [
fhir:linkId [ fhir:v "cmc-4" ] ;
fhir:text [ fhir:v "Is the container closure system validated for 36 months?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "The container closure system is validated for 36 months, with supporting data in the PQI Bundle." ] ] [
fhir:value [
a fhir:Attachment ;
fhir:contentType [ fhir:v "image/svg+xml" ] ;
fhir:data [ fhir:v "PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIxMDAiIGhlaWdodD0iMTAwIj48cmVjdCB3aWR0aD0iMTAwIiBoZWlnaHQ9IjEwMCIgZmlsbD0iI2ZmZiIvPjx0ZXh0IHg9IjUwIiB5PSI1MCIgZm9udC1zaXplPSIxNSIgZmlsbD0iIzAwMCIgdGV4dC1hbmNob3I9Im1pZGRsZSI+U1ZHIFBsYWNlaG9sZGVyPC90ZXh0Pjwvc3ZnPg=="^^xsd:base64Binary ] ;
fhir:title [ fhir:v "Container Closure System Diagram" ] ] ] )
] [
fhir:linkId [ fhir:v "cmc-5" ] ;
fhir:text [ fhir:v "Are degradation products fully characterized for 36 months?" ] ;
( fhir:answer [
fhir:value [
a fhir:string ;
fhir:v "Degradation products are fully characterized. No significant changes were observed in the 36-month stability studies.\nAll identified degradation products remain within acceptable limits, as detailed in the PQI submission." ] ] )
] ) . #
<urn:uuid:provenance-003> a fhir:Provenance ;
fhir:id [ fhir:v "provenance-003"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Provenance_provenance-003\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Provenance provenance-003</b></p><a name=\"provenance-003\"> </a><a name=\"hcprovenance-003\"> </a><p>Provenance for <a href=\"Bundle-List-Of-Questions-Response.html#Bundle_response-bundle-001\">Bundle: type = transaction</a></p><p>Summary</p><table class=\"grid\"><tr><td>Recorded</td><td>2025-06-29 18:15:00-0400</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/pharma-inc\">Organization/pharma-inc</a></td></tr></table></div>"^^rdf:XMLLiteral
] ; #
fhir:target ( [
fhir:reference [ fhir:v "Bundle/response-bundle-001" ]
] ) ; #
fhir:recorded [ fhir:v "2025-06-29T18:15:00-04:00"^^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/pharma-inc" ] ]
] ) ; #
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 "2025-06-29T18:15:00-04:00"^^xsd:dateTime ] ;
fhir:who [
fhir:reference [ fhir:v "Organization/pharma-inc" ] ]
] ) . #
IG © 2025+ Gravitate Health Project. Package hl7.fhir.uv.recon-ig#0.1.0 based on FHIR 5.0.0. Generated 2025-07-06
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QA Report