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

: Type-II-Variation - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@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 "Type-II-Variation"] ; # 
  fhir:type [ fhir:v "transaction"] ; # 
  fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:task-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:task-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Task"^^xsd:anyURI ]     ]
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:doc-ref-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:doc-ref-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "DocumentReference"^^xsd:anyURI ]     ]
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:provenance-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:provenance-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Provenance"^^xsd:anyURI ]     ]
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:application-form-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:application-form-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Bundle"^^xsd:anyURI ]     ]
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:epi-bundle-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:epi-bundle-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Bundle"^^xsd:anyURI ]     ]
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:pqi-bundle-001"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:pqi-bundle-001> ) ;
fhir:request [
fhir:method [ fhir:v "POST" ] ;
fhir:url [ fhir:v "Bundle"^^xsd:anyURI ]     ]
  ] ) . # 

<urn:uuid:task-001> a fhir:Task ;
  fhir:id [ fhir:v "task-001"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Task_task-001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Task task-001</b></p><a name=\"task-001\"> </a><a name=\"hctask-001\"> </a><p><b>status</b>: Requested</p><p><b>intent</b>: proposal</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/task-code submit-variation}\">Submit Type II Variation</span></p><p><b>description</b>: Type II variation for shelf life extension from 24 to 36 months</p><p><b>for</b>: <a href=\"MedicinalProductDefinition/mpd-001\">MedicinalProductDefinition/mpd-001</a></p><p><b>authoredOn</b>: 2025-06-29</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 "requested"] ; # 
  fhir:intent [ fhir:v "proposal"] ; # 
  fhir:code [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/task-code"^^xsd:anyURI ] ;
fhir:code [ fhir:v "submit-variation" ] ;
fhir:display [ fhir:v "Submit Type II Variation" ]     ] )
  ] ; # 
  fhir:description [ fhir:v "Type II variation for shelf life extension from 24 to 36 months"] ; # 
  fhir:for [
fhir:reference [ fhir:v "MedicinalProductDefinition/mpd-001" ]
  ] ; # 
  fhir:authoredOn [ fhir:v "2025-06-29"^^xsd:date] ; # 
  fhir:requester [
fhir:reference [ fhir:v "Organization/pharma-inc" ]
  ] ; # 
  fhir:owner [
fhir:reference [ fhir:v "Organization/ema" ]
  ] . # 

<urn:uuid:doc-ref-001> a fhir:DocumentReference ;
  fhir:id [ fhir:v "doc-ref-001"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_doc-ref-001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference doc-ref-001</b></p><a name=\"doc-ref-001\"> </a><a name=\"hcdoc-ref-001\"> </a><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://loinc.org 51851-4}\">Administrative report</span></p><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>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>Type II Variation Application Form Collection Bundle</td></tr></table></blockquote><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>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>ePI Storage Update Document Bundle</td></tr></table></blockquote><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>Data</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td></tr><tr><td style=\"display: none\">*</td><td>application/json</td><td><code>base64 data placeholder</code></td><td>1234</td><td><code>qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=</code></td><td>PQI Stability Data Collection Bundle</td></tr></table></blockquote></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:status [ fhir:v "current"] ; # 
  fhir:type [
    ( fhir:coding [
a loinc:51851-4 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "51851-4" ] ;
fhir:display [ fhir:v "Administrative report" ]     ] )
  ] ; # 
  fhir:content ( [
fhir:attachment [
fhir:contentType [ fhir:v "application/json" ] ;
fhir:data [ fhir:v "base64 data placeholder"^^xsd:base64Binary ] ;
fhir:size [ fhir:v "1234"^^xsd:long ] ;
fhir:hash [ fhir:v "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c="^^xsd:base64Binary ] ;
fhir:title [ fhir:v "Type II Variation Application Form Collection Bundle" ]     ]
  ] [
fhir:attachment [
fhir:contentType [ fhir:v "application/json" ] ;
fhir:data [ fhir:v "base64 data placeholder"^^xsd:base64Binary ] ;
fhir:size [ fhir:v "1234"^^xsd:long ] ;
fhir:hash [ fhir:v "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c="^^xsd:base64Binary ] ;
fhir:title [ fhir:v "ePI Storage Update Document Bundle" ]     ]
  ] [
fhir:attachment [
fhir:contentType [ fhir:v "application/json" ] ;
fhir:data [ fhir:v "base64 data placeholder"^^xsd:base64Binary ] ;
fhir:size [ fhir:v "1234"^^xsd:long ] ;
fhir:hash [ fhir:v "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c="^^xsd:base64Binary ] ;
fhir:title [ fhir:v "PQI Stability Data Collection Bundle" ]     ]
  ] ) . # 

<urn:uuid:provenance-001> a fhir:Provenance ;
  fhir:id [ fhir:v "provenance-001"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Provenance_provenance-001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Provenance provenance-001</b></p><a name=\"provenance-001\"> </a><a name=\"hcprovenance-001\"> </a><p>Provenance for <a href=\"Bundle-Type-II-Variation.html#DocumentReference_doc-ref-001\">Bundle: type = transaction</a></p><p>Summary</p><table class=\"grid\"><tr><td>Recorded</td><td>2025-06-29 17:25:00-0400</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 "DocumentReference/doc-ref-001" ]
  ] ) ; # 
  fhir:recorded [ fhir:v "2025-06-29T17:25:00-04:00"^^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 "2025-06-29T17:25:00-04:00"^^xsd:dateTime ] ;
fhir:who [
fhir:reference [ fhir:v "Organization/pharma-inc" ]     ]
  ] ) . # 

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

<urn:uuid:activity-definition-001> a fhir:ActivityDefinition ;
  fhir:id [ fhir:v "activity-definition-001"] ; # 
  fhir:status [ fhir:v "draft"] ; # 
  fhir:description [ fhir:v "Type II variation application for shelf life extension from 24 to 36 months"] . # 

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

<urn:uuid:epi-composition-001> a fhir:Composition ;
  fhir:id [ fhir:v "epi-composition-001"] ; # 
  fhir:status [ fhir:v "preliminary"] ; # 
  fhir:type [
    ( fhir:coding [
a loinc:34391-3 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "34391-3" ] ;
fhir:display [ fhir:v "Product Labeling" ]     ] )
  ] ; # 
  fhir:title [ fhir:v "Updated ePI for Monoclonal Antibody"] ; # 
  fhir:section ( [
fhir:title [ fhir:v "Storage" ] ;
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Store at 2-8°C for up to 36 months.</div>"^^rdf:XMLLiteral     ]
  ] ) . # 

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

<urn:uuid:observation-001> a fhir:Observation ;
  fhir:id [ fhir:v "observation-001"] ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:code [
    ( fhir:coding [
a loinc:76662-2 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "76662-2" ] ;
fhir:display [ fhir:v "Stability study" ]     ] )
  ] ; # 
  fhir:value [
a fhir:string ;
fhir:v "Stability data supports shelf life extension to 36 months"
  ] . #