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

API for the Exchange of Medicinal Product Information (APIX), 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

: scenario1 01 initial submission

Page standards status: Informative

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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:Task ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "scenario1-01-initial-submission"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div style=\"font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;background:linear-gradient(to bottom,#f2f6fa,#e8eef5);color:#1d1d1f;margin:0;padding:40px 20px;line-height:1.5;\"><div style=\"max-width:1000px;margin:0 auto;\"><div style=\"background:linear-gradient(135deg,#007aff,#5ac8fa);color:#ffffff;padding:40px 24px;border-radius:18px;text-align:center;box-shadow:0 10px 30px rgba(0,122,255,0.3);margin-bottom:36px;\"><div style=\"margin:0 0 8px 0;font-size:32px;font-weight:600;\">Task: Type IB Variation</div><p style=\"margin:0;opacity:0.95;font-size:17px;\">HL7 FHIR R5 – APIX Implementation Guide</p></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Task Description</div><div style=\"font-size:18px;line-height:1.6;color:#333333;\">Type IB Variation</div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Core Task Information</div><div style=\"display:grid;grid-template-columns:max-content auto;gap:12px 20px;align-items:baseline;\"><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Version ID</span><span style=\"color:#1d1d1f;\">1</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Task ID</span><span style=\"color:#1d1d1f;\">task-workflow-step1</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Instance UUID</span><span style=\"color:#1d1d1f;\">urn:uuid:workflow-step1-instance</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Group Identifier</span><span style=\"color:#1d1d1f;\">urn:uuid:workflow-group-id-12345</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Procedure ID</span><span style=\"color:#1d1d1f;\">not yet assigned</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Task Status</span><span style=\"color:#1d1d1f;\"><span style=\"padding:2px 8px;border-radius:12px;font-size:0.9em;font-weight:500;color:#ffffff;background:#007aff;\">requested</span></span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Business Status</span><span style=\"color:#1d1d1f;\"><span style=\"padding:2px 8px;border-radius:12px;font-size:0.9em;font-weight:500;color:#ffffff;background:#8e8e93;\">Submitted</span></span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Intent</span><span style=\"color:#1d1d1f;\">order</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Priority</span><span style=\"color:#1d1d1f;\">routine</span></div><hr style=\"border:0;border-top:1px solid #eeeeee;margin:20px 0;\"/><div style=\"display:grid;grid-template-columns:max-content auto;gap:12px 20px;align-items:baseline;\"><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Code</span><span style=\"color:#1d1d1f;\">Type IB Variation (variation-type-ib)</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Authored</span><span style=\"color:#1d1d1f;\">2025-11-15 09:00:00 UTC+01:00</span><span style=\"font-weight:600;color:#555555;text-align:right;min-width:150px;\">Last Updated</span><span style=\"color:#1d1d1f;\">2025-11-15 09:00:00 UTC+01:00</span></div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Parties Involved</div><div style=\"margin-bottom:24px;padding-bottom:16px;border-bottom:1px solid #eeeeee;\"><span style=\"font-weight:600;color:#007aff;margin-bottom:4px;display:block;\">Requester</span><div style=\"font-size:16px;font-weight:500;margin-bottom:8px;color:#1d1d1f;\">SynthPharma AG</div><div style=\"font-size:14px;color:#555555;line-height:1.5;\"><strong>Address:</strong> 123 Synthetic Research Blvd, 4000 Basel, Switzerland<br/><strong>Contact:</strong> Dr. John Doe, Head of Regulatory Affairs<br/><strong>Email:</strong> john.doe@synthpharma.example</div></div><div style=\"margin-bottom:0;padding-bottom:0;border-bottom:none;\"><span style=\"font-weight:600;color:#007aff;margin-bottom:4px;display:block;\">Performer</span><div style=\"font-size:16px;font-weight:500;margin-bottom:8px;color:#1d1d1f;\">European Medicines Agency – Human Medicines Evaluation Division</div><div style=\"font-size:14px;color:#555555;line-height:1.5;\"><strong>Address:</strong> Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands<br/><strong>Contact:</strong> Scientific and Regulatory Management<br/><strong>Email:</strong> srm@ema.example.eu</div></div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Input Documents<span style=\"background:#007aff;color:#ffffff;font-size:14px;font-weight:600;padding:6px 14px;border-radius:20px;\">10 documents</span></div><div style=\"margin:24px 0;padding:20px;background:#f8fbff;border-radius:14px;border-left:5px solid #007aff;\"><div style=\"margin:0 0 16px 0;font-size:18px;color:#007aff;font-weight:600;\">Module 1</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Cover Letter</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cover-letter</span><br/>Cover Letter.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Application Form</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">application-form</span><br/>Application Form.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Annotated Label</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">annotated-label</span><br/>Annotated Label.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Clean Label</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">clean-label</span><br/>Clean Label.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Pack Mockup</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">pack-mockup</span><br/>Pack Mockup.pdf</div></div><div style=\"margin:24px 0;padding:20px;background:#f8fbff;border-radius:14px;border-left:5px solid #007aff;\"><div style=\"margin:0 0 16px 0;font-size:18px;color:#007aff;font-weight:600;\">Module 3</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Stability Summary</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-stability-summary</span><br/>CMC Doc 1 - Summary.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Stability Data</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-stability-data</span><br/>CMC Doc 2 - Data.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">Stability Commitment</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-stability-commitment</span><br/>CMC Doc 3 - Commitment.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">DS Stability Summary</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-ds-stability-summary</span><br/>CMC Doc 4 - DS Summary.pdf</div><div style=\"background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);\"><div style=\"font-weight:600;color:#007aff;font-size:15px;\">DS Stability Data</div><span style=\"font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;\">cmc-ds-stability-data</span><br/>CMC Doc 5 - DS Data.pdf</div></div></div><div style=\"background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);\"><div style=\"font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;\">Output Documents</div><div style=\"text-align:center;padding:40px 20px;color:#888888;background:#f9f9f9;border-radius:14px;\">No output content defined in this render script.</div></div></div><div style=\"text-align:center;padding:50px;color:#666666;font-size:14px;\">HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)<br/>Generated Render</div></div></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>         ] ;
fhir:code [ fhir:v "RI" ] ;
fhir:display [ fhir:v "Resource identifier" ]       ] )     ] ;
fhir:system [
fhir:v "http://example.org/european-med-agency/task-id"^^xsd:anyURI ;
fhir:l <http://example.org/european-med-agency/task-id>     ] ;
fhir:value [ fhir:v "urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726" ]
  ] ) ; # 
  fhir:groupIdentifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [
fhir:v "http://example.org/european-med-agency/work-flow-group-id"^^xsd:anyURI ;
fhir:l <http://example.org/european-med-agency/work-flow-group-id>     ] ;
fhir:value [ fhir:v "urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189727" ]
  ] ; # 
  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:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status>       ] ;
fhir:code [ fhir:v "submitted" ] ;
fhir:display [ fhir:v "Submitted" ]     ] )
  ] ; # 
  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:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code>       ] ;
fhir:code [ fhir:v "variation-type-ib" ] ;
fhir:display [ fhir:v "Type IB Variation" ]     ] )
  ] ; # 
  fhir:authoredOn [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:requester [
fhir:l fhir:Organization/org-synthpharma-ag ;
fhir:reference [ fhir:v "Organization/org-synthpharma-ag" ] ;
fhir:display [ fhir:v "SynthPharma AG" ]
  ] ; # 
  fhir:owner [
fhir:l fhir:Organization/org-ema-srm-hmed ;
fhir:reference [ fhir:v "Organization/org-ema-srm-hmed" ] ;
fhir:display [ fhir:v "European Medicines Agency" ]
  ] ; # 
  fhir:input ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.0" ] ;
fhir:display [ fhir:v "Cover Letter" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc1 ;
fhir:reference [ fhir:v "DocumentReference/doc1" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "application-form" ] ;
fhir:display [ fhir:v "Application Form" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc2 ;
fhir:reference [ fhir:v "DocumentReference/doc2" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc3 ;
fhir:reference [ fhir:v "DocumentReference/doc3" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc4 ;
fhir:reference [ fhir:v "DocumentReference/doc4" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.3.2" ] ;
fhir:display [ fhir:v "Mock-ups" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc5 ;
fhir:reference [ fhir:v "DocumentReference/doc5" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "3.2.P.8.1" ] ;
fhir:display [ fhir:v "Stability Summary and Conclusion" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc6 ;
fhir:reference [ fhir:v "DocumentReference/doc6" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "3.2.P.8.3" ] ;
fhir:display [ fhir:v "Stability Data" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc7 ;
fhir:reference [ fhir:v "DocumentReference/doc7" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "3.2.S.7" ] ;
fhir:display [ fhir:v "Stability (Drug Substance)" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc8 ;
fhir:reference [ fhir:v "DocumentReference/doc8" ]     ]
  ] ) . #