API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
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 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
| Page standards status: Informative |
@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 "scenario1-02-validation"] ; #
fhir:meta [
fhir:versionId [ fhir:v "2" ] ;
fhir:lastUpdated [ fhir:v "2025-11-20T14:30:00+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:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Task scenario1-02-validation</b></p><a name=\"scenario1-02-validation\"> </a><a name=\"hcscenario1-02-validation\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 2; Last updated: 2025-11-20 14:30:00+0100</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-apix-task.html\">APIX Regulatory Task</a></p></div><p><b>identifier</b>: <a href=\"http://terminology.hl7.org/7.0.1/NamingSystem-uri.html\" title=\"As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt #xD;#xA;#xD;#xA;This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: #xD;#xA;#xD;#xA;Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.#xD;#xA;#xD;#xA;This OID may also be used in CD.codeSystem.\">Uniform Resource Identifier (URI)</a>/urn:uuid:workflow-step1-instance (use: official, ), <code>http://ema.europa.eu/procedure-number</code>/EMEA/H/C/001234/IB/0025 (use: official, )</p><p><b>basedOn</b>: <a href=\"Task-scenario1-01-initial-submission.html\">Task Type IB Variation</a></p><p><b>groupIdentifier</b>: <a href=\"http://terminology.hl7.org/7.0.1/NamingSystem-uri.html\" title=\"As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt #xD;#xA;#xD;#xA;This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: #xD;#xA;#xD;#xA;Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.#xD;#xA;#xD;#xA;This OID may also be used in CD.codeSystem.\">Uniform Resource Identifier (URI)</a>/urn:uuid:workflow-group-id-12345 (use: official, )</p><p><b>status</b>: Accepted</p><p><b>businessStatus</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status validation-successful}\">Validation Successful</span></p><p><b>intent</b>: order</p><p><b>priority</b>: Routine</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code variation-type-ib}\">Type IB Variation</span></p><p><b>authoredOn</b>: 2025-11-15 09:00:00+0100</p><p><b>lastModified</b>: 2025-11-20 14:30:00+0100</p><p><b>requester</b>: <a href=\"Organization-org-synthpharma-ag.html\">SynthPharma AG</a></p><p><b>owner</b>: <a href=\"Organization-org-ema-srm-hmed.html\">European Medicines Agency</a></p><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type cover-letter}\">Cover Letter</span></p><p><b>value</b>: <a href=\"DocumentReference-doc1.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Cover Letter; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">Regulatory Document</span></p><p><b>value</b>: <a href=\"DocumentReference-doc2.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Application Form; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">Regulatory Document</span></p><p><b>value</b>: <a href=\"DocumentReference-doc3.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Annotated Label; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">Regulatory Document</span></p><p><b>value</b>: <a href=\"DocumentReference-doc4.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Clean Label; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">Regulatory Document</span></p><p><b>value</b>: <a href=\"DocumentReference-doc5.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Mock-ups</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type stability-data}\">Stability Data</span></p><p><b>value</b>: <a href=\"DocumentReference-doc6.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Summary; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type stability-data}\">Stability Data</span></p><p><b>value</b>: <a href=\"DocumentReference-doc7.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Data; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type stability-data}\">Stability Data</span></p><p><b>value</b>: <a href=\"DocumentReference-doc8.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Commitment; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type stability-data}\">Stability Data</span></p><p><b>value</b>: <a href=\"DocumentReference-doc9.html\">DocumentReference: status = current; type = DS Stability Summary</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type stability-data}\">Stability Data</span></p><p><b>value</b>: <a href=\"DocumentReference-doc10.html\">DocumentReference: status = current; type = DS Stability Data</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">Regulatory Document</span></p><p><b>value</b>: <a href=\"DocumentReference-output-ack.html\">DocumentReference: status = current; type = Acknowledgement of Receipt</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">Regulatory Document</span></p><p><b>value</b>: <a href=\"DocumentReference-output-validation.html\">DocumentReference: status = current; type = Validation Report</a></p></blockquote></div>"^^rdf:XMLLiteral ]
] ; #
fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986> ] ;
fhir:value [ fhir:v "urn:uuid:workflow-step1-instance" ]
] [
fhir:use [ fhir:v "official" ] ;
fhir:system [
fhir:v "http://ema.europa.eu/procedure-number"^^xsd:anyURI ;
fhir:l <http://ema.europa.eu/procedure-number> ] ;
fhir:value [ fhir:v "EMEA/H/C/001234/IB/0025" ]
] ) ; #
fhir:basedOn ( [
fhir:l fhir:Task/scenario1-01-initial-submission ;
fhir:reference [ fhir:v "Task/scenario1-01-initial-submission" ]
] ) ; #
fhir:groupIdentifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986> ] ;
fhir:value [ fhir:v "urn:uuid:workflow-group-id-12345" ]
] ; #
fhir:status [ fhir:v "accepted"] ; #
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 "validation-successful" ] ;
fhir:display [ fhir:v "Validation Successful" ] ] )
] ; #
fhir:intent [ fhir:v "order"] ; #
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 "2025-11-20T14:30:00+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/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "cover-letter" ] ;
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:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ] ] ) ] ;
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/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ] ] ) ] ;
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/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ] ] ) ] ;
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/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ] ] ) ] ;
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/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "stability-data" ] ;
fhir:display [ fhir:v "Stability Data" ] ] ) ] ;
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/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "stability-data" ] ;
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/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "stability-data" ] ;
fhir:display [ fhir:v "Stability Data" ] ] ) ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc8 ;
fhir:reference [ fhir:v "DocumentReference/doc8" ] ]
] [
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "stability-data" ] ;
fhir:display [ fhir:v "Stability Data" ] ] ) ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc9 ;
fhir:reference [ fhir:v "DocumentReference/doc9" ] ]
] [
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "stability-data" ] ;
fhir:display [ fhir:v "Stability Data" ] ] ) ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc10 ;
fhir:reference [ fhir:v "DocumentReference/doc10" ] ]
] ) ; #
fhir:output ( [
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ] ] ) ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/output-ack ;
fhir:reference [ fhir:v "DocumentReference/output-ack" ] ]
] [
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type> ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ] ] ) ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/output-validation ;
fhir:reference [ fhir:v "DocumentReference/output-validation" ] ]
] ) . #
IG © 2025+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.apix#0.1.0 based on FHIR 5.0.0. Generated 2026-02-24
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