questionnaireresponse-ID001 - TTL Representation - Response to Regulatory Questions (RTQ) v0.1.0

Response to Regulatory Questions (RTQ), published by HL7 International. 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/rtq-ig/ and changes regularly. See the Directory of published versions
: questionnaireresponse-ID001 - 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:QuestionnaireResponse ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "questionnaireresponse-ID001"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2025-11-20T22:30:00Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse>     ] )
  ] ; # 
  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: QuestionnaireResponse questionnaireresponse-ID001</b></p><a name=\"questionnaireresponse-ID001\"> </a><a name=\"hcquestionnaireresponse-ID001\"> </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: 1; Last updated: 2025-11-20 22:30:00+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse</code></p></div><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 2px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://hl7.org/fhir/R5/formats.html#table\" title=\"The linkID for the item\">LinkID</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://hl7.org/fhir/R5/formats.html#table\" title=\"Text for the item\">Text</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://hl7.org/fhir/R5/formats.html#table\" title=\"Minimum and Maximum # of times the item can appear in the instance\">Definition</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://hl7.org/fhir/R5/formats.html#table\" title=\"The type of the item\">Answer</a><span style=\"float: right\"><a href=\"https://hl7.org/fhir/R5/formats.html#table\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_q_root.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"QuestionnaireResponseRoot\" class=\"hierarchy\"/> questionnaireresponse-ID001</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire:Questionnaire/questionnaire-ID001</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> admin-1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> admin-2</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> product-1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> product-2</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> product-3</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> quality-1</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> quality-2</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> quality-3</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> quality-4</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Item\" class=\"hierarchy\"/> quality-5</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">See extension</td></tr>#xD;\n<tr><td colspan=\"4\" class=\"hierarchy\"><br/><a href=\"https://hl7.org/fhir/R5/formats.html#table\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "org-regulator" ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "https://ema.europa.eu/organization-id"^^xsd:anyURI ;
fhir:l <https://ema.europa.eu/organization-id>       ] ;
fhir:value [ fhir:v "EMA" ]     ] ) ;
fhir:name [ fhir:v "European Medicines Agency" ] ;
    ( fhir:contact [
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "jane.doe@ema.example.eu" ]       ] ) ;
fhir:address [
fhir:text [ fhir:v "Domenico Scarlattilaan 6, 1083 HS Amsterdam, NL" ] ;
        ( fhir:line [ fhir:v "Domenico Scarlattilaan 6" ] ) ;
fhir:city [ fhir:v "Amsterdam" ] ;
fhir:postalCode [ fhir:v "1083 HS" ] ;
fhir:country [ fhir:v "NL" ]       ]     ] )
  ] [
a fhir:Organization ;
fhir:id [ fhir:v "org-mah" ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "https://www.zefix.ch/en/SwissCompanyRegistry/UID"^^xsd:anyURI ;
fhir:l <https://www.zefix.ch/en/SwissCompanyRegistry/UID>       ] ;
fhir:value [ fhir:v "CHE-123.456.789" ]     ] ) ;
fhir:name [ fhir:v "SynthPharma AG" ] ;
    ( fhir:contact [
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "john.doe@synthpharma.ch" ]       ] ) ;
fhir:address [
fhir:text [ fhir:v "Industriestrasse 12, 4056 Basel, CH" ] ;
        ( fhir:line [ fhir:v "Industriestrasse 12" ] ) ;
fhir:city [ fhir:v "Basel" ] ;
fhir:postalCode [ fhir:v "4056" ] ;
fhir:country [ fhir:v "CH" ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "example-docref" ] ;
fhir:meta [
      ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-documentreference"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-documentreference>       ] )     ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986>       ] ;
fhir:value [ fhir:v "urn:oid:1.2.3.4.5" ]     ] ) ;
fhir:version [ fhir:v "1.0" ] ;
fhir:status [ fhir:v "current" ] ;
fhir:docStatus [ fhir:v "final" ] ;
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-5-3" ] ;
fhir:display [ fhir:v "3.2.P.5.3 Validation of Analytical Procedures" ]       ] )     ] ;
    ( fhir:category [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/document-reference-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/document-reference-status>         ] ;
fhir:code [ fhir:v "current" ] ;
fhir:display [ fhir:v "Current" ]       ] )     ] ) ;
fhir:date [ fhir:v "2025-11-20T10:00:00Z"^^xsd:dateTime ] ;
fhir:description [ fhir:v "Comprehensive validation of analytical procedures for the WonderDrug 10mg product lifecycle." ] ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/pdf" ] ;
fhir:title [ fhir:v "Validation Report for HPLC Method" ] ;
fhir:creation [ fhir:v "2025-11-19T15:00:00Z"^^xsd:dateTime ]       ]     ] )
  ] ) ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/rtq/CodeSystem/rtq-identifier-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/rtq/CodeSystem/rtq-identifier-type>         ] ;
fhir:code [ fhir:v "regulator" ] ;
fhir:display [ fhir:v "Regulatory Authority Identifier" ]       ] )     ] ;
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/identifier/qa-request"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/identifier/qa-request>     ] ;
fhir:value [ fhir:v "ID001" ]
  ] ) ; # 
  fhir:questionnaire [
fhir:v "Questionnaire/questionnaire-ID001"^^xsd:anyURI ;
fhir:l fhir:Questionnaire/questionnaire-ID001
  ] ; # 
  fhir:status [ fhir:v "completed"] ; # 
  fhir:subject [
fhir:l fhir:MedicinalProductDefinition/MedicinalProduct-ExampleDrug ;
fhir:reference [ fhir:v "MedicinalProductDefinition/MedicinalProduct-ExampleDrug" ] ;
fhir:display [ fhir:v "ExampleDrug 10 mg Tablets" ]
  ] ; # 
  fhir:authored [ fhir:v "2025-06-25T14:00:00+02:00"^^xsd:dateTime] ; # 
  fhir:author [
fhir:l <#org-regulator> ;
fhir:reference [ fhir:v "#org-regulator" ] ;
fhir:type [
fhir:v "Organization"^^xsd:anyURI ;
fhir:l fhir:Organization     ] ;
fhir:display [ fhir:v "European Medicines Agency" ]
  ] ; # 
  fhir:source [
fhir:l <#org-mah> ;
fhir:reference [ fhir:v "#org-mah" ] ;
fhir:type [
fhir:v "Organization"^^xsd:anyURI ;
fhir:l fhir:Organization     ] ;
fhir:display [ fhir:v "SynthPharma AG" ]
  ] ; # 
  fhir:item ( [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the fee for the Type II variation fully paid and documented?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "admin-1" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the fee was paid on <b>June 25, 2025</b>. Payment confirmation and receipt are included in the application form (see Section 1.1).</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] [
fhir:value [
a fhir:Reference ;
fhir:l <#example-docref> ;
fhir:reference [ fhir:v "#example-docref" ] ;
fhir:display [ fhir:v "Fee Payment Receipt" ]       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are all required metadata fields in the application form complete?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "admin-2" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, all required metadata fields are complete:</p><ul><li><strong>MAH:</strong> SynthPharma AG</li><li><strong>Product:</strong> ExampleDrug 10 mg Tablets</li><li><strong>Procedure:</strong> EMEA/H/C/005432/II/0023</li><li><strong>Submission Date:</strong> 2025-06-25</li></ul></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "product-1" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>No additional patient guidance is required. The ePI clearly states: 'Store in a refrigerator (2°C – 8°C). Do not freeze.' The 36-month shelf life is supported by stability data and does not alter patient handling instructions.</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the patient leaflet revised to clarify the extended shelf life?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "product-2" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the patient leaflet has been updated to state: 'Shelf life after first opening: 36 months when stored at 2–8°C'. The revised leaflet is included in the submission.</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the updated ePI text sufficiently clear for all EU languages?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "product-3" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the ePI text has been translated into all EU languages and reviewed for clarity. All versions are linguistically validated. Status: English (Approved), French (Approved), German (Approved), others (Final review completed).</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "quality-1" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The submission includes both:</p><ul><li><strong>Additional timepoints:</strong> Long-term data extended to 36 months for primary batches A-001, A-002, A-003.</li><li><strong>New stability studies:</strong> Two pilot-scale batches (B-001, B-002) in new Alu/Alu packaging, with 6-month accelerated (40°C/75% RH) and long-term (25°C/60% RH) data.</li></ul><p>No protocol deviations occurred. All studies follow ICH Q1A(R2).</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Does the data support all intended climatic zones?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "quality-2" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, the data supports all ICH climatic zones, including Zone IVb:</p><ul><li><strong>Zone I/II:</strong> 25°C/60% RH (long-term), 40°C/75% RH (accelerated)</li><li><strong>Zone IVb:</strong> 30°C/75% RH (long-term) — data confirms compliance per WHO TRS 1010.</li></ul><p>All batches remain within specification.</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are the test methods used the same as in the previously submitted stability information?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "quality-3" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, all test methods are identical to those validated in the original MAA. No changes were made. Methods remain stability-indicating for assay, impurities, and dissolution.</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are there any new degradation products identified within the newly submitted data?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "quality-4" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>No new degradation products were identified. All observed impurities correspond to previously qualified degradants. Levels remain below 0.10% (ICH Q3B(R2) threshold). No peaks above reporting threshold detected.</p></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] [
    ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>       ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Any changes in the packaging configuration and/or storage of the samples during stability?</p></div>"       ]     ] ) ;
fhir:linkId [ fhir:v "quality-5" ] ;
    ( fhir:answer [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/rendering-xhtml>         ] ;
fhir:value [
a fhir:String ;
fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Yes, a change in packaging configuration was implemented:</p><ul><li><strong>Original:</strong> PVC/PVDC blister pack</li><li><strong>New:</strong> Aluminum/aluminum (Alu/Alu) blister pack</li></ul><p>New stability studies (B-001, B-002) were initiated in the Alu/Alu system. Storage conditions remain unchanged: 25°C/60% RH (long-term), 40°C/75% RH (accelerated).</p><div style=\"background:#e5e5ea;border:1px dashed #999;padding:10px;text-align:center;color:#666;\">[Figure 1: Cross-section of new Alu/Alu blister pack]</div><p style=\"font-size:0.9em;color:#555\"><b>Figure 1:</b> Cross-section of new Alu/Alu blister showing foil thickness and sealing layer.</p><table><tr><th>Parameter</th><th>Original</th><th>New</th></tr><tr><td>Material</td><td>PVC/PVDC</td><td>Alu/Alu</td></tr><tr><td>Storage Condition</td><td>25°C/60% RH</td><td>Unchanged</td></tr></table></div>"         ]       ] ) ;
fhir:value [
a fhir:String ;
fhir:v "See extension"       ]     ] )
  ] ) . #