Response to Regulatory Questions (RTQ)
0.1.0 - ci-build

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

: Responses to Question Set ID001 - TTL Representation

Active as of 2025-11-11

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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:Questionnaire ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "brr-regulatory-qa-questionnaire"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "2025-11-11T22:30:00Z" ] ;
fhir:lastUpdated [ fhir:v "2025-11-11T22:30:00Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaire"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaire>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n            <p><b>EMA List of Questions – Type II Variation (ID001)</b></p>\n            <p><b>From:</b> Dr. Jane Doe, European Medicines Agency</p>\n            <p><b>To:</b> Dr. John Doe, SynthPharma AG</p>\n        </div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/brr-regulatory-qa-questionnaire"^^xsd:anyURI ;
fhir:l <https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/brr-regulatory-qa-questionnaire>
  ] ; # 
  fhir: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:system [
fhir:v "https://ema.europa.eu/procedure-number"^^xsd:anyURI ;
fhir:l <https://ema.europa.eu/procedure-number>     ] ;
fhir:value [ fhir:v "EMEA/H/C/005432/II/0023" ]
  ] ) ; # 
  fhir:version [ fhir:v "0.1.0"] ; # 
  fhir:name [ fhir:v "BRRRegulatoryQAQuestionnaire"] ; # 
  fhir:title [ fhir:v "Responses to Question Set ID001"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:subjectType ( [ fhir:v "MedicinalProductDefinition"] ) ; # 
  fhir:date [ fhir:v "2025-11-11"^^xsd:date] ; # 
  fhir:publisher [ fhir:v "HL7 International"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org" ]     ] )
  ] ) ; # 
  fhir:effectivePeriod [
fhir:start [ fhir:v "2025-11-11"^^xsd:date ] ;
fhir:end [ fhir:v "2025-12-11"^^xsd:date ]
  ] ; # 
  fhir:item ( [
fhir:linkId [ fhir:v "admin-1" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.0" ] ;
fhir:display [ fhir:v "1.0 Administrative Information" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.1" ] ;
fhir:display [ fhir:v "1.1 Application Form" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "admin-2" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.0" ] ;
fhir:display [ fhir:v "1.0 Administrative Information" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.1" ] ;
fhir:display [ fhir:v "1.1 Application Form" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "labeling-1" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.3" ] ;
fhir:display [ fhir:v "1.3 Product Information" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "1.3.1 SmPC, Labelling and Package Leaflet" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "labeling-2" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.3" ] ;
fhir:display [ fhir:v "1.3 Product Information" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "1.3.1 SmPC, Labelling and Package Leaflet" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "labeling-3" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.3" ] ;
fhir:display [ fhir:v "1.3 Product Information" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "1.3.1 SmPC, Labelling and Package Leaflet" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "cmc-1-DP-Stability" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.8" ] ;
fhir:display [ fhir:v "3.2.P.8 Stability" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.8.1" ] ;
fhir:display [ fhir:v "3.2.P.8.1 Stability Summary and Conclusion" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "cmc-2-DP-Stability" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.8" ] ;
fhir:display [ fhir:v "3.2.P.8 Stability" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.8.1" ] ;
fhir:display [ fhir:v "3.2.P.8.1 Stability Summary and Conclusion" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "cmc-3-DP-Analytical Methods" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.5" ] ;
fhir:display [ fhir:v "3.2.P.5 Control of Drug Product" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.5.2" ] ;
fhir:display [ fhir:v "3.2.P.5.2 Analytical Procedures" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "cmc-4-DP-Impurities" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.5" ] ;
fhir:display [ fhir:v "3.2.P.5 Control of Drug Product" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.5.4" ] ;
fhir:display [ fhir:v "3.2.P.5.4 Impurities" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] [
fhir:linkId [ fhir:v "cmc-5-DP-Container Closure System" ] ;
    ( fhir:code [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/CodeSystem/ctd-section>       ] ;
fhir:code [ fhir:v "3.2.P.7" ] ;
fhir:display [ fhir:v "3.2.P.7 Container Closure System" ]     ] ) ;
fhir:text [
      ( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText>         ]       ] )     ] ;
fhir:type [ fhir:v "string" ]
  ] ) . #