Responses to Question Set ID001 - TTL Representation - Structured Regulatory Correspondence (SRC) v0.1.0

Structured Regulatory Correspondence (SRC), published by Gravitate Health and HL7 Biomedical Research & Regulation (BR&R). 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/src-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 "2025-11-11T22:38:00Z" ] ;
fhir:lastUpdated [ fhir:v "2025-11-11T22:38:00Z"^^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>EMA List of Questions – Type II Variation (ID001)</p>\n        </div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "http://hl7.org/fhir/uv/src-ig/Questionnaire/brr-regulatory-qa-questionnaire"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-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 "Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://www.gravitatehealth.eu/" ]     ] )
  ] ) ; # 
  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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "administrative.application-form.fee" ] ;
fhir:display [ fhir:v "Fee Payment Documentation" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "administrative.application-form" ] ;
fhir:display [ fhir:v "Application Form" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "administrative" ] ;
fhir:display [ fhir:v "Administrative Information" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "administrative.application-form.metadata" ] ;
fhir:display [ fhir:v "Metadata Completeness" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "administrative.application-form" ] ;
fhir:display [ fhir:v "Application Form" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "administrative" ] ;
fhir:display [ fhir:v "Administrative Information" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional.labeling.storage-conditions" ] ;
fhir:display [ fhir:v "Storage Conditions" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional.labeling" ] ;
fhir:display [ fhir:v "Labeling and Package Leaflet" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional" ] ;
fhir:display [ fhir:v "Regional Information" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional.labeling.shelf-life" ] ;
fhir:display [ fhir:v "Shelf Life" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional.labeling" ] ;
fhir:display [ fhir:v "Labeling and Package Leaflet" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional" ] ;
fhir:display [ fhir:v "Regional Information" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional.labeling.multilingual" ] ;
fhir:display [ fhir:v "Multilingual Clarity" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional.labeling" ] ;
fhir:display [ fhir:v "Labeling and Package Leaflet" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "regional" ] ;
fhir:display [ fhir:v "Regional Information" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.stability.study-design" ] ;
fhir:display [ fhir:v "Stability Study Design" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.stability" ] ;
fhir:display [ fhir:v "Stability" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product" ] ;
fhir:display [ fhir:v "Drug Product" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.stability.climatic-zones" ] ;
fhir:display [ fhir:v "Climatic Zone Support" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.stability" ] ;
fhir:display [ fhir:v "Stability" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product" ] ;
fhir:display [ fhir:v "Drug Product" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.control.analytical-procedures" ] ;
fhir:display [ fhir:v "Analytical Procedures" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.control" ] ;
fhir:display [ fhir:v "Control of Drug Product" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product" ] ;
fhir:display [ fhir:v "Drug Product" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.control.impurities" ] ;
fhir:display [ fhir:v "Impurities" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.control" ] ;
fhir:display [ fhir:v "Control of Drug Product" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product" ] ;
fhir:display [ fhir:v "Drug Product" ]     ] ) ;
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/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product.container-closure" ] ;
fhir:display [ fhir:v "Container Closure System" ]     ] [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full>       ] ;
fhir:code [ fhir:v "quality.drug-product" ] ;
fhir:display [ fhir:v "Drug Product" ]     ] ) ;
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" ]
  ] ) . #