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
@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"] ; #
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: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:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <p>Dear Assessment Team,</p>\n <p>Please find below the structured responses to the List of Questions issued on 2025-05-20\n for the Type II variation (EMEA/H/C/005432/II/0023) concerning ExampleDrug 10 mg Tablets.</p>\n <p>Yours sincerely,<br/>Dr. John Doe<br/>Head of Regulatory Affairs<br/>SynthPharma AG</p>\n </div>"^^rdf:XMLLiteral ]
] ; #
fhir:questionnaire [
fhir:v "questionnaire_ID001"^^xsd:anyURI ;
fhir:l fhir: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:author [
fhir:type [
fhir:v "Organization"^^xsd:anyURI ;
fhir:l fhir:Organization ] ;
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" ] ]
] ; # Author = Regulatory Authority (EMA) – full inline Organization
fhir:source [
fhir:type [
fhir:v "Organization"^^xsd:anyURI ;
fhir:l fhir:Organization ] ;
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" ] ]
] ; # Source = Marketing Authorisation Holder (SynthPharma AG) – full inline Organization
fhir:authored [ fhir:v "2025-06-25T14:00:00+02:00"^^xsd:dateTime] ; #
fhir:item ( [
fhir:linkId [ fhir:v "1" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "2" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "3" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "4" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "5" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "6" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "7" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "8" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "9" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] [
fhir:linkId [ fhir:v "10" ] ;
( 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:Xhtml ] ] ) ;
( 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:Xhtml ] ] ) ] )
] ) . #
IG © 2025+ HL7 International. Package hl7.fhir.uv.rtq-ig#0.1.0 based on FHIR 5.0.0. Generated 2025-11-22
Links: Table of Contents |
QA Report