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