Structured Regulatory Correspondence (SRC)
0.1.0 - ci-build
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
| Active as of 2025-11-11 |
<Questionnaire xmlns="http://hl7.org/fhir">
<id value="brr-regulatory-qa-questionnaire"/>
<meta>
<versionId value="2025-11-11T22:38:00Z"/>
<lastUpdated value="2025-11-11T22:38:00Z"/>
<profile
value="http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaire"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>EMA List of Questions – Type II Variation (ID001)</p>
</div>
</text>
<url
value="http://hl7.org/fhir/uv/src-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="Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)"/>
<contact>
<name
value="Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)"/>
<telecom>
<system value="url"/>
<value value="https://www.gravitatehealth.eu/"/>
</telecom>
</contact>
<effectivePeriod>
<start value="2025-11-11"/>
<end value="2025-12-11"/>
</effectivePeriod>
<item>
<linkId value="admin-1"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="administrative.application-form.fee"/>
<display value="Fee Payment Documentation"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="administrative.application-form"/>
<display value="Application Form"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="administrative"/>
<display value="Administrative Information"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="admin-2"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="administrative.application-form.metadata"/>
<display value="Metadata Completeness"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="administrative.application-form"/>
<display value="Application Form"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="administrative"/>
<display value="Administrative Information"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="labeling-1"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional.labeling.storage-conditions"/>
<display value="Storage Conditions"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional.labeling"/>
<display value="Labeling and Package Leaflet"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional"/>
<display value="Regional Information"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="labeling-2"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional.labeling.shelf-life"/>
<display value="Shelf Life"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional.labeling"/>
<display value="Labeling and Package Leaflet"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional"/>
<display value="Regional Information"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="labeling-3"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional.labeling.multilingual"/>
<display value="Multilingual Clarity"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional.labeling"/>
<display value="Labeling and Package Leaflet"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="regional"/>
<display value="Regional Information"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="cmc-1-DP-Stability"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.stability.study-design"/>
<display value="Stability Study Design"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.stability"/>
<display value="Stability"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product"/>
<display value="Drug Product"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="cmc-2-DP-Stability"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.stability.climatic-zones"/>
<display value="Climatic Zone Support"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.stability"/>
<display value="Stability"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product"/>
<display value="Drug Product"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="cmc-3-DP-Analytical Methods"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.control.analytical-procedures"/>
<display value="Analytical Procedures"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.control"/>
<display value="Control of Drug Product"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product"/>
<display value="Drug Product"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="cmc-4-DP-Impurities"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.control.impurities"/>
<display value="Impurities"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.control"/>
<display value="Control of Drug Product"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product"/>
<display value="Drug Product"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
<item>
<linkId value="cmc-5-DP-Container Closure System"/>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product.container-closure"/>
<display value="Container Closure System"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"/>
<code value="quality.drug-product"/>
<display value="Drug Product"/>
</code>
<text>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"/>
</text>
<type value="string"/>
</item>
</Questionnaire>