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 |
{
"resourceType" : "Questionnaire",
"id" : "brr-regulatory-qa-questionnaire",
"meta" : {
"versionId" : "2025-11-11T22:38:00Z",
"lastUpdated" : "2025-11-11T22:38:00Z",
"profile" : [
"http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaire"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <p>EMA List of Questions – Type II Variation (ID001)</p>\n </div>"
},
"url" : "http://hl7.org/fhir/uv/src-ig/Questionnaire/brr-regulatory-qa-questionnaire",
"identifier" : [
{
"system" : "http://hl7.org/fhir/uv/brr/identifier/qa-request",
"value" : "ID001"
},
{
"system" : "https://ema.europa.eu/procedure-number",
"value" : "EMEA/H/C/005432/II/0023"
}
],
"version" : "0.1.0",
"name" : "BRRRegulatoryQAQuestionnaire",
"title" : "Responses to Question Set ID001",
"status" : "active",
"subjectType" : [
"MedicinalProductDefinition"
],
"date" : "2025-11-11",
"publisher" : "Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)",
"contact" : [
{
"name" : "Gravitate Health and HL7 Biomedical Research & Regulation (BR&R)",
"telecom" : [
{
"system" : "url",
"value" : "https://www.gravitatehealth.eu/"
}
]
}
],
"effectivePeriod" : {
"start" : "2025-11-11",
"end" : "2025-12-11"
},
"item" : [
{
"linkId" : "admin-1",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "administrative.application-form.fee",
"display" : "Fee Payment Documentation"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "administrative.application-form",
"display" : "Application Form"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "administrative",
"display" : "Administrative Information"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "admin-2",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "administrative.application-form.metadata",
"display" : "Metadata Completeness"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "administrative.application-form",
"display" : "Application Form"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "administrative",
"display" : "Administrative Information"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "labeling-1",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional.labeling.storage-conditions",
"display" : "Storage Conditions"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional.labeling",
"display" : "Labeling and Package Leaflet"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional",
"display" : "Regional Information"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "labeling-2",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional.labeling.shelf-life",
"display" : "Shelf Life"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional.labeling",
"display" : "Labeling and Package Leaflet"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional",
"display" : "Regional Information"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "labeling-3",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional.labeling.multilingual",
"display" : "Multilingual Clarity"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional.labeling",
"display" : "Labeling and Package Leaflet"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "regional",
"display" : "Regional Information"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "cmc-1-DP-Stability",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.stability.study-design",
"display" : "Stability Study Design"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.stability",
"display" : "Stability"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product",
"display" : "Drug Product"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "cmc-2-DP-Stability",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.stability.climatic-zones",
"display" : "Climatic Zone Support"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.stability",
"display" : "Stability"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product",
"display" : "Drug Product"
}
],
"_text" : {
"extension" : [
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"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "cmc-3-DP-Analytical Methods",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.control.analytical-procedures",
"display" : "Analytical Procedures"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.control",
"display" : "Control of Drug Product"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product",
"display" : "Drug Product"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "cmc-4-DP-Impurities",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.control.impurities",
"display" : "Impurities"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.control",
"display" : "Control of Drug Product"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product",
"display" : "Drug Product"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
},
{
"linkId" : "cmc-5-DP-Container Closure System",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product.container-closure",
"display" : "Container Closure System"
},
{
"system" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"code" : "quality.drug-product",
"display" : "Drug Product"
}
],
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText"
}
]
},
"type" : "string"
}
]
}