FHIR IG analytics| Package | hl7.fhir.uv.rtq-ig |
| Resource Type | Questionnaire |
| Id | Questionnaire-questionnaire-ID001-round2.json |
| FHIR Version | R5 |
| Source | https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire-questionnaire-ID001-round2.html |
| URL | http://hl7.org/fhir/uv/rtq/Questionnaire/questionnaire-ID001-round2 |
| Version | 0.2.0 |
| Status | active |
| Date | 2025-12-01 |
| Name | BRRRegulatoryQAQuestionnaireRound2 |
| Title | Question Set ID001-R2 |
| Realm | uv |
| Authority | hl7 |
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Note: links and images are rebased to the (stated) source
Dear SynthPharma AG,
Please find enclosed our assessment of your responses SP-RTQ-2025-0148 to the List of Questions ID001. Eight questions are resolved, including the commitment you offered on question quality-1. Question product-3 is not resolved, and question quality-4 raises two follow-up questions. Please respond to the open questions by 31 December 2025.
National Regulatory Authority, Regulatory Affairs Division
FHIR
FHIRsmith{
"resourceType": "Questionnaire",
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"lastUpdated": "2025-12-01T09:00:00Z",
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]
},
"language": "en",
"text": {
"status": "additional",
"div": "<!-- snip (see above) -->"
},
"extension": [
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"url": "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-procedure-identifier",
"valueIdentifier": {
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"value": "NRA/H/C/005432/II/0023"
}
},
{
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"url": "product",
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"value": "MPID-EX-000123"
}
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{
"url": "authorization",
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"value": "NRA/H/C/005432"
}
}
],
"url": "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-regulatory-subject"
}
],
"url": "http://hl7.org/fhir/uv/rtq/Questionnaire/questionnaire-ID001-round2",
"identifier": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type",
"code": "regulator-id",
"display": "Regulator-issued Identifier"
}
]
},
"system": "https://example-nra.example.org/question-set-id",
"value": "ID001-R2"
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"version": "0.2.0",
"name": "BRRRegulatoryQAQuestionnaireRound2",
"title": "Question Set ID001-R2",
"derivedFrom": [
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],
"status": "active",
"subjectType": [
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],
"date": "2025-12-01",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
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"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
}
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"jurisdiction": [
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"coding": [
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"code": "001",
"display": "World"
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"effectivePeriod": {
"start": "2025-12-01",
"end": "2025-12-31"
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"code": [
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"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs",
"code": "list-of-questions",
"display": "List of Questions"
}
],
"item": [
{
"linkId": "admin-1",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1",
"display": "Administrative Information and Prescribing Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/example-nra-module-1",
"code": "1.1",
"display": "Application Form"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Is the fee for the Type II variation fully paid and documented?",
"_text": {
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the fee for the Type II variation fully paid and documented?</p></div>"
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"type": "text",
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{
"linkId": "admin-2",
"code": [
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"code": "1",
"display": "Administrative Information and Prescribing Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/example-nra-module-1",
"code": "1.1",
"display": "Application Form"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Are all required metadata fields in the application form complete?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are all required metadata fields in the application form complete?</p></div>"
}
]
},
"type": "text",
"required": false
},
{
"linkId": "product-1",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1",
"display": "Administrative Information and Prescribing Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/example-nra-module-1",
"code": "1.3.1",
"display": "SmPC, Labelling and Package Leaflet"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?</p></div>"
}
]
},
"type": "text",
"required": false
},
{
"linkId": "product-2",
"code": [
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"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1",
"display": "Administrative Information and Prescribing Information"
},
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"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/example-nra-module-1",
"code": "1.3.1",
"display": "SmPC, Labelling and Package Leaflet"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Is the patient leaflet revised to clarify the extended shelf life?",
"_text": {
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the patient leaflet revised to clarify the extended shelf life?</p></div>"
}
]
},
"type": "text",
"required": false
},
{
"linkId": "product-3",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "1",
"display": "Administrative Information and Prescribing Information"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/example-nra-module-1",
"code": "1.3.1",
"display": "SmPC, Labelling and Package Leaflet"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-question-category",
"code": "minor-concern",
"display": "Minor Concern"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "not-resolved",
"display": "Not Resolved"
}
],
"text": "Is the updated ePI text sufficiently clear for all applicable languages?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Is the updated ePI text sufficiently clear for all applicable languages?</p></div>"
}
]
},
"type": "text",
"required": true,
"item": [
{
"linkId": "product-3.assessment",
"text": "Assessor comment: the response states that the French and German texts are approved, but the submitted ePI package contains the English text only. Provide the approved French and German ePI texts.",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Assessor comment: the response states that the French and German texts are approved, but the submitted ePI package contains the English text only. Provide the approved French and German ePI texts.</p></div>"
}
]
},
"type": "display"
}
]
},
{
"linkId": "quality-1",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8",
"display": "Stability"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8.1",
"display": "Stability Summary and Conclusion"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?</p></div>"
}
]
},
"type": "text",
"required": false,
"item": [
{
"linkId": "quality-1.assessment",
"text": "Commitment accepted: submit 48-month long-term stability results for batches A-001, A-002 and A-003 by 2027-06-30.",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Commitment accepted: submit 48-month long-term stability results for batches A-001, A-002 and A-003 by 2027-06-30.</p></div>"
}
]
},
"type": "display"
}
]
},
{
"linkId": "quality-2",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8",
"display": "Stability"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.8.1",
"display": "Stability Summary and Conclusion"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Does the data support all intended climatic zones?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Does the data support all intended climatic zones?</p></div>"
}
]
},
"type": "text",
"required": false
},
{
"linkId": "quality-3",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5",
"display": "Control of Drug Product"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5.2",
"display": "Analytical Procedures"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Are the test methods used the same as in the previously submitted stability information?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are the test methods used the same as in the previously submitted stability information?</p></div>"
}
]
},
"type": "text",
"required": false
},
{
"linkId": "quality-4",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5",
"display": "Control of Drug Product"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5.5",
"display": "Characterisation of Impurities"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-question-category",
"code": "major-objection",
"display": "Major Objection"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "further-questions",
"display": "Raises Further Questions"
}
],
"text": "Are there any new degradation products identified within the newly submitted data?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Are there any new degradation products identified within the newly submitted data?</p></div>"
}
]
},
"type": "group",
"required": true,
"item": [
{
"linkId": "quality-4.1",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5",
"display": "Control of Drug Product"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5.5",
"display": "Characterisation of Impurities"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-question-category",
"code": "major-objection",
"display": "Major Objection"
}
],
"text": "The chromatograms for batch B-002 at 6 months accelerated (40°C/75% RH) show an unidentified peak at RRT 0.85 at 0.12%, above the 0.10% identification threshold. Identify this degradation product and propose a specification limit.",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The chromatograms for batch B-002 at 6 months accelerated (40°C/75% RH) show an unidentified peak at RRT 0.85 at 0.12%, above the 0.10% identification threshold. Identify this degradation product and propose a specification limit.</p></div>"
}
]
},
"type": "text",
"required": true
},
{
"linkId": "quality-4.2",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5",
"display": "Control of Drug Product"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.5.5",
"display": "Characterisation of Impurities"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-question-category",
"code": "major-objection",
"display": "Major Objection"
}
],
"text": "Provide the toxicological qualification of this degradation product per ICH Q3B(R2), or justify why qualification is not required.",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Provide the toxicological qualification of this degradation product per ICH Q3B(R2), or justify why qualification is not required.</p></div>"
}
]
},
"type": "text",
"required": true
}
]
},
{
"linkId": "quality-5",
"code": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code": "3.2.P.7",
"display": "Container Closure System"
},
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-assessment-outcome",
"code": "resolved",
"display": "Resolved"
}
],
"text": "Any changes in the packaging configuration and/or storage of the samples during stability?",
"_text": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Any changes in the packaging configuration and/or storage of the samples during stability?</p></div>"
}
]
},
"type": "text",
"required": false
}
]
}