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
<QuestionnaireResponse xmlns="http://hl7.org/fhir">
<id value="questionnaireresponse-ID001"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-20T22:30:00Z"/>
<profile
value="http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: QuestionnaireResponse questionnaireresponse-ID001</b></p><a name="questionnaireresponse-ID001"> </a><a name="hcquestionnaireresponse-ID001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 1; Last updated: 2025-11-20 22:30:00+0000</p><p style="margin-bottom: 0px">Profile: <code>http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse</code></p></div><table border="1" cellpadding="0" cellspacing="0" style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 2px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://hl7.org/fhir/R5/formats.html#table" title="The linkID for the item">LinkID</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://hl7.org/fhir/R5/formats.html#table" title="Text for the item">Text</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://hl7.org/fhir/R5/formats.html#table" title="Minimum and Maximum # of times the item can appear in the instance">Definition</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://hl7.org/fhir/R5/formats.html#table" title="The type of the item">Answer</a><span style="float: right"><a href="https://hl7.org/fhir/R5/formats.html#table" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_q_root.gif" alt="." style="background-color: white; background-color: inherit" title="QuestionnaireResponseRoot" class="hierarchy"/> questionnaireresponse-ID001</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire:Questionnaire/questionnaire-ID001</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> admin-1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> admin-2</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> product-1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> product-2</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> product-3</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> quality-1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> quality-2</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> quality-3</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> quality-4</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> quality-5</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See extension</td></tr>
<tr><td colspan="4" class="hierarchy"><br/><a href="https://hl7.org/fhir/R5/formats.html#table" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<contained>
<Organization>
<id value="org-regulator"/>
<identifier>
<system value="https://ema.europa.eu/organization-id"/>
<value value="EMA"/>
</identifier>
<name value="European Medicines Agency"/>
<contact>
<telecom>
<system value="email"/>
<value value="jane.doe@ema.example.eu"/>
</telecom>
<address>
<text value="Domenico Scarlattilaan 6, 1083 HS Amsterdam, NL"/>
<line value="Domenico Scarlattilaan 6"/>
<city value="Amsterdam"/>
<postalCode value="1083 HS"/>
<country value="NL"/>
</address>
</contact>
</Organization>
</contained>
<contained>
<Organization>
<id value="org-mah"/>
<identifier>
<system value="https://www.zefix.ch/en/SwissCompanyRegistry/UID"/>
<value value="CHE-123.456.789"/>
</identifier>
<name value="SynthPharma AG"/>
<contact>
<telecom>
<system value="email"/>
<value value="john.doe@synthpharma.ch"/>
</telecom>
<address>
<text value="Industriestrasse 12, 4056 Basel, CH"/>
<line value="Industriestrasse 12"/>
<city value="Basel"/>
<postalCode value="4056"/>
<country value="CH"/>
</address>
</contact>
</Organization>
</contained>
<contained>
<DocumentReference>
<id value="example-docref"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-documentreference"/>
</meta>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:1.2.3.4.5"/>
</identifier>
<version value="1.0"/>
<status value="current"/>
<docStatus value="final"/>
<type>
<coding>
<system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
<code value="3-2-P-5-3"/>
<display value="3.2.P.5.3 Validation of Analytical Procedures"/>
</coding>
</type>
<category>
<coding>
<system value="http://hl7.org/fhir/document-reference-status"/>
<code value="current"/>
<display value="Current"/>
</coding>
</category>
<date value="2025-11-20T10:00:00Z"/>
<description
value="Comprehensive validation of analytical procedures for the WonderDrug 10mg product lifecycle."/>
<content>
<attachment>
<contentType value="application/pdf"/>
<title value="Validation Report for HPLC Method"/>
<creation value="2025-11-19T15:00:00Z"/>
</attachment>
</content>
</DocumentReference>
</contained>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/rtq/CodeSystem/rtq-identifier-type"/>
<code value="regulator"/>
<display value="Regulatory Authority Identifier"/>
</coding>
</type>
<system value="http://hl7.org/fhir/uv/brr/identifier/qa-request"/>
<value value="ID001"/>
</identifier>
<questionnaire value="Questionnaire/questionnaire-ID001"/>
<status value="completed"/>
<subject>
<reference
value="MedicinalProductDefinition/MedicinalProduct-ExampleDrug"/>
<display value="ExampleDrug 10 mg Tablets"/>
</subject>
<authored value="2025-06-25T14:00:00+02:00"/>
<author>
<reference value="#org-regulator"/>
<type value="Organization"/>
<display value="European Medicines Agency"/>
</author>
<source>
<reference value="#org-mah"/>
<type value="Organization"/>
<display value="SynthPharma AG"/>
</source>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Is the fee for the Type II variation fully paid and documented?</p></div>"/>
</extension>
<linkId value="admin-1"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Yes, the fee was paid on <b>June 25, 2025</b>. Payment confirmation and receipt are included in the application form (see Section 1.1).</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
<answer>
<valueReference>
<reference value="#example-docref"/>
<display value="Fee Payment Receipt"/>
</valueReference>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Are all required metadata fields in the application form complete?</p></div>"/>
</extension>
<linkId value="admin-2"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Yes, all required metadata fields are complete:</p><ul><li><strong>MAH:</strong> SynthPharma AG</li><li><strong>Product:</strong> ExampleDrug 10 mg Tablets</li><li><strong>Procedure:</strong> EMEA/H/C/005432/II/0023</li><li><strong>Submission Date:</strong> 2025-06-25</li></ul></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<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>"/>
</extension>
<linkId value="product-1"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>No additional patient guidance is required. The ePI clearly states: 'Store in a refrigerator (2°C – 8°C). Do not freeze.' The 36-month shelf life is supported by stability data and does not alter patient handling instructions.</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Is the patient leaflet revised to clarify the extended shelf life?</p></div>"/>
</extension>
<linkId value="product-2"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Yes, the patient leaflet has been updated to state: 'Shelf life after first opening: 36 months when stored at 2–8°C'. The revised leaflet is included in the submission.</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Is the updated ePI text sufficiently clear for all EU languages?</p></div>"/>
</extension>
<linkId value="product-3"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Yes, the ePI text has been translated into all EU languages and reviewed for clarity. All versions are linguistically validated. Status: English (Approved), French (Approved), German (Approved), others (Final review completed).</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<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>"/>
</extension>
<linkId value="quality-1"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>The submission includes both:</p><ul><li><strong>Additional timepoints:</strong> Long-term data extended to 36 months for primary batches A-001, A-002, A-003.</li><li><strong>New stability studies:</strong> Two pilot-scale batches (B-001, B-002) in new Alu/Alu packaging, with 6-month accelerated (40°C/75% RH) and long-term (25°C/60% RH) data.</li></ul><p>No protocol deviations occurred. All studies follow ICH Q1A(R2).</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Does the data support all intended climatic zones?</p></div>"/>
</extension>
<linkId value="quality-2"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Yes, the data supports all ICH climatic zones, including Zone IVb:</p><ul><li><strong>Zone I/II:</strong> 25°C/60% RH (long-term), 40°C/75% RH (accelerated)</li><li><strong>Zone IVb:</strong> 30°C/75% RH (long-term) — data confirms compliance per WHO TRS 1010.</li></ul><p>All batches remain within specification.</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<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>"/>
</extension>
<linkId value="quality-3"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Yes, all test methods are identical to those validated in the original MAA. No changes were made. Methods remain stability-indicating for assay, impurities, and dissolution.</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Are there any new degradation products identified within the newly submitted data?</p></div>"/>
</extension>
<linkId value="quality-4"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>No new degradation products were identified. All observed impurities correspond to previously qualified degradants. Levels remain below 0.10% (ICH Q3B(R2) threshold). No peaks above reporting threshold detected.</p></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<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>"/>
</extension>
<linkId value="quality-5"/>
<answer>
<extension
url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
<valueString
value="<div xmlns="http://www.w3.org/1999/xhtml"><p>Yes, a change in packaging configuration was implemented:</p><ul><li><strong>Original:</strong> PVC/PVDC blister pack</li><li><strong>New:</strong> Aluminum/aluminum (Alu/Alu) blister pack</li></ul><p>New stability studies (B-001, B-002) were initiated in the Alu/Alu system. Storage conditions remain unchanged: 25°C/60% RH (long-term), 40°C/75% RH (accelerated).</p><div style="background:#e5e5ea;border:1px dashed #999;padding:10px;text-align:center;color:#666;">[Figure 1: Cross-section of new Alu/Alu blister pack]</div><p style="font-size:0.9em;color:#555"><b>Figure 1:</b> Cross-section of new Alu/Alu blister showing foil thickness and sealing layer.</p><table><tr><th>Parameter</th><th>Original</th><th>New</th></tr><tr><td>Material</td><td>PVC/PVDC</td><td>Alu/Alu</td></tr><tr><td>Storage Condition</td><td>25°C/60% RH</td><td>Unchanged</td></tr></table></div>"/>
</extension>
<valueString value="See extension"/>
</answer>
</item>
</QuestionnaireResponse>