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="questionnaire-ID001"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-11T22:30:00Z"/>
<profile
value="http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Questionnaire questionnaire-ID001</b></p><a name="questionnaire-ID001"> </a><a name="hcquestionnaire-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: 2025-11-11 22:30:00+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-rtq-questionnaire.html">Questionnaire</a></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">Cardinality</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">Type</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="Additional information about the item">Description & Constraints</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="QuestionnaireRoot" class="hierarchy"/> BRRRegulatoryQAQuestionnaire</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"/><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</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">https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001#0.1.0</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)" id="item.admin-1" 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-question.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="question" 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">Is the fee for the Type II variation fully paid and documented?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.admin-2" 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-group.png" alt="." style="background-color: white; background-color: inherit" title="group" 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">Are all required metadata fields in the application form complete?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-group">group</a></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"/></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)" id="item.product-1" 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-question.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="question" 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">Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.product-2" 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-question.png" alt="." style="background-color: white; background-color: inherit" title="question" 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">Is the patient leaflet revised to clarify the extended shelf life?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.product-3" 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-question.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="question" 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">Is the updated ePI text sufficiently clear for all EU languages?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.quality-1" 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-question.png" alt="." style="background-color: white; background-color: inherit" title="question" 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">Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.quality-2" 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-question.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="question" 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">Does the data support all intended climatic zones?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.quality-3" 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-question.png" alt="." style="background-color: white; background-color: inherit" title="question" 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">Are the test methods used the same as in the previously submitted stability information?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.quality-4" 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-question.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="question" 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">Are there any new degradation products identified within the newly submitted data?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></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)" id="item.quality-5" 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-question.png" alt="." style="background-color: white; background-color: inherit" title="question" 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">Any changes in the packaging configuration and/or storage of the samples during stability?</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">0..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"><a href="https://hl7.org/fhir/R5/codesystem-item-type.html#item-type-question">question</a></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"/></tr>
<tr><td colspan="5" 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>
<url
value="https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001"/>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type"/>
<code value="regulator-id"/>
<display value="Regulator-issued Identifier"/>
</coding>
</type>
<system value="http://hl7.org/fhir/uv/brr/identifier/qa-request"/>
<value value="ID001"/>
</identifier>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type"/>
<code value="regulator-id"/>
<display value="Regulator-issued Identifier"/>
</coding>
</type>
<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="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>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="admin-1"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.0"/>
<display value="1.0 Administrative Information"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.1"/>
<display value="1.1 Application Form"/>
</code>
<text
value="Is the fee for the Type II variation fully paid and documented?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="admin-2"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.0"/>
<display value="Administrative Information"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.1"/>
<display value="Application Form"/>
</code>
<text
value="Are all required metadata fields in the application form complete?"/>
<type value="group"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="product-1"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.3"/>
<display value="1.3 Product Information"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.3.1"/>
<display value="SmPC, Labelling and Package Leaflet"/>
</code>
<text
value="Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="product-2"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.3"/>
<display value="Product Information"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.3.1"/>
<display value="SmPC, Labelling and Package Leaflet"/>
</code>
<text
value="Is the patient leaflet revised to clarify the extended shelf life?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="product-3"/>
<code>
<system
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<code value="1.3"/>
<display value="Product Information"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="1.3.1"/>
<display value="SmPC, Labelling and Package Leaflet"/>
</code>
<text
value="Is the updated ePI text sufficiently clear for all EU languages?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="quality-1"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.8"/>
<display value="Stability"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.8.1"/>
<display value="Stability Summary and Conclusion"/>
</code>
<text
value="Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="quality-2"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.8"/>
<display value="Stability"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.8.1"/>
<display value="Stability Summary and Conclusion"/>
</code>
<text value="Does the data support all intended climatic zones?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="quality-3"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.5"/>
<display value="Control of Drug Product"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.5.2"/>
<display value="Analytical Procedures"/>
</code>
<text
value="Are the test methods used the same as in the previously submitted stability information?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="quality-4"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.5"/>
<display value="Control of Drug Product"/>
</code>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.5.4"/>
<display value="Impurities"/>
</code>
<text
value="Are there any new degradation products identified within the newly submitted data?"/>
<type value="question"/>
</item>
<item>
<extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml"/>
<linkId value="quality-5"/>
<code>
<system
value="http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full"/>
<code value="3.2.P.7"/>
<display value="Container Closure System"/>
</code>
<text
value="Any changes in the packaging configuration and/or storage of the samples during stability?"/>
<type value="question"/>
</item>
</Questionnaire>