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 |
{
"resourceType" : "Questionnaire",
"id" : "questionnaire-ID001",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-11T22:30:00Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire"
]
},
"text" : {
"status" : "generated",
"div" : "<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>\r\n<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>"
},
"url" : "https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001",
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type",
"code" : "regulator-id",
"display" : "Regulator-issued Identifier"
}
]
},
"system" : "http://hl7.org/fhir/uv/brr/identifier/qa-request",
"value" : "ID001"
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type",
"code" : "regulator-id",
"display" : "Regulator-issued Identifier"
}
]
},
"system" : "https://ema.europa.eu/procedure-number",
"value" : "EMEA/H/C/005432/II/0023"
}
],
"version" : "0.1.0",
"name" : "BRRRegulatoryQAQuestionnaire",
"title" : "Question Set ID001",
"status" : "active",
"subjectType" : [
"MedicinalProductDefinition"
],
"date" : "2025-11-11",
"publisher" : "HL7 International",
"contact" : [
{
"name" : "HL7 International",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org"
}
]
}
],
"item" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId" : "admin-1",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.0",
"display" : "1.0 Administrative Information"
},
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.1",
"display" : "1.1 Application Form"
}
],
"text" : "Is the fee for the Type II variation fully paid and documented?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId" : "admin-2",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.0",
"display" : "Administrative Information"
},
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.1",
"display" : "Application Form"
}
],
"text" : "Are all required metadata fields in the application form complete?",
"type" : "group"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId" : "product-1",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.3",
"display" : "1.3 Product Information"
},
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.3.1",
"display" : "SmPC, Labelling and Package Leaflet"
}
],
"text" : "Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId" : "product-2",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.3",
"display" : "Product Information"
},
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.3.1",
"display" : "SmPC, Labelling and Package Leaflet"
}
],
"text" : "Is the patient leaflet revised to clarify the extended shelf life?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId" : "product-3",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.3",
"display" : "Product Information"
},
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "1.3.1",
"display" : "SmPC, Labelling and Package Leaflet"
}
],
"text" : "Is the updated ePI text sufficiently clear for all EU languages?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"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"
}
],
"text" : "Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"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"
}
],
"text" : "Does the data support all intended climatic zones?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"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"
}
],
"text" : "Are the test methods used the same as in the previously submitted stability information?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"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.5.4",
"display" : "Impurities"
}
],
"text" : "Are there any new degradation products identified within the newly submitted data?",
"type" : "question"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
}
],
"linkId" : "quality-5",
"code" : [
{
"system" : "http://hl7.org/fhir/uv/rtq/CodeSystem/ctd-categories-full",
"code" : "3.2.P.7",
"display" : "Container Closure System"
}
],
"text" : "Any changes in the packaging configuration and/or storage of the samples during stability?",
"type" : "question"
}
]
}