FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | External-FomulatnSUB-BIO.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Questionnaire",
"id": "f44da1de-7aed-4270-9a27-c7019b293f21",
"meta": {
"versionId": "9",
"lastUpdated": "2026-02-03T16:25:49.395+00:00",
"source": "#a1c9d5f2ca23e746"
},
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Questionnaire-External-Indicator",
"valueBoolean": true
}
],
"version": "3.0.10",
"title": "Formulatn",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"purpose": "https://files.ontario.ca/moh-drug-submission-ontario-guidelines-notification-change-brand-drug-products-2023-08-30.pdf",
"code": [
{
"code": "SUB-FORMULATION",
"display": "Formulation Change"
},
{
"code": "SUB-BIO-FORMULATION",
"display": "Formulation Change"
},
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Questionnaire-Type",
"code": "SUBMIT",
"display": "Submit "
}
],
"item": [
{
"linkId": "CHANGEDETAILSNAV",
"text": "Change Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "CHANGEDETAILSGROUP",
"text": "Change Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
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"valueCode": "application/pdf"
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{
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"valueDecimal": 10
},
{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "CHANGERATIONALEDOC",
"text": "Rationale for the change(s)",
"type": "attachment",
"required": true,
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "EFFECTIVECHANGEDATE",
"text": "Effective date for the change(s)",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "DISCONTINUATIONDATE",
"text": "Date the currently listed formulation will be discontinued and removed from the market",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "LASTLOTEXPIRYDATE",
"text": "Please specify the expiry date of the last lot of the currently listed product",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
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"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
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"valueCode": "application/pdf"
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{
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"valueDecimal": 10
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "CHANGEFORMULATIONDOC",
"text": "Old and new master formulations or Certified Product Information Document (CPID) and highlights to the changes",
"type": "attachment",
"required": true,
"repeats": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
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"valueCode": "application/msword"
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
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"valueCode": "application/pdf"
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"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "CHANGEMASTERFORMULATIONDOC",
"text": "A list of all changes made to the master formulation, including the percent (%) change in the quantity of ingredient(s)",
"type": "attachment",
"required": true,
"repeats": false
}
]
}
]
},
{
"linkId": "HEALTHCANADADOCUMENTATIONNAV",
"text": "Health Canada Documentation",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-itemExtractionContext",
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"expression": "ServiceRequest"
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"linkId": "HEALTHCANADADOCUMENTATIONGROUP",
"text": "Health Canada Documentation",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
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"coding": [
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
}
],
"linkId": "HEALTHCANADAAPPROVEDCHANGES",
"text": "Please confirm that Health Canada has approved the change(s)",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Repeating-Group-Label",
"valueString": "Notice of Compliance"
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Group-Column-Count",
"valueInteger": 3
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
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}
}
],
"linkId": "NOCAPPROVALGROUP1",
"text": "Notice of Compliance (NOC) or No Objection Letter (NOL) Information",
"type": "group",
"required": true,
"repeats": true,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
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{
"extension": [
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"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
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"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
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],
"linkId": "NOCAPPROVEDDATE1",
"definition": "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-ServiceRequest-New#ServiceRequest.extension.where(url='https://health.gov.on.ca/idms/fhir/StructureDefinition/NOC-Complex').extension.where(url='NOC-Date').valueDate",
"text": "New NOC or NOL Approved Date",
"type": "date",
"required": true
},
{
"extension": [
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"valueInteger": 5
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{
"url": "http://hl7.org/fhir/StructureDefinition/regex",
"valueString": "[0-9]*"
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{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NOCSUBMISSIONUMBER",
"definition": "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-ServiceRequest-New#ServiceRequest.extension.where(url='https://health.gov.on.ca/idms/fhir/StructureDefinition/NOC-Complex').extension.where(url='NOC-Control-Number').valueString",
"text": "New NOC or NOL Control Number",
"type": "string",
"required": true,
"maxLength": 8
},
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
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"valueDecimal": 10
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{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NOTICEOFCOMPLIANCEDOC",
"text": "Updated Notice of Compliance or No Objection Letter",
"type": "attachment",
"required": true,
"repeats": false
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Repeating-Group-Label",
"valueString": "Product Monograph"
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Group-Column-Count",
"valueInteger": 3
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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"expression": "%context.item.where(linkId='HEALTHCANADADOCUMENTATIONNAV').item.where(linkId='HEALTHCANADADOCUMENTATIONGROUP').item.where(linkId='HEALTHCANADAAPPROVEDCHANGES').answer[0].valueBoolean=true"
}
}
],
"linkId": "PRODUCTMONOGRAPHGROUP1",
"text": "Product Monograph",
"type": "group",
"required": false,
"repeats": true,
"item": [
{
"extension": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today()+ 1 day"
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},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PRODUCTMONONGRAPHDATE",
"definition": "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-ServiceRequest-New#ServiceRequest.extension.where(url='https://health.gov.on.ca/idms/fhir/StructureDefinition/Product-Monograph-Complex').extension.where(url='Product-Monograph-Date').valueDate",
"text": "Date of the new Product Monograph",
"type": "date",
"required": true
},
{
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"valueInteger": 5
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{
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{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "PRODUCTMONOGRAPHCONTROLNUMBER",
"definition": "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-ServiceRequest-New#ServiceRequest.extension.where(url='https://health.gov.on.ca/idms/fhir/StructureDefinition/Product-Monograph-Complex').extension.where(url='Product-Monograph-Control-Number').valueString",
"text": "Product Monograph Control Number",
"type": "string",
"required": true,
"repeats": false,
"readOnly": false,
"maxLength": 8
},
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
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{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
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{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
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{
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"valueCode": "application/pdf"
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{
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"valueDecimal": 10
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NONANNOTATEDPRODUCTMONOGRAPHDOC",
"text": "Non-annotated copy of the new Product Monograph",
"type": "attachment",
"required": true,
"repeats": false
},
{
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
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{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
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{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
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{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "ANNOTATEDPRODUCTMONOGRAPHDOC",
"text": "Annotated/tracked copy of the new Product Monograph",
"type": "attachment",
"required": true,
"repeats": false
}
]
}
]
}
]
},
{
"linkId": "BIOAVAILABILITYINFORMATIONNAV",
"text": "Bioavailability Information",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "BIOAVAILABILITYINFORMATIONGROUP",
"text": "Bioavailability Information",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "BIOAVAILABILITYAFFECTED",
"text": "Has bioavailability been affected for the Product?",
"type": "boolean",
"required": true,
"repeats": false
},
{
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"valueDecimal": 10
},
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"valueExpression": {
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}
},
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "BIOAVAILABILITYSUPPORTING",
"text": "Supporting Documents",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
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"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "BIOAVAILABILITYSUPPORTINGHELP",
"text": "If bioavailability has been affected, a new comparative bioavailability study (or a justification for not providing a study), or the scientific data provided to Health Canada is required.",
"type": "display"
}
]
},
{
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}
}
],
"linkId": "BIOAVAILABILITYADDITIONALINFO",
"text": "Additional Information",
"type": "text",
"required": false,
"maxLength": 1000
}
]
}
]
},
{
"linkId": "SUPPLEMENTALNAV",
"text": "Supplemental Information",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "SUPPLEMENTALGROUP",
"text": "Supplemental Information",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
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"valueCodeableConcept": {
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{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "SUPPLEMENTALGROUPHELP",
"text": "Please provide any additional information and/or materials that may aid the ministry in assessing your submission (e.g., Health Canada evaluation reports).",
"type": "display"
},
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
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{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
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{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
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"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
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},
{
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"valueDecimal": 10
}
],
"linkId": "SUPPLEMENTALSUPPORTING",
"text": "Supporting Documents",
"type": "attachment",
"required": false,
"repeats": true,
"readOnly": false
},
{
"linkId": "SUPPLEMENTALADDITIONALINFO",
"text": "Additional Information",
"type": "text",
"required": false,
"maxLength": 1000
}
]
}
]
}
]
}