FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | External-HCchgMULTI.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
{
"resourceType": "Questionnaire",
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"meta": {
"versionId": "6",
"lastUpdated": "2026-02-03T16:26:41.106+00:00",
"source": "#0ab0bc7fcf578ec1"
},
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"valueBoolean": true
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],
"version": "3.0.10",
"title": "HCchg",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"purpose": "https://files.ontario.ca/moh-drug-submission-ontario-guidelines-notification-change-generic-drug-products-2023-08-30.pdf",
"code": [
{
"code": "SUB-MULTI-DRUG-PRODUCT-NAME",
"display": "Drug Product Name Change"
},
{
"code": "SUB-MULTI-DIN-CHANGE",
"display": "Drug Identification Number (DIN) Change"
},
{
"code": "SUB-MULTI-OWNERSHIP",
"display": "Ownership Change"
},
{
"code": "SUB-MULTI-ORG-NAME",
"display": "Organization Name 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": [
{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "CHANGERATIONALEDOC",
"text": "Rationale for the change(s)",
"type": "attachment",
"required": true,
"repeats": false
},
{
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],
"linkId": "EFFECTIVECHANGEDATE",
"text": "Effective date for the change(s)",
"type": "date",
"required": true
},
{
"extension": [
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "DISCONTINUATIONDATE",
"text": "Date the currently listed product 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"
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],
"linkId": "LASTLOTEXPIRYDATE",
"text": "Expiry date of the last lot for the currently listed product",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
}
],
"linkId": "CHANGEMASTERFORMULATIONCHANGES",
"text": "I confirm that the master formulation for the Product has not changed",
"type": "boolean",
"required": true
}
]
}
]
},
{
"linkId": "HEALTHCANADADOCUMENTATIONNAV",
"text": "Health Canada Documentation",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
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"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"
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{
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"valueInteger": 3
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}
}
],
"linkId": "NOCAPPROVALGROUP1",
"text": "Notice of Compliance (NOC) or No Objection Letter (NOL) Information",
"type": "group",
"required": true,
"repeats": true,
"item": [
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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
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],
"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
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],
"linkId": "NOTICEOFCOMPLIANCEDOC",
"text": "Updated Notice of Compliance or No Objection Letter",
"type": "attachment",
"required": true,
"repeats": false
}
]
},
{
"extension": [
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"valueInteger": 3
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],
"linkId": "PRODUCTMONOGRAPHGROUP1",
"text": "Product Monograph",
"type": "group",
"required": false,
"repeats": true,
"item": [
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"required": true
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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": "New Product Monograph Control Number",
"type": "string",
"required": true,
"repeats": false,
"readOnly": false,
"maxLength": 8
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],
"linkId": "NONANNOTATEDPRODUCTMONOGRAPHDOC",
"text": "Non-annotated copy of the new Product Monograph",
"type": "attachment",
"required": true,
"repeats": false
},
{
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"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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],
"linkId": "BIOAVAILABILITYSUPPORTING",
"text": "Supporting Documents",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
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],
"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",
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},
{
"linkId": "SUPPLEMENTALNAV",
"text": "Supplemental Information",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
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"linkId": "SUPPLEMENTALGROUP",
"text": "Supplemental Information",
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"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"
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"linkId": "SUPPLEMENTALSUPPORTING",
"text": "Supporting Documents",
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"required": false,
"repeats": true,
"readOnly": false
},
{
"linkId": "SUPPLEMENTALADDITIONALINFO",
"text": "Additional Information",
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]
}