FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | External-SingleSourceLineExt.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Questionnaire",
"id": "1adca216-f36f-40ae-93bd-c557aedc25d5",
"meta": {
"versionId": "22",
"lastUpdated": "2026-01-20T15:34:55.906+00:00",
"source": "#1bd2875eb44c6e8d"
},
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Questionnaire-External-Indicator",
"valueBoolean": true
}
],
"version": "3.0.10",
"title": "Single source drug product Line Extension",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"purpose": "https://www.ontario.ca/files/2024-03/moh-drug-submission-ontario-guidelines-single-source-drug-products-en-2024-03-20.pdf",
"code": [
{
"code": "SUB-NEW-LINE",
"display": "Line Extension"
},
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Questionnaire-Type",
"code": "SUBMIT",
"display": "Submit"
}
],
"item": [
{
"linkId": "SUBMISSIONDETAILSNAV",
"text": "Submission Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-itemExtractionContext",
"valueExpression": {
"language": "text/fhirpath",
"expression": "ServiceRequest"
}
}
],
"linkId": "SUBMISSIONDETAILSGROUP",
"text": "Submission Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Check-Box-Column-Count",
"valueInteger": 1
}
],
"linkId": "REQUESTEDFUNDING",
"text": "Requested Funding/Listing/Program",
"type": "coding",
"required": true,
"repeats": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/IDMS-Funding-Program-2|1.0.0"
},
{
"linkId": "INDICATIONS",
"definition": "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-ServiceRequest-New#ServiceRequest.extension.where(url='https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Indication').valueString",
"text": "Health Canada Indication(s)",
"type": "text",
"required": true,
"maxLength": 1000,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "INDICATIONSHELP",
"text": "Specify the Health Canada indication(s) for which funding is being sought, using approved language from the Product Monograph",
"type": "display"
}
]
}
]
}
]
},
{
"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",
"valueExpression": {
"language": "text/fhirpath",
"expression": "ServiceRequest"
}
}
],
"linkId": "HEALTHCANADADOCUMENTATIONGROUP",
"text": "Health Canada Documentation",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"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/questionnaire-minOccurs",
"valueExpression": {
"language": "text/fhirpath",
"expression": "1"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NOCAPPROVALGROUP1",
"text": "Notice of Compliance Information",
"type": "group",
"required": true,
"repeats": true,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
}
],
"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": "NOC Approved Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/minLength",
"valueInteger": 5
},
{
"url": "http://hl7.org/fhir/StructureDefinition/regex",
"valueString": "[0-9]*"
},
{
"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": "Submission Control Number",
"type": "string",
"required": true,
"maxLength": 8
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"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": "NOTICEOFCOMPLIANCEDOC",
"text": "Notice of Compliance",
"type": "attachment",
"required": true,
"repeats": true
}
]
},
{
"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": "http://hl7.org/fhir/uv/sdc/StructureDefinition/questionnaire-minOccurs",
"valueExpression": {
"language": "text/fhirpath",
"expression": "1"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PRODUCTMONOGRAPHGINFORROUP",
"text": "Product Monograph Information",
"type": "group",
"required": true,
"repeats": true,
"item": [
{
"extension": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today()+ 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PRODUCTMONONGRAPHREVISIONDATE",
"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 Product Monograph Revision",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/minLength",
"valueInteger": 5
},
{
"url": "http://hl7.org/fhir/StructureDefinition/regex",
"valueString": "[0-9]*"
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"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": "Submission Control Number",
"type": "string",
"required": true,
"repeats": false,
"readOnly": false,
"maxLength": 8
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "PRODUCTMONOGRAPHGROUPHELP",
"text": "Please provide the current Product Monograph approved by Health Canada and enter its date and submission control number.<br/><br/>If Health Canada has not approved a Product Monograph for the drug product (e.g., it is an “old” drug that received a DIN but no NOC), please provide the information outlined in the Guidelines (see “If No Product Monograph Has Been Approved”). All supporting documents should be submitted via the Supplemental Information page.",
"type": "display"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"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": "PRODUCTMONOGRAPHDOC",
"text": "Product Monograph",
"type": "attachment",
"required": true,
"repeats": false
}
]
}
]
}
]
},
{
"linkId": "LINEEXTENSIONDETAILSNAV",
"text": "Line Extension Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "LINEEXTENSIONDETAILSGROUP",
"text": "Line Extension Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "ISADDITIONALSTRENGTH",
"text": "Is this submission for an additional strength of another listed drug product with the same active ingredient(s) in the same or similar dosage form?",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "ISNEWFORMAT",
"text": "Is this submission for a new format of another listed drug product with the same active ingredient(s) in the same or similar dosage form (e.g., tablet versus capsule)?",
"type": "boolean",
"required": true
}
]
},
{
"linkId": "ADDITIONALSTRENGTHINFOGROUP",
"text": "Additional Strength Information",
"type": "group",
"enableWhen": [
{
"question": "ISADDITIONALSTRENGTH",
"operator": "=",
"answerBoolean": true
}
],
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "ISEVIDENCEOFPROPORTIONALITY",
"text": "Is the evidence of proportionality in composition available?",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='LINEEXTENSIONDETAILSNAV').item.where(linkId='ADDITIONALSTRENGTHINFOGROUP').item.where(linkId='ISEVIDENCEOFPROPORTIONALITY').answer.exists() and %context.item.where(linkId='LINEEXTENSIONDETAILSNAV').item.where(linkId='ADDITIONALSTRENGTHINFOGROUP').item.where(linkId='ISEVIDENCEOFPROPORTIONALITY').answer.first().valueBoolean = true"
}
}
],
"linkId": "EVIDENCEOFPROPORTIONALITYCOMPOSITIONDOC",
"text": "Evidence of proportionality in composition",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "PROPORTIONALITYCOMPOSITIONDOCHELP",
"text": "If the different drug strengths have proportional formulations or have the same ingredients with only modest changes in the quantities of inactive ingredients, a manufacturer may rely on the same clinical data for two strengths of the drug product. Manufacturers must provide evidence that the different strengths have the same or very similar proportions of ingredients (e.g., CPID or master formulation for all strengths).",
"type": "display"
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='LINEEXTENSIONDETAILSNAV').item.where(linkId='ADDITIONALSTRENGTHINFOGROUP').item.where(linkId='ISEVIDENCEOFPROPORTIONALITY').answer.exists() and %context.item.where(linkId='LINEEXTENSIONDETAILSNAV').item.where(linkId='ADDITIONALSTRENGTHINFOGROUP').item.where(linkId='ISEVIDENCEOFPROPORTIONALITY').answer.first().valueBoolean = false"
}
}
],
"linkId": "EVIDENCEOFBIOEQUIVALENCEDOC",
"text": "Evidence of bioequivalence",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "EVIDENCEOFBIOEQUIVALENCEDOCHELP",
"text": "If the additional strength of the Drug Product is not proportional in composition and major formulation differences exist between the strengths, the Manufacturer must submit a comparative bioavailability study demonstrating that the two strengths are bioequivalent.",
"type": "display"
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "EVIDENCEOFJUSTIFICATIONDOC",
"text": "Justification of need for the additional strength",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "EVIDENCEOFJUSTIFICATIONDOCHELP",
"text": "Manufacturers must provide a justification for the additional strength and describe the patient population that is most likely to make use of this additional strength, including some data for the use of the additional strength of the product in the targeted patient population. The Manufacturer must also estimate the proportion of patients in whom the additional strength product would be used.",
"type": "display"
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "SUMMARYOFCLINICALSTUDIESDOC",
"text": "Summary of the clinical studies for the already-listed strength",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false
}
]
},
{
"linkId": "NEWFORMATINFOGROUP",
"text": "New Format Information",
"type": "group",
"enableWhen": [
{
"question": "ISNEWFORMAT",
"operator": "=",
"answerBoolean": true
}
],
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "HASMASTERFORMULATIONCHANGED",
"text": "Has the master formulation for the Product changed?",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
}
],
"linkId": "CONFIRMMASTERFORMULATIONNOCHANGE",
"text": "I confirm that the master formulation for the Product has not been changed",
"type": "boolean",
"enableWhen": [
{
"question": "HASMASTERFORMULATIONCHANGED",
"operator": "=",
"answerBoolean": false
}
],
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "HASBIOAVAILABILITYAFFECTED",
"text": "Has bioavailability of the Product been affected?",
"type": "boolean",
"enableWhen": [
{
"question": "HASMASTERFORMULATIONCHANGED",
"operator": "=",
"answerBoolean": true
}
],
"required": true,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "HASBIOAVAILABILITYAFFECTEDHELP",
"text": "When the bioavailability of a drug product in a new format is not identical to that of the listed format of the drug product, manufacturers must submit a comparative bioavailability study demonstrating that the two formats are bioequivalent in order to rely on the clinical data for the listed format.",
"type": "display"
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
}
],
"linkId": "CONFIRMBIOAVAILABILITYNOTAFFECTED",
"text": "I confirm that the bioavailability of the Product has not been affected",
"type": "boolean",
"enableWhen": [
{
"question": "HASBIOAVAILABILITYAFFECTED",
"operator": "=",
"answerBoolean": false
}
],
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "EVIDENCENOBIOAVAILABILITYCHANGEDOC",
"text": "Evidence demonstrating that the change in master formulation has not resulted in a change in bioavailability of the Product",
"type": "attachment",
"enableWhen": [
{
"question": "HASBIOAVAILABILITYAFFECTED",
"operator": "=",
"answerBoolean": false
}
],
"required": true,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "EVIDENCENOBIOAVAILABILITYCHANGEDOCHELP",
"text": "If the master formulation has changed, please provide evidence demonstrating bioequivalence between products.",
"type": "display"
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "COMPARATIVEBIOAVAILABILITYSTUDYDOC",
"text": "Comparative Bioavailability Study",
"type": "attachment",
"enableWhen": [
{
"question": "HASBIOAVAILABILITYAFFECTED",
"operator": "=",
"answerBoolean": true
}
],
"required": true,
"repeats": true,
"readOnly": false
},
{
"linkId": "NEWFORMATADDITIONALINFO",
"text": "Additional Information",
"type": "text",
"enableWhen": [
{
"question": "HASBIOAVAILABILITYAFFECTED",
"operator": "=",
"answerBoolean": true
}
],
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "ISNEWPACKAGINGFORMAT",
"text": "Is this submission for a new packaging format?",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "EVIDENCEOFPHARMACEUTICALEQUIVALENCEDOC",
"text": "Evidence of Pharmaceutical Equivalence",
"type": "attachment",
"enableWhen": [
{
"question": "ISNEWPACKAGINGFORMAT",
"operator": "=",
"answerBoolean": true
}
],
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "EVIDENCEOFPHARMACEUTICALEQUIVALENCEDOCHELP",
"text": "For different packaging formats, manufacturers must submit evidence of pharmaceutical equivalence. Comparative stability test data demonstrating that the two formats are equivalent in terms of performance and product quality to support the entire product shelf life must be provided. In addition, a copy of the stability study protocol/design, including the testing frequency, parameters, specifications and methodologies, etc., is required.",
"type": "display"
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "JUSTIFICATIONNEWFORMATDOC",
"text": "Justification of need for the new format",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "JUSTIFICATIONNEWFORMATDOCHELP",
"text": "Manufacturers must provide a justification for the new format and describe the patient population that is most likely to make use of the new format, including data for use of the new product in the targeted patient population. The manufacturer must also estimate the proportion of patients in whom the new format would be used. A response to this question may be provided within a separate document. In that case, please upload the document below and enter 'attached' in the space provided.",
"type": "display"
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "SUMMARYOFCLINICALSTUDIESFORMATDOC",
"text": "Summary of the clinical studies for the already-listed format of the drug product",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false
}
]
}
]
},
{
"linkId": "FINANCIALIMPACTANALYSIS",
"text": "Financial Impact Analysis",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "FINANCIALIMPACTANALYSISGROUP",
"text": "Financial Impact Analysis",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "FINANCIALIMPACTANALYSISGROUPHELP",
"text": "<p>Please provide an estimate of the net costs to the OPDP in three-year period.</p><p>In assessing financial impact, the ministry is interested in yearly expenditures (drug costs only) for the product(s) under consideration. Drug costs should exclude upcharge (mark-up) and dispensing fee.</p>",
"type": "display"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "BUDGETIMPACTREPORT",
"text": "Budget Impact Analysis Report",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "BUDGETIMPACTMODEL",
"text": "Budget Impact Analysis Model",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "BUDGETIMPACTREPORTSUMMARY",
"text": "OPDP Financial Impact Analysis Summary",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "BUDGETIMPACTREPORTSUMMARYHELP",
"text": "Please refer to the Drug Submissions website for the most recent template.",
"type": "display"
}
]
}
]
}
]
},
{
"linkId": "PHARMACOECONOMICANALYSIS",
"text": "Pharmacoeconomic Analysis",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "PHARMACOECONOMICANALYSISGROUP",
"text": "Pharmacoeconomic Analysis",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"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": "PHARMACOECONOMICANALYSISREPORT",
"text": "Pharmacoeconomic Analysis Report",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"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": "PHARMACOECONOMICANALYSISMODEL",
"text": "Pharmacoeconomic Analysis Model",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"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": "PHARMACOECONOMICANALYSISSUMMARY",
"text": "Pharmacoeconomic Analysis Summary",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "PHARMACOECONOMICANALYSISWORKSHEETHELP",
"text": "Please refer to the Drug Submissions website for the most recent template.",
"type": "display"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"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": "PHARMACOECONOMICANALYSISWORKSHEET",
"text": "Pharmacoeconomic Analysis Worksheet",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "PHARMACOECONOMICANALYSISWORKSHEETHELP",
"text": "Please refer to the Drug Submissions website for the most recent template.",
"type": "display"
}
]
}
]
}
]
},
{
"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": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"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": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"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
}
]
}
]
},
{
"linkId": "ATTESTATIONSNAV",
"text": "Attestations",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "ATTESTATIONSGROUP",
"text": "Attestations",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}
],
"linkId": "ORGANIZATIONVENDORTYPE",
"type": "boolean",
"required": false,
"readOnly": true
},
{
"linkId": "LEGALVENDORAUTHORITY",
"text": "Do you, as a representative of the Vendor, possess legal authority to bind the Manufacturer, as evidenced by your documented business arrangement letter?",
"type": "boolean",
"enableWhen": [
{
"question": "ORGANIZATIONVENDORTYPE",
"operator": "=",
"answerBoolean": true
}
],
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "LETTEROFCONSENT",
"text": "Letter of Consent",
"type": "attachment",
"enableWhen": [
{
"question": "LEGALVENDORAUTHORITY",
"operator": "=",
"answerBoolean": false
}
],
"required": true,
"repeats": false,
"readOnly": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "ABILITYTOSUPPLYLETTER",
"text": "Ability to Supply Letter",
"type": "attachment",
"enableWhen": [
{
"question": "LEGALVENDORAUTHORITY",
"operator": "=",
"answerBoolean": false
}
],
"required": true,
"repeats": false,
"readOnly": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/msword"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "CERTIFICATIONOFNOREBATELETTER",
"text": "Certification of Providing No Rebate Letter",
"type": "attachment",
"enableWhen": [
{
"question": "LEGALVENDORAUTHORITY",
"operator": "=",
"answerBoolean": false
}
],
"required": true,
"repeats": false,
"readOnly": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "(%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='ORGANIZATIONVENDORTYPE').answer.exists() and %context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='ORGANIZATIONVENDORTYPE').answer[0].valueBoolean=false) or (%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='LEGALVENDORAUTHORITY').answer.exists() and %context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='LEGALVENDORAUTHORITY').answer[0].valueBoolean=true)"
}
}
],
"linkId": "MANUFACTURERAUTHORIZATION",
"text": "<p>Pursuant to the requirements under the Ontario Drug Benefit Act and Drug Interchangeability and Dispensing Fee Act (as applicable) but subject to the limitation concerning confidential pricing information set out below, I confirm that the Manufacturer authorizes His Majesty the King in right of Ontario as represented by the Executive Officer of Ontario Public Drug Programs of the Ministry of Health (the “Ministry”), both during and after the Ministry’s Product evaluation process, to:</p><p>a.\tto collect and use information pertaining to the Product and the Manufacturer in the possession of Health Canada, the government of any province or territory in Canada, the Patented Medicine Prices Review Board, Canada’s Drug Agency, or Ontario Health (the “Public Organizations”); and </p><p>b.\tdisclose information pertaining to the Product and the Manufacturer in the possession of the Ministry to any of the Public Organizations.</p><p>Despite the foregoing, neither the Manufacturer nor the Ministry will disclose to any of the Public Organizations any confidential pricing or commercial terms in respect of the Product that are specific to Ontario Public Drug Programs unless the other party has been notified and has authorized the disclosure in writing.</p>",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "(%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='ORGANIZATIONVENDORTYPE').answer.exists() and %context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='ORGANIZATIONVENDORTYPE').answer[0].valueBoolean=false) or (%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='LEGALVENDORAUTHORITY').answer.exists() and %context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='LEGALVENDORAUTHORITY').answer[0].valueBoolean=true)"
}
}
],
"linkId": "ABILITYTOSUPPLY",
"text": "I confirm that the Manufacturer is able to supply the Product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the Product.",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "(%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='ORGANIZATIONVENDORTYPE').answer.exists() and %context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='ORGANIZATIONVENDORTYPE').answer[0].valueBoolean=false) or (%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='LEGALVENDORAUTHORITY').answer.exists() and %context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='LEGALVENDORAUTHORITY').answer[0].valueBoolean=true)"
}
}
],
"linkId": "PROVIDINGNOREBATE",
"text": "I confirm that the Manufacturer hereby represents and warrants that the Manufacturer has not provided a rebate, as defined in subsection 12.1(14) of the Drug Interchangeability and Dispensing Fee Act (DIDFA) and subsection 11.5(15) of the Ontario Drug Benefit Act (ODBA), to any of the persons listed in subsection 11.5(1) of the ODBA and 12.1(1) of the DIDFA, ), as applicable, with respect to the Product contrary to the ODBA and/or DIDFA since Health Canada approved the Product for sale in Canada.",
"type": "boolean",
"required": true
}
]
}
]
}
]
}