FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | External-VHC.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Questionnaire",
"id": "8e70b4c5-6844-4e9f-8804-c4b5137c9aa4",
"meta": {
"versionId": "8",
"lastUpdated": "2026-01-19T18:38:13.517+00:00",
"source": "#c34a9a056faacd22",
"profile": [
"https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-Questionnaire|1.0.0"
]
},
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Questionnaire-External-Indicator",
"valueBoolean": true
}
],
"version": "3.0.10",
"title": "VHC",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"purpose": "https://files.ontario.ca/moh-drug-submission-ontario-guidelines-valved-holding-chambers-2023-08-30.pdf",
"code": [
{
"code": "SUB-VALVED",
"display": "New Valved Holding Chamber (VHC)"
},
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Questionnaire-Type",
"code": "SUBMIT",
"display": "Submit "
}
],
"item": [
{
"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": "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"
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{
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"valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
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"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": "MEDICALDEVICELICENSEDOC",
"text": "Medical Device Licence",
"type": "attachment",
"required": true,
"repeats": 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"
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"valueCode": "application/msword"
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"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": "MEDICALDEVICELICENSEEVIDENCEDOC",
"text": "Medical Device Establishment Licence",
"type": "attachment",
"required": true,
"repeats": 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": "MEDICALDEVICELICENSEEVIDENCEDOCHELP",
"text": "Please provide a copy of the Medical Device Establishment Licence of the manufacturer or distributor of the VHC (as applicable) for the sale or importation of the product in Canada.",
"type": "display"
}
]
}
]
},
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
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"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
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"valueCode": "application/pdf"
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{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"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": "DEVICELABELDOC",
"text": "A copy of the device label",
"type": "attachment",
"required": true,
"repeats": false
}
]
},
{
"linkId": "EVIDENCEANDSAFETYGROUPNAV",
"text": "Evidence of Safety and Effectiveness",
"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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"language": "text/fhirpath",
"expression": "ServiceRequest"
}
}
],
"linkId": "EVIDENCEANDSAFETYGROUP",
"text": "Evidence of Safety and Effectiveness",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"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"
},
{
"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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"valueCode": "application/pdf"
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{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"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": "EVIDENCEANDSAFETYDOC",
"text": "Evidence of Safety and Effectiveness",
"type": "attachment",
"required": true,
"repeats": true,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "EVIDENCEANDSAFETYDOCHELP",
"text": "Please refer to the Guidelines for evidence requirements to support the product's safety and effectiveness.",
"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": "NOCHOKINGCHECK",
"text": "I confirm that that the Product does not pose a choking hazard to children ≤12 years of age (i.e., no choking parts with disassembly) and it is suitable for use with all metered dose inhalers (MDIs).",
"type": "boolean",
"required": true
}
]
}
]
},
{
"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": [
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"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
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"valueCode": "application/msword"
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"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}
],
"linkId": "ODBMARKETSHAREDOC",
"text": "ODB market share penetration or impact analysis on ODB expenditure",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"coding": [
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "ODBMARKETSHAREDOCHELP",
"text": "Please provide ODB market share penetration or impact analysis on ODB expenditure, including the underlying assumptions for the calculations.",
"type": "display"
}
]
},
{
"linkId": "ADDITIONALCOMMENTS",
"text": "Additional Comments",
"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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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"coding": [
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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": [
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/vnd.ms-excel"
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"valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
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"valueCode": "application/msword"
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"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
}
],
"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 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"
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{
"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": [
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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"
},
{
"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"
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{
"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 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
}
]
}
]
}
]
}