FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | External-ODB-MS-STR.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Questionnaire",
"id": "9220733c-23dc-4a09-bb31-206e88a12d47",
"meta": {
"versionId": "35",
"lastUpdated": "2026-03-12T19:08:10.071+00:00",
"source": "#81b829c3db3720da",
"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": "ODB - New Streamlined Product",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"purpose": "https://www.ontario.ca/files/2024-03/moh-drug-submission-ontario-guidelines-multiple-source-drug-products-en-2024-03-20.pdf",
"code": [
{
"code": "NEW-GENERIC-STREAMLINED",
"display": "New Streamlined Product"
},
{
"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": [
{
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}
}
],
"linkId": "SUBMISSIONDETAILSGROUP",
"text": "Submission Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
}
],
"text": "Check box"
}
}
],
"linkId": "NOT_PSEUDOGENERIC",
"text": "Please confirm that this Product does not qualify as a pseudogeneric or cross-referenced drug product",
"type": "boolean",
"required": true,
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"code": "help",
"display": "Help-Button"
}
],
"text": "Help-Button"
}
}
],
"linkId": "NOT_PSEUDOGENERIC_HELP",
"text": "Submissions for pseudogeneric or cross-referenced drug products are not currently accepted through the portal. Please email the submissions to DrugSubmissions.MOH@ontario.ca.",
"type": "display"
}
]
},
{
"linkId": "DECLAREEQUIVALENCE",
"text": "Has a declaration of equivalence (DOE) been received from Health Canada with the brand reference product or another listed interchangeable product with which the Generic Product would be designated as interchangeable?",
"type": "boolean",
"required": true,
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"code": "help",
"display": "Help-Button"
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"text": "Help-Button"
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}
],
"linkId": "DECLAREEQUIVALENCE_HELP",
"text": " A submission is streamlined if it relates to a multiple source (i.e.,generic) product that has received a declaration of equivalence (DOE) from Health Canada with the brand reference product or another listed interchangeable product with which the generic product would be designated as interchangeable.",
"type": "display"
}
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},
{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "check-box",
"display": "Check box"
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"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,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/IDMS-Funding-Program-3|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Repeating-Group-Label",
"valueString": "Reference Product"
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Group-Column-Count",
"valueInteger": 2
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{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "REFERENCE_PRODUCT_GROUP",
"text": "Reference Product",
"type": "group",
"required": false,
"repeats": true,
"readOnly": false,
"item": [
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"code": "help",
"display": "Help-Button"
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"text": "Help-Button"
}
}
],
"linkId": "REFERENCE_PRODUCT_HELP",
"text": "A brand reference product or another listed interchangeable product with which the generic product would be designated as interchangeable.",
"type": "display"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "REFERENCE_PRODUCT_NAME",
"text": "Reference Product Name",
"type": "string",
"required": true,
"maxLength": 100
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "DIN",
"text": "Drug Identification Number (DIN)",
"type": "string",
"required": true,
"maxLength": 10
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "ACTIVE_INGREDIENTS",
"text": "Active Ingredient(s)",
"type": "string",
"required": true,
"maxLength": 100
},
{
"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": "STRENGTH",
"text": "Strength",
"type": "string",
"required": true,
"maxLength": 100
},
{
"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": "DOSAGE_FORM",
"text": "Dosage Form",
"type": "string",
"required": true,
"maxLength": 100
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{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "MANUFACTURER",
"text": "Manufacturer",
"type": "string",
"required": true,
"maxLength": 100
}
]
}
]
}
]
},
{
"linkId": "HEALTHCANADADOCUMENTATIONNAV",
"text": "Health Canada Documentation",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
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"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",
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{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Group-Column-Count",
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "NOCAPPROVALGROUP1",
"text": "Notice of Compliance Information",
"type": "group",
"required": true,
"repeats": true,
"item": [
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"expression": "today() + 1 day"
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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": "NOC Approved Date",
"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": "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
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{
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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": "Notice of Compliance",
"type": "attachment",
"required": true,
"repeats": false
}
]
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Repeating-Group-Label",
"valueString": "Product Monograph"
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{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Group-Column-Count",
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PRODUCTMONOGRAPHGINFORROUP",
"text": "Product Monograph Information",
"type": "group",
"required": true,
"repeats": true,
"item": [
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"extension": [
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"extension": [
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"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
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{
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"valueInteger": 5
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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": "Submission Control Number",
"type": "string",
"required": true,
"repeats": false,
"readOnly": false,
"maxLength": 8
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{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "PRODUCTMONOGRAPHDOC",
"text": "Product Monograph",
"type": "attachment",
"required": true,
"repeats": false
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "ANNOTATEDPRODUCTMONOGRAPHDOC",
"text": "Annotated Product Monograph",
"type": "attachment",
"required": false,
"repeats": false
},
{
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"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"
}
]
}
]
}
]
},
{
"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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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
],
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}
}
],
"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"
},
{
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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": "SUPPLEMENTALSUPPORTING",
"text": "Supporting Documents",
"type": "attachment",
"required": false,
"repeats": true,
"readOnly": false
},
{
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
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}
],
"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": [
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"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": [
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"question": "ORGANIZATIONVENDORTYPE",
"operator": "=",
"answerBoolean": true
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"valueDecimal": 10
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],
"linkId": "LETTEROFCONSENT",
"text": "Letter of Consent",
"type": "attachment",
"enableWhen": [
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"question": "LEGALVENDORAUTHORITY",
"operator": "=",
"answerBoolean": false
}
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"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": "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": "NOPATENTINFRINGEMENTLETTER",
"text": "Letter Confirming No Patent Infringement",
"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
},
{
"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": "NOT_INFRINGE_PATENT",
"text": "I confirm that the Manufacturer hereby represents and warrants that, to the best of the Manufacturer's knowledge, the Product does not infringe any Canadian patents.",
"type": "boolean",
"required": true
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Repeating-Group-Label",
"valueString": "Patent Information"
},
{
"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"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/questionnaire-minOccurs",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='NOT_INFRINGE_PATENT').answer.exists() and %context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='NOT_INFRINGE_PATENT').answer.first().valueBoolean = true, 1, 0)"
}
}
],
"linkId": "PATENTINFOGROUP1",
"text": "Patent Information for the Original Product",
"type": "group",
"enableWhen": [
{
"question": "NOT_INFRINGE_PATENT",
"operator": "=",
"answerBoolean": true
}
],
"required": true,
"repeats": 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": "PATENT_PRODUCT_HELP",
"text": "Please enter information for all Canadian patents, including use patents, for the original product. Please provide all strengths approved by Health Canada for the original product. Please indicate if the Manufacturer does not market a particular strength for the submitted Product.",
"type": "display"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PATENT_PRODUCT_ORIGINALPRODUCTNAME",
"text": "Original Product Name",
"type": "string",
"required": true,
"maxLength": 100
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PATENT_PRODUCT_MANUFACTURERNAME",
"text": "Manufacturer Name",
"type": "string",
"required": true,
"maxLength": 100
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PATENT_PRODUCT_ACTIVE_INGREDIENTS",
"text": "Active Ingredient(s)",
"type": "string",
"required": true,
"maxLength": 100
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PATENT_PRODUCT_STRENGTH",
"text": "Strength",
"type": "string",
"required": true,
"maxLength": 100
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PATENT_PRODUCT_DIN",
"text": "DIN",
"type": "string",
"required": true,
"maxLength": 10
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PATENT_EXIST_IN_EFFECT",
"text": "Does patent exist and still in effect?",
"type": "boolean",
"required": true
},
{
"extension": [
{
"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='PATENTINFOGROUP1')[%repeatingGroupIndex%].item.where(linkId='PATENT_EXIST_IN_EFFECT').answer[0].valueBoolean=true)"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "PATENT_PRODUCT_PATENTNUMBER",
"text": "Patent No.",
"type": "string",
"required": true,
"maxLength": 100
},
{
"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/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "(%context.item.where(linkId='ATTESTATIONSNAV').item.where(linkId='ATTESTATIONSGROUP').item.where(linkId='PATENTINFOGROUP1')[%repeatingGroupIndex%].item.where(linkId='PATENT_EXIST_IN_EFFECT').answer[0].valueBoolean=true)"
}
}
],
"linkId": "PATENT_PRODUCT_DATE_OF_EXPIRY1",
"text": "Date of Expiry",
"type": "date",
"required": true
}
]
}
]
}
]
}
]
}