FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | External-Nutrition.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
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"lastUpdated": "2026-01-19T16:44:22.137+00:00",
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"version": "3.0.10",
"title": "NutritionProduct",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"purpose": "https://files.ontario.ca/moh-drug-submission-ontario-guidelines-nutrition-products-2023-08-30.pdf",
"code": [
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"display": "New Nutrition Product"
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"display": "Submit "
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"item": [
{
"linkId": "NUTRITIONPRODUCTDETAILSNAV",
"text": "Nutrition Product Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "CONFIRMATIONOFELIGIBILITYGROUP",
"text": "Confirmation of Eligibility",
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],
"text": "Check box"
}
}
],
"linkId": "CONFIRMPRODUCTNOTADVERTISEDINONTARIO",
"text": "I confirm that the Product is not advertised in Ontario to the public.",
"type": "boolean",
"required": true
},
{
"extension": [
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"text": "Check box"
}
}
],
"linkId": "CONFIRMDISTRIBUTORLOCATION",
"text": "I confirm that the distributor is located in Canada and does not rely on a direct sales network.",
"type": "boolean",
"required": true
},
{
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],
"linkId": "CONFIRMPRODUCTINTENDENDUSE",
"text": "I confirm that the Product is not intended for any of the following uses: <ul><li>prescribed weight loss in the treatment of obesity</li><li>food allergies</li><li>body building</li><li>voluntary meal replacement </li><li>nutritional supplement</li><li>convenience</li><li>use as a replacement for breast feeding for infants with normal gastrointestinal absorptive function</li></ul>",
"type": "boolean",
"required": true
}
]
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{
"linkId": "NUTRITIONPRODUCTDETAILSGROUP",
"text": "Nutrition Product Details",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
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"code": "drop-down",
"display": "Drop down"
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],
"text": "Drop down"
}
}
],
"linkId": "NUTRITIONPRODUCTCATEGORY",
"text": "Nutrition Product Category",
"type": "coding",
"required": true,
"repeats": false,
"readOnly": false,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Nutrition-Product-Category|1.00",
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"code": "help",
"display": "Help-Button"
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],
"text": "Help-Button"
}
}
],
"linkId": "NUTRITIONPRODUCTCATEGORYHELP",
"text": "Please select the Nutrition Product maximum allowable reimbursement schedule category under which listing in the Ontario Drug Benefit Formulary is being requested.",
"type": "display"
}
]
},
{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "NUTRITIONPRODUCTSUMMARYDOC",
"text": "Nutrition Product Summary Sheet",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false,
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"text": "Help-Button"
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"linkId": "NUTRITIONPRODUCTSUMMARYDOCHELP",
"text": "Please refer to the Drug Submissions website for the most recent template.",
"type": "display"
}
]
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{
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"linkId": "NUTRITIONPRODUCTWORKSHEETDOC",
"text": "Nutrition Product Worksheet",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false,
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"linkId": "NUTRITIONPRODUCTWORKSHEETDOCHELP",
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],
"linkId": "NUTRITIONPRODUCTLABELDOC",
"text": "A copy of the finished label of the Product as sold in Canada",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false
},
{
"extension": [
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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"linkId": "NUTRITIONPRODUCTFORMULADOC",
"text": "Documentation with respect to complete ingredients, nutrient analysis of the Product and the quantitative formula, including support for the classification of the nutrition product (e.g. polymeric, semi-elemental or elemental, or modular product)",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "NUTRITIONPRODUCTVOLUMEDOC",
"text": "Daily volume to meet Recommended Nutrient Intake (RNI)",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false
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{
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
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],
"linkId": "NUTRITIONPRODUCTINDICATIONSDOC",
"text": "Documentation with respect to the indications of use",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false
},
{
"extension": [
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{
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"valueCode": "application/msword"
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NUTRITIONPRODUCTCOSTBENEFITDOC",
"text": "Demonstration of the benefit of the Product in relation to the cost of the Product and to any alternative products or treatments",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false
},
{
"extension": [
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NUTRITIONPRODUCTPATIENTPAYMENT",
"text": "Is it expected that patients would be required to pay a portion in addition to the applicable ODB program co-payment (i.e., the submitted price with mark-up is above the current MAR limit)?",
"type": "boolean",
"required": true
},
{
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}
}
],
"linkId": "NUTRITIONPRODUCTCOPAYAMOUNT",
"text": "Co-payment Amount",
"type": "text",
"required": true,
"repeats": false,
"readOnly": false,
"maxLength": 100,
"item": [
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"display": "Help-Button"
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"linkId": "NUTRITIONPRODUCTCOPAYAMOUNTHELP",
"text": "Where it is expected that patients would be required to pay a portion in addition to the applicable ODB program co-payment (i.e. the submitted price with mark-up is above the current MAR limit), please provide the amount that patients would be required to pay to four decimal places.<br/> A response to this question may be provided within an uploaded document. In that case, please upload the document below and enter 'attached' in the space provided.",
"type": "display"
}
]
},
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}
}
],
"linkId": "NUTRITIONPRODUCTCOPAYJUSTIFICATION",
"text": "Co-payment Justification",
"type": "text",
"required": true,
"repeats": false,
"readOnly": false,
"maxLength": 1000,
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"linkId": "NUTRITIONPRODUCTCOPAYJUSTIFICATIONHELP",
"text": "Where it is expected that patients would be required to pay a portion in addition to the applicable ODB program co-payment (i.e. the submitted price with mark-up is above the current MAR limit), please provide justification for this incremental cost.<br/>A response to this question may be provided within an uploaded document. In that case, please upload the document below and enter 'attached' in the space provided.",
"type": "display"
}
]
},
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}
],
"linkId": "NUTRITIONPRODUCTCOPAYDOC",
"text": "Co-payment Amount and Justification",
"type": "attachment",
"required": false,
"repeats": false,
"readOnly": false
},
{
"linkId": "NUTRITIONPRODUCTADDITIONALINFO",
"text": "Additional Comments",
"type": "text",
"required": false,
"maxLength": 1000
}
]
}
]
},
{
"linkId": "NUTRITIONPRODUCTCLINICALSTUDIESNAV",
"text": "Nutrition Product Clinical Studies",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "NUTRITIONPRODUCTCLINICALSTUDIESGROUP",
"text": "Nutrition Product Clinical Studies",
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NUTRITIONPRODUCTCLINICALSTUDIESDOC",
"text": "Product specific clinical studies (published or unpublished), and other clinical evidence demonstrating the Product's therapeutic effectiveness, efficacy, and safety, including any information that relates to adverse reactions",
"type": "attachment",
"required": true,
"repeats": true,
"readOnly": false,
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"display": "Help-Button"
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],
"text": "Help-Button"
}
}
],
"linkId": "NUTRITIONPRODUCTCLINICALSTUDIESDOCHELP",
"text": "Comparative studies evaluating the product’s therapeutic effectiveness, efficacy, and safety against other products or treatments are of particular interest.",
"type": "display"
}
]
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],
"linkId": "NUTRITIONPRODUCTFORMULATIONDOC",
"text": "Formulation Composition of the test products",
"type": "attachment",
"required": true,
"repeats": false,
"readOnly": false
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{
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},
{
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "NUTRITIONPRODUCTSUPPLEMENTALDATA",
"text": "Supplemental Data",
"type": "attachment",
"required": false,
"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": "NUTRITIONPRODUCTSUPPLEMENTALDATAHELP",
"text": "The manufacturer is encouraged to provide additional data, including post marketing safety reports, consumer feedback data and clinical practice guidelines to support a comprehensive review of the nutrition product’s therapeutic effectiveness and safety profile. Patient populations in studies and clinical evidence must be similar to the indicated patient population which will be served by the ODB program.",
"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 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
}
]
}
]
}
]
}