FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | External-OFI-MS-NON-STR.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
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"title": "OFI - New Non-Streamlined Product",
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"publisher": "DIRECT",
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"text": "Submission Details",
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"text": "Requested Funding/Listing/Program",
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"text": "Reference Product",
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"text": "A brand reference product or another listed interchangeable product with which the generic product would be designated as interchangeable.",
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"text": "Reference Product Name",
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"linkId": "DIN",
"text": "Drug Identification Number (DIN)",
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"linkId": "ACTIVE_INGREDIENTS",
"text": "Active Ingredient(s)",
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"linkId": "STRENGTH",
"text": "Strength",
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"maxLength": 100
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"linkId": "DOSAGE_FORM",
"text": "Dosage Form",
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"required": true,
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"linkId": "MANUFACTURER",
"text": "Manufacturer",
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"maxLength": 100
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{
"linkId": "HEALTHCANADADOCUMENTATIONNAV",
"text": "Health Canada Documentation",
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"text": "Has Notice of Compliance (NOC) been issued for the Drug Product(s)?",
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"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.",
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"text": "Certified Product Identification Document (CPID) or Master Formulation",
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},
{
"linkId": "EVIDENCEOFINTERCHANGENAV",
"text": "Evidence of Interchangeability",
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"repeats": false,
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"linkId": "EVIDENCEOFINTERCHANGEABILITYGROUP",
"text": "Evidence of Interchangeability",
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"linkId": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"text": "Is the comparative bioavailability study available?",
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"text": "Comparative studies",
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"text": "Comparative bioavailability studies on humans, comparative clinical studies on humans, or both, or other in vivo studies that will show the interchangeability of the product with the original product or with another listed interchangeable product with which it would be designated as interchangeable.",
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],
"linkId": "NONNEWDRUGAPPLIES",
"text": "When the submitted drug product is not a new drug as defined in the Food and Drug Regulations made under the Food and Drugs Act (Canada) (i.e., the drug product has a DIN, and no NOC), manufacturers may satisfy this requirement for clinical evidence/studies by submitting the documents noted under Section 6.7 in the Guidelines. Does this apply to the Product(s) in this submission?",
"type": "boolean",
"enableWhen": [
{
"question": "HAS_NOC_ISSUED",
"operator": "=",
"answerBoolean": false
},
{
"question": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"operator": "=",
"answerBoolean": false
}
],
"enableBehavior": "all",
"required": true
},
{
"linkId": "BIOEQ_PARENT",
"type": "group",
"enableWhen": [
{
"question": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"operator": "=",
"answerBoolean": true
}
],
"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": "BIOEQUIVALENCEDATACHECKLIST",
"text": "Completed Bioequivalence Data Checklist",
"type": "attachment",
"enableBehavior": "any",
"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": "BIOEQUIVALENCEDATACHECKLISTHELP",
"text": "The Bioequivalence Data Checklist was developed based on the guidelines that the CED uses during its evaluation. It was designed to help manufacturers prepare submissions that are easy to review and ensure submissions proactively address the CED's anticipated questions. For each question on the Bioequivalence Data Checklist, manufacturers should provide short answers below the question and direct the CED to the supporting reference page(s). Please indicate not applicable (N/A) on the checklist and provide a rationale, if necessary, if a question on the Bioequivalence Data Checklist does not apply. 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": "PHARMACOKINETICWORKSHEET",
"text": "Completed Pharmacokinetic/Statistical Worksheet",
"type": "attachment",
"enableBehavior": "any",
"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": "PHARMACOKINETICWORKSHEETHELP",
"text": "The Pharmacokinetic/Statistical Worksheet was developed based on the guidelines that the CED uses during its evaluation. It was designed to help manufacturers prepare submissions that are easy to review and ensure submissions proactively address the CED's anticipated questions. 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": "BIOLOTMASTERFORMULATION",
"text": "Completed production master formulation for the biolot",
"type": "attachment",
"enableBehavior": "any",
"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": "BIOLOTMASTERFORMULATIONHELP",
"text": "The submission must include the production master formulation for each of the multiple source products used in the studies. The production master formulation refers to the production manufacturing documentation for the test lot (biolot). The document must provide the list of ingredients used to manufacture the drug product of lot/batch number indicated in the bioequivalence study. In addition, the manufacturer must convert the biolot formula into the smallest quantity per unit sample of the drug product, dated and signed by a senior quality assurance personnel.",
"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": "LOTMASTERFORMULATION",
"text": "Completed production master formulation for the test lot",
"type": "attachment",
"enableWhen": [
{
"question": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"operator": "=",
"answerBoolean": false
}
],
"enableBehavior": "any",
"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": "LOTMASTERFORMULATIONHELP",
"text": "The submission must include the production master formulation for each of the multiple source products used in the studies. The production master formulation refers to the production manufacturing documentation for the test lot. The document must provide the list of ingredients used to manufacture the drug product of lot/batch number indicated in the comparative study. In addition, the manufacturer must convert the test lot formula into the smallest quantity per unit sample of the drug product, dated and signed by a senior quality assurance personnel.",
"type": "display"
}
]
},
{
"linkId": "DRUGPRODUCTSWITHOUTNOCGROUP",
"text": "Drug Products with a DIN and No NOC",
"type": "group",
"enableWhen": [
{
"question": "NONNEWDRUGAPPLIES",
"operator": "=",
"answerBoolean": true
}
],
"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": "SCIENTIFICJUSTIFICATION",
"text": "Scientific justification for not conducting in-vivo bioequivalence studies",
"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": "FORMULATIONEVIDENCE",
"text": "Evidence that the product formulations are qualitatively and quantitatively the same between the submitted Product and the reference product",
"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": "STANDARDDISSOLUTION",
"text": "Standard comparative dissolution profiles between the submitted Product and reference product at all strengths",
"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": "BCSDATA",
"text": "Data as outlined by ICH document M9 and/or a copy of the manufacturer’s completed Biopharmaceutics Classification System (BCS) Based Biowaiver Evaluation template as provided to Health Canada",
"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": "HCEVALUATIONREPORTS",
"text": "All evaluation reports generated by Health Canada (e.g., BCS-Based Biowaiver Evaluation Report, Comprehensive Summary-Bioequivalence Review Report, Quality reviews for solutions including injectables, etc.)",
"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": "DINNOCSUPPORTING",
"text": "Supporting Documents",
"type": "attachment",
"required": false,
"repeats": true,
"readOnly": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "DINNOCADDITIONALINFO",
"text": "Additional Information",
"type": "text",
"required": false,
"maxLength": 1000
}
]
},
{
"linkId": "SPECIALCASESGROUP",
"text": "Special Cases",
"type": "group",
"enableWhen": [
{
"question": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"operator": "=",
"answerBoolean": false
},
{
"question": "HAS_NOC_ISSUED",
"operator": "=",
"answerBoolean": true
}
],
"enableBehavior": "all",
"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": "SPECIALCASESGROUPHELP",
"text": "When a comparative bioavailability study cannot be conducted the ministry may consider other studies comparing the safety and efficacy of the multiple source product with the original product or with another listed interchangeable product with which it 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"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "drop-down",
"display": "Drop down"
}
],
"text": "Drop down"
}
}
],
"linkId": "SPECIALCASETYPE",
"text": "Type of Special Case",
"type": "coding",
"enableWhen": [
{
"question": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"operator": "=",
"answerBoolean": false
},
{
"question": "HAS_NOC_ISSUED",
"operator": "=",
"answerBoolean": true
}
],
"enableBehavior": "all",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/OFI-SPECIAL-CASE|1.00"
},
{
"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": "SPECIALCASESUPPORTING",
"text": "Comparative Studies and Supporting Documents",
"type": "attachment",
"enableWhen": [
{
"question": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"operator": "=",
"answerBoolean": false
},
{
"question": "HAS_NOC_ISSUED",
"operator": "=",
"answerBoolean": true
}
],
"enableBehavior": "all",
"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": "AQUEOUSCHECKLIST",
"text": "Aqueous Solutions Checklist",
"type": "attachment",
"enableWhen": [
{
"question": "SPECIALCASETYPE",
"operator": "=",
"answerCoding": {
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/OFI-SPECIAL-CASE",
"code": "AQUEOUS"
}
}
],
"required": true,
"repeats": false,
"readOnly": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"linkId": "SPECIALCASECOMMENTS",
"text": "Additional Comments",
"type": "text",
"enableWhen": [
{
"question": "COMPARATIVEBIOAVAILABILITYAVAILABLE",
"operator": "=",
"answerBoolean": false
},
{
"question": "HAS_NOC_ISSUED",
"operator": "=",
"answerBoolean": true
}
],
"enableBehavior": "all",
"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": [
{
"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
},
{
"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
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
}
],
"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": [
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"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": "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
}
]
}
]
}
]
}
]
}