FHIR © HL7.org  |  FHIRsmith 0.18.1  |  Server Home  |  XIG Home  |  XIG Stats  | 

FHIR IG analytics

Packageca.on.health.idms.agreementmvp
Resource TypeQuestionnaire
IdExternal-NutritionLineExt.json
FHIR VersionR5

Resources that use this resource

No resources found


Resources that this resource uses

No resources found


Narrative

No narrative content found in resource


Source1

{
  "resourceType": "Questionnaire",
  "id": "a0a448a7-cdcc-41bd-b832-46279083e15d",
  "meta": {
    "versionId": "5",
    "lastUpdated": "2026-02-03T20:33:22.402+00:00",
    "source": "#f427047c0c224836"
  },
  "extension": [
    {
      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Questionnaire-External-Indicator",
      "valueBoolean": true
    }
  ],
  "version": "3.0.10",
  "title": "NutritionLineExt",
  "status": "active",
  "experimental": false,
  "publisher": "DIRECT",
  "purpose": "https://files.ontario.ca/moh-drug-submission-ontario-guidelines-nutrition-products-2023-08-30.pdf",
  "code": [
    {
      "code": "SUB-NUTRITIONAL-LINE",
      "display": "Line Extension"
    },
    {
      "system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Questionnaire-Type",
      "code": "SUBMIT",
      "display": "Submit "
    }
  ],
  "item": [
    {
      "linkId": "LINEEXTENSIONDETAILSNAV",
      "text": "Line Extension Details",
      "type": "group",
      "required": false,
      "repeats": false,
      "readOnly": false,
      "item": [
        {
          "linkId": "LINEEXTENSIONDETAILSGROUP",
          "text": "Line Extension Details",
          "type": "group",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "item": [
            {
              "extension": [
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "LINEEXTENSIONDETAILEXPLANATION",
              "text": "Detailed explanation of the change",
              "type": "text",
              "required": true,
              "repeats": false,
              "maxLength": 1000
            },
            {
              "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": "LINEEXTENSIONJUSTIFICATION",
              "text": "Justification of the new pack size or package format",
              "type": "attachment",
              "required": true,
              "repeats": false,
              "readOnly": false
            }
          ]
        }
      ]
    },
    {
      "linkId": "NUTRITIONPRODUCTDETAILSNAV",
      "text": "Nutrition Product Details",
      "type": "group",
      "required": false,
      "repeats": false,
      "readOnly": false,
      "item": [
        {
          "linkId": "NUTRITIONPRODUCTDETAILSGROUP",
          "text": "Nutrition Product Details",
          "type": "group",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "item": [
            {
              "extension": [
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "NUTRITIONPRODUCTDETAILSCLINICALIMPACT",
              "text": "Will the change impact clinical response or product safety?",
              "type": "boolean",
              "required": true
            },
            {
              "extension": [
                {
                  "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='NUTRITIONPRODUCTDETAILSNAV').item.where(linkId='NUTRITIONPRODUCTDETAILSGROUP').item.where(linkId='NUTRITIONPRODUCTDETAILSCLINICALIMPACT').answer[0].valueBoolean=false"
                  }
                }
              ],
              "linkId": "NUTRITIONPRODUCTDETAILSCLINICALIMPACTCONFIRM",
              "text": "I confirm that the change will not impact clinical response or product safety.",
              "type": "boolean",
              "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
                },
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "NUTRITIONPRODUCTSTABILITYSTUDY",
              "text": "Stability study test data to demonstrate the new product format is of suitable performance and quality to support an acceptable shelf life",
              "type": "attachment",
              "required": true,
              "repeats": true,
              "readOnly": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "NUTRITIONPRODUCTSTABILITYSTUDYHELP",
                  "text": "Clinical studies on each pack size are not required if they are of the same container system (open-open or closed-closed system); however, similar stability must be demonstrated at the recommended storage conditions on all sizes.",
                  "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": "NUTRITIONPRODUCTSTABILITYSTUDYPROTOCOL",
              "text": "A copy of the stability study protocol/design for all pack sizes of new formats",
              "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": "NUTRITIONPRODUCTSTABILITYLABELCOPY",
              "text": "A copy of the finished label of the Product as sold in Canada",
              "type": "attachment",
              "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
                },
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "NUTRITIONPRODUCTWORKSHEETDOC",
              "text": "Nutrition Product Worksheet",
              "type": "attachment",
              "required": true,
              "repeats": false,
              "readOnly": false,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "NUTRITIONPRODUCTWORKSHEETDOCHELP",
                  "text": "Please refer to the Drug Submissions website for the most recent template.",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.ms-excel"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/msword"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/pdf"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                  "valueDecimal": 10
                },
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                },
                {
                  "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
                  "valueExpression": {
                    "language": "text/fhirpath",
                    "expression": "%context.item.where(linkId='NUTRITIONPRODUCTDETAILSNAV').item.where(linkId='NUTRITIONPRODUCTDETAILSGROUP').item.where(linkId='NUTRITIONPRODUCTDETAILSCLINICALIMPACT').answer[0].valueBoolean=true"
                  }
                }
              ],
              "linkId": "NUTRITIONPRODUCTWORKSHEETSUPPORTINGINFO",
              "text": "Supporting information/or/study listed for the Nutrition Product Work Sheet ",
              "type": "attachment",
              "required": true,
              "repeats": true,
              "readOnly": false
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.ms-excel"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/msword"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/pdf"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                  "valueDecimal": 10
                }
              ],
              "linkId": "NUTRITIONPRODUCTADDITIONALINFODOC",
              "text": "Additional Documents",
              "type": "attachment",
              "required": false,
              "repeats": true,
              "readOnly": false
            },
            {
              "linkId": "NUTRITIONPRODUCTADDITIONALINFO",
              "text": "Additional Information",
              "type": "text",
              "required": false,
              "repeats": 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
                }
              ],
              "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
            }
          ]
        }
      ]
    }
  ]
}