{
  "resourceType": "StructureDefinition",
  "id": "RegulatedAuthorization",
  "meta": {
    "lastUpdated": "2020-12-30T20:32:20.021+00:00"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
      "valueString": "Specialized.Medication Definition"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
      "valueCode": "anonymous"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status",
      "valueCode": ".status=entered-in-error"
    }
  ],
  "url": "http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization",
  "version": "4.6.0",
  "name": "RegulatedAuthorization",
  "status": "draft",
  "date": "2020-12-30T20:32:20+00:00",
  "publisher": "Health Level Seven International (Biomedical Research and Regulation)",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://hl7.org/fhir"
        }
      ]
    },
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim/index.cfm"
        }
      ]
    }
  ],
  "description": "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.",
  "fhirVersion": "4.6.0",
  "mapping": [
    {
      "identity": "idmp",
      "uri": "https://en.wikipedia.org/wiki/Identification_of_medicinal_products",
      "name": "IDMP Mapping"
    },
    {
      "identity": "w5",
      "uri": "http://hl7.org/fhir/fivews",
      "name": "FiveWs Pattern Mapping"
    },
    {
      "identity": "rim",
      "uri": "http://hl7.org/v3",
      "name": "RIM Mapping"
    }
  ],
  "kind": "resource",
  "abstract": false,
  "type": "RegulatedAuthorization",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource",
  "derivation": "specialization",
  "differential": {
    "element": [
      {
        "id": "RegulatedAuthorization",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/svg",
            "valueCode": "280,0"
          }
        ],
        "path": "RegulatedAuthorization",
        "short": "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product",
        "definition": "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.",
        "min": 0,
        "max": "*",
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation, Clinical Trial Authorisation"
          },
          {
            "identity": "w5",
            "map": "administrative.medication"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.identifier",
        "path": "RegulatedAuthorization.identifier",
        "short": "Business identifier for the authorization, typically assigned by the authorizing body",
        "definition": "Business identifier for the authorization, typically assigned by the authorizing body.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "Identifier"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Marketing Authorisation Number"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.subject",
        "path": "RegulatedAuthorization.subject",
        "short": "The product type, treatment, facility or activity that is being authorized",
        "definition": "The product type, treatment, facility or activity that is being authorized.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition",
              "http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct",
              "http://hl7.org/fhir/StructureDefinition/NutritionProduct",
              "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition",
              "http://hl7.org/fhir/StructureDefinition/SubstanceDefinition",
              "http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
              "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
              "http://hl7.org/fhir/StructureDefinition/ActivityDefinition",
              "http://hl7.org/fhir/StructureDefinition/PlanDefinition",
              "http://hl7.org/fhir/StructureDefinition/ObservationDefinition",
              "http://hl7.org/fhir/StructureDefinition/Practitioner",
              "http://hl7.org/fhir/StructureDefinition/Organization",
              "http://hl7.org/fhir/StructureDefinition/Location"
            ]
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "(the link to Medicinal Product or Packaged Medicinal Product)"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.type",
        "path": "RegulatedAuthorization.type",
        "short": "Overall type of this authorization, for example drug marketing approval, orphan drug designation",
        "definition": "Overall type of this authorization, for example drug marketing approval, orphan drug designation.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "RegulatedAuthorizationType"
            }
          ],
          "strength": "example",
          "description": "Overall type of this authorization.",
          "valueSet": "http://hl7.org/fhir/ValueSet/regulated-authorization-type"
        },
        "mapping": [
          {
            "identity": "idmp",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.description",
        "path": "RegulatedAuthorization.description",
        "short": "General textual supporting information",
        "definition": "General textual supporting information.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "markdown"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.region",
        "path": "RegulatedAuthorization.region",
        "short": "The territory in which the authorization has been granted",
        "definition": "The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "Jurisdiction"
            }
          ],
          "strength": "example",
          "description": "Jurisdiction codes",
          "valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction"
        },
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Country"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.status",
        "path": "RegulatedAuthorization.status",
        "short": "The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications",
        "definition": "The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "PublicationStatus"
            }
          ],
          "strength": "preferred",
          "description": "The lifecycle status of an artifact.",
          "valueSet": "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Authorisation Status"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.statusDate",
        "path": "RegulatedAuthorization.statusDate",
        "short": "The date at which the current status was assigned",
        "definition": "The date at which the current status was assigned.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "dateTime"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Authorisation Status Date"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.validityPeriod",
        "path": "RegulatedAuthorization.validityPeriod",
        "short": "The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date",
        "definition": "The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Period"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Validity Period Start, Marketing Authorisation.Validity Period End"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.indication",
        "path": "RegulatedAuthorization.indication",
        "short": "Condition for which the use of the regulated product applies",
        "definition": "Condition for which the use of the regulated product applies.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableReference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"
            ]
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.intendedUse",
        "path": "RegulatedAuthorization.intendedUse",
        "short": "The intended use of the product, e.g. prevention, treatment",
        "definition": "The intended use of the product, e.g. prevention, treatment, diagnosis.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "ProductIntendedUse"
            }
          ],
          "strength": "preferred",
          "description": "The overall intended use of a product.",
          "valueSet": "http://hl7.org/fhir/ValueSet/product-intended-use"
        },
        "mapping": [
          {
            "identity": "idmp",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.basis",
        "path": "RegulatedAuthorization.basis",
        "short": "The legal/regulatory framework or reasons under which this authorization is granted",
        "definition": "The legal or regulatory framework against which this authorization is granted, or other reasons for it.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "RegulatedAuthorizationBasis"
            }
          ],
          "strength": "example",
          "description": "A legal or regulatory framework against which an authorization is granted, or other reasons for it.",
          "valueSet": "http://hl7.org/fhir/ValueSet/regulated-authorization-basis"
        },
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Status Reasons.Legal Grounds"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.holder",
        "path": "RegulatedAuthorization.holder",
        "short": "The organization that has been granted this authorization, by the regulator",
        "definition": "The organization that has been granted this authorization, by some authoritative body (the 'regulator').",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Organization"
            ]
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Marketing Authorisation Holder (Organisation)"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.regulator",
        "path": "RegulatedAuthorization.regulator",
        "short": "The regulatory authority or authorizing body granting the authorization",
        "definition": "The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Organization"
            ]
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Medicines Regulatory Agency (Organisation)"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.attachedDocument",
        "path": "RegulatedAuthorization.attachedDocument",
        "short": "Additional information or supporting documentation about the authorization",
        "definition": "Additional information or supporting documentation about the authorization.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.case",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/svg",
            "valueCode": "650,0"
          }
        ],
        "path": "RegulatedAuthorization.case",
        "short": "The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)",
        "definition": "The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "BackboneElement"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Marketing Authorisation Procedure, Marketing Authorisation Procedure.Marketing Authorisation Application"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.case.identifier",
        "path": "RegulatedAuthorization.case.identifier",
        "short": "Identifier by which this case can be referenced",
        "definition": "Identifier by which this case can be referenced.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Identifier"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation Procedure.Procedure Identifier / Number, Marketing Authorisation Application.Application Identifier / Number"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.case.type",
        "path": "RegulatedAuthorization.case.type",
        "short": "The defining type of case",
        "definition": "The defining type of case.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "RegulatedAuthorizationCaseType"
            }
          ],
          "strength": "example",
          "description": "The type of a case involved in an application.",
          "valueSet": "http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"
        },
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation Procedure.Procedure Type, Marketing Authorisation Application.Application Type"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.case.status",
        "path": "RegulatedAuthorization.case.status",
        "short": "The status associated with the case",
        "definition": "The status associated with the case.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "PublicationStatus"
            }
          ],
          "strength": "preferred",
          "description": "The lifecycle status of an artifact.",
          "valueSet": "http://hl7.org/fhir/ValueSet/publication-status"
        },
        "mapping": [
          {
            "identity": "idmp",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.case.date[x]",
        "path": "RegulatedAuthorization.case.date[x]",
        "short": "Relevant date for this case",
        "definition": "Relevant date for this case.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Period"
          },
          {
            "code": "dateTime"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation Procedure.Procedure Date Start, Marketing Authorisation Procedure.Procedure Date End, Marketing Authorisation Application.Application Date"
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.case.application",
        "path": "RegulatedAuthorization.case.application",
        "short": "Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure",
        "definition": "A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.",
        "min": 0,
        "max": "*",
        "contentReference": "#RegulatedAuthorization.case",
        "isSummary": true,
        "mapping": [
          {
            "identity": "idmp",
            "map": "Marketing Authorisation.Marketing Authorisation Application"
          }
        ]
      }
    ]
  }
}