Release 5 Preview #2

This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative Compartments: Not linked to any defined compartments

This is a representation of the json schema for RegulatedAuthorization, which is just a part of the full JSON Schema.

{
  "$schema": "http://json-schema.org/draft-06/schema#",
  "id": "http://hl7.org/fhir/json-schema/RegulatedAuthorization",
  "$ref": "#/definitions/RegulatedAuthorization",
  "description": "see http://hl7.org/fhir/json.html#schema for information about the FHIR Json Schemas",
  "definitions": {
    "RegulatedAuthorization": {
      "description": "The regulatory authorization of a medicinal product, device or process.",
      "properties": {
        "resourceType": {
          "description": "This is a RegulatedAuthorization resource",
          "const": "RegulatedAuthorization"
        },
        "id": {
          "description": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
          "$ref": "id.schema.json#/definitions/id"
        },
        "meta": {
          "description": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
          "$ref": "Meta.schema.json#/definitions/Meta"
        },
        "implicitRules": {
          "description": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
          "$ref": "#/definitions/uri"
        },
        "_implicitRules": {
          "description": "Extensions for implicitRules",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "language": {
          "description": "The base language in which the resource is written.",
          "$ref": "#/definitions/code"
        },
        "_language": {
          "description": "Extensions for language",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "text": {
          "description": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
          "$ref": "Narrative.schema.json#/definitions/Narrative"
        },
        "contained": {
          "description": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
          "items": {
            "$ref": "ResourceList.schema.json#/definitions/ResourceList"
          },
          "type": "array"
        },
        "extension": {
          "description": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "modifierExtension": {
          "description": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element\u0027s descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "identifier": {
          "description": "Business identifier for the authorization, typically assigned by the authorizing body.",
          "items": {
            "$ref": "Identifier.schema.json#/definitions/Identifier"
          },
          "type": "array"
        },
        "subject": {
          "description": "The type of product or service that is being authorized.",
          "$ref": "Reference.schema.json#/definitions/Reference"
        },
        "type": {
          "description": "Overall type of this authorization, for example drug marketing approval, orphan drug designation.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "description": {
          "description": "General textual supporting information.",
          "$ref": "#/definitions/markdown"
        },
        "_description": {
          "description": "Extensions for description",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "region": {
          "description": "The region (country, jurisdiction etc.) in which the marketing authorization has been granted.",
          "items": {
            "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
          },
          "type": "array"
        },
        "status": {
          "description": "The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "statusDate": {
          "description": "The date at which the given status became applicable.",
          "$ref": "#/definitions/dateTime"
        },
        "_statusDate": {
          "description": "Extensions for statusDate",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "validityPeriod": {
          "description": "The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.",
          "$ref": "Period.schema.json#/definitions/Period"
        },
        "indicationCodeableConcept": {
          "description": "Condition for which the medicinal use applies.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "indicationReference": {
          "description": "Condition for which the medicinal use applies.",
          "$ref": "Reference.schema.json#/definitions/Reference"
        },
        "intendedUse": {
          "description": "The intended use of the product, e.g. prevention, treatment.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "basis": {
          "description": "The legal or regulatory framework against which this authorization is granted, or other reasons for it.",
          "items": {
            "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
          },
          "type": "array"
        },
        "relatedDate": {
          "description": "Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on.",
          "items": {
            "$ref": "#/definitions/RegulatedAuthorization_RelatedDate"
          },
          "type": "array"
        },
        "jurisdictionalAuthorization": {
          "description": "Authorization in areas within a country.",
          "items": {
            "$ref": "Reference.schema.json#/definitions/Reference"
          },
          "type": "array"
        },
        "holder": {
          "description": "Marketing Authorization Holder.",
          "$ref": "Reference.schema.json#/definitions/Reference"
        },
        "regulator": {
          "description": "Medicines Regulatory Agency.",
          "$ref": "Reference.schema.json#/definitions/Reference"
        },
        "case": {
          "description": "The case or regulatory procedure for granting or amending a marketing authorization.",
          "$ref": "#/definitions/RegulatedAuthorization_Case"
        }
      },
      "additionalProperties": false,
      "required": [
        "resourceType"
      ]
    },
    "RegulatedAuthorization_RelatedDate": {
      "description": "The regulatory authorization of a medicinal product, device or process.",
      "properties": {
        "id": {
          "description": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
          "$ref": "string.schema.json#/definitions/string"
        },
        "extension": {
          "description": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "modifierExtension": {
          "description": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element\u0027s descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "datePeriod": {
          "description": "Another date associated with the authorization.",
          "$ref": "Period.schema.json#/definitions/Period"
        },
        "dateDateTime": {
          "description": "Another date associated with the authorization.",
          "pattern": "^([0-9]([0-9]([0-9][1-9]|[1-9]0)|[1-9]00)|[1-9]000)(-(0[1-9]|1[0-2])(-(0[1-9]|[1-2][0-9]|3[0-1])(T([01][0-9]|2[0-3]):[0-5][0-9]:([0-5][0-9]|60)(\\.[0-9]+)?(Z|(\\+|-)((0[0-9]|1[0-3]):[0-5][0-9]|14:00)))?)?)?$",
          "type": "string"
        },
        "_dateDateTime": {
          "description": "Extensions for dateDateTime",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "type": {
          "description": "Type of this date, for example the data exclusitity period for a medicinal product.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        }
      },
      "additionalProperties": false,
      "required": [
        "type"
      ]
    },
    "RegulatedAuthorization_Case": {
      "description": "The regulatory authorization of a medicinal product, device or process.",
      "properties": {
        "id": {
          "description": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
          "$ref": "string.schema.json#/definitions/string"
        },
        "extension": {
          "description": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "modifierExtension": {
          "description": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element\u0027s descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "identifier": {
          "description": "Identifier by which this case can be referenced.",
          "$ref": "Identifier.schema.json#/definitions/Identifier"
        },
        "type": {
          "description": "The defining type of case.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "status": {
          "description": "The status associated with the case.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "datePeriod": {
          "description": "Relevant date for this of case.",
          "$ref": "Period.schema.json#/definitions/Period"
        },
        "dateDateTime": {
          "description": "Relevant date for this of case.",
          "pattern": "^([0-9]([0-9]([0-9][1-9]|[1-9]0)|[1-9]00)|[1-9]000)(-(0[1-9]|1[0-2])(-(0[1-9]|[1-2][0-9]|3[0-1])(T([01][0-9]|2[0-3]):[0-5][0-9]:([0-5][0-9]|60)(\\.[0-9]+)?(Z|(\\+|-)((0[0-9]|1[0-3]):[0-5][0-9]|14:00)))?)?)?$",
          "type": "string"
        },
        "_dateDateTime": {
          "description": "Extensions for dateDateTime",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "application": {
          "description": "Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure.",
          "items": {
            "$ref": "#/definitions/RegulatedAuthorization_Case"
          },
          "type": "array"
        }
      },
      "additionalProperties": false
    }
  }
}