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11.8 JSON Schema for MedicinalProductAuthorization

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

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

{
  "$schema": "http://json-schema.org/draft-06/schema#",
  "id": "http://hl7.org/fhir/json-schema/MedicinalProductAuthorization",
  "$ref": "#/definitions/MedicinalProductAuthorization",
  "description": "see http://hl7.org/fhir/json.html#schema for information about the FHIR Json Schemas",
  "definitions": {
    "MedicinalProductAuthorization": {
      "description": "The regulatory authorization of a medicinal product.",
      "properties": {
        "resourceType": {
          "description": "This is a MedicinalProductAuthorization resource",
          "const": "MedicinalProductAuthorization"
        },
        "id": {
          "description": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
          "$ref": "id.schema.json#/definitions/id"
        },
        "meta": {
          "description": "Метаданные ресурса. Это такая информация, которая поддерживается инфраструктурой. Изменения этой информации не всегда можно ассоциировать с версионными изменениями ресурса.",
          "$ref": "Meta.schema.json#/definitions/Meta"
        },
        "implicitRules": {
          "description": "Ссылка на свод правил, которым следовали при создании этого ресурса и которые необходимо понимать при обработке этого содержимого. 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": "Основной язык, на котором написан ресурс.",
          "$ref": "#/definitions/code"
        },
        "_language": {
          "description": "Extensions for language",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "text": {
          "description": "Человекочитаемая описательная часть, содержащая краткое изложение ресурса, которая может использоваться для представления содержимого ресурса человеку. От описательной части не требуется кодировать все структурированные данные, но она должна содержать достаточно сведений, чтобы простое её прочтение человеком было \"клинически безопасным\". Определения ресурсов могут описывать, какое содержимое должно быть представлено в описательной части для обеспечения клинической безопасной.",
          "$ref": "Narrative.schema.json#/definitions/Narrative"
        },
        "contained": {
          "description": "Эти ресурсы не обладают независимым существованием вне ресурса, который их содержит - их нельзя идентифицировать независимо, и они не могут иметь своей собственной независимой транзакционной области действия.",
          "items": {
            "$ref": "ResourceList.schema.json#/definitions/ResourceList"
          },
          "type": "array"
        },
        "extension": {
          "description": "Может использоваться для представления дополнительной информации, не являющейся частью базового определения ресурса. Чтобы сделать использование расширений надежным и управляемым, существует строгий набор управления применительно к определению и использованию расширений. Хотя каждому реализатору разрешается определять расширения, имеется набор требований, которые должны выполняться в рамках определения расширения.",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "modifierExtension": {
          "description": "May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
          "items": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "identifier": {
          "description": "Business identifier for the marketing authorization, as assigned by a regulator.",
          "items": {
            "$ref": "Identifier.schema.json#/definitions/Identifier"
          },
          "type": "array"
        },
        "subject": {
          "description": "The medicinal product that is being authorized.",
          "$ref": "Reference.schema.json#/definitions/Reference"
        },
        "country": {
          "description": "The country in which the marketing authorization has been granted.",
          "items": {
            "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
          },
          "type": "array"
        },
        "jurisdiction": {
          "description": "Jurisdiction within a country.",
          "items": {
            "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
          },
          "type": "array"
        },
        "status": {
          "description": "The status of the marketing authorization.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "statusDate": {
          "description": "The date at which the given status has become applicable.",
          "$ref": "#/definitions/dateTime"
        },
        "_statusDate": {
          "description": "Extensions for statusDate",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "restoreDate": {
          "description": "The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.",
          "$ref": "#/definitions/dateTime"
        },
        "_restoreDate": {
          "description": "Extensions for restoreDate",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "validityPeriod": {
          "description": "The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.",
          "$ref": "Period.schema.json#/definitions/Period"
        },
        "dataExclusivityPeriod": {
          "description": "A period of time after authorization before generic product applicatiosn can be submitted.",
          "$ref": "Period.schema.json#/definitions/Period"
        },
        "dateOfFirstAuthorization": {
          "description": "The date when the first authorization was granted by a Medicines Regulatory Agency.",
          "$ref": "#/definitions/dateTime"
        },
        "_dateOfFirstAuthorization": {
          "description": "Extensions for dateOfFirstAuthorization",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "internationalBirthDate": {
          "description": "Date of first marketing authorization for a company\u0027s new medicinal product in any country in the World.",
          "$ref": "#/definitions/dateTime"
        },
        "_internationalBirthDate": {
          "description": "Extensions for internationalBirthDate",
          "$ref": "Element.schema.json#/definitions/Element"
        },
        "legalBasis": {
          "description": "The legal framework against which this authorization is granted.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "jurisdictionalAuthorization": {
          "description": "Authorization in areas within a country.",
          "items": {
            "$ref": "#/definitions/MedicinalProductAuthorization_JurisdictionalAuthorization"
          },
          "type": "array"
        },
        "holder": {
          "description": "Marketing Authorization Holder.",
          "$ref": "Reference.schema.json#/definitions/Reference"
        },
        "regulator": {
          "description": "Medicines Regulatory Agency.",
          "$ref": "Reference.schema.json#/definitions/Reference"
        },
        "procedure": {
          "description": "The regulatory procedure for granting or amending a marketing authorization.",
          "$ref": "#/definitions/MedicinalProductAuthorization_Procedure"
        }
      },
      "additionalProperties": false,
      "required": [
        "resourceType"
      ]
    },
    "MedicinalProductAuthorization_JurisdictionalAuthorization": {
      "description": "The regulatory authorization of a medicinal product.",
      "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. 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": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "identifier": {
          "description": "The assigned number for the marketing authorization.",
          "items": {
            "$ref": "Identifier.schema.json#/definitions/Identifier"
          },
          "type": "array"
        },
        "country": {
          "description": "Country of authorization.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "jurisdiction": {
          "description": "Jurisdiction within a country.",
          "items": {
            "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
          },
          "type": "array"
        },
        "legalStatusOfSupply": {
          "description": "The legal status of supply in a jurisdiction or region.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "validityPeriod": {
          "description": "The start and expected end date of the authorization.",
          "$ref": "Period.schema.json#/definitions/Period"
        }
      },
      "additionalProperties": false
    },
    "MedicinalProductAuthorization_Procedure": {
      "description": "The regulatory authorization of a medicinal product.",
      "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. 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": {
            "$ref": "Extension.schema.json#/definitions/Extension"
          },
          "type": "array"
        },
        "identifier": {
          "description": "Identifier for this procedure.",
          "$ref": "Identifier.schema.json#/definitions/Identifier"
        },
        "type": {
          "description": "Type of procedure.",
          "$ref": "CodeableConcept.schema.json#/definitions/CodeableConcept"
        },
        "datePeriod": {
          "description": "Date of procedure.",
          "$ref": "Period.schema.json#/definitions/Period"
        },
        "dateDateTime": {
          "description": "Date of procedure.",
          "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.",
          "items": {
            "$ref": "#/definitions/MedicinalProductAuthorization_Procedure"
          },
          "type": "array"
        }
      },
      "additionalProperties": false,
      "required": [
        "type"
      ]
    }
  }
}