{
  "resourceType": "StructureDefinition",
  "id": "preMarketAuthorization",
  "url": "https://udi.anvisa.gov.br/fhir/StructureDefinition/PreMarketAuthorization",
  "version": "1.0.0",
  "name": "PreMarketAuthorization",
  "title": "Pre Market Authorization",
  "status": "draft",
  "description": "Representation of a product authorization regulated by Anvisa",
  "fhirVersion": "5.0.0",
  "kind": "resource",
  "abstract": false,
  "type": "RegulatedAuthorization",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "RegulatedAuthorization",
        "path": "RegulatedAuthorization",
        "short": "Representation of a product authorization regulated by Anvisa"
      },
      {
        "id": "RegulatedAuthorization.extension:anvisaNomenclature",
        "path": "RegulatedAuthorization.extension",
        "sliceName": "anvisaNomenclature",
        "short": "The Anvisa's nomenclature name",
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/AnvisaNomenclature"
            ]
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.extension:riskClassification",
        "path": "RegulatedAuthorization.extension",
        "sliceName": "riskClassification",
        "short": "The risk classification of the product",
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/RiskClassification"
            ]
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.identifier",
        "path": "RegulatedAuthorization.identifier",
        "min": 1,
        "max": "1"
      },
      {
        "id": "RegulatedAuthorization.identifier.use",
        "path": "RegulatedAuthorization.identifier.use",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.identifier.type",
        "path": "RegulatedAuthorization.identifier.type",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.identifier.system",
        "path": "RegulatedAuthorization.identifier.system",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.identifier.value",
        "path": "RegulatedAuthorization.identifier.value",
        "short": "The Premarket Authorization Number of the regularization",
        "min": 1,
        "maxLength": 11
      },
      {
        "id": "RegulatedAuthorization.identifier.period",
        "path": "RegulatedAuthorization.identifier.period",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.identifier.assigner",
        "path": "RegulatedAuthorization.identifier.assigner",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.subject",
        "path": "RegulatedAuthorization.subject",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.type",
        "path": "RegulatedAuthorization.type",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.description",
        "path": "RegulatedAuthorization.description",
        "short": "The registered product name",
        "min": 1
      },
      {
        "id": "RegulatedAuthorization.region",
        "path": "RegulatedAuthorization.region",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.status",
        "path": "RegulatedAuthorization.status",
        "short": "The status of the regularization",
        "min": 1,
        "binding": {
          "strength": "required",
          "valueSet": "https://udi.anvisa.gov.br/fhir/ValueSet/RegularizationStatus"
        }
      },
      {
        "id": "RegulatedAuthorization.statusDate",
        "path": "RegulatedAuthorization.statusDate",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.validityPeriod.start",
        "path": "RegulatedAuthorization.validityPeriod.start",
        "short": "The start of the valid life period, referring to a date when the regularization was released publicly"
      },
      {
        "id": "RegulatedAuthorization.validityPeriod.end",
        "path": "RegulatedAuthorization.validityPeriod.end",
        "short": "The end of the valid life period, referring to a date when the regularization was canceled or expired"
      },
      {
        "id": "RegulatedAuthorization.indication",
        "path": "RegulatedAuthorization.indication",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.intendedUse",
        "path": "RegulatedAuthorization.intendedUse",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.basis",
        "path": "RegulatedAuthorization.basis",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.holder",
        "path": "RegulatedAuthorization.holder",
        "short": "A reference to the regularization holder company",
        "min": 1,
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "https://udi.anvisa.gov.br/fhir/StructureDefinition/Holder"
            ]
          }
        ]
      },
      {
        "id": "RegulatedAuthorization.regulator",
        "path": "RegulatedAuthorization.regulator",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.attachedDocument",
        "path": "RegulatedAuthorization.attachedDocument",
        "max": "0"
      },
      {
        "id": "RegulatedAuthorization.case",
        "path": "RegulatedAuthorization.case",
        "max": "0"
      }
    ]
  }
}