{ "description": "This cross-version extension represents MedicinalProduct from http://hl7.org/fhir/StructureDefinition/MedicinalProduct|4.0.1 for use in FHIR R4B.", "_filename": "StructureDefinition-ext-R4-MedicinalProduct.json", "package_name": "rs/hl7.fhir.uv.xver", "date": "2025-06-03T03:13:06.8337024+02:00", "derivation": "constraint", "publisher": null, "fhirVersion": "4.3.0", "name": "ext_R4_MedicinalProduct", "abstract": false, "type": "Extension", "experimental": "false", "resourceType": "StructureDefinition", "title": "Cross-version Extension for R4.MedicinalProduct for use in FHIR R4B", "package_version": "r4.r4b-0.0.1-snapshot-1", "snapshot": { "element": [ { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children unless an empty Parameters resource", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count()) or $this is Parameters" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension", "min": 0, "definition": "Optional Extension Element - found in all resources.", "isModifier": false, "short": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)", "mapping": [ { "map": "n/a", "identity": "rim" }, { "map": "N/A", "identity": "rim" } ], "max": "*", "id": "Extension", "condition": [ "ele-1" ], "base": { "max": "*", "min": 0, "path": "Extension" } }, { "path": "Extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "closed", "ordered": false, "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Regulatory type, e.g. Investigational or Authorized", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "type", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:type", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:type.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "type", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:type.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Regulatory type, e.g. Investigational or Authorized", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:type.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "If this medicine applies to human or veterinary uses", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "domain", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:domain", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:domain.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:domain.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "If this medicine applies to human or veterinary uses", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Coding" } ], "max": "1", "id": "Extension.extension:domain.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "The dose form for a single part product, or combined form of a multiple part product", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "combinedPharmaceuticalDoseForm", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:combinedPharmaceuticalDoseForm", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:combinedPharmaceuticalDoseForm.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "combinedPharmaceuticalDoseForm", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:combinedPharmaceuticalDoseForm.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The dose form for a single part product, or combined form of a multiple part product", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:combinedPharmaceuticalDoseForm.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "The legal status of supply of the medicinal product as classified by the regulator", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "legalStatusOfSupply", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:legalStatusOfSupply", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:legalStatusOfSupply.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The legal status of supply of the medicinal product as classified by the regulator", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:legalStatusOfSupply.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "additionalMonitoringIndicator", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:additionalMonitoringIndicator", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:additionalMonitoringIndicator.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:additionalMonitoringIndicator.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "additionalMonitoringIndicator", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:additionalMonitoringIndicator.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:additionalMonitoringIndicator.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Whether the Medicinal Product is subject to special measures for regulatory reasons", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "specialMeasures", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialMeasures", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialMeasures.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialMeasures.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "specialMeasures", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialMeasures.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Whether the Medicinal Product is subject to special measures for regulatory reasons", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "string" } ], "max": "1", "id": "Extension.extension:specialMeasures.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "If authorised for use in children", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "paediatricUseIndicator", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:paediatricUseIndicator", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:paediatricUseIndicator.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "paediatricUseIndicator", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:paediatricUseIndicator.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "If authorised for use in children", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:paediatricUseIndicator.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "May be used to represent additional information that is not part of the basic definition of the element. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:productClassification.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Marketing status of the medicinal product, in contrast to marketing authorizaton", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "marketingStatus", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "Data type name for MedicinalProduct.marketingStatus from FHIR R4", "isModifier": false, "short": "Data type name for MedicinalProduct.marketingStatus from FHIR R4", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/_datatype" ] } ], "sliceName": "_datatype", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:_datatype", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:_datatype.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus.extension:_datatype.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "http://hl7.org/fhir/StructureDefinition/_datatype", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:_datatype.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 1, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "string" } ], "max": "1", "fixedString": "MarketingStatus", "id": "Extension.extension:marketingStatus.extension:_datatype.value[x]", "comment": "Must be: MarketingStatus", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 1, "definition": "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.", "isModifier": false, "short": "The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "country", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:country", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:country.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus.extension:country.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "country", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:country.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:marketingStatus.extension:country.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "jurisdiction", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:jurisdiction", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:jurisdiction.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus.extension:jurisdiction.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "jurisdiction", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:jurisdiction.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:marketingStatus.extension:jurisdiction.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 1, "definition": "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.", "isModifier": false, "short": "This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "status", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:status", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:status.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus.extension:status.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "status", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:status.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:marketingStatus.extension:status.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 1, "definition": "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.", "isModifier": false, "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "dateRange", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:dateRange", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus.extension:dateRange.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "dateRange", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:dateRange.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Period" } ], "max": "1", "id": "Extension.extension:marketingStatus.extension:dateRange.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "restoreDate", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:restoreDate", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:restoreDate.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:marketingStatus.extension:restoreDate.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "restoreDate", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.extension:restoreDate.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "dateTime" } ], "max": "1", "id": "Extension.extension:marketingStatus.extension:restoreDate.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "marketingStatus", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:marketingStatus.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "canonical" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "url" }, { "code": "uuid" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "CodeableReference" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "ContactDetail" }, { "code": "Contributor" }, { "code": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Dosage" } ], "max": "1", "id": "Extension.extension:marketingStatus.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Pharmaceutical aspects of product", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "pharmaceuticalProduct", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:pharmaceuticalProduct", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:pharmaceuticalProduct.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:pharmaceuticalProduct.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "pharmaceuticalProduct", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:pharmaceuticalProduct.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Pharmaceutical aspects of product", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical" ] } ], "max": "1", "id": "Extension.extension:pharmaceuticalProduct.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Package representation for the product", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "packagedMedicinalProduct", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:packagedMedicinalProduct", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:packagedMedicinalProduct.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "packagedMedicinalProduct", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:packagedMedicinalProduct.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Package representation for the product", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged" ] } ], "max": "1", "id": "Extension.extension:packagedMedicinalProduct.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Supporting documentation, typically for regulatory submission", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "attachedDocument", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:attachedDocument", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:attachedDocument.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "attachedDocument", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:attachedDocument.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Supporting documentation, typically for regulatory submission", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] } ], "max": "1", "id": "Extension.extension:attachedDocument.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "masterFile", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:masterFile", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:masterFile.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:masterFile.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "masterFile", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:masterFile.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] } ], "max": "1", "id": "Extension.extension:masterFile.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "A product specific contact, person (in a role), or an organization", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "contact", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:contact", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:contact.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:contact.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "contact", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:contact.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "A product specific contact, person (in a role), or an organization", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization", "http://hl7.org/fhir/StructureDefinition/PractitionerRole" ] } ], "max": "1", "id": "Extension.extension:contact.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Clinical trials or studies that this product is involved in", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "clinicalTrial", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:clinicalTrial", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:clinicalTrial.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:clinicalTrial.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "clinicalTrial", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:clinicalTrial.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Clinical trials or studies that this product is involved in", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ], "max": "1", "id": "Extension.extension:clinicalTrial.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 1, "definition": "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.", "isModifier": false, "short": "The product's name, including full name and possibly coded parts", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "name", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:name", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:name.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 1, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "closed", "ordered": false, "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:name.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 1, "definition": "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.", "isModifier": false, "short": "The full product name", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "productName", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:name.extension:productName", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:name.extension:productName.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:name.extension:productName.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "productName", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:name.extension:productName.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The full product name", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "string" } ], "max": "1", "id": "Extension.extension:name.extension:productName.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Coding words or phrases of the name", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "namePart", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:name.extension:namePart", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:name.extension:namePart.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 2, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "closed", "ordered": false, "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:name.extension:namePart.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 1, "definition": "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.", "isModifier": false, "short": "A fragment of a product name", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "part", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:name.extension:namePart.extension:part", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:name.extension:namePart.extension:part.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "part", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:name.extension:namePart.extension:part.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "A fragment of a product name", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "string" } ], "max": "1", "id": "Extension.extension:name.extension:namePart.extension:part.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 1, "definition": "May be used to represent additional information that is not part of the basic definition of the element. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:name.extension:namePart.extension:type.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "type", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:name.extension:namePart.extension:type.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. 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The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Reference to another product, e.g. for linking authorised to investigational product", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Identifier" } ], "max": "1", "id": "Extension.extension:crossReference.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "An operation applied to the product, for manufacturing or adminsitrative purpose", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "manufacturingBusinessOperation", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "closed", "ordered": false, "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "The type of manufacturing operation", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "operationType", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:operationType", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:operationType.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension:operationType.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "operationType", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:operationType.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The type of manufacturing operation", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:operationType.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Regulatory authorization reference number", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "authorisationReferenceNumber", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "authorisationReferenceNumber", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Regulatory authorization reference number", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Identifier" } ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Regulatory authorization date", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "effectiveDate", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:effectiveDate", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "effectiveDate", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Regulatory authorization date", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "dateTime" } ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "To indicate if this proces is commercially confidential", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "confidentialityIndicator", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "confidentialityIndicator", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "To indicate if this proces is commercially confidential", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "The manufacturer or establishment associated with the process", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "manufacturer", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension:manufacturer", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:manufacturer.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension:manufacturer.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "manufacturer", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:manufacturer.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The manufacturer or establishment associated with the process", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:manufacturer.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "A regulator which oversees the operation", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "regulator", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:regulator", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:regulator.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:manufacturingBusinessOperation.extension:regulator.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "regulator", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:regulator.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "A regulator which oversees the operation", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.extension:regulator.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "manufacturingBusinessOperation", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "canonical" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "url" }, { "code": "uuid" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "CodeableReference" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "ContactDetail" }, { "code": "Contributor" }, { "code": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Dosage" } ], "max": "1", "id": "Extension.extension:manufacturingBusinessOperation.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "specialDesignation", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "closed", "ordered": false, "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Identifier for the designation, or procedure number", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "identifier", "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:identifier", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:identifier.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:identifier.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "identifier", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:identifier.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Identifier for the designation, or procedure number", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Identifier" } ], "max": "1", "id": "Extension.extension:specialDesignation.extension:identifier.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "The type of special designation, e.g. orphan drug, minor use", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "type", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:type", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:type.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:type.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "type", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:type.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The type of special designation, e.g. orphan drug, minor use", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:specialDesignation.extension:type.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "The intended use of the product, e.g. prevention, treatment", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "intendedUse", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:intendedUse", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:intendedUse.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:intendedUse.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "intendedUse", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:intendedUse.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "The intended use of the product, e.g. prevention, treatment", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:specialDesignation.extension:intendedUse.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Condition for which the medicinal use applies", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "indication[x]", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:indication[x]", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:indication[x].extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Condition for which the medicinal use applies", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" }, { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductIndication" ] } ], "max": "1", "id": "Extension.extension:specialDesignation.extension:indication[x].value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "For example granted, pending, expired or withdrawn", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "status", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:status", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:status.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. 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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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:date.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "date", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:date.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Date when the designation was granted", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "dateTime" } ], "max": "1", "id": "Extension.extension:specialDesignation.extension:date.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Animal species for which this applies", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "species", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:species", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.id", "min": 0, "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "isModifier": false, "short": "Unique id for inter-element referencing", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "id" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:species.id", "base": { "max": "1", "min": 0, "path": "Element.id" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" }, { "key": "ext-1", "human": "Must have either extensions or value[x], not both", "source": "http://hl7.org/fhir/StructureDefinition/Extension", "severity": "error", "expression": "extension.exists() != value.exists()" } ], "path": "Extension.extension.extension.extension", "min": 0, "definition": "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.", "isModifier": false, "short": "Additional content defined by implementations", "mapping": [ { "map": "n/a", "identity": "rim" } ], "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "alias": [ "extensions", "user content" ], "max": "*", "id": "Extension.extension:specialDesignation.extension:species.extension", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "base": { "max": "*", "min": 0, "path": "Element.extension" }, "isSummary": false }, { "path": "Extension.extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "species", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.extension:species.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Animal species for which this applies", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:specialDesignation.extension:species.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "path": "Extension.extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "specialDesignation", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.extension:specialDesignation.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "canonical" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "url" }, { "code": "uuid" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "CodeableReference" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "ContactDetail" }, { "code": "Contributor" }, { "code": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Dosage" } ], "max": "1", "id": "Extension.extension:specialDesignation.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false }, { "path": "Extension.url", "min": 1, "definition": "Source of the definition for the extension code - a logical name or a URL.", "isModifier": false, "short": "identifies the meaning of the extension", "fixedUri": "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "http://hl7.org/fhirpath/System.String", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "uri" } ] } ], "representation": [ "xmlAttr" ], "max": "1", "id": "Extension.url", "comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.", "base": { "max": "1", "min": 1, "path": "Extension.url" }, "isSummary": false }, { "constraint": [ { "key": "ele-1", "human": "All FHIR elements must have a @value or children", "source": "http://hl7.org/fhir/StructureDefinition/Element", "severity": "error", "expression": "hasValue() or (children().count() > id.count())" } ], "path": "Extension.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "base64Binary" }, { "code": "boolean" }, { "code": "canonical" }, { "code": "code" }, { "code": "date" }, { "code": "dateTime" }, { "code": "decimal" }, { "code": "id" }, { "code": "instant" }, { "code": "integer" }, { "code": "markdown" }, { "code": "oid" }, { "code": "positiveInt" }, { "code": "string" }, { "code": "time" }, { "code": "unsignedInt" }, { "code": "uri" }, { "code": "url" }, { "code": "uuid" }, { "code": "Address" }, { "code": "Age" }, { "code": "Annotation" }, { "code": "Attachment" }, { "code": "CodeableConcept" }, { "code": "CodeableReference" }, { "code": "Coding" }, { "code": "ContactPoint" }, { "code": "Count" }, { "code": "Distance" }, { "code": "Duration" }, { "code": "HumanName" }, { "code": "Identifier" }, { "code": "Money" }, { "code": "Period" }, { "code": "Quantity" }, { "code": "Range" }, { "code": "Ratio" }, { "code": "RatioRange" }, { "code": "Reference" }, { "code": "SampledData" }, { "code": "Signature" }, { "code": "Timing" }, { "code": "ContactDetail" }, { "code": "Contributor" }, { "code": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Dosage" } ], "max": "1", "id": "Extension.value[x]", "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false } ] }, "status": "draft", "id": "e6b72097-b5f8-4d8b-bf4a-ed09de49f319", "kind": "complex-type", "url": "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct", "context": [ { "type": "element", "expression": "Basic" } ], "version": "0.0.1-snapshot-1", "differential": { "element": [ { "id": "Extension", "max": "*", "min": 0, "path": "Extension", "short": "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)", "isModifier": false }, { "id": "Extension.extension", "max": "*", "min": 1, "path": "Extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:type", "max": "1", "min": 0, "path": "Extension.extension", "short": "Regulatory type, e.g. Investigational or Authorized", "sliceName": "type", "isModifier": false }, { "id": "Extension.extension:type.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Regulatory type, e.g. Investigational or Authorized" }, { "id": "Extension.extension:domain", "max": "1", "min": 0, "path": "Extension.extension", "short": "If this medicine applies to human or veterinary uses", "sliceName": "domain", "isModifier": false }, { "id": "Extension.extension:domain.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Coding" } ], "short": "If this medicine applies to human or veterinary uses" }, { "id": "Extension.extension:combinedPharmaceuticalDoseForm", "max": "1", "min": 0, "path": "Extension.extension", "short": "The dose form for a single part product, or combined form of a multiple part product", "sliceName": "combinedPharmaceuticalDoseForm", "isModifier": false }, { "id": "Extension.extension:combinedPharmaceuticalDoseForm.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "The dose form for a single part product, or combined form of a multiple part product" }, { "id": "Extension.extension:legalStatusOfSupply", "max": "1", "min": 0, "path": "Extension.extension", "short": "The legal status of supply of the medicinal product as classified by the regulator", "sliceName": "legalStatusOfSupply", "isModifier": false }, { "id": "Extension.extension:legalStatusOfSupply.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "The legal status of supply of the medicinal product as classified by the regulator" }, { "id": "Extension.extension:additionalMonitoringIndicator", "max": "1", "min": 0, "path": "Extension.extension", "short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons", "sliceName": "additionalMonitoringIndicator", "isModifier": false }, { "id": "Extension.extension:additionalMonitoringIndicator.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons" }, { "id": "Extension.extension:specialMeasures", "max": "*", "min": 0, "path": "Extension.extension", "short": "Whether the Medicinal Product is subject to special measures for regulatory reasons", "sliceName": "specialMeasures", "isModifier": false }, { "id": "Extension.extension:specialMeasures.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "string" } ], "short": "Whether the Medicinal Product is subject to special measures for regulatory reasons" }, { "id": "Extension.extension:paediatricUseIndicator", "max": "1", "min": 0, "path": "Extension.extension", "short": "If authorised for use in children", "sliceName": "paediatricUseIndicator", "isModifier": false }, { "id": "Extension.extension:paediatricUseIndicator.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "If authorised for use in children" }, { "id": "Extension.extension:productClassification", "max": "*", "min": 0, "path": "Extension.extension", "short": "Allows the product to be classified by various systems", "sliceName": "productClassification", "isModifier": false }, { "id": "Extension.extension:productClassification.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Allows the product to be classified by various systems" }, { "id": "Extension.extension:marketingStatus", "max": "*", "min": 0, "path": "Extension.extension", "short": "Marketing status of the medicinal product, in contrast to marketing authorizaton", "sliceName": "marketingStatus", "isModifier": false }, { "id": "Extension.extension:marketingStatus.extension:_datatype", "max": "1", "min": 0, "path": "Extension.extension.extension", "type": [ { "code": "Extension", "profile": [ "http://hl7.org/fhir/StructureDefinition/_datatype" ] } ], "short": "Data type name for MedicinalProduct.marketingStatus from FHIR R4", "sliceName": "_datatype", "definition": "Data type name for MedicinalProduct.marketingStatus from FHIR R4" }, { "id": "Extension.extension:marketingStatus.extension:_datatype.value[x]", "max": "1", "min": 1, "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "string" } ], "comment": "Must be: MarketingStatus", "fixedString": "MarketingStatus" }, { "id": "Extension.extension:marketingStatus.extension:country", "max": "1", "min": 1, "path": "Extension.extension.extension", "short": "The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements", "sliceName": "country", "isModifier": false }, { "id": "Extension.extension:marketingStatus.extension:country.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements" }, { "id": "Extension.extension:marketingStatus.extension:jurisdiction", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified", "sliceName": "jurisdiction", "isModifier": false }, { "id": "Extension.extension:marketingStatus.extension:jurisdiction.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified" }, { "id": "Extension.extension:marketingStatus.extension:status", "max": "1", "min": 1, "path": "Extension.extension.extension", "short": "This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples", "sliceName": "status", "isModifier": false }, { "id": "Extension.extension:marketingStatus.extension:status.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples" }, { "id": "Extension.extension:marketingStatus.extension:dateRange", "max": "1", "min": 1, "path": "Extension.extension.extension", "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain", "sliceName": "dateRange", "isModifier": false }, { "id": "Extension.extension:marketingStatus.extension:dateRange.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Period" } ], "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain" }, { "id": "Extension.extension:marketingStatus.extension:restoreDate", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain", "sliceName": "restoreDate", "isModifier": false }, { "id": "Extension.extension:marketingStatus.extension:restoreDate.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "dateTime" } ], "short": "The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain" }, { "id": "Extension.extension:pharmaceuticalProduct", "max": "*", "min": 0, "path": "Extension.extension", "short": "Pharmaceutical aspects of product", "sliceName": "pharmaceuticalProduct", "isModifier": false }, { "id": "Extension.extension:pharmaceuticalProduct.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical" ] } ], "short": "Pharmaceutical aspects of product" }, { "id": "Extension.extension:packagedMedicinalProduct", "max": "*", "min": 0, "path": "Extension.extension", "short": "Package representation for the product", "sliceName": "packagedMedicinalProduct", "isModifier": false }, { "id": "Extension.extension:packagedMedicinalProduct.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged" ] } ], "short": "Package representation for the product" }, { "id": "Extension.extension:attachedDocument", "max": "*", "min": 0, "path": "Extension.extension", "short": "Supporting documentation, typically for regulatory submission", "sliceName": "attachedDocument", "isModifier": false }, { "id": "Extension.extension:attachedDocument.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] } ], "short": "Supporting documentation, typically for regulatory submission" }, { "id": "Extension.extension:masterFile", "max": "*", "min": 0, "path": "Extension.extension", "short": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)", "sliceName": "masterFile", "isModifier": false }, { "id": "Extension.extension:masterFile.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] } ], "short": "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)" }, { "id": "Extension.extension:contact", "max": "*", "min": 0, "path": "Extension.extension", "short": "A product specific contact, person (in a role), or an organization", "sliceName": "contact", "isModifier": false }, { "id": "Extension.extension:contact.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization", "http://hl7.org/fhir/StructureDefinition/PractitionerRole" ] } ], "short": "A product specific contact, person (in a role), or an organization" }, { "id": "Extension.extension:clinicalTrial", "max": "*", "min": 0, "path": "Extension.extension", "short": "Clinical trials or studies that this product is involved in", "sliceName": "clinicalTrial", "isModifier": false }, { "id": "Extension.extension:clinicalTrial.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy" ] } ], "short": "Clinical trials or studies that this product is involved in" }, { "id": "Extension.extension:name", "max": "*", "min": 1, "path": "Extension.extension", "short": "The product's name, including full name and possibly coded parts", "sliceName": "name", "isModifier": false }, { "id": "Extension.extension:name.extension", "max": "*", "min": 1, "path": "Extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:name.extension:productName", "max": "1", "min": 1, "path": "Extension.extension.extension", "short": "The full product name", "sliceName": "productName", "isModifier": false }, { "id": "Extension.extension:name.extension:productName.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "string" } ], "short": "The full product name" }, { "id": "Extension.extension:name.extension:namePart", "max": "*", "min": 0, "path": "Extension.extension.extension", "short": "Coding words or phrases of the name", "sliceName": "namePart", "isModifier": false }, { "id": "Extension.extension:name.extension:namePart.extension", "max": "*", "min": 2, "path": "Extension.extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:name.extension:namePart.extension:part", "max": "1", "min": 1, "path": "Extension.extension.extension.extension", "short": "A fragment of a product name", "sliceName": "part", "isModifier": false }, { "id": "Extension.extension:name.extension:namePart.extension:part.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.value[x]", "type": [ { "code": "string" } ], "short": "A fragment of a product name" }, { "id": "Extension.extension:name.extension:namePart.extension:type", "max": "1", "min": 1, "path": "Extension.extension.extension.extension", "short": "Idenifying type for this part of the name (e.g. strength part)", "sliceName": "type", "isModifier": false }, { "id": "Extension.extension:name.extension:namePart.extension:type.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.value[x]", "type": [ { "code": "Coding" } ], "short": "Idenifying type for this part of the name (e.g. strength part)" }, { "id": "Extension.extension:name.extension:countryLanguage", "max": "*", "min": 0, "path": "Extension.extension.extension", "short": "Country where the name applies", "sliceName": "countryLanguage", "isModifier": false }, { "id": "Extension.extension:name.extension:countryLanguage.extension", "max": "*", "min": 2, "path": "Extension.extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:name.extension:countryLanguage.extension:country", "max": "1", "min": 1, "path": "Extension.extension.extension.extension", "short": "Country code for where this name applies", "sliceName": "country", "isModifier": false }, { "id": "Extension.extension:name.extension:countryLanguage.extension:country.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Country code for where this name applies" }, { "id": "Extension.extension:name.extension:countryLanguage.extension:jurisdiction", "max": "1", "min": 0, "path": "Extension.extension.extension.extension", "short": "Jurisdiction code for where this name applies", "sliceName": "jurisdiction", "isModifier": false }, { "id": "Extension.extension:name.extension:countryLanguage.extension:jurisdiction.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Jurisdiction code for where this name applies" }, { "id": "Extension.extension:name.extension:countryLanguage.extension:language", "max": "1", "min": 1, "path": "Extension.extension.extension.extension", "short": "Language code for this name", "sliceName": "language", "isModifier": false }, { "id": "Extension.extension:name.extension:countryLanguage.extension:language.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Language code for this name" }, { "id": "Extension.extension:crossReference", "max": "*", "min": 0, "path": "Extension.extension", "short": "Reference to another product, e.g. for linking authorised to investigational product", "sliceName": "crossReference", "isModifier": false }, { "id": "Extension.extension:crossReference.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Identifier" } ], "short": "Reference to another product, e.g. for linking authorised to investigational product" }, { "id": "Extension.extension:manufacturingBusinessOperation", "max": "*", "min": 0, "path": "Extension.extension", "short": "An operation applied to the product, for manufacturing or adminsitrative purpose", "sliceName": "manufacturingBusinessOperation", "isModifier": false }, { "id": "Extension.extension:manufacturingBusinessOperation.extension", "max": "*", "min": 0, "path": "Extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:operationType", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The type of manufacturing operation", "sliceName": "operationType", "isModifier": false }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:operationType.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "The type of manufacturing operation" }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "Regulatory authorization reference number", "sliceName": "authorisationReferenceNumber", "isModifier": false }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:authorisationReferenceNumber.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Identifier" } ], "short": "Regulatory authorization reference number" }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:effectiveDate", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "Regulatory authorization date", "sliceName": "effectiveDate", "isModifier": false }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:effectiveDate.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "dateTime" } ], "short": "Regulatory authorization date" }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "To indicate if this proces is commercially confidential", "sliceName": "confidentialityIndicator", "isModifier": false }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:confidentialityIndicator.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "To indicate if this proces is commercially confidential" }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:manufacturer", "max": "*", "min": 0, "path": "Extension.extension.extension", "short": "The manufacturer or establishment associated with the process", "sliceName": "manufacturer", "isModifier": false }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:manufacturer.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "short": "The manufacturer or establishment associated with the process" }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:regulator", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "A regulator which oversees the operation", "sliceName": "regulator", "isModifier": false }, { "id": "Extension.extension:manufacturingBusinessOperation.extension:regulator.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "short": "A regulator which oversees the operation" }, { "id": "Extension.extension:specialDesignation", "max": "*", "min": 0, "path": "Extension.extension", "short": "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease", "sliceName": "specialDesignation", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension", "max": "*", "min": 0, "path": "Extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:specialDesignation.extension:identifier", "max": "*", "min": 0, "path": "Extension.extension.extension", "short": "Identifier for the designation, or procedure number", "sliceName": "identifier", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension:identifier.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Identifier" } ], "short": "Identifier for the designation, or procedure number" }, { "id": "Extension.extension:specialDesignation.extension:type", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The type of special designation, e.g. orphan drug, minor use", "sliceName": "type", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension:type.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "The type of special designation, e.g. orphan drug, minor use" }, { "id": "Extension.extension:specialDesignation.extension:intendedUse", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The intended use of the product, e.g. prevention, treatment", "sliceName": "intendedUse", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension:intendedUse.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "The intended use of the product, e.g. prevention, treatment" }, { "id": "Extension.extension:specialDesignation.extension:indication[x]", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "Condition for which the medicinal use applies", "sliceName": "indication[x]", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension:indication[x].value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" }, { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductIndication" ] } ], "short": "Condition for which the medicinal use applies" }, { "id": "Extension.extension:specialDesignation.extension:status", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "For example granted, pending, expired or withdrawn", "sliceName": "status", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension:status.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "For example granted, pending, expired or withdrawn" }, { "id": "Extension.extension:specialDesignation.extension:date", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "Date when the designation was granted", "sliceName": "date", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension:date.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "dateTime" } ], "short": "Date when the designation was granted" }, { "id": "Extension.extension:specialDesignation.extension:species", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "Animal species for which this applies", "sliceName": "species", "isModifier": false }, { "id": "Extension.extension:specialDesignation.extension:species.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Animal species for which this applies" }, { "id": "Extension.url", "max": "1", "min": 1, "path": "Extension.url", "fixedUri": "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProduct" } ] }, "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension" }