{ "description": "This cross-version extension represents MedicinalProductPharmaceutical from http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical|4.0.1 for use in FHIR R4B.", "_filename": "StructureDefinition-ext-R4-MedicinalProductPharmaceutical.json", "package_name": "hl7.fhir.uv.xver-r4.r4b", "date": "2025-06-03T03:13:07.0115645+02:00", "derivation": "constraint", "publisher": null, "fhirVersion": "4.3.0", "name": "ext_R4_MedicinalProductPharmaceutical", "abstract": false, "type": "Extension", "experimental": "false", "resourceType": "StructureDefinition", "title": "Cross-version Extension for R4.MedicinalProductPharmaceutical for use in FHIR R4B", "package_version": "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": "A pharmaceutical product described in terms of its composition and dose form", "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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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": "Coded expression for the route", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:code.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 first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "firstDose", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:firstDose", "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:routeOfAdministration.extension:firstDose.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:routeOfAdministration.extension:firstDose.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": "firstDose", "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:routeOfAdministration.extension:firstDose.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 first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Quantity" } ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:firstDose.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 maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "maxSingleDose", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:maxSingleDose", "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:routeOfAdministration.extension:maxSingleDose.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:routeOfAdministration.extension:maxSingleDose.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": "maxSingleDose", "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:routeOfAdministration.extension:maxSingleDose.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 maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Quantity" } ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:maxSingleDose.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 maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "maxDosePerDay", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:maxDosePerDay", "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:routeOfAdministration.extension:maxDosePerDay.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:routeOfAdministration.extension:maxDosePerDay.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": "maxDosePerDay", "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:routeOfAdministration.extension:maxDosePerDay.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 maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Quantity" } ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:maxDosePerDay.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 maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "maxDosePerTreatmentPeriod", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:maxDosePerTreatmentPeriod", "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:routeOfAdministration.extension:maxDosePerTreatmentPeriod.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": "maxDosePerTreatmentPeriod", "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:routeOfAdministration.extension:maxDosePerTreatmentPeriod.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 maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "Ratio" } ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:maxDosePerTreatmentPeriod.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 maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation", "mapping": [ { "map": "n/a", "identity": "rim" } ], "type": [ { "code": "Extension" } ], "sliceName": "maxTreatmentPeriod", "alias": [ "extensions", "user content" ], "max": "1", "id": "Extension.extension:routeOfAdministration.extension:maxTreatmentPeriod", "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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{ "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductIngredient" ] } ], "short": "Ingredient" }, { "id": "Extension.extension:device", "max": "*", "min": 0, "path": "Extension.extension", "short": "Accompanying device", "sliceName": "device", "isModifier": false }, { "id": "Extension.extension:device.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.value[x]", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition" ] } ], "short": "Accompanying device" }, { "id": "Extension.extension:characteristics", "max": "*", "min": 0, "path": "Extension.extension", "short": "Characteristics e.g. a products onset of action", "sliceName": "characteristics", "isModifier": false }, { "id": "Extension.extension:characteristics.extension", "max": "*", "min": 1, "path": "Extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:characteristics.extension:code", "max": "1", "min": 1, "path": "Extension.extension.extension", "short": "A coded characteristic", "sliceName": "code", "isModifier": false }, { "id": "Extension.extension:characteristics.extension:code.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "A coded characteristic" }, { "id": "Extension.extension:characteristics.extension:status", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The status of characteristic e.g. assigned or pending", "sliceName": "status", "isModifier": false }, { "id": "Extension.extension:characteristics.extension:status.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "The status of characteristic e.g. assigned or pending" }, { "id": "Extension.extension:routeOfAdministration", "max": "*", "min": 1, "path": "Extension.extension", "short": "The path by which the pharmaceutical product is taken into or makes contact with the body", "sliceName": "routeOfAdministration", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension", "max": "*", "min": 1, "path": "Extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:routeOfAdministration.extension:code", "max": "1", "min": 1, "path": "Extension.extension.extension", "short": "Coded expression for the route", "sliceName": "code", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:code.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Coded expression for the route" }, { "id": "Extension.extension:routeOfAdministration.extension:firstDose", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement", "sliceName": "firstDose", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:firstDose.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Quantity" } ], "short": "The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement" }, { "id": "Extension.extension:routeOfAdministration.extension:maxSingleDose", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement", "sliceName": "maxSingleDose", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:maxSingleDose.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Quantity" } ], "short": "The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement" }, { "id": "Extension.extension:routeOfAdministration.extension:maxDosePerDay", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation", "sliceName": "maxDosePerDay", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:maxDosePerDay.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Quantity" } ], "short": "The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation" }, { "id": "Extension.extension:routeOfAdministration.extension:maxDosePerTreatmentPeriod", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation", "sliceName": "maxDosePerTreatmentPeriod", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:maxDosePerTreatmentPeriod.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Ratio" } ], "short": "The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation" }, { "id": "Extension.extension:routeOfAdministration.extension:maxTreatmentPeriod", "max": "1", "min": 0, "path": "Extension.extension.extension", "short": "The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation", "sliceName": "maxTreatmentPeriod", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:maxTreatmentPeriod.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.value[x]", "type": [ { "code": "Duration" } ], "short": "The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation" }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies", "max": "*", "min": 0, "path": "Extension.extension.extension", "short": "A species for which this route applies", "sliceName": "targetSpecies", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension", "max": "*", "min": 1, "path": "Extension.extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:code", "max": "1", "min": 1, "path": "Extension.extension.extension.extension", "short": "Coded expression for the species", "sliceName": "code", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:code.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Coded expression for the species" }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod", "max": "*", "min": 0, "path": "Extension.extension.extension.extension", "short": "A species specific time during which consumption of animal product is not appropriate", "sliceName": "withdrawalPeriod", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod.extension", "max": "*", "min": 2, "path": "Extension.extension.extension.extension.extension", "slicing": { "rules": "closed", "ordered": false, "discriminator": [ { "path": "url", "type": "value" } ] } }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod.extension:tissue", "max": "1", "min": 1, "path": "Extension.extension.extension.extension.extension", "short": "Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk", "sliceName": "tissue", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod.extension:tissue.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "short": "Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk" }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod.extension:value", "max": "1", "min": 1, "path": "Extension.extension.extension.extension.extension", "short": "A value for the time", "sliceName": "value", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod.extension:value.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.extension.value[x]", "type": [ { "code": "Quantity" } ], "short": "A value for the time" }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod.extension:supportingInformation", "max": "1", "min": 0, "path": "Extension.extension.extension.extension.extension", "short": "Extra information about the withdrawal period", "sliceName": "supportingInformation", "isModifier": false }, { "id": "Extension.extension:routeOfAdministration.extension:targetSpecies.extension:withdrawalPeriod.extension:supportingInformation.value[x]", "base": { "path": "Extension.value[x]" }, "path": "Extension.extension.extension.extension.extension.value[x]", "type": [ { "code": "string" } ], "short": "Extra information about the withdrawal period" }, { "id": "Extension.url", "max": "1", "min": 1, "path": "Extension.url", "fixedUri": "http://hl7.org/fhir/4.0/StructureDefinition/extension-MedicinalProductPharmaceutical" } ] }, "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension" }