{ "description": "Values required in Ingredient.substance.strength", "_filename": "StructureDefinition-strength-extension.json", "package_name": "hl7.fhir.us.pq-cmc-fda", "date": "2024-04-08T17:51:06+00:00", "derivation": "constraint", "publisher": "HL7 International / Biomedical Research and Regulation", "fhirVersion": "5.0.0", "jurisdiction": [ { "coding": [ { "code": "US", "system": "urn:iso:std:iso:3166", "display": "United States of America" } ] } ], "name": "StrengthExtension", "mapping": [ { "uri": "http://hl7.org/v3", "name": "RIM Mapping", "identity": "rim" } ], "abstract": false, "type": "Extension", "experimental": null, "resourceType": "StructureDefinition", "title": "Strength Extension", "package_version": "1.0.0-ballot", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics", "valueCode": "can-bind" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" } ], "snapshot": { "element": [ { "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", "min": 0, "definition": "Values required in Ingredient.substance.strength", "isModifier": false, "short": "Strength Extension", "max": "*", "id": "Extension", "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.value[x]", "min": 0, "definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "required", "valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology" }, "max": "1", "id": "Extension.extension:strengthType.value[x]", "condition": [ "ext-1" ], "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": "The percentage of the component in the drug product. [Source: SME Defined]\nExample: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08", "isModifier": false, "short": "Product Ingredient Content Percent", "type": [ { "code": "Extension" } ], "mustSupport": true, "sliceName": "contentPercent", "max": "1", "id": "Extension.extension:contentPercent", "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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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](http://hl7.org/fhir/R5/extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "decimal" } ], "max": "1", "id": "Extension.extension:contentPercent.value[x]", "condition": [ "ext-1" ], "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": "A mathematical symbol that denotes equality or inequality between two values\nNote: This is typically applicable to biologics ", "isModifier": false, "short": "Strength Operator", "type": [ { "code": "Extension" } ], "mustSupport": true, "sliceName": "strengthOperator", "max": "1", "id": "Extension.extension:strengthOperator", "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:strengthOperator.id", "condition": [ "ele-1" ], "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": "An Extension", "isModifier": false, "short": "Extension", "slicing": { "rules": "open", "description": "Extensions are always sliced by (at least) url", "discriminator": [ { "path": "url", "type": "value" } ] }, "type": [ { "code": "Extension" } ], "max": "0", "id": "Extension.extension:strengthOperator.extension", "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": "strengthOperator", "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:strengthOperator.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](http://hl7.org/fhir/R5/extensibility.html) for a list).", "isModifier": false, "short": "Value of extension", "mapping": [ { "map": "N/A", "identity": "rim" } ], "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "required", "valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology" }, "max": "1", "id": "Extension.extension:strengthOperator.value[x]", "condition": [ "ext-1" ], "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/us/pq-cmc-fda/StructureDefinition/strength-extension", "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](http://hl7.org/fhir/R5/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": "integer64" }, { "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": "DataRequirement" }, { "code": "Expression" }, { "code": "ParameterDefinition" }, { "code": "RelatedArtifact" }, { "code": "TriggerDefinition" }, { "code": "UsageContext" }, { "code": "Availability" }, { "code": "ExtendedContactDetail" }, { "code": "Dosage" }, { "code": "Meta" } ], "max": "0", "id": "Extension.value[x]", "condition": [ "ext-1" ], "base": { "max": "1", "min": 0, "path": "Extension.value[x]" }, "isSummary": false } ] }, "status": "active", "id": "b7b84bfb-9c41-44c8-9fd0-8e90beeaa4a4", "kind": "complex-type", "url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension", "identifier": [ { "value": "urn:oid:2.16.840.1.113883.4.642.40.36.42.33", "system": "urn:ietf:rfc:3986" } ], "context": [ { "type": "element", "expression": "Ingredient.substance.strength" } ], "version": "1.0.0-ballot", "differential": { "element": [ { "id": "Extension", "path": "Extension", "short": "Strength Extension", "definition": "Values required in Ingredient.substance.strength" }, { "id": "Extension.extension", "min": 2, "path": "Extension.extension" }, { "id": "Extension.extension:strengthType", "max": "1", "min": 1, "path": "Extension.extension", "short": "Strength Type (for API)", "sliceName": "strengthType", "definition": "A physical (content) or activity measurement of the strength of the ingredient. [Source: SME Defined]\nExample: Mass, Activity", "mustSupport": true }, { "id": "Extension.extension:strengthType.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:strengthType.url", "path": "Extension.extension.url", "fixedUri": "strengthType" }, { "id": "Extension.extension:strengthType.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "required", "valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology" } }, { "id": "Extension.extension:contentPercent", "max": "1", "min": 1, "path": "Extension.extension", "short": "Product Ingredient Content Percent", "sliceName": "contentPercent", "definition": "The percentage of the component in the drug product. [Source: SME Defined]\nExample: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08", "mustSupport": true }, { "id": "Extension.extension:contentPercent.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:contentPercent.url", "path": "Extension.extension.url", "fixedUri": "contentPercent" }, { "id": "Extension.extension:contentPercent.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "decimal" } ] }, { "id": "Extension.extension:strengthOperator", "max": "1", "min": 0, "path": "Extension.extension", "short": "Strength Operator", "sliceName": "strengthOperator", "definition": "A mathematical symbol that denotes equality or inequality between two values\nNote: This is typically applicable to biologics ", "mustSupport": true }, { "id": "Extension.extension:strengthOperator.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:strengthOperator.url", "path": "Extension.extension.url", "fixedUri": "strengthOperator" }, { "id": "Extension.extension:strengthOperator.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "CodeableConcept" } ], "binding": { "strength": "required", "valueSet": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology" } }, { "id": "Extension.url", "path": "Extension.url", "fixedUri": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/strength-extension" }, { "id": "Extension.value[x]", "max": "0", "path": "Extension.value[x]" } ] }, "contact": [ { "name": "HL7 International / Biomedical Research and Regulation", "telecom": [ { "value": "http://www.hl7.org/Special/committees/rcrim", "system": "url" }, { "value": "brr@lists.HL7.org", "system": "email" } ] } ], "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension" }