Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi | Version: 1.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: SubstanceDefinitionUvEpi | ||
SubstanceDefinition (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from SubstanceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
  identifier | 1..* | Identifier | Identifier by which this substance is known | |
  system | 1..1 | uri | The namespace for the identifier value | |
 value | 1..1 | string | The value that is unique | |
| status | 0..1 | CodeableConcept | draft|active|retired|unknown | |
| domain | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) | |
| description | 0..1 | markdown | Textual description of the substance. | |
 manufacturer | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance | |
| molecularWeight | ||||
 amount | 1..1 | Quantity | The molecular weight. | |
 value | 0..1 | decimal | numerical value. | |
| unit | 0..1 | string | Unit of measure. | |
| code | 0..1 | code | coded form of the unit of measure. | |
| structure | ||||
| molecularFormula | 0..1 | string | Molecular formula (e.g. using the Hill system). | |
| code | 0..* | BackboneElement | Codes associated with the substance. | |
| code | 0..1 | CodeableConcept | The specific code Binding: Substances (example) | |
| name | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. | |
| type | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| SubstanceDefinition.domain | example | MedicinalProductDomain |
| SubstanceDefinition.code.code | example | VsSubstance |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 identifier | Σ | 1..* | Identifier | Identifier by which this substance is known |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) |
| description | Σ | 0..1 | markdown | Textual description of the substance. |
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance |
| code | Σ | 0..* | BackboneElement | Codes associated with the substance. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) |
| name | Σ | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | The actual name |
| type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| SubstanceDefinition.identifier.use | required | IdentifierUse |
| SubstanceDefinition.status | preferred | PublicationStatus |
| SubstanceDefinition.domain | example | MedicinalProductDomain |
| SubstanceDefinition.code.code | example | VsSubstance |
| SubstanceDefinition.name.type | example | SubstanceNameType |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| id | Σ | 0..1 | id | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
 extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 1..* | Identifier | Identifier by which this substance is known |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| version | Σ | 0..1 | string | A business level version identifier of the substance |
| status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| classification | Σ | 0..* | CodeableConcept | A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity |
| domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) |
| grade | Σ | 0..* | CodeableConcept | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP) Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies |
| description | Σ | 0..1 | markdown | Textual description of the substance. |
| informationSource | Σ | 0..* | Reference(Citation) | Supporting literature |
| note | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record |
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance |
| supplier | Σ | 0..* | Reference(Organization) | An entity that is the source for the substance. It may be different from the manufacturer |
| moiety | Σ | 0..* | BackboneElement | Moiety, for structural modifications |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| role | Σ | 0..1 | CodeableConcept | Role that the moiety is playing |
| identifier | Σ | 0..1 | Identifier | Identifier by which this moiety substance is known |
| name | Σ | 0..1 | string | Textual name for this moiety substance |
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. |
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. |
| molecularFormula | Σ | 0..1 | string | Molecular formula for this moiety (e.g. with the Hill system) |
 amount[x] | Σ | 0..1 | Quantitative value for this moiety | |
| amountQuantity | Quantity | |||
| amountString | string | |||
| measurementType | Σ | 0..1 | CodeableConcept | The measurement type of the quantitative value Binding: SubstanceAmountType (example): The relationship between two substance types. |
| characterization | Σ | 0..* | BackboneElement | General specifications for this substance |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| technique | Σ | 0..1 | CodeableConcept | The method used to find the characterization e.g. HPLC Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance. |
| form | Σ | 0..1 | CodeableConcept | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form Binding: SubstanceForm (example) |
| description | Σ | 0..1 | markdown | The description or justification in support of the interpretation of the data file |
| file | Σ | 0..* | Attachment | The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis |
| property | Σ | 0..* | BackboneElement | General specifications for this substance |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
| value[x] | Σ | 0..1 | A value for the property | |
| valueCodeableConcept | CodeableConcept | |||
| valueQuantity | Quantity | |||
| valueDate | date | |||
| valueBoolean | boolean | |||
| valueAttachment | Attachment | |||
| referenceInformation | Σ | 0..1 | Reference(SubstanceReferenceInformation) | General information detailing this substance |
| molecularWeight | Σ | 0..* | BackboneElement | The average mass of a molecule of a compound |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | Σ | 0..1 | CodeableConcept | The method by which the weight was determined Binding: WeightMethod (example): The method by which the substance weight was measured. |
| type | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: WeightType (example): The type of substance weight measurement. |
| amount | Σ | 1..1 | Quantity | The molecular weight. |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| value | Σ | 0..1 | decimal | numerical value. |
| comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit | Σ | 0..1 | string | Unit of measure. |
| system | ΣC | 0..1 | uri | System that defines coded unit form |
| code | ΣC | 0..1 | code | coded form of the unit of measure. |
| structure | Σ | 0..1 | BackboneElement | Structural information |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. |
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. |
| molecularFormula | Σ | 0..1 | string | Molecular formula (e.g. using the Hill system). |
| molecularFormulaByMoiety | Σ | 0..1 | string | Specified per moiety according to the Hill system |
| molecularWeight | Σ | 0..1 | See molecularWeight (SubstanceDefinition) | The molecular weight or weight range |
| technique | Σ | 0..* | CodeableConcept | The method used to find the structure e.g. X-ray, NMR Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance. |
| sourceDocument | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure |
| representation | Σ | 0..* | BackboneElement | A depiction of the structure of the substance |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 0..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: SubstanceRepresentationType (example): A format of a substance representation. |
| representation | Σ | 0..1 | string | The structural representation as a text string in a standard format |
| format | Σ | 0..1 | CodeableConcept | The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format) Binding: SubstanceRepresentationFormat (example): A format of a substance representation. |
| document | Σ | 0..1 | Reference(DocumentReference) | An attachment with the structural representation e.g. a structure graphic or AnIML file |
| code | Σ | 0..* | BackboneElement | Codes associated with the substance. |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) |
| status | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate | Σ | 0..1 | dateTime | The date at which the code status was changed |
| note | Σ | 0..* | Annotation | Any comment can be provided in this field |
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature |
| name | Σ | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | The actual name |
| type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| preferred | Σ | 0..1 | boolean | If this is the preferred name for this substance |
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language |
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. |
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes |
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known |
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language |
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. |
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| date | Σ | 0..1 | dateTime | Date of official name change |
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature |
| relationship | Σ | 0..* | BackboneElement | A link between this substance and another |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substanceDefinition[x] | Σ | 0..1 | A pointer to another substance, as a resource or a representational code | |
| substanceDefinitionReference | Reference(SubstanceDefinition) | |||
| substanceDefinitionCodeableConcept | CodeableConcept | |||
| type | Σ | 1..1 | CodeableConcept | For example "salt to parent", "active moiety" Binding: SubstanceRelationshipType (example): The relationship between two substance types. |
| isDefining | Σ | 0..1 | boolean | For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships |
| amount[x] | Σ | 0..1 | A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other | |
| amountQuantity | Quantity | |||
| amountRatio | Ratio | |||
| amountString | string | |||
| ratioHighLimitAmount | Σ | 0..1 | Ratio | For use when the numeric has an uncertain range |
| comparator | Σ | 0..1 | CodeableConcept | An operator for the amount, for example "average", "approximately", "less than" Binding: SubstanceAmountType (example): The relationship between two substance types. |
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature |
| nucleicAcid | Σ | 0..1 | Reference(SubstanceNucleicAcid) | Data items specific to nucleic acids |
| polymer | Σ | 0..1 | Reference(SubstancePolymer) | Data items specific to polymers |
| protein | Σ | 0..1 | Reference(SubstanceProtein) | Data items specific to proteins |
| sourceMaterial | Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 0..1 | CodeableConcept | Classification of the origin of the raw material. e.g. cat hair is an Animal source type Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material. |
| genus | Σ | 0..1 | CodeableConcept | The genus of an organism e.g. the Latin epithet of the plant/animal scientific name Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. |
| species | Σ | 0..1 | CodeableConcept | The species of an organism e.g. the Latin epithet of the species of the plant/animal Binding: SourceMaterialSpecies (example): A species of origin a substance raw material. |
| part | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism. |
| countryOfOrigin | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: CountryValueSet (required): Jurisdiction codes |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| SubstanceDefinition.language | required | AllLanguages |
| SubstanceDefinition.identifier.use | required | IdentifierUse |
| SubstanceDefinition.identifier.type | extensible | IdentifierTypeCodes |
| SubstanceDefinition.status | preferred | PublicationStatus |
| SubstanceDefinition.domain | example | MedicinalProductDomain |
| SubstanceDefinition.grade | example | SubstanceGrade |
| SubstanceDefinition.moiety.stereochemistry | example | Stereochemistry |
| SubstanceDefinition.moiety.opticalActivity | example | OpticalActivity |
| SubstanceDefinition.moiety.measurementType | example | SubstanceAmountType |
| SubstanceDefinition.characterization.technique | example | StructureTechnique |
| SubstanceDefinition.characterization.form | example | SubstanceForm |
| SubstanceDefinition.property.type | example | ProductCharacteristic |
| SubstanceDefinition.molecularWeight.method | example | WeightMethod |
| SubstanceDefinition.molecularWeight.type | example | WeightType |
| SubstanceDefinition.molecularWeight.amount.comparator | required | QuantityComparator |
| SubstanceDefinition.structure.stereochemistry | example | Stereochemistry |
| SubstanceDefinition.structure.opticalActivity | example | OpticalActivity |
| SubstanceDefinition.structure.technique | example | StructureTechnique |
| SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationType |
| SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormat |
| SubstanceDefinition.code.code | example | VsSubstance |
| SubstanceDefinition.code.status | preferred | PublicationStatus |
| SubstanceDefinition.name.type | example | SubstanceNameType |
| SubstanceDefinition.name.status | preferred | PublicationStatus |
| SubstanceDefinition.name.language | required | AllLanguages |
| SubstanceDefinition.name.domain | example | SubstanceNameDomain |
| SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSet |
| SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthority |
| SubstanceDefinition.name.official.status | preferred | PublicationStatus |
| SubstanceDefinition.relationship.type | example | SubstanceRelationshipType |
| SubstanceDefinition.relationship.comparator | example | SubstanceAmountType |
| SubstanceDefinition.sourceMaterial.type | example | SourceMaterialType |
| SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus |
| SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies |
| SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart |
| SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSet |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from SubstanceDefinition
Summary
Mandatory: 3 elements
Structures
This structure refers to these other structures:
Maturity: 2
Differential View
This structure is derived from SubstanceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| identifier | 1..* | Identifier | Identifier by which this substance is known | |
| system | 1..1 | uri | The namespace for the identifier value | |
| value | 1..1 | string | The value that is unique | |
| status | 0..1 | CodeableConcept | draft|active|retired|unknown | |
| domain | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) | |
| description | 0..1 | markdown | Textual description of the substance. | |
| manufacturer | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance | |
| molecularWeight | ||||
| amount | 1..1 | Quantity | The molecular weight. | |
| value | 0..1 | decimal | numerical value. | |
| unit | 0..1 | string | Unit of measure. | |
| code | 0..1 | code | coded form of the unit of measure. | |
| structure | ||||
| molecularFormula | 0..1 | string | Molecular formula (e.g. using the Hill system). | |
| code | 0..* | BackboneElement | Codes associated with the substance. | |
| code | 0..1 | CodeableConcept | The specific code Binding: Substances (example) | |
| name | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. | |
| type | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| SubstanceDefinition.domain | example | MedicinalProductDomain |
| SubstanceDefinition.code.code | example | VsSubstance |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 1..* | Identifier | Identifier by which this substance is known |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) |
| description | Σ | 0..1 | markdown | Textual description of the substance. |
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance |
| code | Σ | 0..* | BackboneElement | Codes associated with the substance. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) |
| name | Σ | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | The actual name |
| type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| SubstanceDefinition.identifier.use | required | IdentifierUse |
| SubstanceDefinition.status | preferred | PublicationStatus |
| SubstanceDefinition.domain | example | MedicinalProductDomain |
| SubstanceDefinition.code.code | example | VsSubstance |
| SubstanceDefinition.name.type | example | SubstanceNameType |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | SubstanceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | SubstanceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | SubstanceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| SubstanceDefinition | 0..* | SubstanceDefinition | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| id | Σ | 0..1 | id | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 1..* | Identifier | Identifier by which this substance is known |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| period | Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| version | Σ | 0..1 | string | A business level version identifier of the substance |
| status | Σ | 0..1 | CodeableConcept | draft|active|retired|unknown Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| classification | Σ | 0..* | CodeableConcept | A categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity |
| domain | Σ | 0..1 | CodeableConcept | If the substance applies to human or veterinary use Binding: MedicinalProductDomain (example) |
| grade | Σ | 0..* | CodeableConcept | The quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP) Binding: SubstanceGrade (example): The quality standard, established benchmark, to which a substance complies |
| description | Σ | 0..1 | markdown | Textual description of the substance. |
| informationSource | Σ | 0..* | Reference(Citation) | Supporting literature |
| note | Σ | 0..* | Annotation | Textual comment about the substance's catalogue or registry record |
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | The entity that creates, makes, produces or fabricates the substance |
| supplier | Σ | 0..* | Reference(Organization) | An entity that is the source for the substance. It may be different from the manufacturer |
| moiety | Σ | 0..* | BackboneElement | Moiety, for structural modifications |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| role | Σ | 0..1 | CodeableConcept | Role that the moiety is playing |
| identifier | Σ | 0..1 | Identifier | Identifier by which this moiety substance is known |
| name | Σ | 0..1 | string | Textual name for this moiety substance |
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. |
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. |
| molecularFormula | Σ | 0..1 | string | Molecular formula for this moiety (e.g. with the Hill system) |
| amount[x] | Σ | 0..1 | Quantitative value for this moiety | |
| amountQuantity | Quantity | |||
| amountString | string | |||
| measurementType | Σ | 0..1 | CodeableConcept | The measurement type of the quantitative value Binding: SubstanceAmountType (example): The relationship between two substance types. |
| characterization | Σ | 0..* | BackboneElement | General specifications for this substance |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| technique | Σ | 0..1 | CodeableConcept | The method used to find the characterization e.g. HPLC Binding: StructureTechnique (example): The method used to elucidate the characterization of the drug substance. |
| form | Σ | 0..1 | CodeableConcept | Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form Binding: SubstanceForm (example) |
| description | Σ | 0..1 | markdown | The description or justification in support of the interpretation of the data file |
| file | Σ | 0..* | Attachment | The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis |
| property | Σ | 0..* | BackboneElement | General specifications for this substance |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A code expressing the type of property Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
| value[x] | Σ | 0..1 | A value for the property | |
| valueCodeableConcept | CodeableConcept | |||
| valueQuantity | Quantity | |||
| valueDate | date | |||
| valueBoolean | boolean | |||
| valueAttachment | Attachment | |||
| referenceInformation | Σ | 0..1 | Reference(SubstanceReferenceInformation) | General information detailing this substance |
| molecularWeight | Σ | 0..* | BackboneElement | The average mass of a molecule of a compound |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | Σ | 0..1 | CodeableConcept | The method by which the weight was determined Binding: WeightMethod (example): The method by which the substance weight was measured. |
| type | Σ | 0..1 | CodeableConcept | Type of molecular weight e.g. exact, average, weight average Binding: WeightType (example): The type of substance weight measurement. |
| amount | Σ | 1..1 | Quantity | The molecular weight. |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| value | Σ | 0..1 | decimal | numerical value. |
| comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit | Σ | 0..1 | string | Unit of measure. |
| system | ΣC | 0..1 | uri | System that defines coded unit form |
| code | ΣC | 0..1 | code | coded form of the unit of measure. |
| structure | Σ | 0..1 | BackboneElement | Structural information |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| stereochemistry | Σ | 0..1 | CodeableConcept | Stereochemistry type Binding: Stereochemistry (example): The optical rotation type of a substance. |
| opticalActivity | Σ | 0..1 | CodeableConcept | Optical activity type Binding: OpticalActivity (example): The optical rotation type of a substance. |
| molecularFormula | Σ | 0..1 | string | Molecular formula (e.g. using the Hill system). |
| molecularFormulaByMoiety | Σ | 0..1 | string | Specified per moiety according to the Hill system |
| molecularWeight | Σ | 0..1 | See molecularWeight (SubstanceDefinition) | The molecular weight or weight range |
| technique | Σ | 0..* | CodeableConcept | The method used to find the structure e.g. X-ray, NMR Binding: StructureTechnique (example): The method used to elucidate the structure of the drug substance. |
| sourceDocument | Σ | 0..* | Reference(DocumentReference) | Source of information for the structure |
| representation | Σ | 0..* | BackboneElement | A depiction of the structure of the substance |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 0..1 | CodeableConcept | The kind of structural representation (e.g. full, partial) Binding: SubstanceRepresentationType (example): A format of a substance representation. |
| representation | Σ | 0..1 | string | The structural representation as a text string in a standard format |
| format | Σ | 0..1 | CodeableConcept | The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format) Binding: SubstanceRepresentationFormat (example): A format of a substance representation. |
| document | Σ | 0..1 | Reference(DocumentReference) | An attachment with the structural representation e.g. a structure graphic or AnIML file |
| code | Σ | 0..* | BackboneElement | Codes associated with the substance. |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code | Σ | 0..1 | CodeableConcept | The specific code Binding: Substances (example) |
| status | Σ | 0..1 | CodeableConcept | Status of the code assignment, for example 'provisional', 'approved' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate | Σ | 0..1 | dateTime | The date at which the code status was changed |
| note | Σ | 0..* | Annotation | Any comment can be provided in this field |
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature |
| name | Σ | 0..* | BackboneElement | International Non-Proprietary Name (INN) of the substance; or United States Adopted Name (USAN) if applicable. |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | The actual name |
| type | Σ | 0..1 | CodeableConcept | Name type e.g. 'scientific, 'brand' Binding: SubstanceNameType (example): The type of a name given to a substance. |
| status | Σ | 0..1 | CodeableConcept | The status of the name e.g. 'current', 'proposed' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| preferred | Σ | 0..1 | boolean | If this is the preferred name for this substance |
| language | Σ | 0..* | CodeableConcept | Human language that the name is written in Binding: AllLanguages (required): IETF language tag for a human language |
| domain | Σ | 0..* | CodeableConcept | The use context of this name e.g. as an active ingredient or as a food colour additive Binding: SubstanceNameDomain (example): The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive. |
| jurisdiction | Σ | 0..* | CodeableConcept | The jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes |
| synonym | Σ | 0..* | See name (SubstanceDefinition) | A synonym of this particular name, by which the substance is also known |
| translation | Σ | 0..* | See name (SubstanceDefinition) | A translation for this name into another human language |
| official | Σ | 0..* | BackboneElement | Details of the official nature of this name |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| authority | Σ | 0..1 | CodeableConcept | Which authority uses this official name Binding: SubstanceNameAuthority (preferred): An authority that officates substance names. |
| status | Σ | 0..1 | CodeableConcept | The status of the official name, for example 'draft', 'active' Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| date | Σ | 0..1 | dateTime | Date of official name change |
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature |
| relationship | Σ | 0..* | BackboneElement | A link between this substance and another |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substanceDefinition[x] | Σ | 0..1 | A pointer to another substance, as a resource or a representational code | |
| substanceDefinitionReference | Reference(SubstanceDefinition) | |||
| substanceDefinitionCodeableConcept | CodeableConcept | |||
| type | Σ | 1..1 | CodeableConcept | For example "salt to parent", "active moiety" Binding: SubstanceRelationshipType (example): The relationship between two substance types. |
| isDefining | Σ | 0..1 | boolean | For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships |
| amount[x] | Σ | 0..1 | A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other | |
| amountQuantity | Quantity | |||
| amountRatio | Ratio | |||
| amountString | string | |||
| ratioHighLimitAmount | Σ | 0..1 | Ratio | For use when the numeric has an uncertain range |
| comparator | Σ | 0..1 | CodeableConcept | An operator for the amount, for example "average", "approximately", "less than" Binding: SubstanceAmountType (example): The relationship between two substance types. |
| source | Σ | 0..* | Reference(DocumentReference) | Supporting literature |
| nucleicAcid | Σ | 0..1 | Reference(SubstanceNucleicAcid) | Data items specific to nucleic acids |
| polymer | Σ | 0..1 | Reference(SubstancePolymer) | Data items specific to polymers |
| protein | Σ | 0..1 | Reference(SubstanceProtein) | Data items specific to proteins |
| sourceMaterial | Σ | 0..1 | BackboneElement | Material or taxonomic/anatomical source |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 0..1 | CodeableConcept | Classification of the origin of the raw material. e.g. cat hair is an Animal source type Binding: SourceMaterialType (example): A classification that provides the origin of the substance raw material. |
| genus | Σ | 0..1 | CodeableConcept | The genus of an organism e.g. the Latin epithet of the plant/animal scientific name Binding: SourceMaterialGenus (example): The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name. |
| species | Σ | 0..1 | CodeableConcept | The species of an organism e.g. the Latin epithet of the species of the plant/animal Binding: SourceMaterialSpecies (example): A species of origin a substance raw material. |
| part | Σ | 0..1 | CodeableConcept | An anatomical origin of the source material within an organism Binding: SourceMaterialPart (example): An anatomical origin of the source material within an organism. |
| countryOfOrigin | Σ | 0..* | CodeableConcept | The country or countries where the material is harvested Binding: CountryValueSet (required): Jurisdiction codes |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| SubstanceDefinition.language | required | AllLanguages |
| SubstanceDefinition.identifier.use | required | IdentifierUse |
| SubstanceDefinition.identifier.type | extensible | IdentifierTypeCodes |
| SubstanceDefinition.status | preferred | PublicationStatus |
| SubstanceDefinition.domain | example | MedicinalProductDomain |
| SubstanceDefinition.grade | example | SubstanceGrade |
| SubstanceDefinition.moiety.stereochemistry | example | Stereochemistry |
| SubstanceDefinition.moiety.opticalActivity | example | OpticalActivity |
| SubstanceDefinition.moiety.measurementType | example | SubstanceAmountType |
| SubstanceDefinition.characterization.technique | example | StructureTechnique |
| SubstanceDefinition.characterization.form | example | SubstanceForm |
| SubstanceDefinition.property.type | example | ProductCharacteristic |
| SubstanceDefinition.molecularWeight.method | example | WeightMethod |
| SubstanceDefinition.molecularWeight.type | example | WeightType |
| SubstanceDefinition.molecularWeight.amount.comparator | required | QuantityComparator |
| SubstanceDefinition.structure.stereochemistry | example | Stereochemistry |
| SubstanceDefinition.structure.opticalActivity | example | OpticalActivity |
| SubstanceDefinition.structure.technique | example | StructureTechnique |
| SubstanceDefinition.structure.representation.type | example | SubstanceRepresentationType |
| SubstanceDefinition.structure.representation.format | example | SubstanceRepresentationFormat |
| SubstanceDefinition.code.code | example | VsSubstance |
| SubstanceDefinition.code.status | preferred | PublicationStatus |
| SubstanceDefinition.name.type | example | SubstanceNameType |
| SubstanceDefinition.name.status | preferred | PublicationStatus |
| SubstanceDefinition.name.language | required | AllLanguages |
| SubstanceDefinition.name.domain | example | SubstanceNameDomain |
| SubstanceDefinition.name.jurisdiction | example | JurisdictionValueSet |
| SubstanceDefinition.name.official.authority | preferred | SubstanceNameAuthority |
| SubstanceDefinition.name.official.status | preferred | PublicationStatus |
| SubstanceDefinition.relationship.type | example | SubstanceRelationshipType |
| SubstanceDefinition.relationship.comparator | example | SubstanceAmountType |
| SubstanceDefinition.sourceMaterial.type | example | SourceMaterialType |
| SubstanceDefinition.sourceMaterial.genus | example | SourceMaterialGenus |
| SubstanceDefinition.sourceMaterial.species | example | SourceMaterialSpecies |
| SubstanceDefinition.sourceMaterial.part | example | SourceMaterialPart |
| SubstanceDefinition.sourceMaterial.countryOfOrigin | required | CountryValueSet |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from SubstanceDefinition
Summary
Mandatory: 3 elements
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
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