Extensions for Using Data Elements from FHIR R4B in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR STU3 - Downloaded Version null See the Directory of published versions
| Official URL: http://hl7.org/fhir/4.3/StructureDefinition/profile-MedicinalProductDefinition | Version: 0.1.0 | |||
| Standards status: Trial-use | Maturity Level: 0 | Computable Name: Profile_R4B_MedicinalProductDefinition_R3 | ||
This cross-version profile allows R4B MedicinalProductDefinition content to be represented via FHIR STU3 Basic resources.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Path | Status | Usage | ValueSet | Version | Source |
| Basic.code | Base | example | Basic Resource Types | 📍3.0.2 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| dom-2 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Basic | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource |
contained.where(('#'+id in %resource.descendants().reference).not()).empty()
|
| dom-4 | error | Basic | 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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (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 Basic
| Path | Status | Usage | ValueSet | Version | Source |
| Basic.language | Base | extensible | Common Languages | 📍3.0.2 | FHIR Std. |
| Basic.code | Base | example | Basic Resource Types | 📍3.0.2 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| dom-2 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Basic | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource |
contained.where(('#'+id in %resource.descendants().reference).not()).empty()
|
| dom-4 | error | Basic | 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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (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 Basic
Summary
Mandatory: 2 elements
Extensions
This structure refers to these extensions:
Maturity: 0
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Basic |
0..* | Basic | Resource for non-supported content | |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
  Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
   extension:type |
0..1 | CodeableConcept | R4B: Regulatory type, e.g. Investigational or Authorized (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.type Binding: R4BMedicinalProductTypeForR3 (0.1.0) (example): Overall defining type of this medicinal product. | |
| extension:domain |
0..1 | CodeableConcept | R4B: If this medicine applies to human or veterinary uses (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R4BMedicinalProductDomainForR3 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary). | |
| extension:version |
0..1 | string | R4B: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.version | |
| extension:statusDate |
0..1 | dateTime | R4B: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.statusDate | |
| extension:description |
0..1 | markdown | R4B: General description of this product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.description | |
| extension:combinedPharmaceuticalDoseForm |
0..1 | CodeableConcept | R4B: The dose form for a single part product, or combined form of a multiple part product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.combinedPharmaceuticalDoseForm Binding: R4BCombinedDoseFormForR3 (0.1.0) (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing | |
| extension:route |
0..* | CodeableConcept | R4B: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.route | |
| extension:indication |
0..1 | markdown | R4B: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.indication | |
| extension:legalStatusOfSupply |
0..1 | CodeableConcept | R4B: The legal status of supply of the medicinal product as classified by the regulator (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.legalStatusOfSupply Binding: R4BLegalStatusOfSupplyForR3 (0.1.0) (example): The prescription supply types appropriate to a medicinal product | |
| extension:additionalMonitoringIndicator |
0..1 | CodeableConcept | R4B: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.additionalMonitoringIndicator Binding: R4BMedicinalProductAdditionalMonitoringForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | |
| extension:specialMeasures |
0..* | CodeableConcept | R4B: Whether the Medicinal Product is subject to special measures for regulatory reasons (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R4BMedicinalProductSpecialMeasuresForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies. | |
| extension:pediatricUseIndicator |
0..1 | CodeableConcept | R4B: If authorised for use in children (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R4BMedicinalProductPediatricUseForR3 (0.1.0) (example): Suitability for age groups, in particular children. | |
| extension:classification |
0..* | CodeableConcept | R4B: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.classification | |
| extension:marketingStatus |
0..* | (Complex) | R4B: Marketing status of the medicinal product, in contrast to marketing authorization (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.marketingStatus | |
| extension:packagedMedicinalProduct |
0..* | CodeableConcept | R4B: Package type for the product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R4BMedicinalProductPackageTypeForR3 (0.1.0) (example): Types of medicinal product packs | |
| extension:ingredient |
0..* | CodeableConcept | R4B: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.ingredient | |
| extension:impurity |
0..* | (Complex) | R4B: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.impurity | |
| extension:attachedDocument |
0..* | Reference(Cross-version Profile for R4B.DocumentReference for use in FHIR STU3(0.1.0) | DocumentReference) | R4B: Additional documentation about the medicinal product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.attachedDocument | |
| extension:masterFile |
0..* | Reference(Cross-version Profile for R4B.DocumentReference for use in FHIR STU3(0.1.0) | DocumentReference) | R4B: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.masterFile | |
| extension:contact |
0..* | (Complex) | R4B: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.contact | |
| extension:clinicalTrial |
0..* | Reference(Cross-version Profile for R4B.ResearchStudy for use in FHIR STU3(0.1.0) | ResearchStudy) | R4B: Clinical trials or studies that this product is involved in (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.clinicalTrial | |
| extension:code |
0..* | Coding | R4B: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.code | |
| extension:name |
1..* | (Complex) | R4B: The product's name, including full name and possibly coded parts (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.name | |
| extension:crossReference |
0..* | (Complex) | R4B: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.crossReference | |
| extension:operation |
0..* | (Complex) | R4B: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.operation | |
 extension:characteristic |
0..* | (Complex) | R4B: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.characteristic | |
 Slices for modifierExtension |
?! | 0..* | Extension | Extension Slice: Unordered, Open by value:url |
| modifierExtension:status |
?! | 0..1 | CodeableConcept | R4B: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
  code |
?!Σ | 1..1 | CodeableConcept | Kind of Resource Binding: Basic Resource Types (example): Codes for identifying types of resources not yet defined by FHIR |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Basic.code | Base | example | Basic Resource Types | 📍3.0.2 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| dom-2 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Basic | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource |
contained.where(('#'+id in %resource.descendants().reference).not()).empty()
|
| dom-4 | error | Basic | 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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
This structure is derived from Basic
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Basic |
0..* | Basic | Resource for non-supported content | |
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:type |
0..1 | CodeableConcept | R4B: Regulatory type, e.g. Investigational or Authorized (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.type Binding: R4BMedicinalProductTypeForR3 (0.1.0) (example): Overall defining type of this medicinal product. | |
| extension:domain |
0..1 | CodeableConcept | R4B: If this medicine applies to human or veterinary uses (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R4BMedicinalProductDomainForR3 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary). | |
| extension:version |
0..1 | string | R4B: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.version | |
| extension:statusDate |
0..1 | dateTime | R4B: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.statusDate | |
| extension:description |
0..1 | markdown | R4B: General description of this product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.description | |
| extension:combinedPharmaceuticalDoseForm |
0..1 | CodeableConcept | R4B: The dose form for a single part product, or combined form of a multiple part product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.combinedPharmaceuticalDoseForm Binding: R4BCombinedDoseFormForR3 (0.1.0) (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing | |
| extension:route |
0..* | CodeableConcept | R4B: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.route | |
| extension:indication |
0..1 | markdown | R4B: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.indication | |
| extension:legalStatusOfSupply |
0..1 | CodeableConcept | R4B: The legal status of supply of the medicinal product as classified by the regulator (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.legalStatusOfSupply Binding: R4BLegalStatusOfSupplyForR3 (0.1.0) (example): The prescription supply types appropriate to a medicinal product | |
| extension:additionalMonitoringIndicator |
0..1 | CodeableConcept | R4B: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.additionalMonitoringIndicator Binding: R4BMedicinalProductAdditionalMonitoringForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | |
| extension:specialMeasures |
0..* | CodeableConcept | R4B: Whether the Medicinal Product is subject to special measures for regulatory reasons (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R4BMedicinalProductSpecialMeasuresForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies. | |
| extension:pediatricUseIndicator |
0..1 | CodeableConcept | R4B: If authorised for use in children (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R4BMedicinalProductPediatricUseForR3 (0.1.0) (example): Suitability for age groups, in particular children. | |
| extension:classification |
0..* | CodeableConcept | R4B: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.classification | |
| extension:marketingStatus |
0..* | (Complex) | R4B: Marketing status of the medicinal product, in contrast to marketing authorization (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.marketingStatus | |
| extension:packagedMedicinalProduct |
0..* | CodeableConcept | R4B: Package type for the product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R4BMedicinalProductPackageTypeForR3 (0.1.0) (example): Types of medicinal product packs | |
| extension:ingredient |
0..* | CodeableConcept | R4B: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.ingredient | |
| extension:impurity |
0..* | (Complex) | R4B: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.impurity | |
| extension:attachedDocument |
0..* | Reference(Cross-version Profile for R4B.DocumentReference for use in FHIR STU3(0.1.0) | DocumentReference) | R4B: Additional documentation about the medicinal product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.attachedDocument | |
| extension:masterFile |
0..* | Reference(Cross-version Profile for R4B.DocumentReference for use in FHIR STU3(0.1.0) | DocumentReference) | R4B: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.masterFile | |
| extension:contact |
0..* | (Complex) | R4B: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.contact | |
| extension:clinicalTrial |
0..* | Reference(Cross-version Profile for R4B.ResearchStudy for use in FHIR STU3(0.1.0) | ResearchStudy) | R4B: Clinical trials or studies that this product is involved in (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.clinicalTrial | |
| extension:code |
0..* | Coding | R4B: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.code | |
| extension:name |
1..* | (Complex) | R4B: The product's name, including full name and possibly coded parts (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.name | |
| extension:crossReference |
0..* | (Complex) | R4B: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.crossReference | |
| extension:operation |
0..* | (Complex) | R4B: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.operation | |
| extension:characteristic |
0..* | (Complex) | R4B: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.characteristic | |
 Slices for modifierExtension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 modifierExtension:status |
0..1 | CodeableConcept | R4B: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Basic |
0..* | Basic | Resource for non-supported content | |||||
| 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: Common Languages (extensible): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:type |
0..1 | CodeableConcept | R4B: Regulatory type, e.g. Investigational or Authorized (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.type Binding: R4BMedicinalProductTypeForR3 (0.1.0) (example): Overall defining type of this medicinal product. | |||||
| extension:domain |
0..1 | CodeableConcept | R4B: If this medicine applies to human or veterinary uses (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R4BMedicinalProductDomainForR3 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary). | |||||
| extension:version |
0..1 | string | R4B: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.version | |||||
| extension:statusDate |
0..1 | dateTime | R4B: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.statusDate | |||||
| extension:description |
0..1 | markdown | R4B: General description of this product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.description | |||||
| extension:combinedPharmaceuticalDoseForm |
0..1 | CodeableConcept | R4B: The dose form for a single part product, or combined form of a multiple part product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.combinedPharmaceuticalDoseForm Binding: R4BCombinedDoseFormForR3 (0.1.0) (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing | |||||
| extension:route |
0..* | CodeableConcept | R4B: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.route | |||||
| extension:indication |
0..1 | markdown | R4B: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.indication | |||||
| extension:legalStatusOfSupply |
0..1 | CodeableConcept | R4B: The legal status of supply of the medicinal product as classified by the regulator (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.legalStatusOfSupply Binding: R4BLegalStatusOfSupplyForR3 (0.1.0) (example): The prescription supply types appropriate to a medicinal product | |||||
| extension:additionalMonitoringIndicator |
0..1 | CodeableConcept | R4B: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.additionalMonitoringIndicator Binding: R4BMedicinalProductAdditionalMonitoringForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | |||||
| extension:specialMeasures |
0..* | CodeableConcept | R4B: Whether the Medicinal Product is subject to special measures for regulatory reasons (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R4BMedicinalProductSpecialMeasuresForR3 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies. | |||||
| extension:pediatricUseIndicator |
0..1 | CodeableConcept | R4B: If authorised for use in children (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R4BMedicinalProductPediatricUseForR3 (0.1.0) (example): Suitability for age groups, in particular children. | |||||
| extension:classification |
0..* | CodeableConcept | R4B: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.classification | |||||
| extension:marketingStatus |
0..* | (Complex) | R4B: Marketing status of the medicinal product, in contrast to marketing authorization (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.marketingStatus | |||||
| extension:packagedMedicinalProduct |
0..* | CodeableConcept | R4B: Package type for the product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R4BMedicinalProductPackageTypeForR3 (0.1.0) (example): Types of medicinal product packs | |||||
| extension:ingredient |
0..* | CodeableConcept | R4B: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.ingredient | |||||
| extension:impurity |
0..* | (Complex) | R4B: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.impurity | |||||
| extension:attachedDocument |
0..* | Reference(Cross-version Profile for R4B.DocumentReference for use in FHIR STU3(0.1.0) | DocumentReference) | R4B: Additional documentation about the medicinal product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.attachedDocument | |||||
| extension:masterFile |
0..* | Reference(Cross-version Profile for R4B.DocumentReference for use in FHIR STU3(0.1.0) | DocumentReference) | R4B: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.masterFile | |||||
| extension:contact |
0..* | (Complex) | R4B: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.contact | |||||
| extension:clinicalTrial |
0..* | Reference(Cross-version Profile for R4B.ResearchStudy for use in FHIR STU3(0.1.0) | ResearchStudy) | R4B: Clinical trials or studies that this product is involved in (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.clinicalTrial | |||||
| extension:code |
0..* | Coding | R4B: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.code | |||||
| extension:name |
1..* | (Complex) | R4B: The product's name, including full name and possibly coded parts (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.name | |||||
| extension:crossReference |
0..* | (Complex) | R4B: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.crossReference | |||||
| extension:operation |
0..* | (Complex) | R4B: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.operation | |||||
| extension:characteristic |
0..* | (Complex) | R4B: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.characteristic | |||||
| Slices for modifierExtension |
?! | 0..* | Extension | Extension Slice: Unordered, Open by value:url | ||||
| modifierExtension:status |
?! | 0..1 | CodeableConcept | R4B: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/4.3/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| identifier |
Σ | 0..* | Identifier | Business identifier | ||||
| code |
?!Σ | 1..1 | CodeableConcept | Kind of Resource Binding: Basic Resource Types (example): Codes for identifying types of resources not yet defined by FHIR | ||||
 subject |
Σ | 0..1 | Reference(Resource) | Identifies the focus of this resource | ||||
| created |
Σ | 0..1 | date | When created | ||||
| author |
Σ | 0..1 | Reference(Practitioner | Patient | RelatedPerson) | Who created | ||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Basic.language | Base | extensible | Common Languages | 📍3.0.2 | FHIR Std. |
| Basic.code | Base | example | Basic Resource Types | 📍3.0.2 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| dom-2 | error | Basic | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Basic | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource |
contained.where(('#'+id in %resource.descendants().reference).not()).empty()
|
| dom-4 | error | Basic | 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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (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 Basic
Summary
Mandatory: 2 elements
Extensions
This structure refers to these extensions:
Maturity: 0
Other representations of profile: CSV, Excel, Schematron
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r4b.r3#0.1.0 based on FHIR 3.0.2. Generated 2026-03-20
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