0.1.0 - ci-build

AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Medicinal Product Definition

Official URL: https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-medicinalProductDefinition Version: 0.1.0
Draft as of 2024-05-24 Computable Name: AT_MedicinalProduct_MedicinalProductDefinition

Medicinal Product Definition profiled resource containing a subset of attributes needed for the Austrian eHealth Community

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... Slices for identifier 1..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:pmsId 0..1 AT_MedicinalProduct_Identifier An identifier intended for computation
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.ages.at/fhir/GRZ
.... identifier:GRZ 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/pmsId
... domain 0..1 AT_MedicinalProduct_CodeableConcept Domain
.... coding 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: The Domain Value Set (required)
... combinedPharmaceuticalDoseForm 1..1 AT_MedicinalProduct_CodeableConcept Pharmaceutical dose form
... classification 0..* AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
.... Slices for coding 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:interactionRelevance 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri Drug intercation
Required Pattern: https://www.ages.at/fhir/interactionRelevance
..... coding:elgaImpfziel 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri Immunization target
Required Pattern: https://termgit.elga.gv.at/CodeSystem/eimpf-ergaenzung
..... coding:ATCCodeRMS 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
..... coding:ATCCodeWHO 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri WHO ATC
Required Pattern: http://www.whocc.no/atc
... name
.... productName 1..1 string Authorization Name
.... Slices for part 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... type
....... coding 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
..... part:inventedName 1..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Part name
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:tradeName 1..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Trade name
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://www.ages.at/fhir/medicinalproduct/CodeSystem/at-medprod-cs-additionalMedicinalProductNamePartType
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: tradeName

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.domain.codingrequiredDomainVs (a valid code from Domain)
https://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
https://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs
https://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... 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:pmsId C 0..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: https://www.ages.at/fhir/GRZ
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:GRZ C 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: http://ema.europa.eu/fhir/pmsId
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... domain 0..1 AT_MedicinalProduct_CodeableConcept Domain
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

.... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: The Domain Value Set (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... combinedPharmaceuticalDoseForm 1..1 AT_MedicinalProduct_CodeableConcept Pharmaceutical dose form
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing

... legalStatusOfSupply 1..1 AT_MedicinalProduct_CodeableConcept Prescription requirement state
Binding: The Legal Status of Supply Value Set (required)
... classification 0..* AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


.... Slices for coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by pattern:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
..... coding:interactionRelevance C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Drug intercation
Required Pattern: https://www.ages.at/fhir/interactionRelevance
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
..... coding:elgaImpfziel C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Immunization target
Required Pattern: https://termgit.elga.gv.at/CodeSystem/eimpf-ergaenzung
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
..... coding:ATCCodeRMS C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
..... coding:ATCCodeWHO C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri WHO ATC
Required Pattern: http://www.whocc.no/atc
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
... name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string Authorization Name
.... Slices for part Σ 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

....... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
..... part:inventedName Σ 1..1 BackboneElement Coding words or phrases of the name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Part name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:tradeName Σ 1..1 BackboneElement Coding words or phrases of the name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Trade name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://www.ages.at/fhir/medicinalproduct/CodeSystem/at-medprod-cs-additionalMedicinalProductNamePartType
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: tradeName

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.identifier:pmsId.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:GRZ.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.domain.codingrequiredDomainVs (a valid code from Domain)
https://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleCombinedDoseForm
http://hl7.org/fhir/ValueSet/combined-dose-form
from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
https://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs
https://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:tradeName.typeexamplePattern: tradeName
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cod-1warningMedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodeRMS, MedicinalProductDefinition.classification.coding:ATCCodeWHO, MedicinalProductDefinition.name.part.type.codingA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf 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-4errorMedicinalProductDefinitionIf 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-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ident-1warningMedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... 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

Additional BindingsPurpose
CommonLanguages Starter Set
... 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
... Slices for identifier Σ 1..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:pmsId C 0..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: https://www.ages.at/fhir/GRZ
..... 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)
.... identifier:GRZ C 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: http://ema.europa.eu/fhir/pmsId
..... 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)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.

... domain 0..1 AT_MedicinalProduct_CodeableConcept Domain
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: The Domain Value Set (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
.... text Σ 0..1 string Plain text representation of the concept
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm 1..1 AT_MedicinalProduct_CodeableConcept Pharmaceutical dose form
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing

... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.


... indication Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply 1..1 AT_MedicinalProduct_CodeableConcept Prescription requirement state
Binding: The Legal Status of Supply Value Set (required)
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.

... classification 0..* AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by pattern:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
..... coding:interactionRelevance C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Drug intercation
Required Pattern: https://www.ages.at/fhir/interactionRelevance
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:elgaImpfziel C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Immunization target
Required Pattern: https://termgit.elga.gv.at/CodeSystem/eimpf-ergaenzung
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:ATCCodeRMS C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:ATCCodeWHO C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri WHO ATC
Required Pattern: http://www.whocc.no/atc
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization
.... 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 Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.


... name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... 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
.... productName Σ 1..1 string Authorization Name
.... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.

.... Slices for part Σ 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
....... text Σ 0..1 string Plain text representation of the concept
..... part:inventedName Σ 1..1 BackboneElement Coding words or phrases of the 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Part name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
..... part:tradeName Σ 1..1 BackboneElement Coding words or phrases of the 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Trade name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://www.ages.at/fhir/medicinalproduct/CodeSystem/at-medprod-cs-additionalMedicinalProductNamePartType
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: tradeName
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
..... 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
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... 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
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... 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 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... 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 characteristic
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 characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:pmsId.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:pmsId.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.identifier:GRZ.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:GRZ.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.domain.codingrequiredDomainVs (a valid code from Domain)
https://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleCombinedDoseForm
http://hl7.org/fhir/ValueSet/combined-dose-form
from the FHIR Standard
MedicinalProductDefinition.routeexampleSNOMEDCTRouteCodes
http://hl7.org/fhir/ValueSet/route-codes
from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
https://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs
https://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:tradeName.typeexamplePattern: tradeName
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.typeexampleProductCrossReferenceType
http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicatorexampleProductConfidentiality
http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
from the FHIR Standard
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cod-1warningMedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodeRMS, MedicinalProductDefinition.classification.coding:ATCCodeWHO, MedicinalProductDefinition.name.part.type.codingA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf 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-4errorMedicinalProductDefinitionIf 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-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ident-1warningMedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: value.exists()

This structure is derived from MedicinalProductDefinition

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... Slices for identifier 1..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:pmsId 0..1 AT_MedicinalProduct_Identifier An identifier intended for computation
..... system 1..1 uri The namespace for the identifier value
Required Pattern: https://www.ages.at/fhir/GRZ
.... identifier:GRZ 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/pmsId
... domain 0..1 AT_MedicinalProduct_CodeableConcept Domain
.... coding 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: The Domain Value Set (required)
... combinedPharmaceuticalDoseForm 1..1 AT_MedicinalProduct_CodeableConcept Pharmaceutical dose form
... classification 0..* AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
.... Slices for coding 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:interactionRelevance 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri Drug intercation
Required Pattern: https://www.ages.at/fhir/interactionRelevance
..... coding:elgaImpfziel 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri Immunization target
Required Pattern: https://termgit.elga.gv.at/CodeSystem/eimpf-ergaenzung
..... coding:ATCCodeRMS 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
..... coding:ATCCodeWHO 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
...... system 1..1 uri WHO ATC
Required Pattern: http://www.whocc.no/atc
... name
.... productName 1..1 string Authorization Name
.... Slices for part 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... type
....... coding 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
..... part:inventedName 1..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Part name
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:tradeName 1..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Trade name
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://www.ages.at/fhir/medicinalproduct/CodeSystem/at-medprod-cs-additionalMedicinalProductNamePartType
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: tradeName

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.domain.codingrequiredDomainVs (a valid code from Domain)
https://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
https://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs
https://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... 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:pmsId C 0..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: https://www.ages.at/fhir/GRZ
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:GRZ C 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: http://ema.europa.eu/fhir/pmsId
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... domain 0..1 AT_MedicinalProduct_CodeableConcept Domain
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

.... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: The Domain Value Set (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... combinedPharmaceuticalDoseForm 1..1 AT_MedicinalProduct_CodeableConcept Pharmaceutical dose form
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing

... legalStatusOfSupply 1..1 AT_MedicinalProduct_CodeableConcept Prescription requirement state
Binding: The Legal Status of Supply Value Set (required)
... classification 0..* AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


.... Slices for coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by pattern:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
..... coding:interactionRelevance C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Drug intercation
Required Pattern: https://www.ages.at/fhir/interactionRelevance
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
..... coding:elgaImpfziel C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Immunization target
Required Pattern: https://termgit.elga.gv.at/CodeSystem/eimpf-ergaenzung
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
..... coding:ATCCodeRMS C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
..... coding:ATCCodeWHO C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... Slices for extension Content/Rules for all slices
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri WHO ATC
Required Pattern: http://www.whocc.no/atc
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
... name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string Authorization Name
.... Slices for part Σ 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

....... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
..... part:inventedName Σ 1..1 BackboneElement Coding words or phrases of the name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Part name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:tradeName Σ 1..1 BackboneElement Coding words or phrases of the name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Trade name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://www.ages.at/fhir/medicinalproduct/CodeSystem/at-medprod-cs-additionalMedicinalProductNamePartType
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: tradeName

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.identifier:pmsId.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:GRZ.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.domain.codingrequiredDomainVs (a valid code from Domain)
https://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleCombinedDoseForm
http://hl7.org/fhir/ValueSet/combined-dose-form
from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
https://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs
https://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:tradeName.typeexamplePattern: tradeName
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cod-1warningMedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodeRMS, MedicinalProductDefinition.classification.coding:ATCCodeWHO, MedicinalProductDefinition.name.part.type.codingA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf 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-4errorMedicinalProductDefinitionIf 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-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ident-1warningMedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... 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

Additional BindingsPurpose
CommonLanguages Starter Set
... 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
... Slices for identifier Σ 1..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:pmsId C 0..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: https://www.ages.at/fhir/GRZ
..... 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)
.... identifier:GRZ C 1..1 AT_MedicinalProduct_Identifier An identifier intended for computation
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
..... 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
Required Pattern: http://ema.europa.eu/fhir/pmsId
..... 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)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.

... domain 0..1 AT_MedicinalProduct_CodeableConcept Domain
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).

.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: The Domain Value Set (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
.... text Σ 0..1 string Plain text representation of the concept
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm 1..1 AT_MedicinalProduct_CodeableConcept Pharmaceutical dose form
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing

... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.


... indication Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply 1..1 AT_MedicinalProduct_CodeableConcept Prescription requirement state
Binding: The Legal Status of Supply Value Set (required)
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.

... classification 0..* AT_MedicinalProduct_CodeableConcept Concept - reference to a terminology or just text
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Slice: Unordered, Open by pattern:system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
..... coding:interactionRelevance C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Drug intercation
Required Pattern: https://www.ages.at/fhir/interactionRelevance
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:elgaImpfziel C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Immunization target
Required Pattern: https://termgit.elga.gv.at/CodeSystem/eimpf-ergaenzung
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:ATCCodeRMS C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:ATCCodeWHO C 0..1 AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
...... id 0..1 id Unique id for inter-element referencing
...... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... codeSystemName 0..1 string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
...... system Σ 1..1 uri WHO ATC
Required Pattern: http://www.whocc.no/atc
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization
.... 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 Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.


... name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... 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
.... productName Σ 1..1 string Authorization Name
.... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.

.... Slices for part Σ 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding C 0..* AT_MedicinalProduct_Coding A reference to a code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
cod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
....... text Σ 0..1 string Plain text representation of the concept
..... part:inventedName Σ 1..1 BackboneElement Coding words or phrases of the 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Part name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
..... part:tradeName Σ 1..1 BackboneElement Coding words or phrases of the 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Trade name
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: https://www.ages.at/fhir/medicinalproduct/CodeSystem/at-medprod-cs-additionalMedicinalProductNamePartType
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: tradeName
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
..... 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
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... 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
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... 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 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... 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 characteristic
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 characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:pmsId.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:pmsId.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.identifier:GRZ.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier:GRZ.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.domain.codingrequiredDomainVs (a valid code from Domain)
https://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleCombinedDoseForm
http://hl7.org/fhir/ValueSet/combined-dose-form
from the FHIR Standard
MedicinalProductDefinition.routeexampleSNOMEDCTRouteCodes
http://hl7.org/fhir/ValueSet/route-codes
from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
https://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs
https://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:tradeName.typeexamplePattern: tradeName
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.typeexampleProductCrossReferenceType
http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicatorexampleProductConfidentiality
http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
from the FHIR Standard
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cod-1warningMedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodeRMS, MedicinalProductDefinition.classification.coding:ATCCodeWHO, MedicinalProductDefinition.name.part.type.codingA Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text
: code.exists().not() implies display.exists().not()
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf 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-4errorMedicinalProductDefinitionIf 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-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ident-1warningMedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZIdentifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason
: value.exists()

This structure is derived from MedicinalProductDefinition

 

Other representations of profile: CSV, Excel, Schematron