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
Official URL: https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-medicinalProductDefinition | Version: 0.1.0 | |||
Draft as of 2024-05-27 | Computable Name: AT_MedicinalProduct_MedicinalProductDefinition |
Medicinal Product Definition profiled resource containing a subset of attributes needed for the Austrian eHealth Community
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from MedicinalProductDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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/referenceNumber | |
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 | If this medicine applies to human or veterinary uses (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 | The dose form for a single part product, or combined form of a multiple part product (pharmaceutical dose form) | |
legalStatusOfSupply | 1..1 | AT_MedicinalProduct_CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator (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 | |
Slices for coding | 1..* | 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:ATCCodePharos | 1..* | AT_MedicinalProduct_Coding | A reference to a code defined by a terminology system | |
system | 1..1 | uri | ATC Codes from RMS merged with local Austrian codes Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533 | |
coding:ATCCodeWHO | 0..* | 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 | The full product name (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..* | Coding | 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 | AT_MedicinalProduct_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 | AT_MedicinalProduct_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 | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.domain.coding | required | DomainVshttps://www.ages.at/fhir/domain from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)https://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVshttps://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs from this IG |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 |
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 |
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/referenceNumber |
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 | If this medicine applies to human or veterinary uses (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 | The dose form for a single part product, or combined form of a multiple part product (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 | The legal status of supply of the medicinal product as classified by the regulator (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 | 1..* | 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:ATCCodePharos | C | 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 | ATC Codes from RMS merged with local Austrian codes 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..* | 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 | The full product name (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 | Σ | 0..* | Coding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) |
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 | 1..1 | AT_MedicinalProduct_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 | 1..1 | AT_MedicinalProduct_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 | |
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.identifier:pmsId.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:GRZ.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.domain.coding | required | DomainVshttps://www.ages.at/fhir/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)https://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVshttps://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:tradeName.type | example | Pattern: tradeNamehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cod-1 | warning | MedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodePharos, MedicinalProductDefinition.classification.coding:ATCCodeWHO | 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 : code.exists().not() implies display.exists().not() | |
dom-2 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | MedicinalProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ident-1 | warning | MedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZ | 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 : value.exists() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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
| |||||
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/referenceNumber | ||||
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 | If this medicine applies to human or veterinary uses (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 | The dose form for a single part product, or combined form of a multiple part product (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 | The legal status of supply of the medicinal product as classified by the regulator (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 | 1..* | 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:ATCCodePharos | C | 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 | ATC Codes from RMS merged with local Austrian codes 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..* | 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 | The full product name (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 | Σ | 0..* | Coding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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 | 1..1 | AT_MedicinalProduct_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 | 1..1 | AT_MedicinalProduct_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
| ||||
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 | |||||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:pmsId.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:pmsId.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.identifier:GRZ.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:GRZ.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.domain.coding | required | DomainVshttps://www.ages.at/fhir/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard | |
MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)https://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring from the FHIR Standard | |
MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard | |
MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard | |
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard | |
MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVshttps://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:tradeName.type | example | Pattern: tradeNamehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard | |
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cod-1 | warning | MedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodePharos, MedicinalProductDefinition.classification.coding:ATCCodeWHO | 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 : code.exists().not() implies display.exists().not() | |
dom-2 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | MedicinalProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ident-1 | warning | MedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZ | 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 : value.exists() |
This structure is derived from MedicinalProductDefinition
Differential View
This structure is derived from MedicinalProductDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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/referenceNumber | |
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 | If this medicine applies to human or veterinary uses (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 | The dose form for a single part product, or combined form of a multiple part product (pharmaceutical dose form) | |
legalStatusOfSupply | 1..1 | AT_MedicinalProduct_CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator (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 | |
Slices for coding | 1..* | 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:ATCCodePharos | 1..* | AT_MedicinalProduct_Coding | A reference to a code defined by a terminology system | |
system | 1..1 | uri | ATC Codes from RMS merged with local Austrian codes Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533 | |
coding:ATCCodeWHO | 0..* | 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 | The full product name (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..* | Coding | 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 | AT_MedicinalProduct_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 | AT_MedicinalProduct_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 | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.domain.coding | required | DomainVshttps://www.ages.at/fhir/domain from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)https://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVshttps://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs from this IG |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 |
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 |
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/referenceNumber |
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 | If this medicine applies to human or veterinary uses (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 | The dose form for a single part product, or combined form of a multiple part product (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 | The legal status of supply of the medicinal product as classified by the regulator (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 | 1..* | 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:ATCCodePharos | C | 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 | ATC Codes from RMS merged with local Austrian codes 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..* | 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 | The full product name (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 | Σ | 0..* | Coding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) |
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 | 1..1 | AT_MedicinalProduct_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 | 1..1 | AT_MedicinalProduct_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 | |
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.identifier:pmsId.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:GRZ.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.domain.coding | required | DomainVshttps://www.ages.at/fhir/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)https://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVshttps://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:tradeName.type | example | Pattern: tradeNamehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cod-1 | warning | MedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodePharos, MedicinalProductDefinition.classification.coding:ATCCodeWHO | 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 : code.exists().not() implies display.exists().not() | |
dom-2 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | MedicinalProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ident-1 | warning | MedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZ | 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 : value.exists() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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
| |||||
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/referenceNumber | ||||
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 | If this medicine applies to human or veterinary uses (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 | The dose form for a single part product, or combined form of a multiple part product (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 | The legal status of supply of the medicinal product as classified by the regulator (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 | 1..* | 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:ATCCodePharos | C | 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 | ATC Codes from RMS merged with local Austrian codes 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..* | 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 | The full product name (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 | Σ | 0..* | Coding | Code defined by a terminology system Binding: Medicinal Product Name Part Type (required) | ||||
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 | 1..1 | AT_MedicinalProduct_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 | 1..1 | AT_MedicinalProduct_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
| ||||
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 | |||||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:pmsId.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:pmsId.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.identifier:GRZ.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier:GRZ.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.domain.coding | required | DomainVshttps://www.ages.at/fhir/domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard | |
MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | required | LegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)https://ema.europa.eu/fhir/vs/legalStatusForTheSupply from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring from the FHIR Standard | |
MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard | |
MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard | |
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard | |
MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type.coding | required | MedicinalProductNamePartTypeVshttps://www.ages.at/fhir/medicinalproduct/ValueSet/medicinalProductNamePartTypeVs from this IG | |
MedicinalProductDefinition.name.part:inventedName.type | example | Pattern: 220000000002http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.part:tradeName.type | example | Pattern: tradeNamehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard | |
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cod-1 | warning | MedicinalProductDefinition.domain.coding, MedicinalProductDefinition.classification.coding, MedicinalProductDefinition.classification.coding:interactionRelevance, MedicinalProductDefinition.classification.coding:elgaImpfziel, MedicinalProductDefinition.classification.coding:ATCCodePharos, MedicinalProductDefinition.classification.coding:ATCCodeWHO | 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 : code.exists().not() implies display.exists().not() | |
dom-2 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | MedicinalProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | MedicinalProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | MedicinalProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
ident-1 | warning | MedicinalProductDefinition.identifier:pmsId, MedicinalProductDefinition.identifier:GRZ | 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 : value.exists() |
This structure is derived from MedicinalProductDefinition
Other representations of profile: CSV, Excel, Schematron