WHO-UMC IDMP Management and Publish API, published by Uppsala Monitoring Centre. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/Uppsala-Monitoring-Centre/WHO-UMC-IDMP-Service/ and changes regularly. See the Directory of published versions
Official URL: http://who-umc.org/idmp/StructureDefinition/MedicinalProductDefinition-who-php-pub | Version: 0.1.0 | |||
Active as of 2024-11-11 | Computable Name: MedicinalProductDefinitionWhoPhP |
This profile specifies how the MedicinalProductDefinition is published by the WHO-UMC IDMP FHIR Service representing the WHODrug dictionary
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 | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
id | 1..1 | id | Logical id of this artifact | |
contained | 0..1 | Organization | Contained, inline Resources | |
identifier | 1..* | Identifier | Business identifier for this product. Could be an MPID | |
system | 1..1 | uri | The namespace for the identifier value Binding: MPID system (extensible) | |
value | 1..1 | string | The value that is unique | |
type | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized. | |
domain | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses. Binding: MedicinalProductDomain (required) | |
status | 0..1 | CodeableConcept | The status within the lifecycle of this product record. | |
statusDate | 0..1 | dateTime | Not used in this profile | |
description | 0..1 | markdown | Not used in this profile | |
combinedPharmaceuticalDoseForm | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: EDQM Pharmaceutical Form (example) | |
route | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (example) | |
indication | 0..1 | markdown | Not used in this profile | |
legalStatusOfSupply | 0..1 | CodeableConcept | Not used in this profile | |
additionalMonitoringIndicator | 0..1 | CodeableConcept | Not used in this profile | |
specialMeasures | 0..* | CodeableConcept | Not used in this profile | |
pediatricUseIndicator | 0..1 | CodeableConcept | Not used in this profile | |
classification | 0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | |
marketingStatus | 0..* | MarketingStatus | Not used in this profile | |
packagedMedicinalProduct | 0..* | CodeableConcept | Not used in this profile | |
contact | ||||
type | 0..1 | CodeableConcept | Allows the Marketing Authorization Holder to be classified | |
contact | 1..1 | Reference(Organization | PractitionerRole) | A specific Marketing Authorization Holder for this product | |
name | ||||
productName | 1..1 | string | The full product name. | |
part | ||||
part | 1..1 | string | A fragment of a product name. | |
type | 1..1 | CodeableConcept | Type for this part of the name (e.g. strength part) | |
usage | 1..1 | BackboneElement | Country and jurisdiction where the name applies | |
country | 1..1 | CodeableConcept | Country where this name applies | |
coding | 1..1 | Coding | Code defined by a terminology system | |
system | 0..1 | uri | Identity of the terminology system Required Pattern: urn:iso:std:iso:3166 | |
code | 1..1 | code | Symbol in syntax defined by the system | |
jurisdiction | 0..1 | CodeableConcept | Jurisdiction where this name applies | |
coding | 1..1 | Coding | Code defined by a terminology system | |
code | 1..1 | code | Symbol in syntax defined by the system Binding: Jurisdiction Value Set (example) | |
language | 1..1 | CodeableConcept | Language for this name | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-system from this IG | |
MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalForm from this IG | |
MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministration from this IG | |
MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassification from this IG | |
MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdiction from this IG |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
id | Σ | 1..1 | id | Logical id of this artifact | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
contained | 0..1 | Organization | Contained, inline Resources | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 1..* | Identifier | Business identifier for this product. Could be an MPID | ||||
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 Binding: MPID system (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized. Binding: MedicinalProductType (example): Overall defining type of this medicinal product. | ||||
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses. Binding: MedicinalProductDomain (required) | ||||
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 | Not used in this profile | ||||
description | Σ | 0..1 | markdown | Not used in this profile | ||||
combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: EDQM Pharmaceutical Form (example) | ||||
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (example) | ||||
indication | Σ | 0..1 | markdown | Not used in this profile | ||||
legalStatusOfSupply | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
specialMeasures | Σ | 0..* | CodeableConcept | Not used in this profile Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
pediatricUseIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: PediatricUse (example): Suitability for age groups, in particular children. | ||||
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | ||||
marketingStatus | Σ | 0..* | MarketingStatus | Not used in this profile | ||||
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Not used in this profile Binding: MedicinalProductPackageType (example): Types of medicinal product packs | ||||
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. | ||||
usage | Σ | 1..1 | BackboneElement | Country and jurisdiction where the name applies | ||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
country | Σ | 1..1 | CodeableConcept | Country where this name applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
coding | Σ | 1..1 | Coding | Code defined by a terminology system | ||||
system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: urn:iso:std:iso:3166 | ||||
code | ΣC | 1..1 | code | Symbol in syntax defined by the system | ||||
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
coding | Σ | 1..1 | Coding | Code defined by a terminology system | ||||
code | ΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Jurisdiction Value Set (example) | ||||
language | Σ | 1..1 | CodeableConcept | Language for this name Binding: AllLanguages (required): IETF language tag for a human language
| ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-system from this IG | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalForm from this IG | |
MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministration from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard | |
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 | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassification from this IG | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-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.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdiction from this IG | |
MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
id | Σ | 1..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..1 | Organization | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 1..* | Identifier | Business identifier for this product. Could be an MPID | ||||
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 Binding: MPID system (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized. Binding: MedicinalProductType (example): Overall defining type of this medicinal product. | ||||
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses. Binding: MedicinalProductDomain (required) | ||||
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 | Not used in this profile | ||||
description | Σ | 0..1 | markdown | Not used in this profile | ||||
combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: EDQM Pharmaceutical Form (example) | ||||
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (example) | ||||
indication | Σ | 0..1 | markdown | Not used in this profile | ||||
legalStatusOfSupply | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
specialMeasures | Σ | 0..* | CodeableConcept | Not used in this profile Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
pediatricUseIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: PediatricUse (example): Suitability for age groups, in particular children. | ||||
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | ||||
marketingStatus | Σ | 0..* | MarketingStatus | Not used in this profile | ||||
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Not used in this profile 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 Marketing Authorization Holder to be classified Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A specific Marketing Authorization Holder for this product | ||||
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. | ||||
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. | ||||
part | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
part | Σ | 1..1 | string | A fragment of a product name. | ||||
type | Σ | 1..1 | CodeableConcept | Type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
usage | Σ | 1..1 | 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 where this name applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
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 | 1..1 | Coding | Code defined by a terminology system | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: urn:iso:std:iso:3166 | ||||
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 | 0..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 | ||||
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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 | 1..1 | Coding | Code defined by a terminology system | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
system | Σ | 0..1 | uri | Identity of the terminology system | ||||
version | Σ | 0..1 | string | Version of the system - if relevant | ||||
code | ΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Jurisdiction Value Set (example) | ||||
display | ΣC | 0..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 | ||||
language | Σ | 1..1 | CodeableConcept | Language 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 | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-system from this IG | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalForm from this IG | |
MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministration from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard | |
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 | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassification from this IG | |
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.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.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdiction from this IG | |
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 |
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() |
This structure is derived from MedicinalProductDefinition
Differential View
This structure is derived from MedicinalProductDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
id | 1..1 | id | Logical id of this artifact | |
contained | 0..1 | Organization | Contained, inline Resources | |
identifier | 1..* | Identifier | Business identifier for this product. Could be an MPID | |
system | 1..1 | uri | The namespace for the identifier value Binding: MPID system (extensible) | |
value | 1..1 | string | The value that is unique | |
type | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized. | |
domain | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses. Binding: MedicinalProductDomain (required) | |
status | 0..1 | CodeableConcept | The status within the lifecycle of this product record. | |
statusDate | 0..1 | dateTime | Not used in this profile | |
description | 0..1 | markdown | Not used in this profile | |
combinedPharmaceuticalDoseForm | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: EDQM Pharmaceutical Form (example) | |
route | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (example) | |
indication | 0..1 | markdown | Not used in this profile | |
legalStatusOfSupply | 0..1 | CodeableConcept | Not used in this profile | |
additionalMonitoringIndicator | 0..1 | CodeableConcept | Not used in this profile | |
specialMeasures | 0..* | CodeableConcept | Not used in this profile | |
pediatricUseIndicator | 0..1 | CodeableConcept | Not used in this profile | |
classification | 0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | |
marketingStatus | 0..* | MarketingStatus | Not used in this profile | |
packagedMedicinalProduct | 0..* | CodeableConcept | Not used in this profile | |
contact | ||||
type | 0..1 | CodeableConcept | Allows the Marketing Authorization Holder to be classified | |
contact | 1..1 | Reference(Organization | PractitionerRole) | A specific Marketing Authorization Holder for this product | |
name | ||||
productName | 1..1 | string | The full product name. | |
part | ||||
part | 1..1 | string | A fragment of a product name. | |
type | 1..1 | CodeableConcept | Type for this part of the name (e.g. strength part) | |
usage | 1..1 | BackboneElement | Country and jurisdiction where the name applies | |
country | 1..1 | CodeableConcept | Country where this name applies | |
coding | 1..1 | Coding | Code defined by a terminology system | |
system | 0..1 | uri | Identity of the terminology system Required Pattern: urn:iso:std:iso:3166 | |
code | 1..1 | code | Symbol in syntax defined by the system | |
jurisdiction | 0..1 | CodeableConcept | Jurisdiction where this name applies | |
coding | 1..1 | Coding | Code defined by a terminology system | |
code | 1..1 | code | Symbol in syntax defined by the system Binding: Jurisdiction Value Set (example) | |
language | 1..1 | CodeableConcept | Language for this name | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-system from this IG | |
MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalForm from this IG | |
MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministration from this IG | |
MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassification from this IG | |
MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdiction from this IG |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
id | Σ | 1..1 | id | Logical id of this artifact | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
contained | 0..1 | Organization | Contained, inline Resources | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 1..* | Identifier | Business identifier for this product. Could be an MPID | ||||
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 Binding: MPID system (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized. Binding: MedicinalProductType (example): Overall defining type of this medicinal product. | ||||
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses. Binding: MedicinalProductDomain (required) | ||||
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 | Not used in this profile | ||||
description | Σ | 0..1 | markdown | Not used in this profile | ||||
combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: EDQM Pharmaceutical Form (example) | ||||
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (example) | ||||
indication | Σ | 0..1 | markdown | Not used in this profile | ||||
legalStatusOfSupply | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
specialMeasures | Σ | 0..* | CodeableConcept | Not used in this profile Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
pediatricUseIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: PediatricUse (example): Suitability for age groups, in particular children. | ||||
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | ||||
marketingStatus | Σ | 0..* | MarketingStatus | Not used in this profile | ||||
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Not used in this profile Binding: MedicinalProductPackageType (example): Types of medicinal product packs | ||||
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. | ||||
usage | Σ | 1..1 | BackboneElement | Country and jurisdiction where the name applies | ||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
country | Σ | 1..1 | CodeableConcept | Country where this name applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
coding | Σ | 1..1 | Coding | Code defined by a terminology system | ||||
system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: urn:iso:std:iso:3166 | ||||
code | ΣC | 1..1 | code | Symbol in syntax defined by the system | ||||
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
coding | Σ | 1..1 | Coding | Code defined by a terminology system | ||||
code | ΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Jurisdiction Value Set (example) | ||||
language | Σ | 1..1 | CodeableConcept | Language for this name Binding: AllLanguages (required): IETF language tag for a human language
| ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-system from this IG | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalForm from this IG | |
MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministration from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard | |
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 | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassification from this IG | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-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.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdiction from this IG | |
MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |||||
id | Σ | 1..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..1 | Organization | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
identifier | Σ | 1..* | Identifier | Business identifier for this product. Could be an MPID | ||||
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 Binding: MPID system (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
value | ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized. Binding: MedicinalProductType (example): Overall defining type of this medicinal product. | ||||
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses. Binding: MedicinalProductDomain (required) | ||||
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 | Not used in this profile | ||||
description | Σ | 0..1 | markdown | Not used in this profile | ||||
combinedPharmaceuticalDoseForm | Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: EDQM Pharmaceutical Form (example) | ||||
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Route Of Administration (example) | ||||
indication | Σ | 0..1 | markdown | Not used in this profile | ||||
legalStatusOfSupply | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
additionalMonitoringIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
specialMeasures | Σ | 0..* | CodeableConcept | Not used in this profile Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
pediatricUseIndicator | Σ | 0..1 | CodeableConcept | Not used in this profile Binding: PediatricUse (example): Suitability for age groups, in particular children. | ||||
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | ||||
marketingStatus | Σ | 0..* | MarketingStatus | Not used in this profile | ||||
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Not used in this profile 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 Marketing Authorization Holder to be classified Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A specific Marketing Authorization Holder for this product | ||||
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. | ||||
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. | ||||
part | Σ | 0..* | BackboneElement | Coding words or phrases of the name | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
part | Σ | 1..1 | string | A fragment of a product name. | ||||
type | Σ | 1..1 | CodeableConcept | Type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
usage | Σ | 1..1 | 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 where this name applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
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 | 1..1 | Coding | Code defined by a terminology system | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: urn:iso:std:iso:3166 | ||||
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 | 0..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 | ||||
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
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 | 1..1 | Coding | Code defined by a terminology system | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
system | Σ | 0..1 | uri | Identity of the terminology system | ||||
version | Σ | 0..1 | string | Version of the system - if relevant | ||||
code | ΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Jurisdiction Value Set (example) | ||||
display | ΣC | 0..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 | ||||
language | Σ | 1..1 | CodeableConcept | Language 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 | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-system from this IG | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalForm from this IG | |
MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministration from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard | |
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 | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassification from this IG | |
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.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.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdiction from this IG | |
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 |
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() |
This structure is derived from MedicinalProductDefinition
Other representations of profile: CSV, Excel, Schematron