WHO-UMC IDMP Management and Publish API
0.1.0 - CI Build
WHO-UMC IDMP Management and Publish API
0.1.0 - CI Build
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-req | Version: 0.1.0 | |||
| Active as of 2024-11-29 | Computable Name: MedicinalProductDefinitionWhoPhPRequest | |||
This profile specified how the MedicinalProductDefinition is used in request (for a new PhPID) (as contained resource) by the WHO-UMC IDMP FHIR Service
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 | |||
  id |
1..1 | id | Logical id of this artifact | |
| contained |
0..* | Resource | Not used in this profile | |
 identifier |
1..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 | General description of the medicinal product referred by the ePI | |
| 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 | Narrative text of the authorized indication(s) for this product. | |
| 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 | |
| attachedDocument |
1..1 | Reference(DocumentReference) | Additional documentation about the medicinal product | |
| display |
1..1 | string | The document that describes the product in detail | |
| contact |
1..1 | BackboneElement | A product specific contact, person (in a role), or an organization | |
| type |
0..1 | CodeableConcept | Should be ProposedMAH | |
 contact |
1..1 | Reference(Marketing Authorization Holder) | A specific contact that represents an organization that is the market 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-systemfrom this IG | |
| MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdictionfrom 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..* | Resource | Not used in this profile | |||||
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
 identifier |
Σ | 1..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 | General description of the medicinal product referred by the ePI | ||||
| 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 | Narrative text of the authorized indication(s) for this product. | ||||
| 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 | ||||
| attachedDocument |
Σ | 1..1 | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| display |
ΣC | 1..1 | string | The document that describes the product in detail | ||||
| contact |
Σ | 1..1 | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
Σ | 0..1 | CodeableConcept | Should be ProposedMAH Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact |
Σ | 1..1 | Reference(Marketing Authorization Holder) | A specific contact that represents an organization that is the market authorization holder for this product. | ||||
| 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|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-systemfrom this IG | |
| MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoringfrom the FHIR Standard | |
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measuresfrom the FHIR Standard | |
| MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-usefrom the FHIR Standard | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdictionfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from 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..* | Resource | Not used in this profile | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 1..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 | General description of the medicinal product referred by the ePI | ||||
| 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 | Narrative text of the authorized indication(s) for this product. | ||||
| 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 | 1..1 | Reference(DocumentReference) | Additional documentation about the 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 | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier |
ΣC | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
ΣC | 1..1 | string | The document that describes the product in detail | ||||
| masterFile |
Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
| contact |
Σ | 1..1 | 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 | Should be ProposedMAH Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact |
Σ | 1..1 | Reference(Marketing Authorization Holder) | A specific contact that represents an organization that is the market 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|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-systemfrom this IG | |
| MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoringfrom the FHIR Standard | |
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measuresfrom the FHIR Standard | |
| MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-usefrom the FHIR Standard | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom the FHIR Standard | |
| MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.attachedDocument.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdictionfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-typefrom the FHIR Standard | |
| MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentialityfrom the FHIR Standard | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom 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 |
MedicinalProductDefinition | |||
| id |
1..1 | id | Logical id of this artifact | |
| contained |
0..* | Resource | Not used in this profile | |
| identifier |
1..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 | General description of the medicinal product referred by the ePI | |
| 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 | Narrative text of the authorized indication(s) for this product. | |
| 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 | |
| attachedDocument |
1..1 | Reference(DocumentReference) | Additional documentation about the medicinal product | |
| display |
1..1 | string | The document that describes the product in detail | |
| contact |
1..1 | BackboneElement | A product specific contact, person (in a role), or an organization | |
| type |
0..1 | CodeableConcept | Should be ProposedMAH | |
| contact |
1..1 | Reference(Marketing Authorization Holder) | A specific contact that represents an organization that is the market 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-systemfrom this IG | |
| MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdictionfrom 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..* | Resource | Not used in this profile | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 1..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 | General description of the medicinal product referred by the ePI | ||||
| 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 | Narrative text of the authorized indication(s) for this product. | ||||
| 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 | ||||
| attachedDocument |
Σ | 1..1 | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| display |
ΣC | 1..1 | string | The document that describes the product in detail | ||||
| contact |
Σ | 1..1 | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
Σ | 0..1 | CodeableConcept | Should be ProposedMAH Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact |
Σ | 1..1 | Reference(Marketing Authorization Holder) | A specific contact that represents an organization that is the market authorization holder for this product. | ||||
| 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|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-systemfrom this IG | |
| MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoringfrom the FHIR Standard | |
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measuresfrom the FHIR Standard | |
| MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-usefrom the FHIR Standard | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom the FHIR Standard | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdictionfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from 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..* | Resource | Not used in this profile | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 1..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 | General description of the medicinal product referred by the ePI | ||||
| 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 | Narrative text of the authorized indication(s) for this product. | ||||
| 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 | 1..1 | Reference(DocumentReference) | Additional documentation about the 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 | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||
| identifier |
ΣC | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
ΣC | 1..1 | string | The document that describes the product in detail | ||||
| masterFile |
Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
| contact |
Σ | 1..1 | 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 | Should be ProposedMAH Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact |
Σ | 1..1 | Reference(Marketing Authorization Holder) | A specific contact that represents an organization that is the market 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|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-typefrom the FHIR Standard | |
| MedicinalProductDefinition.identifier.system | extensible | VsMpIdSystemhttp://who-umc.org/idmp/ValueSet/mpid-systemfrom this IG | |
| MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | required | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | pharmaceuticalFormhttp://who-umc.org/idmp/ValueSet/pharmaceuticalFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://who-umc.org/idmp/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoringfrom the FHIR Standard | |
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measuresfrom the FHIR Standard | |
| MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-usefrom the FHIR Standard | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://who-umc.org/idmp/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom the FHIR Standard | |
| MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.attachedDocument.type | extensible | ResourceTypehttp://hl7.org/fhir/ValueSet/resource-typesfrom the FHIR Standard | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction.coding.code | example | VsJurisdictionhttp://who-umc.org/idmp/ValueSet/jurisdictionfrom this IG | |
| MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-typefrom the FHIR Standard | |
| MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentialityfrom the FHIR Standard | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom 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
IG © 2024+ Uppsala Monitoring Centre. Package idmp.who-umc.org.fhir#0.1.0 based on FHIR 5.0.0. Generated 2024-11-29
