Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi | Version: 1.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: MedicinalProductDefinitionUvEpi | ||
Description of the packaged authorized medicinal product(s) associated to this ePI document.
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 | |||
  identifier |
1..* | Identifier | Business identifier for this product. Could be an MPID | |
  system |
1..1 | uri | The namespace for the identifier value | |
 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 (example) | |
| version |
0..1 | string | A business identifier relating to a specific version of the product. | |
| status |
0..1 | CodeableConcept | The status within the lifecycle of this product record. | |
| statusDate |
0..1 | dateTime | The date at which this status became applicable. | |
| 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: Dose 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 | The legal status of supply of the medicinal product as classified by the regulator. | |
| additionalMonitoringIndicator |
0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. | |
| specialMeasures |
0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons. | |
| pediatricUseIndicator |
0..1 | CodeableConcept | If authorised for pediatric use | |
| classification |
0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | |
| marketingStatus |
||||
| country |
0..1 | CodeableConcept | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ISO Country two letter code (preferred) | |
| status |
1..1 | CodeableConcept | Status of the marketing of the medicinal product. | |
| dateRange |
0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder | |
| packagedMedicinalProduct |
0..* | CodeableConcept | Package type for the product. | |
| contact |
||||
| type |
0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. | |
| contact |
1..1 | Reference(Organization | PractitionerRole) | A specific contact, person (in a role), or an organization for this product | |
 name |
||||
 productName |
1..1 | string | The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form | |
| usage |
||||
| country |
1..1 | CodeableConcept | Country where this name applies | |
| jurisdiction |
0..1 | CodeableConcept | Jurisdiction where this name applies | |
| language |
1..1 | CodeableConcept | Language for this name | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | VsDoseFormhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.marketingStatus.country | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition |
0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
 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 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 (example) |
| version |
Σ | 0..1 | string | A business identifier relating to a specific version of the product. |
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record. Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate |
Σ | 0..1 | dateTime | The date at which this status became applicable. |
| 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: Dose 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 | The legal status of supply of the medicinal product as classified by the regulator. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product |
| additionalMonitoringIndicator |
Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). |
| specialMeasures |
Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. |
| pediatricUseIndicator |
Σ | 0..1 | CodeableConcept | If authorised for pediatric use 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) |
| packagedMedicinalProduct |
Σ | 0..* | CodeableConcept | Package type for the product. 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 expressed as Proprietary Name (Non-Proprietary Name) strength dose form |
| 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.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | example | 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 | VsDoseFormhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://hl7.org/fhir/uv/emedicinal-product-info/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://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom 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 | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| 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 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 (example) | ||||
| version |
Σ | 0..1 | string | A business identifier relating to a specific version of the product. | ||||
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record. Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate |
Σ | 0..1 | dateTime | The date at which this status became applicable. | ||||
| 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: Dose 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 | The legal status of supply of the medicinal product as classified by the regulator. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
| additionalMonitoringIndicator |
Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
| specialMeasures |
Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
| pediatricUseIndicator |
Σ | 0..1 | CodeableConcept | If authorised for pediatric use 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 | Marketing status of the medicinal product, in contrast to marketing authorization | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country |
Σ | 0..1 | CodeableConcept | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ISO Country two letter code (preferred) | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified | ||||
| status |
Σ | 1..1 | CodeableConcept | Status of the marketing of the medicinal product. | ||||
| dateRange |
Σ | 0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder | ||||
| restoreDate |
Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain | ||||
| packagedMedicinalProduct |
Σ | 0..* | CodeableConcept | Package type for the product. Binding: MedicinalProductPackageType (example): Types of medicinal product packs | ||||
| comprisedOf |
Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes | ||||
| ingredient |
Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| impurity |
Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| attachedDocument |
Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
| masterFile |
Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
| contact |
Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact |
Σ | 1..1 | Reference(Organization | PractitionerRole) | A specific contact, person (in a role), or an organization 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 expressed as Proprietary Name (Non-Proprietary Name) strength dose form | ||||
| 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 | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
| usage |
Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country |
Σ | 1..1 | CodeableConcept | Country where this name applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| 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.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | example | 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 | VsDoseFormhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://hl7.org/fhir/uv/emedicinal-product-info/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://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.marketingStatus.country | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom 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.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.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 | |||
| identifier |
1..* | Identifier | Business identifier for this product. Could be an MPID | |
| system |
1..1 | uri | The namespace for the identifier value | |
| 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 (example) | |
| version |
0..1 | string | A business identifier relating to a specific version of the product. | |
| status |
0..1 | CodeableConcept | The status within the lifecycle of this product record. | |
| statusDate |
0..1 | dateTime | The date at which this status became applicable. | |
| 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: Dose 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 | The legal status of supply of the medicinal product as classified by the regulator. | |
| additionalMonitoringIndicator |
0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. | |
| specialMeasures |
0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons. | |
| pediatricUseIndicator |
0..1 | CodeableConcept | If authorised for pediatric use | |
| classification |
0..* | CodeableConcept | Allows the product to be classified by various systems (e.g. ATC) Binding: WHO ATC (example) | |
| marketingStatus |
||||
| country |
0..1 | CodeableConcept | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ISO Country two letter code (preferred) | |
| status |
1..1 | CodeableConcept | Status of the marketing of the medicinal product. | |
| dateRange |
0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder | |
| packagedMedicinalProduct |
0..* | CodeableConcept | Package type for the product. | |
| contact |
||||
| type |
0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. | |
| contact |
1..1 | Reference(Organization | PractitionerRole) | A specific contact, person (in a role), or an organization for this product | |
| name |
||||
| productName |
1..1 | string | The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form | |
| usage |
||||
| country |
1..1 | CodeableConcept | Country where this name applies | |
| jurisdiction |
0..1 | CodeableConcept | Jurisdiction where this name applies | |
| language |
1..1 | CodeableConcept | Language for this name | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | VsDoseFormhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministrationfrom this IG | |
| MedicinalProductDefinition.classification | example | VsAtcClassificationhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.marketingStatus.country | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition |
0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| 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 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 (example) |
| version |
Σ | 0..1 | string | A business identifier relating to a specific version of the product. |
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record. Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| statusDate |
Σ | 0..1 | dateTime | The date at which this status became applicable. |
| 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: Dose 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 | The legal status of supply of the medicinal product as classified by the regulator. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product |
| additionalMonitoringIndicator |
Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). |
| specialMeasures |
Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. |
| pediatricUseIndicator |
Σ | 0..1 | CodeableConcept | If authorised for pediatric use 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) |
| packagedMedicinalProduct |
Σ | 0..* | CodeableConcept | Package type for the product. 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 expressed as Proprietary Name (Non-Proprietary Name) strength dose form |
| 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.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | example | 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 | VsDoseFormhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://hl7.org/fhir/uv/emedicinal-product-info/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://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom 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 | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| 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 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 (example) | ||||
| version |
Σ | 0..1 | string | A business identifier relating to a specific version of the product. | ||||
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record. Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate |
Σ | 0..1 | dateTime | The date at which this status became applicable. | ||||
| 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: Dose 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 | The legal status of supply of the medicinal product as classified by the regulator. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
| additionalMonitoringIndicator |
Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
| specialMeasures |
Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | ||||
| pediatricUseIndicator |
Σ | 0..1 | CodeableConcept | If authorised for pediatric use 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 | Marketing status of the medicinal product, in contrast to marketing authorization | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country |
Σ | 0..1 | CodeableConcept | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ISO Country two letter code (preferred) | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified | ||||
| status |
Σ | 1..1 | CodeableConcept | Status of the marketing of the medicinal product. | ||||
| dateRange |
Σ | 0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder | ||||
| restoreDate |
Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain | ||||
| packagedMedicinalProduct |
Σ | 0..* | CodeableConcept | Package type for the product. Binding: MedicinalProductPackageType (example): Types of medicinal product packs | ||||
| comprisedOf |
Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes | ||||
| ingredient |
Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| impurity |
Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| attachedDocument |
Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product | ||||
| masterFile |
Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) | ||||
| contact |
Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | ||||
| contact |
Σ | 1..1 | Reference(Organization | PractitionerRole) | A specific contact, person (in a role), or an organization 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 expressed as Proprietary Name (Non-Proprietary Name) strength dose form | ||||
| 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 | Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. | ||||
| usage |
Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country |
Σ | 1..1 | CodeableConcept | Country where this name applies Binding: CountryValueSet (example): Jurisdiction codes | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| 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.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | example | 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 | VsDoseFormhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseFormfrom this IG | |
| MedicinalProductDefinition.route | example | VsRouteOfAdministrationhttp://hl7.org/fhir/uv/emedicinal-product-info/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://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassificationfrom this IG | |
| MedicinalProductDefinition.marketingStatus.country | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/countryfrom 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.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.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 © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2024-04-08
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