Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. 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/uv-dx-pq/ and changes regularly. See the Directory of published versions

## Resource Profile: MedicinalProductDefinition - Drug Product

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq | Version: 1.0.0
Active as of 2024-05-08 | Computable Name: MedicinalProductDefinitionDrugProductPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.30

This MedicinalProductDefinition profile represents information that identifies the drug product.

Usage:

- Use this Resource Profile: Bundle – Analytical Procedure PQ, Bundle – Batch Analysis PQ, Bundle – Batch Formula PQ, Bundle – Container Closure System PQ... Show 11 more, Bundle – drug Product Batch Information PQ, Bundle - Drug Product Compatibility PQ, Bundle – Drug Product Composition PQ, Bundle – Drug Product Excipients PQ, Bundle – Drug Product Microbiological Attributes PQ, Bundle - Drug Product PQ, Bundle – Drug Product Specification PQ, Bundle – Drug Stability PQ, Bundle - Product Impurities PQ, Bundle - Product Manufacturing PQ and Bundle - Product Process Validation PQ
- Refer to this Resource Profile: Composition - Drug PQ and Extension - Medication Definition PQ
- Examples for this Resource Profile: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1

### Formal Views of Profile Content

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

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from MedicinalProductDefinition

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product
identifier | S | 0..* | Identifier | Business identifier for this product. Could be an MPID
combinedPharmaceuticalDoseForm | S | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.
route |  | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.
name | S | 1..* | BackboneElement | The product's name, including full name and possibly coded parts
type | S | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Type (example)
characteristic |  | 0..* | BackboneElement | Key product features such as "sugar free", "modified release"
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
substance-property-range | S | 0..1 | Range | substance-property-range URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type
Slices for value[x] |  | 0..1 | CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment | A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueQuantity |  | 0..1 | Quantity | A value for the characteristic
system |  | 0..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code |  | 0..1 | code | Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | A value for the characteristic
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | MedicineDoseFormEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform` from this IG
MedicinalProductDefinition.route | preferred | MedicineRouteOfAdministrationEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration` from this IG
MedicinalProductDefinition.name.type | example | VsProductNameTypePQ (a valid code from Product Name Type - example) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq` from this IG
MedicinalProductDefinition.characteristic.type | example | MedicinalProductCharacteristicType `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type` from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code | required | UnitsOfMeasureCaseSensitive (a valid code from UCUM) `http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive`

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 | S Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm | S Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.
name | S 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
type | S Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Type (example)
characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release"
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
substance-property-range | S | 0..1 | Range | substance-property-range URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
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: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type
Slices for value[x] | Σ | 0..1 |  | A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueMarkdown |  |  | markdown |
valueQuantity |  |  | Quantity |
valueInteger |  |  | integer |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
value[x]:valueQuantity | Σ | 0..1 | Quantity | A value for the characteristic
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
system | Σ C | 0..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code | Σ C | 0..1 | code | Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueCodeableConcept | Σ | 0..1 | CodeableConcept | A value for the characteristic
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | MedicineDoseFormEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform` from this IG
MedicinalProductDefinition.route | preferred | MedicineRouteOfAdministrationEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration` from this IG
MedicinalProductDefinition.name.type | example | VsProductNameTypePQ (a valid code from Product Name Type - example) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq` from this IG
MedicinalProductDefinition.characteristic.type | example | MedicinalProductCharacteristicType `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type` from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code | required | UnitsOfMeasureCaseSensitive (a valid code from UCUM) `http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive`

#### Constraints

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
Additional Bindings | Purpose
CommonLanguages | Starter Set
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID
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): Applicable domain for this product (e.g. human, veterinary).
version | Σ | 0..1 | string | A business identifier relating to a specific version of the product
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable
description | Σ | 0..1 | markdown | General description of this product
combinedPharmaceuticalDoseForm | S Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.
indication | Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required
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 use in children Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs
comprisedOf | Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity | Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product
masterFile | Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization
clinicalTrial | Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in
code | Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
name | S 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 | S Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Type (example)
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 code for where this name applies Binding: CountryValueSet (example): Jurisdiction codes
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes
language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter Set
crossReference | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
product | Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product
type | Σ | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | Σ | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate | Σ | 0..1 | Period | Date range of applicability
organization | Σ | 0..* | Reference(Organization) | The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator | Σ | 0..1 | CodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release"
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
substance-property-range | S | 0..1 | Range | substance-property-range URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
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: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type
Slices for value[x] | Σ | 0..1 |  | A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueMarkdown |  |  | markdown |
valueQuantity |  |  | Quantity |
valueInteger |  |  | integer |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
value[x]:valueQuantity | Σ | 0..1 | Quantity | A value for the characteristic
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | Σ | 0..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code | Σ C | 0..1 | code | Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueCodeableConcept | Σ | 0..1 | CodeableConcept | A value for the characteristic
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
MedicinalProductDefinition.type | example | MedicinalProductType `http://hl7.org/fhir/ValueSet/medicinal-product-type` from the FHIR Standard
MedicinalProductDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` from the FHIR Standard
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | MedicineDoseFormEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform` from this IG
MedicinalProductDefinition.route | preferred | MedicineRouteOfAdministrationEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration` from this IG
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupply `http://hl7.org/fhir/ValueSet/legal-status-of-supply` from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoring `http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring` from the FHIR Standard
MedicinalProductDefinition.specialMeasures | example | SpecialMeasures `http://hl7.org/fhir/ValueSet/medicinal-product-special-measures` from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUse `http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use` from the FHIR Standard
MedicinalProductDefinition.classification | example | ProductClassification `http://hl7.org/fhir/ValueSet/medicinal-product-classification` from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageType `http://hl7.org/fhir/ValueSet/medicinal-product-package-type` from the FHIR Standard
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` from the FHIR Standard
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` from the FHIR Standard
MedicinalProductDefinition.contact.type | example | ProductContactType `http://hl7.org/fhir/ValueSet/medicinal-product-contact-type` from the FHIR Standard
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodes `http://hl7.org/fhir/ValueSet/medication-codes` from the FHIR Standard
MedicinalProductDefinition.name.type | example | VsProductNameTypePQ (a valid code from Product Name Type - example) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq` from this IG
MedicinalProductDefinition.name.part.type | example | ProductNamePartType `http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type` from the FHIR Standard
MedicinalProductDefinition.name.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` from the FHIR Standard
MedicinalProductDefinition.name.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceType `http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type` from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentiality `http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality` from the FHIR Standard
MedicinalProductDefinition.characteristic.type | example | MedicinalProductCharacteristicType `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type` from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code | required | UnitsOfMeasureCaseSensitive (a valid code from UCUM) `http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive`

#### Constraints

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

Summary

Must-Support: 5 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of MedicinalProductDefinition.characteristic.value[x] (Closed)

Differential View

This structure is derived from MedicinalProductDefinition

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product
identifier | S | 0..* | Identifier | Business identifier for this product. Could be an MPID
combinedPharmaceuticalDoseForm | S | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.
route |  | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.
name | S | 1..* | BackboneElement | The product's name, including full name and possibly coded parts
type | S | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Type (example)
characteristic |  | 0..* | BackboneElement | Key product features such as "sugar free", "modified release"
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
substance-property-range | S | 0..1 | Range | substance-property-range URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
type |  | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type
Slices for value[x] |  | 0..1 | CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment | A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueQuantity |  | 0..1 | Quantity | A value for the characteristic
system |  | 0..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code |  | 0..1 | code | Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | A value for the characteristic
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | MedicineDoseFormEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform` from this IG
MedicinalProductDefinition.route | preferred | MedicineRouteOfAdministrationEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration` from this IG
MedicinalProductDefinition.name.type | example | VsProductNameTypePQ (a valid code from Product Name Type - example) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq` from this IG
MedicinalProductDefinition.characteristic.type | example | MedicinalProductCharacteristicType `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type` from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code | required | UnitsOfMeasureCaseSensitive (a valid code from UCUM) `http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive`

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 | S Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm | S Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.
name | S 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
type | S Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Type (example)
characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release"
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
substance-property-range | S | 0..1 | Range | substance-property-range URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
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: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type
Slices for value[x] | Σ | 0..1 |  | A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueMarkdown |  |  | markdown |
valueQuantity |  |  | Quantity |
valueInteger |  |  | integer |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
value[x]:valueQuantity | Σ | 0..1 | Quantity | A value for the characteristic
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
system | Σ C | 0..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code | Σ C | 0..1 | code | Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueCodeableConcept | Σ | 0..1 | CodeableConcept | A value for the characteristic
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | MedicineDoseFormEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform` from this IG
MedicinalProductDefinition.route | preferred | MedicineRouteOfAdministrationEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration` from this IG
MedicinalProductDefinition.name.type | example | VsProductNameTypePQ (a valid code from Product Name Type - example) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq` from this IG
MedicinalProductDefinition.characteristic.type | example | MedicinalProductCharacteristicType `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type` from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code | required | UnitsOfMeasureCaseSensitive (a valid code from UCUM) `http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive`

#### Constraints

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
Additional Bindings | Purpose
CommonLanguages | Starter Set
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID
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): Applicable domain for this product (e.g. human, veterinary).
version | Σ | 0..1 | string | A business identifier relating to a specific version of the product
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable
description | Σ | 0..1 | markdown | General description of this product
combinedPharmaceuticalDoseForm | S Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: Medicine Dose Form EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes.
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: Medicine Route of Administration EDQM (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes.
indication | Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required
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 use in children Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs
comprisedOf | Σ | 0..* | Reference(ManufacturedItemDefinition | DeviceDefinition) | Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity | Σ | 0..* | CodeableReference(SubstanceDefinition) | Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product
masterFile | Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization
clinicalTrial | Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in
code | Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
name | S 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 | S Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Type (example)
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 code for where this name applies Binding: CountryValueSet (example): Jurisdiction codes
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes
language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter Set
crossReference | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
product | Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product
type | Σ | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type | Σ | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate | Σ | 0..1 | Period | Date range of applicability
organization | Σ | 0..* | Reference(Organization) | The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator | Σ | 0..1 | CodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release"
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
substance-property-range | S | 0..1 | Range | substance-property-range URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq
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: MedicinalProduct Characteristic Type (example): Example codes for MedicinalProduct.characteristic.type
Slices for value[x] | Σ | 0..1 |  | A value for the characteristic Slice: Unordered, Open by type:$this
valueCodeableConcept |  |  | CodeableConcept |
valueMarkdown |  |  | markdown |
valueQuantity |  |  | Quantity |
valueInteger |  |  | integer |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
value[x]:valueQuantity | Σ | 0..1 | Quantity | A value for the characteristic
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
value | Σ | 0..1 | decimal | Numerical value (with implicit precision)
comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit | Σ | 0..1 | string | Unit representation
system | Σ C | 0..1 | uri | System that defines coded unit form Required Pattern: http://unitsofmeasure.org
code | Σ C | 0..1 | code | Coded form of the unit Binding: UnitsOfMeasureCaseSensitive (required): UCUM codes for unit
value[x]:valueCodeableConcept | Σ | 0..1 | CodeableConcept | A value for the characteristic
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
MedicinalProductDefinition.type | example | MedicinalProductType `http://hl7.org/fhir/ValueSet/medicinal-product-type` from the FHIR Standard
MedicinalProductDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` from the FHIR Standard
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | preferred | MedicineDoseFormEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-doseform` from this IG
MedicinalProductDefinition.route | preferred | MedicineRouteOfAdministrationEDQM `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicine-route-of-administration` from this IG
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupply `http://hl7.org/fhir/ValueSet/legal-status-of-supply` from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoring `http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring` from the FHIR Standard
MedicinalProductDefinition.specialMeasures | example | SpecialMeasures `http://hl7.org/fhir/ValueSet/medicinal-product-special-measures` from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUse `http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use` from the FHIR Standard
MedicinalProductDefinition.classification | example | ProductClassification `http://hl7.org/fhir/ValueSet/medicinal-product-classification` from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageType `http://hl7.org/fhir/ValueSet/medicinal-product-package-type` from the FHIR Standard
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` from the FHIR Standard
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` from the FHIR Standard
MedicinalProductDefinition.contact.type | example | ProductContactType `http://hl7.org/fhir/ValueSet/medicinal-product-contact-type` from the FHIR Standard
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodes `http://hl7.org/fhir/ValueSet/medication-codes` from the FHIR Standard
MedicinalProductDefinition.name.type | example | VsProductNameTypePQ (a valid code from Product Name Type - example) `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-productNameType-pq` from this IG
MedicinalProductDefinition.name.part.type | example | ProductNamePartType `http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type` from the FHIR Standard
MedicinalProductDefinition.name.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSet `http://hl7.org/fhir/ValueSet/jurisdiction` from the FHIR Standard
MedicinalProductDefinition.name.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` from the FHIR Standard
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceType `http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type` from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentiality `http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality` from the FHIR Standard
MedicinalProductDefinition.characteristic.type | example | MedicinalProductCharacteristicType `http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-medicinalproduct-characteristic-type` from this IG
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.comparator | required | QuantityComparator `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` from the FHIR Standard
MedicinalProductDefinition.characteristic.value[x]:valueQuantity.code | required | UnitsOfMeasureCaseSensitive (a valid code from UCUM) `http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive`

#### Constraints

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

Summary

Must-Support: 5 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-substance-property-range-pq

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of MedicinalProductDefinition.characteristic.value[x] (Closed)

Other representations of profile: CSV, Excel, Schematron