## Profile Comparison between http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq vs http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq

Left: | MedicinalProductDefinition - Drug Product PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq)
Right: | MedicinalProductDefinition - Drug Product PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq)

### Messages

Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot' vs '1.0.0'
Information | StructureDefinition.date | Values for date differ: '2023-12-18T16:00:45+00:00' vs '2024-05-08T12:53:57+00:00'
Information | MedicinalProductDefinition.combinedPharmaceuticalDoseForm | Example/preferred bindings differ at MedicinalProductDefinition.combinedPharmaceuticalDoseForm using binding from MedicinalProductDefinitionDrugProductPq
Information | MedicinalProductDefinition.route | Example/preferred bindings differ at MedicinalProductDefinition.route using binding from MedicinalProductDefinitionDrugProductPq
Warning | MedicinalProductDefinition.name.type | Elements differ in definition for mustSupport: 'false' vs 'true'
Information | StructureDefinition.short | Values for short differ: 'Additional content defined by implementations' vs 'Extension'
Information | StructureDefinition.definition | Values for definition differ: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'An Extension'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition |
copyright |  |
date | 2023-12-18T16:00:45+00:00 | 2024-05-08T12:53:57+00:00 | Values Differ
description | Section 1.1 - Drug Product Identification | This MedicinalProductDefinition profile represents information that identifies the drug product. | Values Differ
experimental |  |
fhirVersion | 5.0.0 |
jurisdiction |  |
jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 |
kind | resource |
name | MedicinalProductDefinitionDrugProductPq |
publisher | HL7 International / Biomedical Research and Regulation |
purpose |  |
status | active |
title | MedicinalProductDefinition - Drug Product PQ |
type | MedicinalProductDefinition |
url | http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq |
version | 1.0.0-ballot | 1.0.0 | Values Differ

### Structure

Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments
--- | --- | --- | --- | --- | --- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product |
id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact |
meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
language |  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
|  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation |  | 0..1 | Narrative | Text summary of the resource, for human interpretation |
contained |  | 0..* | Resource | Contained, inline Resources |  | 0..* | Resource | Contained, inline Resources |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
identifier | S Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID | 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: ?? (example): Overall defining type of this medicinal product. | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: ?? (example): Overall defining type of this medicinal product. |
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary). | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: ?? (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 | 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: ?? (preferred): The lifecycle status of an artifact. | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: ?? (preferred): The lifecycle status of an artifact. |
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable | Σ | 0..1 | dateTime | The date at which the given status became applicable |
description | Σ | 0..1 | markdown | General description of this product | 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: ?? (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes. | S Σ | 0..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: ?? (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes. | Example/preferred bindings differ at MedicinalProductDefinition.combinedPharmaceuticalDoseForm using binding from MedicinalProductDefinitionDrugProductPq
route | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: ?? (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes. | Σ | 0..* | CodeableConcept | The path by which the product is taken into or makes contact with the body Binding: ?? (preferred): EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes. | Example/preferred bindings differ at MedicinalProductDefinition.route using binding from MedicinalProductDefinitionDrugProductPq
indication | Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | 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: ?? (example): The prescription supply types appropriate to a medicinal product | Σ | 0..1 | CodeableConcept | The legal status of supply of the medicinal product as classified by the regulator Binding: ?? (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: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | Σ | 0..1 | CodeableConcept | Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: ?? (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: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. | Σ | 0..* | CodeableConcept | Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: ?? (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: ?? (example): Suitability for age groups, in particular children. | Σ | 0..1 | CodeableConcept | If authorised for use in children Binding: ?? (example): Suitability for age groups, in particular children. |
classification | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: ?? (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set. | Σ | 0..* | CodeableConcept | Allows the product to be classified by various systems Binding: ?? (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 | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization |
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Package type for the product Binding: ?? (example): Types of medicinal product packs | Σ | 0..* | CodeableConcept | Package type for the product Binding: ?? (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 | 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: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | Σ | 0..* | CodeableConcept | The ingredients of this medicinal product - when not detailed in other resources Binding: ?? (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: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | 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: ?? (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 | 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) | 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 | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | Σ | 0..1 | CodeableConcept | Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ?? (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 | 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 | 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: ?? (example): A coded concept that defines the type of a medication. | Σ | 0..* | Coding | A code that this product is known by, within some formal terminology Binding: ?? (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 | 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 |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
productName | Σ | 1..1 | string | The full product name | Σ | 1..1 | string | The full product name |
type | Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ?? (example): Type of a name for a Medicinal Product. | S Σ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ?? (example) | Elements differ in definition for mustSupport: 'false' vs 'true'
part | Σ | 0..* | BackboneElement | Coding words or phrases of the name | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
part | Σ | 1..1 | string | A fragment of a product name | 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: ?? (example): Type of part of a name for a Medicinal Product. | Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product. |
usage | Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies | Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
country | Σ | 1..1 | CodeableConcept | Country code for where this name applies Binding: ?? (example): Jurisdiction codes | Σ | 1..1 | CodeableConcept | Country code for where this name applies Binding: ?? (example): Jurisdiction codes |
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ?? (example): Jurisdiction codes | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ?? (example): Jurisdiction codes |
language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
| Σ | 1..1 | CodeableConcept | Language code for this name Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
crossReference | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product | 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 |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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 | 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: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. | Σ | 0..1 | CodeableConcept | The type of relationship, for instance branded to generic or virtual to actual product Binding: ?? (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 | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Additional content defined by implementations |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!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 | 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 | 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 | 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: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product. | Σ | 0..1 | CodeableConcept | Specifies whether this process is considered proprietary or confidential Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product. |
characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release" | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release" |
id |  | 0..1 | string | Unique id for inter-element referencing |  | 0..1 | string | Unique id for inter-element referencing |
extension |  | 0..* | Extension | Additional content defined by implementations |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): Example codes for MedicinalProduct.characteristic.type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): Example codes for MedicinalProduct.characteristic.type |
Slices for value[x] | Σ | 0..1 | CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment | A value for the characteristic Slice: Unordered, Open by type:$this | Σ | 0..1 | CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment | A value for the characteristic Slice: Unordered, Open by type:$this |
Documentation for this format