abstractbaseDefinitioncopyrightdate- Values Differ
description- Values Differ
experimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| 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) |
| 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 '2024-05-08T13:55:35+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' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition | ||
| copyright | |||
| date | 2023-12-18T16:00:45+00:00 | 2024-05-08T13:55:35+00:00 |
|
| description | Section 1.1 - Drug Product Identification | This MedicinalProductDefinition profile represents information that identifies the drug product. |
|
| 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 |
|
| 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
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| 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 | SΣ | 0..* | Identifier | Business identifier for this product. Could be an MPID | SΣ | 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 | SΣ | 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. | SΣ | 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. |
| ||||||||
| 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. |
| ||||||||
| 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 | SΣ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts | SΣ | 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. | SΣ | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ?? (example) |
| ||||||||
| 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
| Σ | 1..1 | CodeableConcept | Language code for this name Binding: ?? (required): IETF language tag for a human language
| |||||||||
| 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 | |||||||||||||||||