## Union of http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq and http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq

This is the set of resources that conform to either of the profiles MedicinalProductDefinition - Drug Product PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq) and MedicinalProductDefinition - Drug Product PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq). E.g. what you have to deal with if you get resources conforming to one of them

### Structure

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* |  | Detailed definition of a medicinal product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
meta | Σ | 0..1 | Meta | Metadata about the resource ele-1: All FHIR elements must have a @value or children
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
language |  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language ele-1: All FHIR elements must have a @value or children
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation ele-1: All FHIR elements must have a @value or children
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier | S Σ | 0..* | Identifier | Business identifier for this product. Could be an MPID ele-1: All FHIR elements must have a @value or children
type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: ?? (example): Overall defining type of this medicinal product. ele-1: All FHIR elements must have a @value or children
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). ele-1: All FHIR elements must have a @value or children
version | Σ | 0..1 | string | A business identifier relating to a specific version of the product ele-1: All FHIR elements must have a @value or children
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: ?? (preferred): The lifecycle status of an artifact. ele-1: All FHIR elements must have a @value or children
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable ele-1: All FHIR elements must have a @value or children
description | Σ | 0..1 | markdown | General description of this product ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
indication | Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
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). ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
pediatricUseIndicator | Σ | 0..1 | CodeableConcept | If authorised for use in children Binding: ?? (example): Suitability for age groups, in particular children. ele-1: All FHIR elements must have a @value or 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. ele-1: All FHIR elements must have a @value or children
marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization ele-1: All FHIR elements must have a @value or children
packagedMedicinalProduct | Σ | 0..* | CodeableConcept | Package type for the product Binding: ?? (example): Types of medicinal product packs ele-1: All FHIR elements must have a @value or children
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 ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional documentation about the medicinal product ele-1: All FHIR elements must have a @value or children
masterFile | Σ | 0..* | Reference(DocumentReference) | A master file for the medicinal product (e.g. Pharmacovigilance System Master File) ele-1: All FHIR elements must have a @value or children
contact | Σ | 0..* | BackboneElement | A product specific contact, person (in a role), or an organization ele-1: All FHIR elements must have a @value or children
extension |  | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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. ele-1: All FHIR elements must have a @value or children
contact | Σ | 1..1 | Reference(Organization | PractitionerRole) | A product specific contact, person (in a role), or an organization ele-1: All FHIR elements must have a @value or children
clinicalTrial | Σ | 0..* | Reference(ResearchStudy) | Clinical trials or studies that this product is involved in ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
name | S Σ | 1..* | BackboneElement | The product's name, including full name and possibly coded parts ele-1: All FHIR elements must have a @value or children
extension |  | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
productName | Σ | 1..1 | string | The full product name ele-1: All FHIR elements must have a @value or children
type | S 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. ele-1: All FHIR elements must have a @value or children
part | Σ | 0..* | BackboneElement | Coding words or phrases of the name ele-1: All FHIR elements must have a @value or children
extension |  | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
part | Σ | 1..1 | string | A fragment of a product name ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
usage | Σ | 0..* | BackboneElement | Country and jurisdiction where the name applies ele-1: All FHIR elements must have a @value or children
extension |  | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
country | Σ | 1..1 | CodeableConcept | Country code for where this name applies Binding: ?? (example): Jurisdiction codes ele-1: All FHIR elements must have a @value or children
jurisdiction | Σ | 0..1 | CodeableConcept | Jurisdiction code for where this name applies Binding: ?? (example): Jurisdiction codes ele-1: All FHIR elements must have a @value or children
language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: ?? (required): IETF language tag for a human language ele-1: All FHIR elements must have a @value or children
crossReference | Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product ele-1: All FHIR elements must have a @value or children
extension |  | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
product | Σ | 1..1 | CodeableReference(MedicinalProductDefinition) | Reference to another product, e.g. for linking authorised to investigational product ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
operation | Σ | 0..* | BackboneElement | A manufacturing or administrative process for the medicinal product ele-1: All FHIR elements must have a @value or children
extension |  | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
type | Σ | 0..1 | CodeableReference(ActivityDefinition | PlanDefinition) | The type of manufacturing operation e.g. manufacturing itself, re-packaging ele-1: All FHIR elements must have a @value or children
effectiveDate | Σ | 0..1 | Period | Date range of applicability ele-1: All FHIR elements must have a @value or children
organization | Σ | 0..* | Reference(Organization) | The organization responsible for the particular process, e.g. the manufacturer or importer ele-1: All FHIR elements must have a @value or children
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. ele-1: All FHIR elements must have a @value or children
characteristic | Σ | 0..* | BackboneElement | Key product features such as "sugar free", "modified release" ele-1: All FHIR elements must have a @value or children
extension |  | 0..* | Extension | left: Additional content defined by implementations; right: Extension ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): Example codes for MedicinalProduct.characteristic.type ele-1: All FHIR elements must have a @value or children
value[x] | Σ | 0..1 |  | A value for the characteristic ele-1: All FHIR elements must have a @value or children
valueCodeableConcept |  |  | CodeableConcept |
valueMarkdown |  |  | markdown |
valueQuantity |  |  | Quantity |
valueInteger |  |  | integer |
valueDate |  |  | date |
valueBoolean |  |  | boolean |
valueAttachment |  |  | Attachment |
Documentation for this format