Intersection of http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description and http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description

This is the set of resources that conform to both Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description) and Drug Product Description (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description).

Structure

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..*Detailed definition of a medicinal product
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: ?? (required): IETF language tag for a human language
... text 0..1NarrativeText summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1Identifieroptional user designated identifier
... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
Binding: ?? (example): Overall defining type of this medicinal product.
... domain Σ0..1CodeableConceptIf this medicine applies to human or veterinary uses
Binding: ?? (example): Applicable domain for this product (e.g. human, veterinary).
... version Σ0..1stringA business identifier relating to a specific version of the product
... status ?!Σ0..1CodeableConceptThe status within the lifecycle of this product record
Binding: ?? (preferred): The lifecycle status of an artifact.
... statusDate Σ0..1dateTimeThe date at which the given status became applicable
... description SΣ1..1markdownDrug Product Description
... combinedPharmaceuticalDoseForm SΣ1..1CodeableConceptProduct Dosage Form
Binding: ?? (required)
... route SΣ1..*CodeableConceptRoute of Administration
Binding: ?? (required)
... indication Σ0..1markdownDescription of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ0..1CodeableConceptThe 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 Σ0..1CodeableConceptWhether 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 Σ0..*CodeableConceptWhether 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 Σ0..1CodeableConceptIf authorised for use in children
Binding: ?? (example): Suitability for age groups, in particular children.
... classification Σ0..*CodeableConceptAllows 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 Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ0..*CodeableConceptPackage type for the product
Binding: ?? (example): Types of medicinal product packs
... comprisedOf Σ0..*Reference(ManufacturedItemDefinition | DeviceDefinition)Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ0..*CodeableConceptThe 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 Σ0..*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 Σ0..*Reference(DocumentReference)Additional documentation about the medicinal product
... masterFile Σ0..*Reference(DocumentReference)A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ0..*BackboneElementA product specific contact, person (in a role), or an organization
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableConceptAllows 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 Σ1..1Reference(Organization | PractitionerRole)A product specific contact, person (in a role), or an organization
... clinicalTrial Σ0..*Reference(ResearchStudy)Clinical trials or studies that this product is involved in
... code Σ0..*CodingA code that this product is known by, within some formal terminology
Binding: ?? (example): A coded concept that defines the type of a medication.
... name SΣ1..2BackboneElementThe product's name, including full name and possibly coded parts
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... productName SΣ1..1stringThe full product name
.... type SΣ1..1CodeableConceptType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ?? (required)
.... part Σ0..*BackboneElementCoding words or phrases of the name
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodeableConceptIdentifying type for this part of the name (e.g. strength part)
Binding: ?? (example): Type of part of a name for a Medicinal Product.
.... usage Σ0..*BackboneElementCountry and jurisdiction where the name applies
..... extension 0..*ExtensionAdditional content defined by implementations
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... country Σ1..1CodeableConceptCountry code for where this name applies
Binding: ?? (example): Jurisdiction codes
..... language Σ1..1CodeableConceptLanguage code for this name
Binding: ?? (required): IETF language tag for a human language
... crossReference SΣ0..*BackboneElementReference to another product, e.g. for linking authorised to investigational product
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... product S1..1LiteralCodeableReference(Drug Product Handle | #sd-pqcmc-drug-product-handle-pqcmc-drug-product-handle) {b}Co-Packaged Product
.... type Σ0..1CodeableConceptThe 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 Σ0..*BackboneElementA manufacturing or administrative process for the medicinal product
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ0..1CodeableReference(ActivityDefinition | PlanDefinition)The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ0..1PeriodDate range of applicability
.... organization Σ0..*Reference(Organization)The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ0..1CodeableConceptSpecifies whether this process is considered proprietary or confidential
Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ0..*BackboneElementKey product features such as "sugar free", "modified release"
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type Σ1..1CodeableConceptA code expressing the type of characteristic
Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ0..1A value for the characteristic
..... valueCodeableConceptCodeableConcept
..... valueMarkdownmarkdown
..... valueQuantityQuantity
..... valueIntegerinteger
..... valueDatedate
..... valueBooleanboolean
..... valueAttachmentAttachment

doco Documentation for this format