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Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial Use Compartments: Not linked to any defined compartments

Подробное описание элементов ресурса MedicinalProduct.

MedicinalProduct
Element IdMedicinalProduct
Definition

Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).

Control0..*
TypeDomainResource
Summarytrue
MedicinalProduct.identifier
Element IdMedicinalProduct.identifier
Definition

Business identifier for this product. Could be an MPID.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Alternate NamesMPID
Summarytrue
MedicinalProduct.type
Element IdMedicinalProduct.type
Definition

Regulatory type, e.g. Investigational or Authorized.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.domain
Element IdMedicinalProduct.domain
Definition

If this medicine applies to human or veterinary uses.

Control0..1
TypeCoding
Summarytrue
MedicinalProduct.combinedPharmaceuticalDoseForm
Element IdMedicinalProduct.combinedPharmaceuticalDoseForm
Definition

The dose form for a single part product, or combined form of a multiple part product.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.legalStatusOfSupply
Element IdMedicinalProduct.legalStatusOfSupply
Definition

The legal status of supply of the medicinal product as classified by the regulator.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.additionalMonitoringIndicator
Element IdMedicinalProduct.additionalMonitoringIndicator
Definition

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.specialMeasures
Element IdMedicinalProduct.specialMeasures
Definition

Whether the Medicinal Product is subject to special measures for regulatory reasons.

Control0..*
Typestring
Summarytrue
MedicinalProduct.paediatricUseIndicator
Element IdMedicinalProduct.paediatricUseIndicator
Definition

If authorised for use in children.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.productClassification
Element IdMedicinalProduct.productClassification
Definition

Allows the product to be classified by various systems.

Control0..*
TypeCodeableConcept
Summarytrue
MedicinalProduct.marketingStatus
Element IdMedicinalProduct.marketingStatus
Definition

Marketing status of the medicinal product, in contrast to marketing authorizaton.

Control0..*
TypeMarketingStatus
Summarytrue
MedicinalProduct.pharmaceuticalProduct
Element IdMedicinalProduct.pharmaceuticalProduct
Definition

Pharmaceutical aspects of product.

Control0..*
TypeReference(MedicinalProductPharmaceutical)
Summarytrue
MedicinalProduct.packagedMedicinalProduct
Element IdMedicinalProduct.packagedMedicinalProduct
Definition

Package representation for the product.

Control0..*
TypeReference(MedicinalProductPackaged)
Summarytrue
MedicinalProduct.attachedDocument
Element IdMedicinalProduct.attachedDocument
Definition

Supporting documentation, typically for regulatory submission.

Control0..*
TypeReference(DocumentReference)
Summarytrue
MedicinalProduct.masterFile
Element IdMedicinalProduct.masterFile
Definition

A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).

Control0..*
TypeReference(DocumentReference)
Summarytrue
MedicinalProduct.contact
Element IdMedicinalProduct.contact
Definition

A product specific contact, person (in a role), or an organization.

Control0..*
TypeReference(Organization | PractitionerRole)
Summarytrue
MedicinalProduct.clinicalTrial
Element IdMedicinalProduct.clinicalTrial
Definition

Clinical trials or studies that this product is involved in.

Control0..*
TypeReference(ResearchStudy)
Summarytrue
MedicinalProduct.name
Element IdMedicinalProduct.name
Definition

The product's name, including full name and possibly coded parts.

Control1..*
Summarytrue
MedicinalProduct.name.productName
Element IdMedicinalProduct.name.productName
Definition

The full product name.

Control1..1
Typestring
Summarytrue
MedicinalProduct.name.namePart
Element IdMedicinalProduct.name.namePart
Definition

Coding words or phrases of the name.

Control0..*
Summarytrue
MedicinalProduct.name.namePart.part
Element IdMedicinalProduct.name.namePart.part
Definition

A fragment of a product name.

Control1..1
Typestring
Summarytrue
MedicinalProduct.name.namePart.type
Element IdMedicinalProduct.name.namePart.type
Definition

Idenifying type for this part of the name (e.g. strength part).

Control1..1
TypeCoding
Summarytrue
MedicinalProduct.name.countryLanguage
Element IdMedicinalProduct.name.countryLanguage
Definition

Country where the name applies.

Control0..*
Summarytrue
MedicinalProduct.name.countryLanguage.country
Element IdMedicinalProduct.name.countryLanguage.country
Definition

Country code for where this name applies.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.name.countryLanguage.jurisdiction
Element IdMedicinalProduct.name.countryLanguage.jurisdiction
Definition

Jurisdiction code for where this name applies.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.name.countryLanguage.language
Element IdMedicinalProduct.name.countryLanguage.language
Definition

Language code for this name.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.crossReference
Element IdMedicinalProduct.crossReference
Definition

Reference to another product, e.g. for linking authorised to investigational product.

Control0..*
TypeIdentifier
Summarytrue
MedicinalProduct.manufacturingBusinessOperation
Element IdMedicinalProduct.manufacturingBusinessOperation
Definition

An operation applied to the product, for manufacturing or adminsitrative purpose.

Control0..*
Summarytrue
MedicinalProduct.manufacturingBusinessOperation.operationType
Element IdMedicinalProduct.manufacturingBusinessOperation.operationType
Definition

The type of manufacturing operation.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber
Element IdMedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber
Definition

Regulatory authorization reference number.

Control0..1
TypeIdentifier
Summarytrue
MedicinalProduct.manufacturingBusinessOperation.effectiveDate
Element IdMedicinalProduct.manufacturingBusinessOperation.effectiveDate
Definition

Regulatory authorization date.

Control0..1
TypedateTime
Summarytrue
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator
Element IdMedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator
Definition

To indicate if this proces is commercially confidential.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.manufacturingBusinessOperation.manufacturer
Element IdMedicinalProduct.manufacturingBusinessOperation.manufacturer
Definition

The manufacturer or establishment associated with the process.

Control0..*
TypeReference(Organization)
Summarytrue
MedicinalProduct.manufacturingBusinessOperation.regulator
Element IdMedicinalProduct.manufacturingBusinessOperation.regulator
Definition

A regulator which oversees the operation.

Control0..1
TypeReference(Organization)
Summarytrue
MedicinalProduct.specialDesignation
Element IdMedicinalProduct.specialDesignation
Definition

Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.

Control0..*
Summarytrue
MedicinalProduct.specialDesignation.identifier
Element IdMedicinalProduct.specialDesignation.identifier
Definition

Identifier for the designation, or procedure number.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Summarytrue
MedicinalProduct.specialDesignation.type
Element IdMedicinalProduct.specialDesignation.type
Definition

The type of special designation, e.g. orphan drug, minor use.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.specialDesignation.intendedUse
Element IdMedicinalProduct.specialDesignation.intendedUse
Definition

The intended use of the product, e.g. prevention, treatment.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.specialDesignation.indication[x]
Element IdMedicinalProduct.specialDesignation.indication[x]
Definition

Condition for which the medicinal use applies.

Control0..1
TypeCodeableConcept|Reference(MedicinalProductIndication)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
MedicinalProduct.specialDesignation.status
Element IdMedicinalProduct.specialDesignation.status
Definition

For example granted, pending, expired or withdrawn.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProduct.specialDesignation.date
Element IdMedicinalProduct.specialDesignation.date
Definition

Date when the designation was granted.

Control0..1
TypedateTime
Summarytrue
MedicinalProduct.specialDesignation.species
Element IdMedicinalProduct.specialDesignation.species
Definition

Animal species for which this applies.

Control0..1
TypeCodeableConcept
Summarytrue