R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions

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

Detailed Descriptions for the elements in the MedicinalProduct resource.

MedicinalProduct
Element Id MedicinalProduct
Definition

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

Control 1..1
Type DomainResource
Summary true
MedicinalProduct.identifier
Element Id MedicinalProduct.identifier
Definition

Business idenfifier for this product. Could be an MPID.

Note This is a business identifer, not a resource identifier (see discussion )
Control 1..1 0..*
Type Identifier
Alternate Names MPID
Summary true
MedicinalProduct.type
Element Id MedicinalProduct.type
Definition

Regulatory type, e.g. Investigational or Authorized.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.domain
Element Id MedicinalProduct.domain
Definition

If this medicine applies to human or veterinary uses.

Control 0..1
Type Coding
Summary true
MedicinalProduct.combinedPharmaceuticalDoseForm
Element Id MedicinalProduct.combinedPharmaceuticalDoseForm
Definition

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

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.additionalMonitoringIndicator
Element Id MedicinalProduct.additionalMonitoringIndicator
Definition

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

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.specialMeasures
Element Id MedicinalProduct.specialMeasures
Definition

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

Control 0..*
Type string
Summary true
MedicinalProduct.paediatricUseIndicator
Element Id MedicinalProduct.paediatricUseIndicator
Definition

If authorised for use in children.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.orphanDesignationStatus MedicinalProduct.productClassification
Element Id MedicinalProduct.orphanDesignationStatus MedicinalProduct.productClassification
Definition

Indicates if Allows the medicinal product has an orphan designation for the treatment of a rare disease. to be classified by various systems.

Control 0..1 0..*
Type CodeableConcept
Summary true
MedicinalProduct.productClassification MedicinalProduct.marketingStatus
Element Id MedicinalProduct.productClassification MedicinalProduct.marketingStatus
Definition

Allows Marketing status of the product medicinal product, in contrast to be classified by various systems. marketing authorizaton.

Control 0..*
Type CodeableConcept MarketingStatus
Summary true
MedicinalProduct.marketingAuthorization
Element Id MedicinalProduct.marketingAuthorization
Definition

Product regulatory authorization.

Control 0..1
Type Reference ( MedicinalProductAuthorization )
Summary true
MedicinalProduct.packagedMedicinalProduct
Element Id MedicinalProduct.packagedMedicinalProduct
Definition

Package representation for the product.

Control 0..*
Type Reference ( MedicinalProductPackaged )
Summary true
MedicinalProduct.pharmaceuticalProduct
Element Id MedicinalProduct.pharmaceuticalProduct
Definition

Pharmaceutical aspects of product.

Control 0..*
Type Reference ( MedicinalProductPharmaceutical )
Summary true
MedicinalProduct.clinicalParticulars MedicinalProduct.contraindication
Element Id MedicinalProduct.clinicalParticulars MedicinalProduct.contraindication
Definition

Clinical particulars, indications etc. contraindications, reasons for not giving this.

Control 0..*
Type Reference ( MedicinalProductClinicals MedicinalProductContraindication )
Summary true
MedicinalProduct.interaction
Element Id MedicinalProduct.interaction
Definition

Clinical interactions with other medications or substances.

Control 0..*
Type Reference ( MedicinalProductInteraction )
Summary true
MedicinalProduct.therapeuticIndication
Element Id MedicinalProduct.therapeuticIndication
Definition

Clinical reason for use.

Control 0..*
Type Reference ( MedicinalProductIndication )
Summary true
MedicinalProduct.undesirableEffect
Element Id MedicinalProduct.undesirableEffect
Definition

Potential clinical unwanted effects of use.

Control 0..*
Type Reference ( MedicinalProductUndesirableEffect )
Summary true
MedicinalProduct.attachedDocument
Element Id MedicinalProduct.attachedDocument
Definition

Supporting documentation, typically for regulatory submission.

Control 0..*
Type Reference ( DocumentReference )
Summary true
MedicinalProduct.masterFile
Element Id MedicinalProduct.masterFile
Definition

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

Control 0..*
Type Reference ( DocumentReference )
Summary true
MedicinalProduct.contact
Element Id MedicinalProduct.contact
Definition

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

Control 0..*
Type Reference ( Organization | PractitionerRole )
Summary true
MedicinalProduct.clinicalTrial
Element Id MedicinalProduct.clinicalTrial
Definition

Clinical trials or studies that this product is involved in.

Control 0..*
Type Reference ( ResearchStudy )
Summary true
MedicinalProduct.name
Element Id MedicinalProduct.name
Definition

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

Control 1..*
Summary true
MedicinalProduct.name.fullName MedicinalProduct.name.productName
Element Id MedicinalProduct.name.fullName MedicinalProduct.name.productName
Definition

The full product name.

Control 1..1
Type string
Summary true
MedicinalProduct.name.namePart
Element Id MedicinalProduct.name.namePart
Definition

Coding words or phrases of the name.

Control 0..*
Summary true
MedicinalProduct.name.namePart.part
Element Id MedicinalProduct.name.namePart.part
Definition

A fragment of a product name.

Control 1..1
Type string
Summary true
MedicinalProduct.name.namePart.type
Element Id MedicinalProduct.name.namePart.type
Definition

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

Control 1..1
Type Coding
Summary true
MedicinalProduct.name.countryLanguage
Element Id MedicinalProduct.name.countryLanguage
Definition

Country where the name applies.

Control 0..*
Summary true
MedicinalProduct.name.countryLanguage.country
Element Id MedicinalProduct.name.countryLanguage.country
Definition

Country code for where this name applies.

Control 1..1
Type CodeableConcept
Summary true
MedicinalProduct.name.countryLanguage.jurisdiction
Element Id MedicinalProduct.name.countryLanguage.jurisdiction
Definition

Jurisdiction code for where this name applies.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.name.countryLanguage.language
Element Id MedicinalProduct.name.countryLanguage.language
Definition

Language code for this name.

Control 1..1
Type CodeableConcept
Summary true
MedicinalProduct.crossReference
Element Id MedicinalProduct.crossReference
Definition

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

Control 0..*
Type Identifier
Summary true
MedicinalProduct.manufacturingBusinessOperation
Element Id MedicinalProduct.manufacturingBusinessOperation
Definition

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

Control 0..*
Summary true
MedicinalProduct.manufacturingBusinessOperation.operationType
Element Id MedicinalProduct.manufacturingBusinessOperation.operationType
Definition

The type of manufacturing operation.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber
Element Id MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber
Definition

Regulatory authorization reference number.

Control 0..1
Type Identifier
Summary true
MedicinalProduct.manufacturingBusinessOperation.effectiveDate
Element Id MedicinalProduct.manufacturingBusinessOperation.effectiveDate
Definition

Regulatory authorization date.

Control 0..1
Type dateTime
Summary true
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator
Element Id MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator
Definition

To indicate if this proces is commercially confidential.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.manufacturingBusinessOperation.manufacturer
Element Id MedicinalProduct.manufacturingBusinessOperation.manufacturer
Definition

The manufacturer or establishment associated with the process.

Control 0..*
Type Reference ( Organization )
Summary true
MedicinalProduct.manufacturingBusinessOperation.regulator
Element Id MedicinalProduct.manufacturingBusinessOperation.regulator
Definition

A regulator which oversees the operation.

Control 0..1
Type Reference ( Organization )
Summary true
MedicinalProduct.specialDesignation
Element Id MedicinalProduct.specialDesignation
Definition

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

Control 0..*
Summary true
MedicinalProduct.specialDesignation.identifier
Element Id MedicinalProduct.specialDesignation.identifier
Definition

Identifier for the designation, or procedure number.

Note This is a business identifer, not a resource identifier (see discussion )
Control 0..*
Type Identifier
Summary true
MedicinalProduct.specialDesignation.intendedUse
Element Id MedicinalProduct.specialDesignation.intendedUse
Definition

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

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.specialDesignation.indication
Element Id MedicinalProduct.specialDesignation.indication
Definition

Condition for which the medicinal use applies.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.specialDesignation.status
Element Id MedicinalProduct.specialDesignation.status
Definition

For example granted, pending, expired or withdrawn.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProduct.specialDesignation.date
Element Id MedicinalProduct.specialDesignation.date
Definition

Date when the designation was granted.

Control 0..1
Type dateTime
Summary true
MedicinalProduct.specialDesignation.species
Element Id MedicinalProduct.specialDesignation.species
Definition

Animal species for which this applies.

Control 0..1
Type CodeableConcept
Summary true