R4 Ballot #1 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: R4 Ballot 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 GroupMaturity Level: 0 Draft Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProduct resource.

MedicinalProduct
Element IdMedicinalProduct
Definition

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

Control1..1
Summarytrue
MedicinalProduct.identifier
Element IdMedicinalProduct.identifier
Definition

Business idenfifier for this product. Could be an MPID.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control1..1
TypeIdentifier
Alternate NamesMPID
Summarytrue
MedicinalProduct.type
Element IdMedicinalProduct.type
Definition

Regulatory type, e.g. Investigational or Authorized.

Control0..1
TypeCodeableConcept
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.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.orphanDesignationStatus
Element IdMedicinalProduct.orphanDesignationStatus
Definition

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

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

Allows the product to be classified by various systems.

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

Product regulatory authorization.

Control0..1
TypeReference(MedicinalProductAuthorization)
Summarytrue
MedicinalProduct.packagedMedicinalProduct
Element IdMedicinalProduct.packagedMedicinalProduct
Definition

Package representation for the product.

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

Pharmaceutical aspects of product.

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

Clinical particulars, indications etc.

Control0..*
TypeReference(MedicinalProductClinicals)
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.name
Element IdMedicinalProduct.name
Definition

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

Control1..*
Summarytrue
MedicinalProduct.name.fullName
Element IdMedicinalProduct.name.fullName
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