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Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProductDefinition resource.

MedicinalProductDefinition
Element IdMedicinalProductDefinition
Definition

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

Cardinality0..*
TypeDomainResource
Summarytrue
MedicinalProductDefinition.identifier
Element IdMedicinalProductDefinition.identifier
Definition

Business identifier for this product. Could be an MPID.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Alternate NamesMPID
Summarytrue
MedicinalProductDefinition.type
Element IdMedicinalProductDefinition.type
Definition

Regulatory type, e.g. Investigational or Authorized.

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.domain
Element IdMedicinalProductDefinition.domain
Definition

If this medicine applies to human or veterinary uses.

Cardinality0..1
TypeCoding
Summarytrue
MedicinalProductDefinition.description
Element IdMedicinalProductDefinition.description
Definition

General description of this product.

Cardinality0..1
Typestring
Summarytrue
MedicinalProductDefinition.combinedPharmaceuticalDoseForm
Element IdMedicinalProductDefinition.combinedPharmaceuticalDoseForm
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.indication
Element IdMedicinalProductDefinition.indication
Definition

General combined description of indication(s) for this product. See also MedicinalProductDefinitionIndication.

Cardinality0..1
Typemarkdown
Summarytrue
MedicinalProductDefinition.legalStatusOfSupply
Element IdMedicinalProductDefinition.legalStatusOfSupply
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.additionalMonitoringIndicator
Element IdMedicinalProductDefinition.additionalMonitoringIndicator
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.specialMeasure
Element IdMedicinalProductDefinition.specialMeasure
Definition

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

Cardinality0..*
Typestring
Summarytrue
MedicinalProductDefinition.paediatricUseIndicator
Element IdMedicinalProductDefinition.paediatricUseIndicator
Definition

If authorised for use in children.

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.productClassification
Element IdMedicinalProductDefinition.productClassification
Definition

Allows the product to be classified by various systems.

Cardinality0..*
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.marketingStatus
Element IdMedicinalProductDefinition.marketingStatus
Definition

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

Cardinality0..*
TypeMarketingStatus
Summarytrue
MedicinalProductDefinition.pharmaceuticalProduct
Element IdMedicinalProductDefinition.pharmaceuticalProduct
Definition

Pharmaceutical aspects of product.

Cardinality0..*
TypeReference(AdministrableProductDefinition)
Summarytrue
MedicinalProductDefinition.packagedMedicinalProduct
Element IdMedicinalProductDefinition.packagedMedicinalProduct
Definition

Package representation for the product.

Cardinality0..*
TypeReference(PackagedProductDefinition)
Summarytrue
MedicinalProductDefinition.attachedDocument
Element IdMedicinalProductDefinition.attachedDocument
Definition

Supporting documentation, typically for regulatory submission.

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
MedicinalProductDefinition.masterFile
Element IdMedicinalProductDefinition.masterFile
Definition

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

Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
MedicinalProductDefinition.contact
Element IdMedicinalProductDefinition.contact
Definition

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

Cardinality0..*
Summarytrue
MedicinalProductDefinition.contact.type
Element IdMedicinalProductDefinition.contact.type
Definition

Allows the contact to be classified, for example QPPV, Pharmacovigilence Enquiry Information.

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.contact.contact
Element IdMedicinalProductDefinition.contact.contact
Definition

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

Cardinality1..1
TypeReference(Organization | PractitionerRole)
PatternsReference(Organization,PractitionerRole): Common patterns = Participant
Summarytrue
MedicinalProductDefinition.clinicalTrial
Element IdMedicinalProductDefinition.clinicalTrial
Definition

Clinical trials or studies that this product is involved in.

Cardinality0..*
TypeReference(ResearchStudy)
Summarytrue
MedicinalProductDefinition.name
Element IdMedicinalProductDefinition.name
Definition

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

Cardinality1..*
Summarytrue
MedicinalProductDefinition.name.productName
Element IdMedicinalProductDefinition.name.productName
Definition

The full product name.

Cardinality1..1
Typestring
Summarytrue
MedicinalProductDefinition.name.type
Element IdMedicinalProductDefinition.name.type
Definition

Type of the product name, such as rINN or BAN.

Cardinality0..1
TypeCoding
Summarytrue
MedicinalProductDefinition.name.namePart
Element IdMedicinalProductDefinition.name.namePart
Definition

Coding words or phrases of the name.

Cardinality0..*
Summarytrue
MedicinalProductDefinition.name.namePart.part
Element IdMedicinalProductDefinition.name.namePart.part
Definition

A fragment of a product name.

Cardinality1..1
Typestring
Summarytrue
MedicinalProductDefinition.name.namePart.type
Element IdMedicinalProductDefinition.name.namePart.type
Definition

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

Cardinality1..1
TypeCoding
Summarytrue
MedicinalProductDefinition.name.countryLanguage
Element IdMedicinalProductDefinition.name.countryLanguage
Definition

Country where the name applies.

Cardinality0..*
Summarytrue
MedicinalProductDefinition.name.countryLanguage.country
Element IdMedicinalProductDefinition.name.countryLanguage.country
Definition

Country code for where this name applies.

Cardinality1..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.countryLanguage.jurisdiction
Element IdMedicinalProductDefinition.name.countryLanguage.jurisdiction
Definition

Jurisdiction code for where this name applies.

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.countryLanguage.language
Element IdMedicinalProductDefinition.name.countryLanguage.language
Definition

Language code for this name.

Cardinality1..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.crossReference
Element IdMedicinalProductDefinition.crossReference
Definition

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

Cardinality0..*
TypeIdentifier
Summarytrue
MedicinalProductDefinition.manufacturingBusinessOperation
Element IdMedicinalProductDefinition.manufacturingBusinessOperation
Definition

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

Cardinality0..*
Summarytrue
MedicinalProductDefinition.manufacturingBusinessOperation.operationType
Element IdMedicinalProductDefinition.manufacturingBusinessOperation.operationType
Definition

The type of manufacturing operation e.g. manufacturing itself, re-packaging.

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.manufacturingBusinessOperation.authorisationReferenceNumber
Element IdMedicinalProductDefinition.manufacturingBusinessOperation.authorisationReferenceNumber
Definition

Regulatory authorization reference number.

Cardinality0..1
TypeIdentifier
Summarytrue
MedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate
Element IdMedicinalProductDefinition.manufacturingBusinessOperation.effectiveDate
Definition

Regulatory authorization date.

Cardinality0..1
TypePeriod
Summarytrue
MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator
Element IdMedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator
Definition

To indicate if this proces is commercially confidential.

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.manufacturingBusinessOperation.manufacturer
Element IdMedicinalProductDefinition.manufacturingBusinessOperation.manufacturer
Definition

The manufacturer or establishment associated with the process.

Cardinality0..*
TypeReference(Organization)
Summarytrue
MedicinalProductDefinition.manufacturingBusinessOperation.regulator
Element IdMedicinalProductDefinition.manufacturingBusinessOperation.regulator
Definition

A regulator which oversees the operation.

Cardinality0..1
TypeReference(Organization)
Summarytrue
MedicinalProductDefinition.specialDesignation
Element IdMedicinalProductDefinition.specialDesignation
Definition

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

Cardinality0..*
Summarytrue
MedicinalProductDefinition.specialDesignation.identifier
Element IdMedicinalProductDefinition.specialDesignation.identifier
Definition

Identifier for the designation, or procedure number.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
MedicinalProductDefinition.specialDesignation.type
Element IdMedicinalProductDefinition.specialDesignation.type
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.specialDesignation.intendedUse
Element IdMedicinalProductDefinition.specialDesignation.intendedUse
Definition

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

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.specialDesignation.indication[x]
Element IdMedicinalProductDefinition.specialDesignation.indication[x]
Definition

Condition for which the medicinal use applies.

Cardinality0..1
TypeCodeableConcept|Reference(ClinicalUseIssue)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
MedicinalProductDefinition.specialDesignation.status
Element IdMedicinalProductDefinition.specialDesignation.status
Definition

For example granted, pending, expired or withdrawn.

Cardinality0..1
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.specialDesignation.date
Element IdMedicinalProductDefinition.specialDesignation.date
Definition

Date when the designation was granted.

Cardinality0..1
TypedateTime
Summarytrue
MedicinalProductDefinition.specialDesignation.species
Element IdMedicinalProductDefinition.specialDesignation.species
Definition

Animal species for which this applies.

Cardinality0..1
TypeCodeableConcept
Summarytrue