Release 5 Draft Ballot
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, drug catalogs).

Cardinality0..*
TypeDomainResource
Summaryfalse
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
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.version
Element IdMedicinalProductDefinition.version
Definition

A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summarytrue
MedicinalProductDefinition.status
Element IdMedicinalProductDefinition.status
Definition

The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.

Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.statusDate
Element IdMedicinalProductDefinition.statusDate
Definition

The date at which the given status became applicable.

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

General description of this product.

Cardinality0..1
Typemarkdown
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

Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseIssue resource. An indication is a medical situation for which using the product is appropriate.

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.specialMeasures
Element IdMedicinalProductDefinition.specialMeasures
Definition

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

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

If authorised for use in children.

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

Allows the product to be classified by various systems.

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

Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

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

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

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

The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by the AdministrableProductDefinition or via the PackagedProductDefinition references above. In cases where those levels of detail are not used, the ingredients may be specified directly here.

Cardinality0..*
TypeCodeableReference(Ingredient)
Summarytrue
MedicinalProductDefinition.impurity
Element IdMedicinalProductDefinition.impurity
Definition

Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.

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

Additional information or supporting documentation about the medicinal product.

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, Pharmacovigilance 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 product name, such as rINN, BAN, Proprietary, Non-Proprietary.

Cardinality0..1
TypeCodeableConcept
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

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

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

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

Cardinality1..1
TypeCodeableReference(MedicinalProductDefinition)
Summarytrue
MedicinalProductDefinition.crossReference.type
Element IdMedicinalProductDefinition.crossReference.type
Definition

The type of relationship, for instance branded to generic, product to development product (investigational), parallel import version.

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

A manufacturing or administrative process or step associated with (or performed on) the medicinal product.

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

The type of manufacturing operation e.g. manufacturing itself, re-packaging. This may be a subtype of some other wider scope of authorized operation, referenced by the authorization attribute.

Cardinality0..1
TypeCodeableReference(ActivityDefinition)
Summarytrue
MedicinalProductDefinition.operation.effectiveDate
Element IdMedicinalProductDefinition.operation.effectiveDate
Definition

Date range of applicability.

Cardinality0..1
TypePeriod
Summarytrue
MedicinalProductDefinition.operation.organization
Element IdMedicinalProductDefinition.operation.organization
Definition

The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.

Cardinality0..*
TypeReference(Organization)
Summarytrue
MedicinalProductDefinition.operation.authorization
Element IdMedicinalProductDefinition.operation.authorization
Definition

An authorization for this process, either as a logical reference, holding just an identifier, or a full reference to a resource that captures the details. The authorization may possibly apply to several products or a wider scope of process of which this is a part.

Cardinality0..1
TypeReference(RegulatedAuthorization)
Summarytrue
MedicinalProductDefinition.operation.confidentialityIndicator
Element IdMedicinalProductDefinition.operation.confidentialityIndicator
Definition

Specifies whether this particular business or manufacturing process is considered proprietary or confidential.

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

Package representation for the product.

Cardinality0..*
Summaryfalse
MedicinalProductDefinition.package.type
Element IdMedicinalProductDefinition.package.type
Definition

A descriptive type for this package, such as box, carton or bottle.

Cardinality0..1
TypeCodeableConcept
Summaryfalse
MedicinalProductDefinition.package.size[x]
Element IdMedicinalProductDefinition.package.size[x]
Definition

The amount of items, or of substance, in the package.

Cardinality0..1
TypeQuantity|integer
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
MedicinalProductDefinition.package.package
Element IdMedicinalProductDefinition.package.package
Definition

Full package representation for the product.

Cardinality0..1
TypeReference(PackagedProductDefinition)
Summaryfalse
MedicinalProductDefinition.administrableProduct
Element IdMedicinalProductDefinition.administrableProduct
Definition

The product in its final form, mixed from its components if necessary, and ready to be administered to the patient. Also known as the 'Pharmaceutical Product'. Can repeat, for cases where the product has components that result in more than one administrable item.

Cardinality0..*
Summarytrue
MedicinalProductDefinition.administrableProduct.route
Element IdMedicinalProductDefinition.administrableProduct.route
Definition

The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route.

Cardinality0..*
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.administrableProduct.product
Element IdMedicinalProductDefinition.administrableProduct.product
Definition

Full description of the administrable product.

Cardinality0..1
TypeReference(AdministrableProductDefinition)
Summarytrue