Release 5

This page is part of the FHIR Specification (v5.0.0: R5 - STU). This is the current published version. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Biomedical Research and Regulation icon Work GroupMaturity Level: 3 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

Detailed Descriptions for the elements in the MedicinalProductDefinition resource.

MedicinalProductDefinition
Element IdMedicinalProductDefinition
Definition

A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).

Short DisplayDetailed definition of a medicinal product
Cardinality0..*
TypeDomainResource
Summaryfalse
MedicinalProductDefinition.identifier
Element IdMedicinalProductDefinition.identifier
Definition

Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

Short DisplayBusiness 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.

Short DisplayRegulatory type, e.g. Investigational or Authorized
Cardinality0..1
Terminology BindingMedicinal Product Type (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.domain
Element IdMedicinalProductDefinition.domain
Definition

If this medicine applies to human or veterinary uses.

Short DisplayIf this medicine applies to human or veterinary uses
Cardinality0..1
Terminology BindingMedicinal Product Domain (Example)
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.

Short DisplayA business identifier relating to a specific version of the 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.

Short DisplayThe status within the lifecycle of this product record
Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Is Modifiertrue (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid)
Summarytrue
MedicinalProductDefinition.statusDate
Element IdMedicinalProductDefinition.statusDate
Definition

The date at which the given status became applicable.

Short DisplayThe date at which the given status became applicable
Cardinality0..1
TypedateTime
Summarytrue
MedicinalProductDefinition.description
Element IdMedicinalProductDefinition.description
Definition

General description of this product.

Short DisplayGeneral 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. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).

Short DisplayThe dose form for a single part product, or combined form of a multiple part product
Cardinality0..1
Terminology BindingCombined Dose Form (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.route
Element IdMedicinalProductDefinition.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. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.

Short DisplayThe path by which the product is taken into or makes contact with the body
Cardinality0..*
Terminology BindingSNOMED CT Route Codes (Example)
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 ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.

Short DisplayDescription of indication(s) for this product, used when structured indications are not required
Cardinality0..1
Typemarkdown
Summarytrue
MedicinalProductDefinition.legalStatusOfSupply
Element IdMedicinalProductDefinition.legalStatusOfSupply
Definition

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

Short DisplayThe legal status of supply of the medicinal product as classified by the regulator
Cardinality0..1
Terminology BindingLegal Status Of Supply (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.additionalMonitoringIndicator
Element IdMedicinalProductDefinition.additionalMonitoringIndicator
Definition

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.

Short DisplayWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
Cardinality0..1
Terminology BindingAdditional Monitoring (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.specialMeasures
Element IdMedicinalProductDefinition.specialMeasures
Definition

Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.

Short DisplayWhether the Medicinal Product is subject to special measures for regulatory reasons
Cardinality0..*
Terminology BindingSpecial Measures (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.pediatricUseIndicator
Element IdMedicinalProductDefinition.pediatricUseIndicator
Definition

If authorised for use in children, or infants, neonates etc.

Short DisplayIf authorised for use in children
Cardinality0..1
Terminology BindingPediatric Use (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.classification
Element IdMedicinalProductDefinition.classification
Definition

Allows the product to be classified by various systems, commonly WHO ATC.

Short DisplayAllows the product to be classified by various systems
Cardinality0..*
Terminology BindingProduct Classification (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.marketingStatus
Element IdMedicinalProductDefinition.marketingStatus
Definition

Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).

Short DisplayMarketing status of the medicinal product, in contrast to marketing authorization
Cardinality0..*
TypeMarketingStatus
Summarytrue
MedicinalProductDefinition.packagedMedicinalProduct
Element IdMedicinalProductDefinition.packagedMedicinalProduct
Definition

Package type for the product. See also the PackagedProductDefinition resource.

Short DisplayPackage type for the product
Cardinality0..*
Terminology BindingMedicinal Product Package Type (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.comprisedOf
Element IdMedicinalProductDefinition.comprisedOf
Definition

Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).

Short DisplayTypes of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
Cardinality0..*
TypeReference(ManufacturedItemDefinition | DeviceDefinition)
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 incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.

Short DisplayThe ingredients of this medicinal product - when not detailed in other resources
Cardinality0..*
Terminology BindingSNOMED CT Substance Codes (Example)
TypeCodeableConcept
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.

Short DisplayAny component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Cardinality0..*
Terminology BindingSNOMED CT Substance Codes (Example)
TypeCodeableReference(SubstanceDefinition)
Summarytrue
MedicinalProductDefinition.attachedDocument
Element IdMedicinalProductDefinition.attachedDocument
Definition

Additional information or supporting documentation about the medicinal product.

Short DisplayAdditional documentation about the medicinal product
Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
MedicinalProductDefinition.masterFile
Element IdMedicinalProductDefinition.masterFile
Definition

A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.

Short DisplayA master file for 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.

Short DisplayA 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.

Short DisplayAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Cardinality0..1
Terminology BindingProduct Contact Type (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.contact.contact
Element IdMedicinalProductDefinition.contact.contact
Definition

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

Short DisplayA product specific contact, person (in a role), or an organization
Cardinality1..1
TypeReference(Organization | PractitionerRole)
Summarytrue
MedicinalProductDefinition.clinicalTrial
Element IdMedicinalProductDefinition.clinicalTrial
Definition

Clinical trials or studies that this product is involved in.

Short DisplayClinical trials or studies that this product is involved in
Cardinality0..*
TypeReference(ResearchStudy)
Summarytrue
MedicinalProductDefinition.code
Element IdMedicinalProductDefinition.code
Definition

A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.

Short DisplayA code that this product is known by, within some formal terminology
Cardinality0..*
Terminology BindingSNOMED CT Medication Codes (Example)
TypeCoding
Summarytrue
MedicinalProductDefinition.name
Element IdMedicinalProductDefinition.name
Definition

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

Short DisplayThe product's name, including full name and possibly coded parts
Cardinality1..*
Summarytrue
MedicinalProductDefinition.name.productName
Element IdMedicinalProductDefinition.name.productName
Definition

The full product name.

Short DisplayThe 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.

Short DisplayType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Cardinality0..1
Terminology BindingProduct Name Type (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.part
Element IdMedicinalProductDefinition.name.part
Definition

Coding words or phrases of the name.

Short DisplayCoding words or phrases of the name
Cardinality0..*
Summarytrue
MedicinalProductDefinition.name.part.part
Element IdMedicinalProductDefinition.name.part.part
Definition

A fragment of a product name.

Short DisplayA fragment of a product name
Cardinality1..1
Typestring
Summarytrue
MedicinalProductDefinition.name.part.type
Element IdMedicinalProductDefinition.name.part.type
Definition

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

Short DisplayIdentifying type for this part of the name (e.g. strength part)
Cardinality1..1
Terminology BindingProduct Name Part Type (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.usage
Element IdMedicinalProductDefinition.name.usage
Definition

Country and jurisdiction where the name applies, and associated language.

Short DisplayCountry and jurisdiction where the name applies
Cardinality0..*
Summarytrue
MedicinalProductDefinition.name.usage.country
Element IdMedicinalProductDefinition.name.usage.country
Definition

Country code for where this name applies.

Short DisplayCountry code for where this name applies
Cardinality1..1
Terminology BindingCountry ValueSet (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.usage.jurisdiction
Element IdMedicinalProductDefinition.name.usage.jurisdiction
Definition

Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).

Short DisplayJurisdiction code for where this name applies
Cardinality0..1
Terminology BindingJurisdiction ValueSet (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.usage.language
Element IdMedicinalProductDefinition.name.usage.language
Definition

Language code for this name.

Short DisplayLanguage code for this name
Cardinality1..1
Terminology BindingAll Languages (Required)
Additional BindingsPurpose
Common LanguagesStarter Set
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.crossReference
Element IdMedicinalProductDefinition.crossReference
Definition

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

Short DisplayReference 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.

Short DisplayReference 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, virtual to actual product, product to development product (investigational), parallel import version.

Short DisplayThe type of relationship, for instance branded to generic or virtual to actual product
Cardinality0..1
Terminology BindingProduct Cross Reference Type (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.operation
Element IdMedicinalProductDefinition.operation
Definition

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

Short DisplayA manufacturing or administrative process for the medicinal product
Cardinality0..*
Summarytrue
MedicinalProductDefinition.operation.type
Element IdMedicinalProductDefinition.operation.type
Definition

The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.

Short DisplayThe type of manufacturing operation e.g. manufacturing itself, re-packaging
Cardinality0..1
TypeCodeableReference(ActivityDefinition | PlanDefinition)
Summarytrue
MedicinalProductDefinition.operation.effectiveDate
Element IdMedicinalProductDefinition.operation.effectiveDate
Definition

Date range of applicability.

Short DisplayDate 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.

Short DisplayThe organization responsible for the particular process, e.g. the manufacturer or importer
Cardinality0..*
TypeReference(Organization)
Summarytrue
MedicinalProductDefinition.operation.confidentialityIndicator
Element IdMedicinalProductDefinition.operation.confidentialityIndicator
Definition

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

Short DisplaySpecifies whether this process is considered proprietary or confidential
Cardinality0..1
Terminology BindingProduct Confidentiality (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.characteristic
Element IdMedicinalProductDefinition.characteristic
Definition

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

Short DisplayKey product features such as "sugar free", "modified release"
Cardinality0..*
Summarytrue
MedicinalProductDefinition.characteristic.type
Element IdMedicinalProductDefinition.characteristic.type
Definition

A code expressing the type of characteristic.

Short DisplayA code expressing the type of characteristic
Cardinality1..1
Terminology BindingProduct Characteristic (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.characteristic.value[x]
Element IdMedicinalProductDefinition.characteristic.value[x]
Definition

A value for the characteristic.text.

Short DisplayA value for the characteristic
Cardinality0..1
TypeCodeableConcept|markdown|Quantity|integer|date|boolean|Attachment
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
Comments

Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text.