Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

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

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).

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.

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
Terminology BindingMedicinalProductType (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.domain
Element IdMedicinalProductDefinition.domain
Definition

If this medicine applies to human or veterinary uses.

Cardinality0..1
Terminology BindingMedicinalProductDomain (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.

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
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.

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. 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).

Cardinality0..1
Terminology BindingCombinedDoseForm (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.

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.

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
Terminology BindingLegalStatusOfSupply (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.

Cardinality0..1
Terminology BindingAdditionalMonitoring (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-authorisation studies.

Cardinality0..*
Terminology BindingSpecialMeasures (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.pediatricUseIndicator
Element IdMedicinalProductDefinition.pediatricUseIndicator
Definition

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

Cardinality0..1
Terminology BindingPediatricUse (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.classification
Element IdMedicinalProductDefinition.classification
Definition

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

Cardinality0..*
Terminology BindingProductClassification :
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).

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

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

Cardinality0..*
Terminology BindingMedicinalProductPackageType (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.comprisedOf
Element IdMedicinalProductDefinition.comprisedOf
Definition

A medicinal manufactured item that this product consists of, such as a tablet or capsule. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).

Cardinality0..*
TypeReference(ManufacturedItemDefinition)
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.

Cardinality0..*
Terminology BindingSNOMEDCTSubstanceCodes :
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.

Cardinality0..*
Terminology BindingSNOMEDCTSubstanceCodes :
TypeCodeableReference(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 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.

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
Terminology BindingProductContactType (Example)
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.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.

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.

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
Terminology BindingProductNameType (Example)
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
Terminology BindingProductNamePartType (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.countryLanguage
Element IdMedicinalProductDefinition.name.countryLanguage
Definition

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

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

Country code for where this name applies.

Cardinality1..1
Terminology BindingCountry (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.countryLanguage.jurisdiction
Element IdMedicinalProductDefinition.name.countryLanguage.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).

Cardinality0..1
Terminology BindingJurisdiction (Example)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.name.countryLanguage.language
Element IdMedicinalProductDefinition.name.countryLanguage.language
Definition

Language code for this name.

Cardinality1..1
Terminology BindingCommon Languages (Preferred but limited to All Languages)
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.crossReference
Element IdMedicinalProductDefinition.crossReference
Definition

Reference to another product, e.g. for linking authorised to investigational product, or a virtual 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, virtual to actual product, product to development product (investigational), parallel import version.

Cardinality0..1
Terminology BindingProductCrossReferenceType (Example)
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. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.

Cardinality0..1
TypeCodeableReference(ActivityDefinition | PlanDefinition)
PatternsCodeableReference(ActivityDefinition,PlanDefinition): Common patterns = Definition
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.confidentialityIndicator
Element IdMedicinalProductDefinition.operation.confidentialityIndicator
Definition

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

Cardinality0..1
Terminology BindingProductConfidentiality (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".

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

A code expressing the type of characteristic.

Cardinality1..1
Terminology BindingProductCharacteristic :
TypeCodeableConcept
Summarytrue
MedicinalProductDefinition.characteristic.value[x]
Element IdMedicinalProductDefinition.characteristic.value[x]
Definition

A value for the characteristic.text.

Cardinality0..1
TypeCodeableConcept|string|Quantity|integer|date|boolean|Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
Comments

String 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. (temporary text to make build work: The usage of CodeableConcept is for concepts that are normally coded but for which a code is not available - for example a device implant size that is not standardized. The property string is for text characteristics, e.g. long descriptions, warnings, etc.).