type: resource-definitionsresource: MedicinalProductDefinition

MedicinalProductDefinition Definitions

MedicinalProductDefinition

Detailed definition of a medicinal product

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).

Cardinality: 0..*

Mappings: idmp=Medicinal Product and Investigational Medicinal Product; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']; w5=administrative.medication

MedicinalProductDefinition.identifier

Business identifier for this product. Could be an MPID

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.

Aliases: MPID

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: w5=FiveWs.class; idmp=Medicinal Product.MPID, Investigational Medicinal Product.IMPID; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code

MedicinalProductDefinition.type

Regulatory type, e.g. Investigational or Authorized

Definition: Regulatory type, e.g. Investigational or Authorized.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-type

Summary: true

Mappings: idmp=(indicates if this is Medicinal Product or an Investigational Medicinal Product); rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code

MedicinalProductDefinition.domain

If this medicine applies to human or veterinary uses

Definition: If this medicine applies to human or veterinary uses.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-domain

Summary: true

Mappings: idmp=n/a; rim=ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value

MedicinalProductDefinition.version

A business identifier relating to a specific version of the product

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

Cardinality: 0..1

Type: string

Summary: true

Mappings: idmp=Medicinal Product.Header.Version Number; rim=n/a

MedicinalProductDefinition.status

The status within the lifecycle of this product record

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.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

Is Modifier: true (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)

Mappings: idmp=n/a; rim=n/a

MedicinalProductDefinition.statusDate

The date at which the given status became applicable

Definition: The date at which the given status became applicable.

Cardinality: 0..1

Type: dateTime

Summary: true

Mappings: idmp=n/a; rim=n/a

MedicinalProductDefinition.description

General description of this product

Definition: General description of this product.

Cardinality: 0..1

Type: markdown

Summary: true

Mappings: idmp=n/a; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc

MedicinalProductDefinition.combinedPharmaceuticalDoseForm

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

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).

Cardinality: 0..1

Type: CodeableConcept

Binding: example:combined-dose-form

Summary: true

Mappings: idmp=Medicinal Product.Combined Pharmaceutical Dose Form; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode

MedicinalProductDefinition.route

The path by which the product is taken into or makes contact with the body

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 licensed or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:route-codes

Summary: true

Mappings: idmp=Pharmaceutical Product.Route of Administration; rim=ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode

MedicinalProductDefinition.indication

Description of indication(s) for this product, used when structured indications are not required

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.

Cardinality: 0..1

Type: markdown

Summary: true

Mappings: idmp=(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular); rim=ManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value

MedicinalProductDefinition.legalStatusOfSupply

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:legal-status-of-supply

Summary: true

Mappings: idmp=Marketing Authorisation.Legal Status of Supply (moved here for practicality); rim=ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code

MedicinalProductDefinition.additionalMonitoringIndicator

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-additional-monitoring

Summary: true

Mappings: idmp=Medicinal Product.Additional Monitoring Indicator; rim=ManufacturedProduct[classCode='MANU'].subjectOf.policy.code

MedicinalProductDefinition.specialMeasures

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

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:medicinal-product-special-measures

Summary: true

Mappings: idmp=Medicinal Product.Special Measures; rim=ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName

MedicinalProductDefinition.pediatricUseIndicator

If authorised for use in children

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-pediatric-use

Summary: true

Mappings: idmp=Medicinal Product.Pediatric Use Indicator; rim=ManufacturedProduct[classCode='MANU'].subjectOf.policy.code

MedicinalProductDefinition.classification

Allows the product to be classified by various systems

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:medicinal-product-classification

Summary: true

Mappings: idmp=Product Classification.Value; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code

MedicinalProductDefinition.marketingStatus

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

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).

Cardinality: 0..*

Type: MarketingStatus

Summary: true

Mappings: idmp=Marketing Status; rim=ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode

MedicinalProductDefinition.packagedMedicinalProduct

Package type for the product

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:medicinal-product-package-type

Summary: true

Mappings: idmp=Packaged Medicinal Product; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code

MedicinalProductDefinition.comprisedOf

Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes

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).

Cardinality: 0..*

Type: Reference(ManufacturedItemDefinition, DeviceDefinition)

Summary: true

Mappings: idmp=Manufactured Item; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode

MedicinalProductDefinition.ingredient

The ingredients of this medicinal product - when not detailed in other resources

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.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:substance-codes

Summary: true

Mappings: idmp=Medicinal Product.Ingredient (see also FHIR Ingredient resource); rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code

MedicinalProductDefinition.impurity

Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product

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.

Cardinality: 0..*

Type: CodeableReference

Binding: example:substance-codes

Summary: true

Mappings: idmp=n/a; rim=(to do)

MedicinalProductDefinition.attachedDocument

Additional documentation about the medicinal product

Definition: Additional information or supporting documentation about the medicinal product.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp=Attached Document; rim=ManufacturedProduct[classCode='MANU'].subjectOf.document

MedicinalProductDefinition.masterFile

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

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.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp=Master File; rim=ManufacturedProduct[classCode='MANU'].subjectOf.document

MedicinalProductDefinition.contact

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

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=n/a; rim=ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty

MedicinalProductDefinition.contact.type

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

Definition: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-contact-type

Summary: true

Mappings: idmp=n/a; rim=ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code

MedicinalProductDefinition.contact.contact

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

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

Cardinality: 1..1

Type: Reference(Organization, PractitionerRole)

Summary: true

Mappings: idmp=n/a; rim=ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty

MedicinalProductDefinition.clinicalTrial

Clinical trials or studies that this product is involved in

Definition: Clinical trials or studies that this product is involved in.

Cardinality: 0..*

Type: Reference(ResearchStudy)

Summary: true

Mappings: idmp=Investigational Medicinal Product.Clinical Trial Status; rim=ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram

MedicinalProductDefinition.code

A code that this product is known by, within some formal terminology

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.

Cardinality: 0..*

Type: Coding

Binding: example:medication-codes

Summary: true

Mappings: idmp=n/a; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code

MedicinalProductDefinition.name

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

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

Cardinality: 1..*

Type: BackboneElement

Summary: true

Mappings: idmp=Medicinal Product Name; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.name

MedicinalProductDefinition.name.productName

The full product name

Definition: The full product name.

Cardinality: 1..1

Type: string

Summary: true

Mappings: idmp=Medicinal Product Name.Full Name; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.name

MedicinalProductDefinition.name.type

Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary

Definition: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-name-type

Summary: true

Mappings: idmp=n/a; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code

MedicinalProductDefinition.name.part

Coding words or phrases of the name

Definition: Coding words or phrases of the name.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=(any and all of the name parts e.g. Medicinal Product Name.Formulation Part); rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix

MedicinalProductDefinition.name.part.part

A fragment of a product name

Definition: A fragment of a product name.

Cardinality: 1..1

Type: string

Summary: true

Mappings: idmp=(text of any of the name parts e.g. Medicinal Product Name.Formulation Part); rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix

MedicinalProductDefinition.name.part.type

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

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

Cardinality: 1..1

Type: CodeableConcept

Binding: example:medicinal-product-name-part-type

Summary: true

Mappings: idmp=(which of the name parts this is e.g. Formulation Part); rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code

MedicinalProductDefinition.name.usage

Country and jurisdiction where the name applies

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=Country / Language; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity

MedicinalProductDefinition.name.usage.country

Country code for where this name applies

Definition: Country code for where this name applies.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:country

Summary: true

Mappings: idmp=Country / Language.Country; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code

MedicinalProductDefinition.name.usage.jurisdiction

Jurisdiction code for where this name applies

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).

Cardinality: 0..1

Type: CodeableConcept

Binding: example:jurisdiction

Summary: true

Mappings: idmp=Country / Language.Jurisdiction; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code

MedicinalProductDefinition.name.usage.language

Language code for this name

Definition: Language code for this name.

Cardinality: 1..1

Type: CodeableConcept

Binding: required:all-languages

Summary: true

Mappings: idmp=Country / Language.Language; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang

MedicinalProductDefinition.crossReference

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

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=Product Cross-Reference; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity

MedicinalProductDefinition.crossReference.product

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

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

Cardinality: 1..1

Type: CodeableReference

Summary: true

Mappings: idmp=Product Cross-Reference; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code

MedicinalProductDefinition.crossReference.type

The type of relationship, for instance branded to generic or virtual to actual product

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-cross-reference-type

Summary: true

Mappings: idmp=Product Cross-Reference; rim=ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code

MedicinalProductDefinition.operation

A manufacturing or administrative process for the medicinal product

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=Manufacturing / Business Operation; rim=ManufacturedProduct[classCode='MANU'].subjectOf.action

MedicinalProductDefinition.operation.type

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

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.

Cardinality: 0..1

Type: CodeableReference

Summary: true

Mappings: idmp=Manufacturing / Business Operation.Operation Type; rim=ManufacturedProduct[classCode='MANU'].subjectOf.action.code

MedicinalProductDefinition.operation.effectiveDate

Date range of applicability

Definition: Date range of applicability.

Cardinality: 0..1

Type: Period

Summary: true

Mappings: idmp=Manufacturing / Business Operation.Effective Date; rim=ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime

MedicinalProductDefinition.operation.organization

The organization responsible for the particular process, e.g. the manufacturer or importer

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

Cardinality: 0..*

Type: Reference(Organization)

Summary: true

Mappings: idmp=Manufacturer / Establishment (Organisation); rim=ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation

MedicinalProductDefinition.operation.confidentialityIndicator

Specifies whether this process is considered proprietary or confidential

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:medicinal-product-confidentiality

Summary: true

Mappings: idmp=Manufacturing / Business Operation.Confidentiality Indicator; rim=ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode

MedicinalProductDefinition.characteristic

Key product features such as "sugar free", "modified release"

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=Package Item (Container).Physical Characteristics; rim=ManufacturedProduct[classCode='MANU'].subjectOf.characteristic

MedicinalProductDefinition.characteristic.type

A code expressing the type of characteristic

Definition: A code expressing the type of characteristic.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:product-characteristic-codes

Summary: true

Mappings: idmp=Physical Characteristics, all attributes; rim=ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']

MedicinalProductDefinition.characteristic.value[x]

A value for the characteristic

Definition: A value for the characteristic.text.

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.

Cardinality: 0..1

Type: CodeableConcept, markdown, Quantity, Range, integer, date, boolean, Attachment

Summary: true

Mappings: idmp=Physical Characteristics, attribute's value; rim=ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value