---
type: "resource-definitions"
title: "MedicinalProductDefinition Definitions"
resource: "MedicinalProductDefinition"
---

# MedicinalProductDefinition Definitions

<a id="MedicinalProductDefinition"></a>

## 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


<a id="MedicinalProductDefinition.identifier"></a>

## 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](/Identifier)

**Summary:** true

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


<a id="MedicinalProductDefinition.type"></a>

## MedicinalProductDefinition.type
Regulatory type, e.g. Investigational or Authorized

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

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[medicinal-product-type](/valueset-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


<a id="MedicinalProductDefinition.domain"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-domain](/valueset-medicinal-product-domain)

**Summary:** true

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


<a id="MedicinalProductDefinition.version"></a>

## 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](/string)

**Summary:** true

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


<a id="MedicinalProductDefinition.status"></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](/CodeableConcept)

**Binding:** preferred:[publication-status](/valueset-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


<a id="MedicinalProductDefinition.statusDate"></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](/dateTime)

**Summary:** true

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


<a id="MedicinalProductDefinition.description"></a>

## MedicinalProductDefinition.description
General description of this product

**Definition:** General description of this product.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)

**Summary:** true

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


<a id="MedicinalProductDefinition.combinedPharmaceuticalDoseForm"></a>

## 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](/CodeableConcept)

**Binding:** example:[combined-dose-form](/valueset-combined-dose-form)

**Summary:** true

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


<a id="MedicinalProductDefinition.route"></a>

## 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](/CodeableConcept)

**Binding:** example:[route-codes](/valueset-route-codes)

**Summary:** true

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


<a id="MedicinalProductDefinition.indication"></a>

## 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](/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


<a id="MedicinalProductDefinition.legalStatusOfSupply"></a>

## 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](/CodeableConcept)

**Binding:** example:[legal-status-of-supply](/valueset-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


<a id="MedicinalProductDefinition.additionalMonitoringIndicator"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-additional-monitoring](/valueset-medicinal-product-additional-monitoring)

**Summary:** true

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


<a id="MedicinalProductDefinition.specialMeasures"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-special-measures](/valueset-medicinal-product-special-measures)

**Summary:** true

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


<a id="MedicinalProductDefinition.pediatricUseIndicator"></a>

## MedicinalProductDefinition.pediatricUseIndicator
If authorised for use in children

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

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[medicinal-product-pediatric-use](/valueset-medicinal-product-pediatric-use)

**Summary:** true

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


<a id="MedicinalProductDefinition.classification"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-classification](/valueset-medicinal-product-classification)

**Summary:** true

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


<a id="MedicinalProductDefinition.marketingStatus"></a>

## 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](/MarketingStatus)

**Summary:** true

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


<a id="MedicinalProductDefinition.packagedMedicinalProduct"></a>

## MedicinalProductDefinition.packagedMedicinalProduct
Package type for the product

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

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[medicinal-product-package-type](/valueset-medicinal-product-package-type)

**Summary:** true

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


<a id="MedicinalProductDefinition.comprisedOf"></a>

## 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](/ManufacturedItemDefinition), [DeviceDefinition](/DeviceDefinition))

**Summary:** true

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


<a id="MedicinalProductDefinition.ingredient"></a>

## 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](/CodeableConcept)

**Binding:** example:[substance-codes](/valueset-substance-codes)

**Summary:** true

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


<a id="MedicinalProductDefinition.impurity"></a>

## 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](/CodeableReference)

**Binding:** example:[substance-codes](/valueset-substance-codes)

**Summary:** true

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


<a id="MedicinalProductDefinition.attachedDocument"></a>

## MedicinalProductDefinition.attachedDocument
Additional documentation about the medicinal product

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

**Cardinality:** 0..*

**Type:** Reference([DocumentReference](/DocumentReference))

**Summary:** true

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


<a id="MedicinalProductDefinition.masterFile"></a>

## 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](/DocumentReference))

**Summary:** true

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


<a id="MedicinalProductDefinition.contact"></a>

## 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](/BackboneElement)

**Summary:** true

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


<a id="MedicinalProductDefinition.contact.type"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-contact-type](/valueset-medicinal-product-contact-type)

**Summary:** true

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


<a id="MedicinalProductDefinition.contact.contact"></a>

## 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](/Organization), [PractitionerRole](/PractitionerRole))

**Summary:** true

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


<a id="MedicinalProductDefinition.clinicalTrial"></a>

## 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](/ResearchStudy))

**Summary:** true

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


<a id="MedicinalProductDefinition.code"></a>

## 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](/Coding)

**Binding:** example:[medication-codes](/valueset-medication-codes)

**Summary:** true

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


<a id="MedicinalProductDefinition.name"></a>

## 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](/BackboneElement)

**Summary:** true

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


<a id="MedicinalProductDefinition.name.productName"></a>

## MedicinalProductDefinition.name.productName
The full product name

**Definition:** The full product name.

**Cardinality:** 1..1

**Type:** [string](/string)

**Summary:** true

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


<a id="MedicinalProductDefinition.name.type"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-name-type](/valueset-medicinal-product-name-type)

**Summary:** true

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


<a id="MedicinalProductDefinition.name.part"></a>

## MedicinalProductDefinition.name.part
Coding words or phrases of the name

**Definition:** Coding words or phrases of the name.

**Cardinality:** 0..*

**Type:** [BackboneElement](/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


<a id="MedicinalProductDefinition.name.part.part"></a>

## MedicinalProductDefinition.name.part.part
A fragment of a product name

**Definition:** A fragment of a product name.

**Cardinality:** 1..1

**Type:** [string](/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


<a id="MedicinalProductDefinition.name.part.type"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-name-part-type](/valueset-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


<a id="MedicinalProductDefinition.name.usage"></a>

## 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](/BackboneElement)

**Summary:** true

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


<a id="MedicinalProductDefinition.name.usage.country"></a>

## MedicinalProductDefinition.name.usage.country
Country code for where this name applies

**Definition:** Country code for where this name applies.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[country](/valueset-country)

**Summary:** true

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


<a id="MedicinalProductDefinition.name.usage.jurisdiction"></a>

## 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](/CodeableConcept)

**Binding:** example:[jurisdiction](/valueset-jurisdiction)

**Summary:** true

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


<a id="MedicinalProductDefinition.name.usage.language"></a>

## MedicinalProductDefinition.name.usage.language
Language code for this name

**Definition:** Language code for this name.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** required:[all-languages](/valueset-all-languages)

**Summary:** true

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


<a id="MedicinalProductDefinition.crossReference"></a>

## 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](/BackboneElement)

**Summary:** true

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


<a id="MedicinalProductDefinition.crossReference.product"></a>

## 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](/CodeableReference)

**Summary:** true

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


<a id="MedicinalProductDefinition.crossReference.type"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-cross-reference-type](/valueset-medicinal-product-cross-reference-type)

**Summary:** true

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


<a id="MedicinalProductDefinition.operation"></a>

## 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](/BackboneElement)

**Summary:** true

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


<a id="MedicinalProductDefinition.operation.type"></a>

## 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](/CodeableReference)

**Summary:** true

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


<a id="MedicinalProductDefinition.operation.effectiveDate"></a>

## MedicinalProductDefinition.operation.effectiveDate
Date range of applicability

**Definition:** Date range of applicability.

**Cardinality:** 0..1

**Type:** [Period](/Period)

**Summary:** true

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


<a id="MedicinalProductDefinition.operation.organization"></a>

## 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](/Organization))

**Summary:** true

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


<a id="MedicinalProductDefinition.operation.confidentialityIndicator"></a>

## 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](/CodeableConcept)

**Binding:** example:[medicinal-product-confidentiality](/valueset-medicinal-product-confidentiality)

**Summary:** true

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


<a id="MedicinalProductDefinition.characteristic"></a>

## 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](/BackboneElement)

**Summary:** true

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


<a id="MedicinalProductDefinition.characteristic.type"></a>

## MedicinalProductDefinition.characteristic.type
A code expressing the type of characteristic

**Definition:** A code expressing the type of characteristic.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[product-characteristic-codes](/valueset-product-characteristic-codes)

**Summary:** true

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


<a id="MedicinalProductDefinition.characteristic.value[x]"></a>

## 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](/CodeableConcept), [markdown](/markdown), [Quantity](/Quantity), [Range](/Range), [integer](/integer), [date](/date), [boolean](/boolean), [Attachment](/Attachment)

**Summary:** true

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