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

# RegulatedAuthorization Definitions

<a id="RegulatedAuthorization"></a>

## RegulatedAuthorization
Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product

**Definition:** Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.

**Cardinality:** 0..*

**Mappings:** idmp=Marketing Authorization, Clinical Trial Authorization; w5=administrative.medication


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

## RegulatedAuthorization.identifier
Business identifier for the authorization, typically assigned by the authorizing body

**Definition:** Business identifier for the authorization, typically assigned by the authorizing body.

**Cardinality:** 0..*

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Marketing Authorization Number; w5=FiveWs.class


<a id="RegulatedAuthorization.subject"></a>

## RegulatedAuthorization.subject
The product type, treatment, facility or activity that is being authorized

**Definition:** The product type, treatment, facility or activity that is being authorized.

**Cardinality:** 0..*

**Type:** Reference([MedicinalProductDefinition](/MedicinalProductDefinition), [BiologicallyDerivedProduct](/BiologicallyDerivedProduct), [NutritionProduct](/NutritionProduct), [PackagedProductDefinition](/PackagedProductDefinition), [ManufacturedItemDefinition](/ManufacturedItemDefinition), [Ingredient](/Ingredient), [SubstanceDefinition](/SubstanceDefinition), [DeviceDefinition](/DeviceDefinition), [ResearchStudy](/ResearchStudy), [ActivityDefinition](/ActivityDefinition), [PlanDefinition](/PlanDefinition), [ObservationDefinition](/ObservationDefinition), [Practitioner](/Practitioner), [Organization](/Organization), [Location](/Location))

**Summary:** true

**Mappings:** idmp=(the link to Medicinal Product or Packaged Medicinal Product)


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

## RegulatedAuthorization.type
Overall type of this authorization, for example drug marketing approval, orphan drug designation

**Definition:** Overall type of this authorization, for example drug marketing approval, orphan drug designation.

**Cardinality:** 0..1

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

**Binding:** example:[regulated-authorization-type](/valueset-regulated-authorization-type)

**Summary:** true

**Mappings:** idmp=n/a


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

## RegulatedAuthorization.description
General textual supporting information

**Definition:** General textual supporting information.

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=n/a


<a id="RegulatedAuthorization.region"></a>

## RegulatedAuthorization.region
The territory in which the authorization has been granted

**Definition:** The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.

**Cardinality:** 0..*

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

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Country


<a id="RegulatedAuthorization.status"></a>

## RegulatedAuthorization.status
The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications

**Definition:** The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.

**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=Marketing Authorization.Authorization Status


<a id="RegulatedAuthorization.statusDate"></a>

## RegulatedAuthorization.statusDate
The date at which the current status was assigned

**Definition:** The date at which the current status was assigned.

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Authorization Status Date


<a id="RegulatedAuthorization.validityPeriod"></a>

## RegulatedAuthorization.validityPeriod
The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date

**Definition:** The time period in which the regulatory approval, clearance or licensing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End


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

## RegulatedAuthorization.indication
Condition for which the use of the regulated product applies

**Definition:** Condition for which the use of the regulated product applies.

**Cardinality:** 0..*

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

**Summary:** true

**Mappings:** idmp=n/a


<a id="RegulatedAuthorization.intendedUse"></a>

## RegulatedAuthorization.intendedUse
The intended use of the product, e.g. prevention, treatment

**Definition:** The intended use of the product, e.g. prevention, treatment, diagnosis.

**Cardinality:** 0..1

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

**Binding:** preferred:[product-intended-use](/valueset-product-intended-use)

**Summary:** true

**Mappings:** idmp=n/a


<a id="RegulatedAuthorization.basis"></a>

## RegulatedAuthorization.basis
The legal/regulatory framework or reasons under which this authorization is granted

**Definition:** The legal or regulatory framework against which this authorization is granted, or other reasons for it.

**Cardinality:** 0..*

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

**Binding:** example:[regulated-authorization-basis](/valueset-regulated-authorization-basis)

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Status Reasons.Legal Grounds


<a id="RegulatedAuthorization.holder"></a>

## RegulatedAuthorization.holder
The organization that has been granted this authorization, by the regulator

**Definition:** The organization that has been granted this authorization, by some authoritative body (the 'regulator').

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Marketing Authorization Holder (Organisation)


<a id="RegulatedAuthorization.regulator"></a>

## RegulatedAuthorization.regulator
The regulatory authority or authorizing body granting the authorization

**Definition:** The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Medicines Regulatory Agency (Organisation)


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

## RegulatedAuthorization.attachedDocument
Additional information or supporting documentation about the authorization

**Definition:** Additional information or supporting documentation about the authorization.

**Cardinality:** 0..*

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

**Summary:** true

**Mappings:** idmp=n/a


<a id="RegulatedAuthorization.case"></a>

## RegulatedAuthorization.case
The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)

**Definition:** The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application


<a id="RegulatedAuthorization.case.identifier"></a>

## RegulatedAuthorization.case.identifier
Identifier by which this case can be referenced

**Definition:** Identifier by which this case can be referenced.

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number


<a id="RegulatedAuthorization.case.type"></a>

## RegulatedAuthorization.case.type
The defining type of case

**Definition:** The defining type of case.

**Cardinality:** 0..1

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

**Binding:** example:[regulated-authorization-case-type](/valueset-regulated-authorization-case-type)

**Summary:** true

**Mappings:** idmp=Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type


<a id="RegulatedAuthorization.case.status"></a>

## RegulatedAuthorization.case.status
The status associated with the case

**Definition:** The status associated with the case.

**Cardinality:** 0..1

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

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

**Summary:** true

**Mappings:** idmp=n/a


<a id="RegulatedAuthorization.case.date[x]"></a>

## RegulatedAuthorization.case.date[x]
Relevant date for this case

**Definition:** Relevant date for this case.

**Cardinality:** 0..1

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

**Summary:** true

**Mappings:** idmp=Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date


<a id="RegulatedAuthorization.case.application"></a>

## RegulatedAuthorization.case.application
Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

**Definition:** A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.

**Cardinality:** 0..*

**Summary:** true

**Mappings:** idmp=Marketing Authorization.Marketing Authorization Application