Vulcan ePI FHIR Implementation Guide
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Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: RegulatedAuthorization (ePI)

Official URL: http://hl7.org/fhir/uv/vulcan-epi/StructureDefinition/RegulatedAuthorization-uv-epi Version: 0.1.0
Active as of 2022-09-02 Computable Name: RegulatedAuthorizationUvEpi

RegulatedAuthorization (ePI)

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 4 elements (3 nested mandatory elements)

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element RegulatedAuthorization.type.coding is sliced based on the value of value:system

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 0..*RegulatedAuthorizationRegulatory approval, clearance or licencing 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
... identifier 1..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body
.... system 1..1uriThe namespace for the identifier value
Binding: RegulatedAuthorization identifier systems (extensible)
.... value 1..1stringThe value that is unique
... subject 0..*Reference(MedicinalProductDefinition (ePI))The product type, treatment, facility or activity that is being authorized
... type
.... Slices for coding 0..*CodingCode defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:spor 0..*CodingType of authorization
...... system 1..1uriIdentity of the terminology system
Required Pattern: https://spor.ema.europa.eu
...... code 1..1codeSymbol in syntax defined by the system
... region 0..*CodeableConceptThe jusrisdiction in which the authorization has been granted
... status 0..1CodeableConceptThe current status of this authorization
Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]}
... statusDate 0..1dateTimeThe date at which the current status was assigned
Example null: 2015-02-07T13:28:17Z
... indication
.... reference 1..1Reference(ClinicalUseDefinition Indication (ePI))Reference to the
... holder 1..1Reference(Organization (ePI))The organization that holds the granted authorization
... regulator 0..1Reference(Organization (ePI))The regulatory authority or authorizing body granting the authorization
... case 0..1BackboneElementThe regulatory procedure for granting or amending a regulated authorization.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 0..*RegulatedAuthorizationRegulatory approval, clearance or licencing 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
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Binding: RegulatedAuthorization identifier systems (extensible)
Example General: http://www.acme.com/identifiers/patient
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... subject Σ0..*Reference(MedicinalProductDefinition (ePI))The product type, treatment, facility or activity that is being authorized
... type Σ0..1CodeableConceptOverall type of this authorization, for example drug marketing approval, orphan drug designation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding Σ0..*CodingCode defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:spor Σ0..*CodingType of authorization
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ1..1uriIdentity of the terminology system
Required Pattern: https://spor.ema.europa.eu
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ1..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... description Σ0..1markdownBrief description of the authorization
... region Σ0..*CodeableConceptThe jusrisdiction in which the authorization has been granted
... status Σ0..1CodeableConceptThe current status of this authorization
Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]}
... statusDate Σ0..1dateTimeThe date at which the current status was assigned
Example null: 2015-02-07T13:28:17Z
... validityPeriod Σ0..1PeriodThe time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
... indication Σ0..1CodeableReference(ClinicalUseDefinition)Condition for which the use of the regulated product applies
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... concept Σ0..1CodeableConceptReference to a concept (by class)
.... reference Σ1..1Reference(ClinicalUseDefinition Indication (ePI))Reference to the
... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
... basis Σ0..*CodeableConceptThe legal or regulatory framework against which this authorization is granted, or other reasons for it
... holder Σ1..1Reference(Organization (ePI))The organization that holds the granted authorization
... regulator Σ0..1Reference(Organization (ePI))The regulatory authority or authorizing body granting the authorization
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the authorization
... case Σ0..1BackboneElementThe regulatory procedure for granting or amending a regulated authorization.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... identifier Σ0..1IdentifierIdentifier by which this case can be referenced
.... type Σ0..1CodeableConceptThe defining type of case
.... status Σ0..1CodeableConceptThe status associated with the case
.... date[x] Σ0..1Relevant date for this of case
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*See case (RegulatedAuthorization)Applications submitted to obtain a marketing authorization. Steps within the longer running case or procedure

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 0..*RegulatedAuthorizationRegulatory approval, clearance or licencing 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

doco Documentation for this format

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 4 elements (3 nested mandatory elements)

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element RegulatedAuthorization.type.coding is sliced based on the value of value:system

Differential View

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 0..*RegulatedAuthorizationRegulatory approval, clearance or licencing 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
... identifier 1..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body
.... system 1..1uriThe namespace for the identifier value
Binding: RegulatedAuthorization identifier systems (extensible)
.... value 1..1stringThe value that is unique
... subject 0..*Reference(MedicinalProductDefinition (ePI))The product type, treatment, facility or activity that is being authorized
... type
.... Slices for coding 0..*CodingCode defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:spor 0..*CodingType of authorization
...... system 1..1uriIdentity of the terminology system
Required Pattern: https://spor.ema.europa.eu
...... code 1..1codeSymbol in syntax defined by the system
... region 0..*CodeableConceptThe jusrisdiction in which the authorization has been granted
... status 0..1CodeableConceptThe current status of this authorization
Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]}
... statusDate 0..1dateTimeThe date at which the current status was assigned
Example null: 2015-02-07T13:28:17Z
... indication
.... reference 1..1Reference(ClinicalUseDefinition Indication (ePI))Reference to the
... holder 1..1Reference(Organization (ePI))The organization that holds the granted authorization
... regulator 0..1Reference(Organization (ePI))The regulatory authority or authorizing body granting the authorization
... case 0..1BackboneElementThe regulatory procedure for granting or amending a regulated authorization.

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 0..*RegulatedAuthorizationRegulatory approval, clearance or licencing 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
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ1..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Binding: RegulatedAuthorization identifier systems (extensible)
Example General: http://www.acme.com/identifiers/patient
.... value Σ1..1stringThe value that is unique
Example General: 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... subject Σ0..*Reference(MedicinalProductDefinition (ePI))The product type, treatment, facility or activity that is being authorized
... type Σ0..1CodeableConceptOverall type of this authorization, for example drug marketing approval, orphan drug designation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding Σ0..*CodingCode defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:spor Σ0..*CodingType of authorization
...... id 0..1stringUnique id for inter-element referencing
...... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ1..1uriIdentity of the terminology system
Required Pattern: https://spor.ema.europa.eu
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ1..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... description Σ0..1markdownBrief description of the authorization
... region Σ0..*CodeableConceptThe jusrisdiction in which the authorization has been granted
... status Σ0..1CodeableConceptThe current status of this authorization
Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]}
... statusDate Σ0..1dateTimeThe date at which the current status was assigned
Example null: 2015-02-07T13:28:17Z
... validityPeriod Σ0..1PeriodThe time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
... indication Σ0..1CodeableReference(ClinicalUseDefinition)Condition for which the use of the regulated product applies
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... concept Σ0..1CodeableConceptReference to a concept (by class)
.... reference Σ1..1Reference(ClinicalUseDefinition Indication (ePI))Reference to the
... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
... basis Σ0..*CodeableConceptThe legal or regulatory framework against which this authorization is granted, or other reasons for it
... holder Σ1..1Reference(Organization (ePI))The organization that holds the granted authorization
... regulator Σ0..1Reference(Organization (ePI))The regulatory authority or authorizing body granting the authorization
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the authorization
... case Σ0..1BackboneElementThe regulatory procedure for granting or amending a regulated authorization.
.... id 0..1idUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... identifier Σ0..1IdentifierIdentifier by which this case can be referenced
.... type Σ0..1CodeableConceptThe defining type of case
.... status Σ0..1CodeableConceptThe status associated with the case
.... date[x] Σ0..1Relevant date for this of case
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*See case (RegulatedAuthorization)Applications submitted to obtain a marketing authorization. Steps within the longer running case or procedure

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
RegulatedAuthorization.languagepreferredCommonLanguages
Max Binding: AllLanguages
RegulatedAuthorization.identifier.userequiredIdentifierUse
RegulatedAuthorization.identifier.typeextensibleIdentifier Type Codes
RegulatedAuthorization.identifier.systemextensibleVsRegulatedAuthIdSystems