UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/tree/master and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• XML
• JSON
• TTL

Resource Profile: Processing Profile - Marketing Authorisation

Intermediate profile for processing PPL Marketing Authorisation (Regulated Authorization) data

Usage:

• This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
identifier		0..*	Identifier	Marketing authorisation number
system		0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
subject		0..*	Reference(Processing Profile - Medicinal Product | Processing Profile - Packaged Product)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type		0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000061
display		1..1	string	Representation defined by the system Fixed Value: Marketing Authorisation
region		0..1	CodeableConcept	The territory in which the authorization has been granted
status		0..1	CodeableConcept	Marketing authorisation status
statusDate		0..1	dateTime	Issue/changing date of the marketing authorisation
holder		0..1	Reference(Processing Profile - Organization)	The organization that has been granted this authorization, by the regulator
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Marketing authorisation number
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
subject	Σ	0..*	Reference(Processing Profile - Medicinal Product | Processing Profile - Packaged Product)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000061
display		1..1	string	Representation defined by the system Fixed Value: Marketing Authorisation
region	Σ	0..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
status	Σ	0..1	CodeableConcept	Marketing authorisation status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	Issue/changing date of the marketing authorisation
holder	Σ	0..1	Reference(Processing Profile - Organization)	The organization that has been granted this authorization, by the regulator
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
RegulatedAuthorization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
RegulatedAuthorization.type	example	Pattern: 220000000061("Marketing Authorisation") http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Marketing authorisation number
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
subject	Σ	0..*	Reference(Processing Profile - Medicinal Product | Processing Profile - Packaged Product)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000061
display		1..1	string	Representation defined by the system Fixed Value: Marketing Authorisation
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
status	Σ	0..1	CodeableConcept	Marketing authorisation status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	Issue/changing date of the marketing authorisation
validityPeriod	Σ	0..1	Period	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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product.
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
holder	Σ	0..1	Reference(Processing Profile - Organization)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	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)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
status	Σ	0..1	CodeableConcept	The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
RegulatedAuthorization.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
RegulatedAuthorization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
RegulatedAuthorization.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
RegulatedAuthorization.type	example	Pattern: 220000000061("Marketing Authorisation") http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
RegulatedAuthorization.intendedUse	preferred	ProductIntendedUse http://hl7.org/fhir/ValueSet/product-intended-use from the FHIR Standard
RegulatedAuthorization.basis	example	RegulatedAuthorizationBasis http://hl7.org/fhir/ValueSet/regulated-authorization-basis from the FHIR Standard
RegulatedAuthorization.case.type	example	RegulatedAuthorizationCaseType http://hl7.org/fhir/ValueSet/regulated-authorization-case-type from the FHIR Standard
RegulatedAuthorization.case.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Structures

This structure refers to these other structures:

• Processing Profile - Medicinal Product (http://unicom-project.eu/fhir/StructureDefinition/TransitionMedicinalProductDefinition)
• Processing Profile - Packaged Product (http://unicom-project.eu/fhir/StructureDefinition/TransitionPackagedProductDefinition)
• Processing Profile - Organization (http://unicom-project.eu/fhir/StructureDefinition/TransitionOrganization)

Differential View

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
identifier		0..*	Identifier	Marketing authorisation number
system		0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
subject		0..*	Reference(Processing Profile - Medicinal Product | Processing Profile - Packaged Product)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type		0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000061
display		1..1	string	Representation defined by the system Fixed Value: Marketing Authorisation
region		0..1	CodeableConcept	The territory in which the authorization has been granted
status		0..1	CodeableConcept	Marketing authorisation status
statusDate		0..1	dateTime	Issue/changing date of the marketing authorisation
holder		0..1	Reference(Processing Profile - Organization)	The organization that has been granted this authorization, by the regulator
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Marketing authorisation number
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
subject	Σ	0..*	Reference(Processing Profile - Medicinal Product | Processing Profile - Packaged Product)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000061
display		1..1	string	Representation defined by the system Fixed Value: Marketing Authorisation
region	Σ	0..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
status	Σ	0..1	CodeableConcept	Marketing authorisation status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	Issue/changing date of the marketing authorisation
holder	Σ	0..1	Reference(Processing Profile - Organization)	The organization that has been granted this authorization, by the regulator
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
RegulatedAuthorization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
RegulatedAuthorization.type	example	Pattern: 220000000061("Marketing Authorisation") http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Marketing authorisation number
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
value	ΣC	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
subject	Σ	0..*	Reference(Processing Profile - Medicinal Product | Processing Profile - Packaged Product)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: https://spor.ema.europa.eu/v1/lists/220000000060
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 220000000061
display		1..1	string	Representation defined by the system Fixed Value: Marketing Authorisation
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
status	Σ	0..1	CodeableConcept	Marketing authorisation status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	Issue/changing date of the marketing authorisation
validityPeriod	Σ	0..1	Period	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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product.
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
holder	Σ	0..1	Reference(Processing Profile - Organization)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	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)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.
status	Σ	0..1	CodeableConcept	The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
RegulatedAuthorization.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
RegulatedAuthorization.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
RegulatedAuthorization.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
RegulatedAuthorization.type	example	Pattern: 220000000061("Marketing Authorisation") http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
RegulatedAuthorization.intendedUse	preferred	ProductIntendedUse http://hl7.org/fhir/ValueSet/product-intended-use from the FHIR Standard
RegulatedAuthorization.basis	example	RegulatedAuthorizationBasis http://hl7.org/fhir/ValueSet/regulated-authorization-basis from the FHIR Standard
RegulatedAuthorization.case.type	example	RegulatedAuthorizationCaseType http://hl7.org/fhir/ValueSet/regulated-authorization-case-type from the FHIR Standard
RegulatedAuthorization.case.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from RegulatedAuthorization

Summary

Structures

This structure refers to these other structures:

• Processing Profile - Medicinal Product (http://unicom-project.eu/fhir/StructureDefinition/TransitionMedicinalProductDefinition)
• Processing Profile - Packaged Product (http://unicom-project.eu/fhir/StructureDefinition/TransitionPackagedProductDefinition)
• Processing Profile - Organization (http://unicom-project.eu/fhir/StructureDefinition/TransitionOrganization)

Other representations of profile: CSV, Excel, Schematron