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: PPL Marketing Authorisation profile

Regulated Authorization profile defines the Marketing Authorisation on product or package level

Usage:

• Examples for this Resource Profile: RegulatedAuthorization/Agen-5mg-Tablet-EE-RA, RegulatedAuthorization/CanifugCremolum-EE-RA and RegulatedAuthorization/Cefuroxime-MIP-1500mg-EE-RA

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		1..*	Identifier	Marketing authorisation number
system		0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
subject		1..1	Reference(PPL Medicinal Product profile | PPL Packaged Product profile)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type		1..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		1..1	CodeableConcept	The territory in which the authorization has been granted
coding		0..*	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
status		1..1	CodeableConcept	Marketing authorisation status Binding: EMA SPOR Regulatory Entitlement Status (required)
statusDate		0..1	dateTime	Issue/changing date of the marketing authorisation
holder		1..1	Reference(PPL Organization)	The organization that has been granted this authorization, by the regulator
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
RegulatedAuthorization.region.coding	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
RegulatedAuthorization.status	required	SporRegulatoryStatus (a valid code from Regulatory Entitlement Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/regulatory-status-spor-vs from this IG

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	1..*	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	1..1	Reference(PPL Medicinal Product profile | PPL Packaged Product profile)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	1..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	1..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
status	Σ	1..1	CodeableConcept	Marketing authorisation status Binding: EMA SPOR Regulatory Entitlement Status (required)
statusDate	Σ	0..1	dateTime	Issue/changing date of the marketing authorisation
holder	Σ	1..1	Reference(PPL 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.region.coding	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
RegulatedAuthorization.status	required	SporRegulatoryStatus (a valid code from Regulatory Entitlement Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/regulatory-status-spor-vs from this IG

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	1..*	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	1..1	Reference(PPL Medicinal Product profile | PPL Packaged Product profile)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	1..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	1..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
text	Σ	0..1	string	Plain text representation of the concept
status	Σ	1..1	CodeableConcept	Marketing authorisation status Binding: EMA SPOR Regulatory Entitlement Status (required)
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	1..1	Reference(PPL 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.region.coding	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
RegulatedAuthorization.status	required	SporRegulatoryStatus (a valid code from Regulatory Entitlement Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/regulatory-status-spor-vs from this IG
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

Mandatory: 6 elements

Structures

This structure refers to these other structures:

• PPL Medicinal Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition)
• PPL Packaged Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition)
• PPL Organization (http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization)

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		1..*	Identifier	Marketing authorisation number
system		0..1	uri	The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber
subject		1..1	Reference(PPL Medicinal Product profile | PPL Packaged Product profile)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type		1..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		1..1	CodeableConcept	The territory in which the authorization has been granted
coding		0..*	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
status		1..1	CodeableConcept	Marketing authorisation status Binding: EMA SPOR Regulatory Entitlement Status (required)
statusDate		0..1	dateTime	Issue/changing date of the marketing authorisation
holder		1..1	Reference(PPL Organization)	The organization that has been granted this authorization, by the regulator
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
RegulatedAuthorization.region.coding	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
RegulatedAuthorization.status	required	SporRegulatoryStatus (a valid code from Regulatory Entitlement Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/regulatory-status-spor-vs from this IG

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	1..*	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	1..1	Reference(PPL Medicinal Product profile | PPL Packaged Product profile)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	1..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	1..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
status	Σ	1..1	CodeableConcept	Marketing authorisation status Binding: EMA SPOR Regulatory Entitlement Status (required)
statusDate	Σ	0..1	dateTime	Issue/changing date of the marketing authorisation
holder	Σ	1..1	Reference(PPL 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.region.coding	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
RegulatedAuthorization.status	required	SporRegulatoryStatus (a valid code from Regulatory Entitlement Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/regulatory-status-spor-vs from this IG

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	1..*	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	1..1	Reference(PPL Medicinal Product profile | PPL Packaged Product profile)	Reference to the medicinal product or a single package, depending on how the MA has been issued
type	Σ	1..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	1..1	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: EMA SPOR Country (required)
text	Σ	0..1	string	Plain text representation of the concept
status	Σ	1..1	CodeableConcept	Marketing authorisation status Binding: EMA SPOR Regulatory Entitlement Status (required)
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	1..1	Reference(PPL 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.region.coding	required	CountryEMA (a valid code from Country EMA) http://unicom-project.eu/fhir/ValueSet/country-ema-vs from this IG
RegulatedAuthorization.status	required	SporRegulatoryStatus (a valid code from Regulatory Entitlement Status EMA SPOR) http://unicom-project.eu/fhir/ValueSet/regulatory-status-spor-vs from this IG
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

Mandatory: 6 elements

Structures

This structure refers to these other structures:

• PPL Medicinal Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition)
• PPL Packaged Product profile (http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition)
• PPL Organization (http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization)

Other representations of profile: CSV, Excel, Schematron