0.1.0 - ci-build

AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: AT_MedicinalProduct_MarketingRegulatedAuthorization - Detailed Descriptions

Draft as of 2024-05-27

Definitions for the at-medprod-marketingRegulatedAuthorization resource profile.

Guidance on how to interpret the contents of this table can be found here

0. RegulatedAuthorization
2. RegulatedAuthorization.identifier
ShortBusiness identifier for the authorization, typically assigned by the authorizing body (authorization number)
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
TypeIdentifier(Identifier)
4. RegulatedAuthorization.identifier.system
Pattern Valuehttp://ema.europa.eu/fhir/marketingAuthorizationNumber
6. RegulatedAuthorization.subject
Control1..1
TypeReference(Medicinal Product Definition)
8. RegulatedAuthorization.type
Control1..?
TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
Pattern Value{
  "coding" : [{
    "system" : "https://spor.ema.europa.eu/v1/lists/220000000060",
    "code" : "220000000061"
  }]
}
10. RegulatedAuthorization.status
ShortThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)
Control1..?
TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
12. RegulatedAuthorization.status.coding
BindingThe codes SHALL be taken from The Regulatory Entitlement Status Value Set
(required to https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus)
14. RegulatedAuthorization.holder
ShortThe organization that has been granted this authorization, by the regulator (authorization holder)
16. RegulatedAuthorization.holder.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..?
18. RegulatedAuthorization.holder.identifier.system
Control1..?
Pattern Valuehttps://spor.ema.europa.eu/omswi
20. RegulatedAuthorization.holder.identifier.value
ShortThis value contains the Location ID from the EMA SPOR OMS System
Control1..?
22. RegulatedAuthorization.holder.display
ShortThe name of the marketing authorisation holder
Control1..?

Guidance on how to interpret the contents of this table can be found here

0. RegulatedAuthorization
Definition

Regulatory 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.

ShortRegulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. RegulatedAuthorization.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. RegulatedAuthorization.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. RegulatedAuthorization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. RegulatedAuthorization.identifier
Definition

An identifier - identifies some entity uniquely and unambiguously. Typically this is used for business identifiers.


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

ShortBusiness identifier for the authorization, typically assigned by the authorizing body (authorization number)
Comments

The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..1*
TypeIdentifier(Identifier)
Is Modifierfalse
Must Supportfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason (value.exists())
10. RegulatedAuthorization.identifier.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. RegulatedAuthorization.identifier.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Pattern Valuehttp://ema.europa.eu/fhir/marketingAuthorizationNumber
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. RegulatedAuthorization.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control10..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. RegulatedAuthorization.subject
Definition

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

ShortThe product type, treatment, facility or activity that is being authorized
Control10..1*
TypeReference(Medicinal Product Definition, MedicinalProductDefinition, BiologicallyDerivedProduct, NutritionProduct, PackagedProductDefinition, ManufacturedItemDefinition, Ingredient, SubstanceDefinition, DeviceDefinition, ResearchStudy, ActivityDefinition, PlanDefinition, ObservationDefinition, Practitioner, Organization, Location)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. RegulatedAuthorization.type
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


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

ShortConcept - reference to a terminology or just textOverall type of this authorization, for example drug marketing approval, orphan drug designation
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Control10..1
BindingFor example codes, see RegulatedAuthorizationTypehttp://hl7.org/fhir/ValueSet/regulated-authorization-type
(example to http://hl7.org/fhir/ValueSet/regulated-authorization-type)

Overall type of this authorization.

TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
Is Modifierfalse
Must Supportfalse
Pattern Value{
  "coding" : [{
    "system" : "https://spor.ema.europa.eu/v1/lists/220000000060",
    "code" : "220000000061"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. RegulatedAuthorization.status
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


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

ShortThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Control10..1
BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status
(preferred to http://hl7.org/fhir/ValueSet/publication-status)

The lifecycle status of an artifact.

TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
Is Modifierfalse
Must Supportfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. RegulatedAuthorization.status.coding
Definition

A reference to a code defined by a terminology system.

ShortA reference to a code defined by a terminology systemCode defined by a terminology system
Comments

Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.


Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control0..*
BindingThe codes SHALL be taken from For codes, see The Regulatory Entitlement Status Value Set
(required to https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus)
TypeCoding(Coding)
Is Modifierfalse
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantscod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text (code.exists().not() implies display.exists().not())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. RegulatedAuthorization.holder
Definition

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

ShortThe organization that has been granted this authorization, by the regulator (authorization holder)
Control0..1
TypeReference(Organization)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. RegulatedAuthorization.holder.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

ShortLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control0..1
This element is affected by the following invariants: ref-2, ref-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. RegulatedAuthorization.holder.identifier
Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

ShortLogical reference, when literal reference is not known
Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..1
This element is affected by the following invariants: ref-2
TypeIdentifier
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. RegulatedAuthorization.holder.identifier.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. RegulatedAuthorization.holder.identifier.system
Definition

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control10..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Pattern Valuehttps://spor.ema.europa.eu/omswi
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. RegulatedAuthorization.holder.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThis value contains the Location ID from the EMA SPOR OMS SystemThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control10..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. RegulatedAuthorization.holder.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

ShortThe name of the marketing authorisation holderText alternative for the resource
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control10..1
This element is affected by the following invariants: ref-2
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. RegulatedAuthorization
Definition

Regulatory 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.

ShortRegulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. RegulatedAuthorization.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

Control0..1
Typeid
Is Modifierfalse
Must Supportfalse
Summarytrue
4. RegulatedAuthorization.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. RegulatedAuthorization.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. RegulatedAuthorization.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

IETF language tag for a human language

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. RegulatedAuthorization.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. RegulatedAuthorization.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. RegulatedAuthorization.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. RegulatedAuthorization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. RegulatedAuthorization.identifier
Definition

An identifier - identifies some entity uniquely and unambiguously. Typically this is used for business identifiers.

ShortBusiness identifier for the authorization, typically assigned by the authorizing body (authorization number)
Comments

The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
TypeIdentifier(Identifier)
Is Modifierfalse
Must Supportfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason (value.exists())
20. RegulatedAuthorization.identifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
22. RegulatedAuthorization.identifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 24. RegulatedAuthorization.identifier.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUse
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. RegulatedAuthorization.identifier.type
    Definition

    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

    ShortDescription of identifier
    Comments

    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

    Control0..1
    BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
    (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

    TypeCodeableConcept
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows users to make use of identifiers when the identifier system is not known.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. RegulatedAuthorization.identifier.system
    Definition

    Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

    Control1..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

    Pattern Valuehttp://ema.europa.eu/fhir/marketingAuthorizationNumber
    Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. RegulatedAuthorization.identifier.value
    Definition

    The portion of the identifier typically relevant to the user and which is unique within the context of the system.

    ShortThe value that is unique
    Comments

    If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

    Control1..1
    This element is affected by the following invariants: ident-1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Example<br/><b>General</b>:123456
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. RegulatedAuthorization.identifier.period
    Definition

    Time period during which identifier is/was valid for use.

    ShortTime period when id is/was valid for use
    Control0..1
    TypePeriod
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. RegulatedAuthorization.identifier.assigner
    Definition

    Organization that issued/manages the identifier.

    ShortOrganization that issued id (may be just text)
    Comments

    The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

    Control0..1
    TypeReference(Organization)
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. RegulatedAuthorization.subject
    Definition

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

    ShortThe product type, treatment, facility or activity that is being authorized
    Control1..1
    TypeReference(Medicinal Product Definition)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    38. RegulatedAuthorization.type
    Definition

    A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

    ShortConcept - reference to a terminology or just text
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control1..1
    BindingFor example codes, see RegulatedAuthorizationType
    (example to http://hl7.org/fhir/ValueSet/regulated-authorization-type)

    Overall type of this authorization.

    TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
    Is Modifierfalse
    Must Supportfalse
    Pattern Value{
      "coding" : [{
        "system" : "https://spor.ema.europa.eu/v1/lists/220000000060",
        "code" : "220000000061"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    40. RegulatedAuthorization.description
    Definition

    General textual supporting information.

    ShortGeneral textual supporting information
    Control0..1
    Typemarkdown
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. RegulatedAuthorization.region
    Definition

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

    ShortThe territory in which the authorization has been granted
    Control0..*
    BindingFor example codes, see JurisdictionValueSet
    (example to http://hl7.org/fhir/ValueSet/jurisdiction)

    Jurisdiction codes

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    44. RegulatedAuthorization.status
    Definition

    A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

    ShortThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control1..1
    BindingThe codes SHOULD be taken from PublicationStatus
    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

    The lifecycle status of an artifact.

    TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
    Is Modifierfalse
    Must Supportfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    46. RegulatedAuthorization.status.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    This element is affected by the following invariants: ele-1
    Typeid
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    48. RegulatedAuthorization.status.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on RegulatedAuthorization.status.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 50. RegulatedAuthorization.status.coding
      Definition

      A reference to a code defined by a terminology system.

      ShortA reference to a code defined by a terminology system
      Comments

      Codes may be defined very casually in enumerations or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.

      Control0..*
      BindingThe codes SHALL be taken from The Regulatory Entitlement Status Value Set
      (required to https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus)
      TypeCoding(Coding)
      Is Modifierfalse
      Requirements

      Allows for alternative encodings within a code system, and translations to other code systems.

      Invariantscod-1: A Coding SHOULD NOT have a display unless a code is also present. Computation on Coding.display alone is generally unsafe. Consider using CodeableConcept.text (code.exists().not() implies display.exists().not())
      ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      52. RegulatedAuthorization.status.text
      Definition

      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

      ShortPlain text representation of the concept
      Comments

      Very often the text is the same as a displayName of one of the codings.

      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      54. RegulatedAuthorization.statusDate
      Definition

      The date at which the current status was assigned.

      ShortThe date at which the current status was assigned
      Control0..1
      TypedateTime
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      56. RegulatedAuthorization.validityPeriod
      Definition

      The 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.

      ShortThe 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
      Control0..1
      TypePeriod
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. RegulatedAuthorization.indication
      Definition

      Condition for which the use of the regulated product applies.

      ShortCondition for which the use of the regulated product applies
      Control0..*
      TypeCodeableReference(ClinicalUseDefinition)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. RegulatedAuthorization.intendedUse
      Definition

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

      ShortThe intended use of the product, e.g. prevention, treatment
      Control0..1
      BindingThe codes SHOULD be taken from ProductIntendedUse
      (preferred to http://hl7.org/fhir/ValueSet/product-intended-use)

      The overall intended use of a product.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      62. RegulatedAuthorization.basis
      Definition

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

      ShortThe legal/regulatory framework or reasons under which this authorization is granted
      Control0..*
      BindingFor example codes, see RegulatedAuthorizationBasis
      (example to http://hl7.org/fhir/ValueSet/regulated-authorization-basis)

      A legal or regulatory framework against which an authorization is granted, or other reasons for it.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      64. RegulatedAuthorization.holder
      Definition

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

      ShortThe organization that has been granted this authorization, by the regulator (authorization holder)
      Control0..1
      TypeReference(Organization)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      66. RegulatedAuthorization.holder.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typeid
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      68. RegulatedAuthorization.holder.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on RegulatedAuthorization.holder.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 70. RegulatedAuthorization.holder.reference
        Definition

        A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

        ShortLiteral reference, Relative, internal or absolute URL
        Comments

        Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

        Control0..1
        This element is affected by the following invariants: ref-2, ref-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        72. RegulatedAuthorization.holder.type
        Definition

        The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

        The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

        ShortType the reference refers to (e.g. "Patient") - must be a resource in resources
        Comments

        This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.

        Control0..1
        BindingUnless not suitable, these codes SHALL be taken from ResourceType
        (extensible to http://hl7.org/fhir/ValueSet/resource-types)

        Aa resource (or, for logical models, the URI of the logical model).

        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        74. RegulatedAuthorization.holder.identifier
        Definition

        An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

        ShortLogical reference, when literal reference is not known
        Comments

        When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

        When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

        Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

        Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

        This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control1..1
        This element is affected by the following invariants: ref-2
        TypeIdentifier
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        76. RegulatedAuthorization.holder.identifier.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeid
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        78. RegulatedAuthorization.holder.identifier.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on RegulatedAuthorization.holder.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 80. RegulatedAuthorization.holder.identifier.use
          Definition

          The purpose of this identifier.

          Shortusual | official | temp | secondary | old (If known)
          Comments

          Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

          Control0..1
          BindingThe codes SHALL be taken from IdentifierUse
          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

          Identifies the purpose for this identifier, if known .

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          82. RegulatedAuthorization.holder.identifier.type
          Definition

          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

          ShortDescription of identifier
          Comments

          This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

          Control0..1
          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows users to make use of identifiers when the identifier system is not known.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          84. RegulatedAuthorization.holder.identifier.system
          Definition

          Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

          ShortThe namespace for the identifier value
          Comments

          Identifier.system is always case sensitive.

          Control1..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

          Pattern Valuehttps://spor.ema.europa.eu/omswi
          Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          86. RegulatedAuthorization.holder.identifier.value
          Definition

          The portion of the identifier typically relevant to the user and which is unique within the context of the system.

          ShortThis value contains the Location ID from the EMA SPOR OMS System
          Comments

          If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

          Control1..1
          This element is affected by the following invariants: ident-1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Example<br/><b>General</b>:123456
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          88. RegulatedAuthorization.holder.identifier.period
          Definition

          Time period during which identifier is/was valid for use.

          ShortTime period when id is/was valid for use
          Control0..1
          TypePeriod
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          90. RegulatedAuthorization.holder.identifier.assigner
          Definition

          Organization that issued/manages the identifier.

          ShortOrganization that issued id (may be just text)
          Comments

          The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

          Control0..1
          TypeReference(Organization)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          92. RegulatedAuthorization.holder.display
          Definition

          Plain text narrative that identifies the resource in addition to the resource reference.

          ShortThe name of the marketing authorisation holder
          Comments

          This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

          Control1..1
          This element is affected by the following invariants: ref-2
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          94. RegulatedAuthorization.regulator
          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.

          ShortThe regulatory authority or authorizing body granting the authorization
          Control0..1
          TypeReference(Organization)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          96. RegulatedAuthorization.attachedDocument
          Definition

          Additional information or supporting documentation about the authorization.

          ShortAdditional information or supporting documentation about the authorization
          Control0..*
          TypeReference(DocumentReference)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          98. RegulatedAuthorization.case
          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).

          ShortThe 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)
          Control0..1
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          100. RegulatedAuthorization.case.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          102. RegulatedAuthorization.case.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          104. RegulatedAuthorization.case.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          106. RegulatedAuthorization.case.identifier
          Definition

          Identifier by which this case can be referenced.

          ShortIdentifier by which this case can be referenced
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..1
          TypeIdentifier
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          108. RegulatedAuthorization.case.type
          Definition

          The defining type of case.

          ShortThe defining type of case
          Control0..1
          BindingFor example codes, see RegulatedAuthorizationCaseType
          (example to http://hl7.org/fhir/ValueSet/regulated-authorization-case-type)

          The type of a case involved in an application.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          110. RegulatedAuthorization.case.status
          Definition

          The status associated with the case.

          ShortThe status associated with the case
          Control0..1
          BindingThe codes SHOULD be taken from PublicationStatus
          (preferred to http://hl7.org/fhir/ValueSet/publication-status)

          The lifecycle status of an artifact.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          112. RegulatedAuthorization.case.date[x]
          Definition

          Relevant date for this case.

          ShortRelevant date for this case
          Control0..1
          TypeChoice of: Period, dateTime
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          114. RegulatedAuthorization.case.application
          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.

          ShortApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
          Control0..*
          TypeSeettp://hl7.org/fhir/StructureDefinition/RegulatedAuthorization#RegulatedAuthorization.case
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))