"Id","Path","Slice Name","Alias(s)","Label","Min","Max","Must Support?","Is Modifier?","Is Summary?","Type(s)","Short","Definition","Comments","Requirements","Default Value","Meaning When Missing","Fixed Value","Pattern","Example","Minimum Value","Maximum Value","Maximum Length","Binding Strength","Binding Description","Binding Value Set","Code","Slicing Discriminator","Slicing Description","Slicing Ordered","Slicing Rules","Base Path","Base Min","Base Max","Condition(s)","Constraint(s)","Mapping: FiveWs Pattern Mapping","Mapping: IDMP Mapping","Mapping: RIM Mapping" "RegulatedAuthorization","RegulatedAuthorization","","","",0,*,"","","","null {[]} {[]} ","Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product","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.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization",0,*,"","dom-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()}","administrative.medication","Marketing Authorization, Clinical Trial Authorization","Entity, Role, or Act" "RegulatedAuthorization.id","RegulatedAuthorization.id","","","",0,1,"","","Y","id {[]} {[]} ","Logical id of this artifact","The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.","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.","","","","","","","","",,,,,"",,,,"Resource.id",0,1,"","" "RegulatedAuthorization.meta","RegulatedAuthorization.meta","","","",0,1,"","","Y","Meta {[]} {[]} ","Metadata about the resource","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.","","","","","","","","","",,,,,"",,,,"Resource.meta",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} " "RegulatedAuthorization.implicitRules","RegulatedAuthorization.implicitRules","","","",0,1,"","Y","Y","uri {[]} {[]} ","A set of rules under which this content was created","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.","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.","","","","","","","","",,,,,"",,,,"Resource.implicitRules",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} " "RegulatedAuthorization.language","RegulatedAuthorization.language","","","",0,1,"","","","code {[]} {[]} ","Language of the resource content","The base language in which the resource is written.","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).","","","","","","","","",,"required","IETF language tag for a human language","http://hl7.org/fhir/ValueSet/all-languages|5.0.0","",,,,"Resource.language",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} " "RegulatedAuthorization.text","RegulatedAuthorization.text","","narrative htmlxhtmldisplay","",0,1,"","","","Narrative {[]} {[]} ","Text summary of the resource, for human interpretation","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.","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.","","","","","","","","",,,,,"",,,,"DomainResource.text",0,1,"dom-6 ","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Act.text?" "RegulatedAuthorization.contained","RegulatedAuthorization.contained","","inline resources anonymous resourcescontained resources","",0,*,"","","","Resource {[]} {[]} ","Contained, inline Resources","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.","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.","","","","","","","","",,,,,"",,,,"DomainResource.contained",0,*,"dom-2 dom-4dom-3dom-5","","N/A" "RegulatedAuthorization.extension","RegulatedAuthorization.extension","","extensions user content","",0,*,"","","","Extension {[]} {[]} ","Additional content defined by implementations","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.","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.","","","","","","","","",,,,,"",,,,"DomainResource.extension",0,*,"","ele-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()}","N/A" "RegulatedAuthorization.modifierExtension","RegulatedAuthorization.modifierExtension","","extensions user content","",0,*,"","Y","Y","Extension {[]} {[]} ","Extensions that cannot be ignored","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).","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.","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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).","","","","","","","",,,,,"",,,,"DomainResource.modifierExtension",0,*,"","ele-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()}","N/A" "RegulatedAuthorization.identifier","RegulatedAuthorization.identifier","","","",1,1,"","","Y","Identifier {[CanonicalType[https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-identifier]]} {[]} ","Business identifier for the authorization, typically assigned by the authorizing body (authorization number)","Business identifier for the authorization, typically assigned by the authorizing body.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.identifier",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","FiveWs.class","Marketing Authorization.Marketing Authorization Number" "RegulatedAuthorization.identifier.id","RegulatedAuthorization.identifier.id","","","",0,1,"","","","id {[]} {[]} ","Unique id for inter-element referencing","Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.","","","","","","","","","",,,,,"",,,,"Element.id",0,1,"ele-1 ","","n/a" "RegulatedAuthorization.identifier.extension","RegulatedAuthorization.identifier.extension","","extensions user content","",0,*,"","","","Extension {[]} {[]} ","Additional content defined by implementations","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.","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.","","","","","","","","",,,,,"","value:url} ","Extensions are always sliced by (at least) url",,"open","Element.extension",0,*,"","ele-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()}","n/a" "RegulatedAuthorization.identifier.use","RegulatedAuthorization.identifier.use","","","",0,1,"","Y","Y","code {[]} {[]} ","usual | official | temp | secondary | old (If known)","The purpose of this identifier.","Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.","Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.","","","","","","","",,"required","Identifies the purpose for this identifier, if known .","http://hl7.org/fhir/ValueSet/identifier-use|5.0.0","",,,,"Identifier.use",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Role.code or implied by context" "RegulatedAuthorization.identifier.type","RegulatedAuthorization.identifier.type","","","",0,1,"","","Y","CodeableConcept {[]} {[]} ","Description of identifier","A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.","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.","Allows users to make use of identifiers when the identifier system is not known.","","","","","","","",,"extensible","A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.","http://hl7.org/fhir/ValueSet/identifier-type","",,,,"Identifier.type",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Role.code or implied by context" "RegulatedAuthorization.identifier.system","RegulatedAuthorization.identifier.system","","","",1,1,"","","Y","uri {[]} {[]} ","The namespace for the identifier value","Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.","Identifier.system is always case sensitive.","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.","","","","","","","",,,,,"",,,,"Identifier.system",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","II.root or Role.id.root" "RegulatedAuthorization.identifier.value","RegulatedAuthorization.identifier.value","","","",1,1,"","","Y","string {[]} {[]} ","The value that is unique","The portion of the identifier typically relevant to the user and which is unique within the context of the system.","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](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). 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.","","","","","","","","",,,,,"",,,,"Identifier.value",0,1,"ident-1 ","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" "RegulatedAuthorization.identifier.period","RegulatedAuthorization.identifier.period","","","",0,1,"","","Y","Period {[]} {[]} ","Time period when id is/was valid for use","Time period during which identifier is/was valid for use.","","","","","","","","","",,,,,"",,,,"Identifier.period",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Role.effectiveTime or implied by context" "RegulatedAuthorization.identifier.assigner","RegulatedAuthorization.identifier.assigner","","","",0,1,"","","Y","Reference {[]} {[CanonicalType[http://hl7.org/fhir/StructureDefinition/Organization]]} ","Organization that issued id (may be just text)","Organization that issued/manages the identifier.","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.","","","","","","","","",,,,,"",,,,"Identifier.assigner",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" "RegulatedAuthorization.subject","RegulatedAuthorization.subject","","","",1,1,"","","Y","Reference {[]} {[CanonicalType[https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-medicinalproductdefinition]]} ","The product type, treatment, facility or activity that is being authorized","The product type, treatment, facility or activity that is being authorized.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.subject",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","(the link to Medicinal Product or Packaged Medicinal Product)" "RegulatedAuthorization.type","RegulatedAuthorization.type","","","",1,1,"","","Y","CodeableConcept {[CanonicalType[https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-codeableconcept]]} {[]} ","Overall type of this authorization, for example drug marketing approval, orphan drug designation","Overall type of this authorization, for example drug marketing approval, orphan drug designation.","","","","",""," ","","","",,"example","Overall type of this authorization.","http://hl7.org/fhir/ValueSet/regulated-authorization-type","",,,,"RegulatedAuthorization.type",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","n/a" "RegulatedAuthorization.description","RegulatedAuthorization.description","","","",0,1,"","","Y","markdown {[]} {[]} ","General textual supporting information","General textual supporting information.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.description",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","n/a" "RegulatedAuthorization.region","RegulatedAuthorization.region","","","",0,*,"","","Y","CodeableConcept {[]} {[]} ","The territory in which the authorization has been granted","The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.","","","","","","","","","",,"example","Jurisdiction codes","http://hl7.org/fhir/ValueSet/jurisdiction","",,,,"RegulatedAuthorization.region",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Country" "RegulatedAuthorization.status","RegulatedAuthorization.status","","","",1,1,"","","Y","CodeableConcept {[CanonicalType[https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-codeableconcept]]} {[]} ","The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications (authorization status)","The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.","","","","","","","","","",,"preferred","The lifecycle status of an artifact.","http://hl7.org/fhir/ValueSet/publication-status","",,,,"RegulatedAuthorization.status",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Authorization Status" "RegulatedAuthorization.status.id","RegulatedAuthorization.status.id","","","",0,1,"","","","id {[]} {[]} ","Unique id for inter-element referencing","Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.","","","","","","","","","",,,,,"",,,,"Element.id",0,1,"ele-1 ","","n/a" "RegulatedAuthorization.status.extension","RegulatedAuthorization.status.extension","","extensions user content","",0,*,"","","","Extension {[]} {[]} ","Additional content defined by implementations","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.","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.","","","","","","","","",,,,,"","value:url} ","Extensions are always sliced by (at least) url",,"open","Element.extension",0,*,"","ele-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()}","n/a" "RegulatedAuthorization.status.coding","RegulatedAuthorization.status.coding","","","",0,*,"","","Y","Coding {[CanonicalType[https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-coding]]} {[]} ","Code defined by a terminology system","A reference to a code defined by a terminology system.","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.","Allows for alternative encodings within a code system, and translations to other code systems.","","","","","","","",,"required","","https://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus","",,,,"CodeableConcept.coding",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","union(., ./translation)" "RegulatedAuthorization.status.text","RegulatedAuthorization.status.text","","","",0,1,"","","Y","string {[]} {[]} ","Plain text representation of the concept","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.","Very often the text is the same as a displayName of one of the codings.","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.","","","","","","","",,,,,"",,,,"CodeableConcept.text",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","./originalText[mediaType/code=""text/plain""]/data" "RegulatedAuthorization.statusDate","RegulatedAuthorization.statusDate","","","",0,1,"","","Y","dateTime {[]} {[]} ","The date at which the current status was assigned","The date at which the current status was assigned.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.statusDate",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Authorization Status Date" "RegulatedAuthorization.validityPeriod","RegulatedAuthorization.validityPeriod","","","",0,1,"","","Y","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","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.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.validityPeriod",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End" "RegulatedAuthorization.indication","RegulatedAuthorization.indication","","","",0,*,"","","Y","CodeableReference {[]} {[CanonicalType[http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition]]} ","Condition for which the use of the regulated product applies","Condition for which the use of the regulated product applies.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.indication",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","n/a" "RegulatedAuthorization.intendedUse","RegulatedAuthorization.intendedUse","","","",0,1,"","","Y","CodeableConcept {[]} {[]} ","The intended use of the product, e.g. prevention, treatment","The intended use of the product, e.g. prevention, treatment, diagnosis.","","","","","","","","","",,"preferred","The overall intended use of a product.","http://hl7.org/fhir/ValueSet/product-intended-use","",,,,"RegulatedAuthorization.intendedUse",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","n/a" "RegulatedAuthorization.basis","RegulatedAuthorization.basis","","","",0,*,"","","Y","CodeableConcept {[]} {[]} ","The legal/regulatory framework or reasons under which this authorization is granted","The legal or regulatory framework against which this authorization is granted, or other reasons for it.","","","","","","","","","",,"example","A legal or regulatory framework against which an authorization is granted, or other reasons for it.","http://hl7.org/fhir/ValueSet/regulated-authorization-basis","",,,,"RegulatedAuthorization.basis",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Status Reasons.Legal Grounds" "RegulatedAuthorization.holder","RegulatedAuthorization.holder","","","",0,1,"","","Y","Reference {[]} {[CanonicalType[http://hl7.org/fhir/StructureDefinition/Organization]]} ","The organization that has been granted this authorization, by the regulator (authorization holder)","The organization that has been granted this authorization, by some authoritative body (the 'regulator').","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.holder",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Marketing Authorization Holder (Organisation)" "RegulatedAuthorization.holder.id","RegulatedAuthorization.holder.id","","","",0,1,"","","","id {[]} {[]} ","Unique id for inter-element referencing","Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.","","","","","","","","","",,,,,"",,,,"Element.id",0,1,"ele-1 ","","n/a" "RegulatedAuthorization.holder.extension","RegulatedAuthorization.holder.extension","","extensions user content","",0,*,"","","","Extension {[]} {[]} ","Additional content defined by implementations","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.","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.","","","","","","","","",,,,,"","value:url} ","Extensions are always sliced by (at least) url",,"open","Element.extension",0,*,"","ele-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()}","n/a" "RegulatedAuthorization.holder.reference","RegulatedAuthorization.holder.reference","","","",0,1,"","","Y","string {[]} {[]} ","Literal reference, Relative, internal or absolute URL","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.","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.","","","","","","","","",,,,,"",,,,"Reference.reference",0,1,"ref-2 ref-1","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","N/A" "RegulatedAuthorization.holder.type","RegulatedAuthorization.holder.type","","","",0,1,"","","Y","uri {[]} {[]} ","Type the reference refers to (e.g. ""Patient"") - must be a resource in resources","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).","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.","","","","","","","","",,"extensible","Aa resource (or, for logical models, the URI of the logical model).","http://hl7.org/fhir/ValueSet/resource-types","",,,,"Reference.type",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","N/A" "RegulatedAuthorization.holder.identifier","RegulatedAuthorization.holder.identifier","","","",1,1,"","","Y","Identifier {[]} {[]} ","Logical reference, when literal reference is not known","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.","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](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.","","","","","","","","",,,,,"",,,,"Reference.identifier",0,1,"ref-2 ","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ",".identifier" "RegulatedAuthorization.holder.identifier.id","RegulatedAuthorization.holder.identifier.id","","","",0,1,"","","","id {[]} {[]} ","Unique id for inter-element referencing","Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.","","","","","","","","","",,,,,"",,,,"Element.id",0,1,"ele-1 ","","n/a" "RegulatedAuthorization.holder.identifier.extension","RegulatedAuthorization.holder.identifier.extension","","extensions user content","",0,*,"","","","Extension {[]} {[]} ","Additional content defined by implementations","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.","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.","","","","","","","","",,,,,"","value:url} ","Extensions are always sliced by (at least) url",,"open","Element.extension",0,*,"","ele-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()}","n/a" "RegulatedAuthorization.holder.identifier.use","RegulatedAuthorization.holder.identifier.use","","","",0,1,"","Y","Y","code {[]} {[]} ","usual | official | temp | secondary | old (If known)","The purpose of this identifier.","Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.","Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.","","","","","","","",,"required","Identifies the purpose for this identifier, if known .","http://hl7.org/fhir/ValueSet/identifier-use|5.0.0","",,,,"Identifier.use",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Role.code or implied by context" "RegulatedAuthorization.holder.identifier.type","RegulatedAuthorization.holder.identifier.type","","","",0,1,"","","Y","CodeableConcept {[]} {[]} ","Description of identifier","A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.","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.","Allows users to make use of identifiers when the identifier system is not known.","","","","","","","",,"extensible","A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.","http://hl7.org/fhir/ValueSet/identifier-type","",,,,"Identifier.type",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Role.code or implied by context" "RegulatedAuthorization.holder.identifier.system","RegulatedAuthorization.holder.identifier.system","","","",1,1,"","","Y","uri {[]} {[]} ","The namespace for the identifier value","Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.","Identifier.system is always case sensitive.","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.","","","","","","","",,,,,"",,,,"Identifier.system",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","II.root or Role.id.root" "RegulatedAuthorization.holder.identifier.value","RegulatedAuthorization.holder.identifier.value","","","",1,1,"","","Y","string {[]} {[]} ","This value contains the Location ID from the EMA SPOR OMS System","The portion of the identifier typically relevant to the user and which is unique within the context of the system.","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](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). 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.","","","","","","","","",,,,,"",,,,"Identifier.value",0,1,"ident-1 ","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" "RegulatedAuthorization.holder.identifier.period","RegulatedAuthorization.holder.identifier.period","","","",0,1,"","","Y","Period {[]} {[]} ","Time period when id is/was valid for use","Time period during which identifier is/was valid for use.","","","","","","","","","",,,,,"",,,,"Identifier.period",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Role.effectiveTime or implied by context" "RegulatedAuthorization.holder.identifier.assigner","RegulatedAuthorization.holder.identifier.assigner","","","",0,1,"","","Y","Reference {[]} {[CanonicalType[http://hl7.org/fhir/StructureDefinition/Organization]]} ","Organization that issued id (may be just text)","Organization that issued/manages the identifier.","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.","","","","","","","","",,,,,"",,,,"Identifier.assigner",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" "RegulatedAuthorization.holder.display","RegulatedAuthorization.holder.display","","","",1,1,"","","Y","string {[]} {[]} ","The name of the marketing authorisation holder","Plain text narrative that identifies the resource in addition to the resource reference.","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.","","","","","","","","",,,,,"",,,,"Reference.display",0,1,"ref-2 ","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","N/A" "RegulatedAuthorization.regulator","RegulatedAuthorization.regulator","","","",0,1,"","","Y","Reference {[]} {[CanonicalType[http://hl7.org/fhir/StructureDefinition/Organization]]} ","The regulatory authority or authorizing body granting the authorization","The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.regulator",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Medicines Regulatory Agency (Organisation)" "RegulatedAuthorization.attachedDocument","RegulatedAuthorization.attachedDocument","","","",0,*,"","","Y","Reference {[]} {[CanonicalType[http://hl7.org/fhir/StructureDefinition/DocumentReference]]} ","Additional information or supporting documentation about the authorization","Additional information or supporting documentation about the authorization.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.attachedDocument",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","n/a" "RegulatedAuthorization.case","RegulatedAuthorization.case","","","",0,1,"","","Y","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)","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).","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.case",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application" "RegulatedAuthorization.case.id","RegulatedAuthorization.case.id","","","",0,1,"","","","string {[]} {[]} ","Unique id for inter-element referencing","Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.","","","","","","","","","",,,,,"",,,,"Element.id",0,1,"ele-1 ","","n/a" "RegulatedAuthorization.case.extension","RegulatedAuthorization.case.extension","","extensions user content","",0,*,"","","","Extension {[]} {[]} ","Additional content defined by implementations","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.","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.","","","","","","","","",,,,,"",,,,"Element.extension",0,*,"","ele-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()}","n/a" "RegulatedAuthorization.case.modifierExtension","RegulatedAuthorization.case.modifierExtension","","extensions user contentmodifiers","",0,*,"","Y","Y","Extension {[]} {[]} ","Extensions that cannot be ignored even if unrecognized","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).","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.","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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).","","","","","","","",,,,,"",,,,"BackboneElement.modifierExtension",0,*,"","ele-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()}","N/A" "RegulatedAuthorization.case.identifier","RegulatedAuthorization.case.identifier","","","",0,1,"","","Y","Identifier {[]} {[]} ","Identifier by which this case can be referenced","Identifier by which this case can be referenced.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.case.identifier",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number" "RegulatedAuthorization.case.type","RegulatedAuthorization.case.type","","","",0,1,"","","Y","CodeableConcept {[]} {[]} ","The defining type of case","The defining type of case.","","","","","","","","","",,"example","The type of a case involved in an application.","http://hl7.org/fhir/ValueSet/regulated-authorization-case-type","",,,,"RegulatedAuthorization.case.type",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type" "RegulatedAuthorization.case.status","RegulatedAuthorization.case.status","","","",0,1,"","","Y","CodeableConcept {[]} {[]} ","The status associated with the case","The status associated with the case.","","","","","","","","","",,"preferred","The lifecycle status of an artifact.","http://hl7.org/fhir/ValueSet/publication-status","",,,,"RegulatedAuthorization.case.status",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","n/a" "RegulatedAuthorization.case.date[x]","RegulatedAuthorization.case.date[x]","","","",0,1,"","","Y","Period {[]} {[]} dateTime {[]} {[]}","Relevant date for this case","Relevant date for this case.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.case.date[x]",0,1,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date" "RegulatedAuthorization.case.application","RegulatedAuthorization.case.application","","","",0,*,"","","Y","null {[]} {[]} ","Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure","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.","","","","","","","","","",,,,,"",,,,"RegulatedAuthorization.case.application",0,*,"","ele-1:All FHIR elements must have a @value or children {hasValue() or (children().count() > id.count())} ","Marketing Authorization.Marketing Authorization Application"