{"abstract":false,"baseDefinition":"http://hl7.org/fhir/StructureDefinition/DomainResource","contact":[{"telecom":[{"system":"url","value":"http://www.hl7.org/Special/committees/fiwg"}]},{"telecom":[{"system":"url","value":"http://www.hl7.org/Special/committees/rcrim"}]}],"date":"2026-03-31T17:06:59+00:00","derivation":"specialization","description":"Regulatory approval, clearance or licensing 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.","differential":{"element":[{"definition":"Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.","id":"RegulatedAuthorization","isModifier":false,"mapping":[{"identity":"w5","map":"administrative.medication"},{"identity":"idmp","map":"Marketing Authorization, Clinical Trial Authorization"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization","short":"Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product"},{"definition":"Business identifier for the authorization, typically assigned by the authorizing body.","id":"RegulatedAuthorization.identifier","isModifier":false,"isSummary":true,"mapping":[{"identity":"w5","map":"FiveWs.class"},{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Number"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.identifier","short":"Business identifier for the authorization, typically assigned by the authorizing body","type":[{"code":"Identifier"}]},{"definition":"The product type, treatment, facility or activity that is being authorized.","id":"RegulatedAuthorization.subject","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"(the link to Medicinal Product or Packaged Medicinal Product)"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.subject","short":"The product type, treatment, facility or activity that is being authorized","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition","http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct","http://hl7.org/fhir/StructureDefinition/NutritionProduct","http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition","http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition","http://hl7.org/fhir/StructureDefinition/Ingredient","http://hl7.org/fhir/StructureDefinition/SubstanceDefinition","http://hl7.org/fhir/StructureDefinition/DeviceDefinition","http://hl7.org/fhir/StructureDefinition/ResearchStudy","http://hl7.org/fhir/StructureDefinition/ActivityDefinition","http://hl7.org/fhir/StructureDefinition/PlanDefinition","http://hl7.org/fhir/StructureDefinition/ObservationDefinition","http://hl7.org/fhir/StructureDefinition/Practitioner","http://hl7.org/fhir/StructureDefinition/Organization","http://hl7.org/fhir/StructureDefinition/Location"]}]},{"binding":{"description":"Overall type of this authorization.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"RegulatedAuthorizationType"}],"strength":"example","valueSet":"http://hl7.org/fhir/ValueSet/regulated-authorization-type"},"definition":"Overall type of this authorization, for example drug marketing approval, orphan drug designation.","id":"RegulatedAuthorization.type","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.type","short":"Overall type of this authorization, for example drug marketing approval, orphan drug designation","type":[{"code":"CodeableConcept"}]},{"definition":"General textual supporting information.","id":"RegulatedAuthorization.description","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.description","short":"General textual supporting information","type":[{"code":"markdown"}]},{"binding":{"description":"Jurisdiction codes","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"Jurisdiction"},{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding","valueBoolean":true}],"strength":"example","valueSet":"http://terminology.hl7.org/ValueSet/jurisdiction"},"definition":"The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.","id":"RegulatedAuthorization.region","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Country"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.region","short":"The territory in which the authorization has been granted","type":[{"code":"CodeableConcept"}]},{"binding":{"description":"The lifecycle status of an artifact.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"PublicationStatus"},{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding","valueBoolean":true}],"strength":"preferred","valueSet":"http://hl7.org/fhir/ValueSet/publication-status"},"definition":"The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.","id":"RegulatedAuthorization.status","isModifier":true,"isModifierReason":"This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid","isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Authorization Status"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.status","short":"The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications","type":[{"code":"CodeableConcept"}]},{"definition":"The date at which the current status was assigned.","id":"RegulatedAuthorization.statusDate","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Authorization Status Date"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.statusDate","short":"The date at which the current status was assigned","type":[{"code":"dateTime"}]},{"definition":"The time period in which the regulatory approval, clearance or licensing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.","id":"RegulatedAuthorization.validityPeriod","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.validityPeriod","short":"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","type":[{"code":"Period"}]},{"definition":"Condition for which the use of the regulated product applies.","id":"RegulatedAuthorization.indication","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.indication","short":"Condition for which the use of the regulated product applies","type":[{"code":"CodeableReference","targetProfile":["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]}]},{"binding":{"description":"The overall intended use of a product.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"ProductIntendedUse"}],"strength":"preferred","valueSet":"http://hl7.org/fhir/ValueSet/product-intended-use"},"definition":"The intended use of the product, e.g. prevention, treatment, diagnosis.","id":"RegulatedAuthorization.intendedUse","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.intendedUse","short":"The intended use of the product, e.g. prevention, treatment","type":[{"code":"CodeableConcept"}]},{"binding":{"description":"A legal or regulatory framework against which an authorization is granted, or other reasons for it.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"RegulatedAuthorizationBasis"}],"strength":"example","valueSet":"http://hl7.org/fhir/ValueSet/regulated-authorization-basis"},"definition":"The legal or regulatory framework against which this authorization is granted, or other reasons for it.","id":"RegulatedAuthorization.basis","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Status Reasons.Legal Grounds"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.basis","short":"The legal/regulatory framework or reasons under which this authorization is granted","type":[{"code":"CodeableConcept"}]},{"definition":"The organization that has been granted this authorization, by some authoritative body (the 'regulator').","id":"RegulatedAuthorization.holder","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Holder (Organisation)"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.holder","short":"The organization that has been granted this authorization, by the regulator","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/Organization"]}]},{"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.","id":"RegulatedAuthorization.regulator","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Medicines Regulatory Agency (Organisation)"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.regulator","short":"The regulatory authority or authorizing body granting the authorization","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/Organization"]}]},{"definition":"Additional information or supporting documentation about the authorization.","id":"RegulatedAuthorization.attachedDocument","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.attachedDocument","short":"Additional information or supporting documentation about the authorization","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/DocumentReference"]}]},{"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).","id":"RegulatedAuthorization.case","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case","short":"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)","type":[{"code":"BackboneElement"}]},{"definition":"Identifier by which this case can be referenced.","id":"RegulatedAuthorization.case.identifier","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.identifier","short":"Identifier by which this case can be referenced","type":[{"code":"Identifier"}]},{"binding":{"description":"The type of a case involved in an application.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"RegulatedAuthorizationCaseType"}],"strength":"example","valueSet":"http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"},"definition":"The defining type of case.","id":"RegulatedAuthorization.case.type","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.type","short":"The defining type of case","type":[{"code":"CodeableConcept"}]},{"binding":{"description":"The lifecycle status of an artifact.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"PublicationStatus"},{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding","valueBoolean":true}],"strength":"preferred","valueSet":"http://hl7.org/fhir/ValueSet/publication-status"},"definition":"The status associated with the case.","id":"RegulatedAuthorization.case.status","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.status","short":"The status associated with the case","type":[{"code":"CodeableConcept"}]},{"definition":"Relevant date for this case.","id":"RegulatedAuthorization.case.date[x]","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.date[x]","short":"Relevant date for this case","type":[{"code":"Period"},{"code":"dateTime"}]},{"contentReference":"#RegulatedAuthorization.case","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.","id":"RegulatedAuthorization.case.application","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Application"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.application","short":"Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure"}]},"experimental":false,"extension":[{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status","valueCode":"normative"},{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-wg","valueCode":"brr"},{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm","valueInteger":2},{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category","valueCode":"anonymous"}],"fhirVersion":"6.0.0-ballot4","id":"RegulatedAuthorization","jurisdiction":[{"coding":[{"code":"001","display":"World","system":"http://unstats.un.org/unsd/methods/m49/m49.htm"}]}],"kind":"resource","mapping":[{"identity":"w5","name":"FiveWs Pattern Mapping","uri":"http://hl7.org/fhir/fivews"},{"identity":"idmp","name":"IDMP Mapping","uri":"https://www.iso.org/obp/ui/#iso:std:iso:11615"},{"identity":"rim","name":"RIM Mapping","uri":"http://hl7.org/v3"}],"meta":{"lastUpdated":"2026-03-31T17:06:59.649+00:00"},"name":"RegulatedAuthorization","publisher":"HL7 International / Biomedical Research and Regulation","resourceType":"StructureDefinition","snapshot":{"element":[{"base":{"max":"*","min":0,"path":"RegulatedAuthorization"},"constraint":[{"expression":"contained.contained.empty()","human":"If the resource is contained in another resource, it SHALL NOT contain nested Resources","key":"dom-2","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/DomainResource"},{"expression":"contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()","human":"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","key":"dom-3","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/DomainResource"},{"expression":"contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()","human":"If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated","key":"dom-4","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/DomainResource"},{"expression":"contained.meta.security.empty()","human":"If a resource is contained in another resource, it SHALL NOT have a security label","key":"dom-5","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/DomainResource"},{"expression":"text.`div`.exists()","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice","valueBoolean":true},{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation","valueMarkdown":"When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."}],"human":"A resource should have narrative for robust management","key":"dom-6","severity":"warning","source":"http://hl7.org/fhir/StructureDefinition/DomainResource"}],"definition":"Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.","id":"RegulatedAuthorization","isModifier":false,"isSummary":false,"mapping":[{"identity":"rim","map":"Entity, Role, or Act"},{"identity":"w5","map":"administrative.medication"},{"identity":"idmp","map":"Marketing Authorization, Clinical Trial Authorization"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization","short":"Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product"},{"base":{"max":"1","min":0,"path":"Resource.id"},"comment":"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.","definition":"The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.","id":"RegulatedAuthorization.id","isModifier":false,"isSummary":true,"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.id","short":"Logical id of this artifact","type":[{"code":"http://hl7.org/fhirpath/System.String","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type","valueUrl":"string"}]}]},{"base":{"max":"1","min":0,"path":"Resource.meta"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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.","id":"RegulatedAuthorization.meta","isModifier":false,"isSummary":true,"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.meta","short":"Metadata about the resource","type":[{"code":"Meta"}]},{"base":{"max":"1","min":0,"path":"Resource.implicitRules"},"comment":"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.","constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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. For DomainResources, if more than one implicitRules policy applies, additional policies may be conveyed using the [additionalImplicitRules](https://build.fhir.org/ig/HL7/fhir-extensions/StructureDefinition-additionalImplicitRules.html) extension.","id":"RegulatedAuthorization.implicitRules","isModifier":true,"isModifierReason":"This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation","isSummary":true,"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.implicitRules","short":"A set of rules under which this content was created","type":[{"code":"uri"}]},{"base":{"max":"1","min":0,"path":"Resource.language"},"binding":{"additional":[{"purpose":"starter","valueSet":"http://hl7.org/fhir/ValueSet/languages"}],"description":"IETF language tag for a human language","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"Language"},{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding","valueBoolean":true}],"strength":"required","valueSet":"http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot4"},"comment":"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).","constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The base language in which the resource is written.","id":"RegulatedAuthorization.language","isModifier":false,"isSummary":false,"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.language","short":"Language of the resource content","type":[{"code":"code"}]},{"alias":["narrative","html","xhtml","display"],"base":{"max":"1","min":0,"path":"DomainResource.text"},"comment":"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.","condition":["dom-6"],"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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.","id":"RegulatedAuthorization.text","isModifier":false,"isSummary":false,"mapping":[{"identity":"rim","map":"Act.text?"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.text","short":"Text summary of the resource, for human interpretation","type":[{"code":"Narrative"}]},{"alias":["inline resources","anonymous resources","contained resources"],"base":{"max":"*","min":0,"path":"DomainResource.contained"},"comment":"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. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](resource.html#additional).","condition":["dom-2","dom-4","dom-3","dom-5"],"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.","id":"RegulatedAuthorization.contained","isModifier":false,"isSummary":false,"mapping":[{"identity":"rim","map":"N/A"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.contained","short":"Contained, inline Resources","type":[{"code":"Resource"}]},{"alias":["extensions","user content"],"base":{"max":"*","min":0,"path":"DomainResource.extension"},"comment":"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.","constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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.","id":"RegulatedAuthorization.extension","isModifier":false,"isSummary":false,"mapping":[{"identity":"rim","map":"N/A"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.extension","short":"Additional content defined by implementations","type":[{"code":"Extension"}]},{"alias":["extensions","user content"],"base":{"max":"*","min":0,"path":"DomainResource.modifierExtension"},"comment":"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.","constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).","id":"RegulatedAuthorization.modifierExtension","isModifier":true,"isModifierReason":"Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them","isSummary":true,"mapping":[{"identity":"rim","map":"N/A"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.modifierExtension","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](extensibility.html#modifierExtension).","short":"Extensions that cannot be ignored","type":[{"code":"Extension"}]},{"base":{"max":"*","min":0,"path":"RegulatedAuthorization.identifier"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"Business identifier for the authorization, typically assigned by the authorizing body.","id":"RegulatedAuthorization.identifier","isModifier":false,"isSummary":true,"mapping":[{"identity":"w5","map":"FiveWs.class"},{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Number"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.identifier","short":"Business identifier for the authorization, typically assigned by the authorizing body","type":[{"code":"Identifier"}]},{"base":{"max":"*","min":0,"path":"RegulatedAuthorization.subject"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The product type, treatment, facility or activity that is being authorized.","id":"RegulatedAuthorization.subject","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"(the link to Medicinal Product or Packaged Medicinal Product)"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.subject","short":"The product type, treatment, facility or activity that is being authorized","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition","http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct","http://hl7.org/fhir/StructureDefinition/NutritionProduct","http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition","http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition","http://hl7.org/fhir/StructureDefinition/Ingredient","http://hl7.org/fhir/StructureDefinition/SubstanceDefinition","http://hl7.org/fhir/StructureDefinition/DeviceDefinition","http://hl7.org/fhir/StructureDefinition/ResearchStudy","http://hl7.org/fhir/StructureDefinition/ActivityDefinition","http://hl7.org/fhir/StructureDefinition/PlanDefinition","http://hl7.org/fhir/StructureDefinition/ObservationDefinition","http://hl7.org/fhir/StructureDefinition/Practitioner","http://hl7.org/fhir/StructureDefinition/Organization","http://hl7.org/fhir/StructureDefinition/Location"]}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.type"},"binding":{"description":"Overall type of this authorization.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"RegulatedAuthorizationType"}],"strength":"example","valueSet":"http://hl7.org/fhir/ValueSet/regulated-authorization-type"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"Overall type of this authorization, for example drug marketing approval, orphan drug designation.","id":"RegulatedAuthorization.type","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.type","short":"Overall type of this authorization, for example drug marketing approval, orphan drug designation","type":[{"code":"CodeableConcept"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.description"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"General textual supporting information.","id":"RegulatedAuthorization.description","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.description","short":"General textual supporting information","type":[{"code":"markdown"}]},{"base":{"max":"*","min":0,"path":"RegulatedAuthorization.region"},"binding":{"description":"Jurisdiction codes","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"Jurisdiction"},{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding","valueBoolean":true}],"strength":"example","valueSet":"http://terminology.hl7.org/ValueSet/jurisdiction"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.","id":"RegulatedAuthorization.region","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Country"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.region","short":"The territory in which the authorization has been 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Intermediate states and actions can be tracked with cases and applications.","id":"RegulatedAuthorization.status","isModifier":true,"isModifierReason":"This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid","isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Authorization Status"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.status","short":"The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications","type":[{"code":"CodeableConcept"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.statusDate"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The date at which the current status was assigned.","id":"RegulatedAuthorization.statusDate","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Authorization Status Date"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.statusDate","short":"The date at which the current status was assigned","type":[{"code":"dateTime"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.validityPeriod"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The time period in which the regulatory approval, clearance or licensing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.","id":"RegulatedAuthorization.validityPeriod","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.validityPeriod","short":"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","type":[{"code":"Period"}]},{"base":{"max":"*","min":0,"path":"RegulatedAuthorization.indication"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"Condition for which the use of the regulated product applies.","id":"RegulatedAuthorization.indication","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.indication","short":"Condition for which the use of the regulated product applies","type":[{"code":"CodeableReference","targetProfile":["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.intendedUse"},"binding":{"description":"The overall intended use of a product.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"ProductIntendedUse"}],"strength":"preferred","valueSet":"http://hl7.org/fhir/ValueSet/product-intended-use"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The intended use of the product, e.g. prevention, treatment, diagnosis.","id":"RegulatedAuthorization.intendedUse","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.intendedUse","short":"The intended use of the product, e.g. prevention, treatment","type":[{"code":"CodeableConcept"}]},{"base":{"max":"*","min":0,"path":"RegulatedAuthorization.basis"},"binding":{"description":"A legal or regulatory framework against which an authorization is granted, or other reasons for it.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"RegulatedAuthorizationBasis"}],"strength":"example","valueSet":"http://hl7.org/fhir/ValueSet/regulated-authorization-basis"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The legal or regulatory framework against which this authorization is granted, or other reasons for it.","id":"RegulatedAuthorization.basis","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Status Reasons.Legal Grounds"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.basis","short":"The legal/regulatory framework or reasons under which this authorization is granted","type":[{"code":"CodeableConcept"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.holder"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The organization that has been granted this authorization, by some authoritative body (the 'regulator').","id":"RegulatedAuthorization.holder","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Holder (Organisation)"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.holder","short":"The organization that has been granted this authorization, by the regulator","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/Organization"]}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.regulator"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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.","id":"RegulatedAuthorization.regulator","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Medicines Regulatory Agency (Organisation)"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.regulator","short":"The regulatory authority or authorizing body granting the authorization","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/Organization"]}]},{"base":{"max":"*","min":0,"path":"RegulatedAuthorization.attachedDocument"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"Additional information or supporting documentation about the authorization.","id":"RegulatedAuthorization.attachedDocument","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.attachedDocument","short":"Additional information or supporting documentation about the authorization","type":[{"code":"Reference","targetProfile":["http://hl7.org/fhir/StructureDefinition/DocumentReference"]}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.case"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children or both","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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).","id":"RegulatedAuthorization.case","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case","short":"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)","type":[{"code":"BackboneElement"}]},{"base":{"max":"1","min":0,"path":"Element.id"},"condition":["ele-1"],"definition":"Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.","id":"RegulatedAuthorization.case.id","isModifier":false,"isSummary":false,"mapping":[{"identity":"rim","map":"n/a"}],"max":"1","min":0,"path":"RegulatedAuthorization.case.id","representation":["xmlAttr"],"short":"Unique id for inter-element referencing","type":[{"code":"http://hl7.org/fhirpath/System.String","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type","valueUrl":"string"}]}]},{"alias":["extensions","user content"],"base":{"max":"*","min":0,"path":"Element.extension"},"comment":"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.","constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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.","id":"RegulatedAuthorization.case.extension","isModifier":false,"isSummary":false,"mapping":[{"identity":"rim","map":"n/a"}],"max":"*","min":0,"path":"RegulatedAuthorization.case.extension","short":"Additional content defined by implementations","type":[{"code":"Extension"}]},{"alias":["extensions","user content","modifiers"],"base":{"max":"*","min":0,"path":"BackboneElement.modifierExtension"},"comment":"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.","constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).","id":"RegulatedAuthorization.case.modifierExtension","isModifier":true,"isModifierReason":"Modifier extensions are expected to modify the meaning or interpretation of the element that contains them","isSummary":true,"mapping":[{"identity":"rim","map":"N/A"}],"max":"*","min":0,"path":"RegulatedAuthorization.case.modifierExtension","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](extensibility.html#modifierExtension).","short":"Extensions that cannot be ignored even if unrecognized","type":[{"code":"Extension"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.case.identifier"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"Identifier by which this case can be referenced.","id":"RegulatedAuthorization.case.identifier","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.identifier","short":"Identifier by which this case can be referenced","type":[{"code":"Identifier"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.case.type"},"binding":{"description":"The type of a case involved in an application.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"RegulatedAuthorizationCaseType"}],"strength":"example","valueSet":"http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The defining type of case.","id":"RegulatedAuthorization.case.type","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.type","short":"The defining type of case","type":[{"code":"CodeableConcept"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.case.status"},"binding":{"description":"The lifecycle status of an artifact.","extension":[{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName","valueString":"PublicationStatus"},{"url":"http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding","valueBoolean":true}],"strength":"preferred","valueSet":"http://hl7.org/fhir/ValueSet/publication-status"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"The status associated with the case.","id":"RegulatedAuthorization.case.status","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"n/a"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.status","short":"The status associated with the case","type":[{"code":"CodeableConcept"}]},{"base":{"max":"1","min":0,"path":"RegulatedAuthorization.case.date[x]"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"definition":"Relevant date for this case.","id":"RegulatedAuthorization.case.date[x]","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date"}],"max":"1","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.date[x]","short":"Relevant date for this case","type":[{"code":"Period"},{"code":"dateTime"}]},{"base":{"max":"*","min":0,"path":"RegulatedAuthorization.case.application"},"constraint":[{"expression":"hasValue() or (children().count() > id.count())","human":"All FHIR elements must have a @value or children","key":"ele-1","severity":"error","source":"http://hl7.org/fhir/StructureDefinition/Element"}],"contentReference":"#RegulatedAuthorization.case","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.","id":"RegulatedAuthorization.case.application","isModifier":false,"isSummary":true,"mapping":[{"identity":"idmp","map":"Marketing Authorization.Marketing Authorization Application"}],"max":"*","min":0,"mustSupport":false,"path":"RegulatedAuthorization.case.application","short":"Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure"}]},"status":"active","text":{"div":"
\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
NameFlagsCard.TypeDescription & Constraints\"doco\"
\".\"\".\" RegulatedAuthorization NDomainResourceRegulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
\".\"\".\"\".\" identifier Σ0..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body

\".\"\".\"\".\" subject Σ0..*Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location)The product type, treatment, facility or activity that is being authorized

\".\"\".\"\".\" type Σ0..1CodeableConceptOverall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: Regulated Authorization Type (Example)
\".\"\".\"\".\" description Σ0..1markdownGeneral textual supporting information
\".\"\".\"\".\" region Σ0..*CodeableConceptThe territory in which the authorization has been granted
Binding: Jurisdiction ValueSet (Example)

\".\"\".\"\".\" status ?!Σ0..1CodeableConceptThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: PublicationStatus (Preferred)
\".\"\".\"\".\" statusDate Σ0..1dateTimeThe date at which the current status was assigned
\".\"\".\"\".\" validityPeriod Σ0..1PeriodThe time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
\".\"\".\"\".\" indication Σ0..*CodeableReference(ClinicalUseDefinition)Condition for which the use of the regulated product applies

\".\"\".\"\".\" intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
Binding: Product Intended Use (Preferred)
\".\"\".\"\".\" basis Σ0..*CodeableConceptThe legal/regulatory framework or reasons under which this authorization is granted
Binding: Regulated Authorization Basis (Example)

\".\"\".\"\".\" holder Σ0..1Reference(Organization)The organization that has been granted this authorization, by the regulator
\".\"\".\"\".\" regulator Σ0..1Reference(Organization)The regulatory authority or authorizing body granting the authorization
\".\"\".\"\".\" attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the authorization

\".\"\".\"\".\" case Σ0..1BackboneElementThe 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)
\".\"\".\"\".\"\".\" identifier Σ0..1IdentifierIdentifier by which this case can be referenced
\".\"\".\"\".\"\".\" type Σ0..1CodeableConceptThe defining type of case
Binding: Regulated Authorization Case Type (Example)
\".\"\".\"\".\"\".\" status Σ0..1CodeableConceptThe status associated with the case
Binding: PublicationStatus (Preferred)
\".\"\".\"\".\"\".\" date[x] Σ0..1Relevant date for this case
\".\"\".\"\".\"\".\"\".\" datePeriodPeriod
\".\"\".\"\".\"\".\"\".\" dateDateTimedateTime
\".\"\".\"\".\"\".\" application Σ0..*see caseApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure


\"doco\" Documentation for this format
","status":"generated"},"type":"RegulatedAuthorization","url":"http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization","version":"6.0.0-ballot4"}