R6 Ballot (1st Draft)
Medication DefinitionThis page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
Raw XML (canonical form + also see XML Format Specification)
StructureDefinition for regulatedauthorization
<?xml version="1.0" encoding="UTF-8"?> <StructureDefinition xmlns="http://hl7.org/fhir"> <id value="RegulatedAuthorization"/> <meta> <lastUpdated value="2023-12-18T15:12:07.602+11:00"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"> <tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a> </th> <th class="hierarchy" style="width: 100px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a> <span style="float: right"> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"> <img alt="doco" src="data:(snipped in html view)" style="background-color: inherit"/> </a> </span> </th> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAgDsHd9/w4EQIOamFnaBgAA4M MKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Resource"/> <span title="RegulatedAuthorization : 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</span> <a name="RegulatedAuthorization"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="versions.html#std-process" style="padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #fff5e6" title="Standards Status = Trial Use">TU</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="domainresource.html">DomainResource</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product <br/> <br/> Elements defined in Ancestors: <a href="resource.html#Resource" title="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.">id</a> , <a href="resource.html#Resource" title="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.">meta</a> , <a href="resource.html#Resource" title="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.">implicitRules</a> , <a href="resource.html#Resource" title="The base language in which the resource is written.">language</a> , <a href="domainresource.html#DomainResource" title="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.">text</a> , <a href="domainresource.html#DomainResource" title="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.">contained</a> , <a href="domainresource.html#DomainResource" title="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.">extension</a> , <a href="domainresource.html#DomainResource" title="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).">modifierExtension</a> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.identifier : Business identifier for the authorization, typically assigned by the authorizing body.">identifier</span> <a name="RegulatedAuthorization.identifier"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Identifier">Identifier</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Business identifier for the authorization, typically assigned by the authorizing body <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="RegulatedAuthorization.subject : The product type, treatment, facility or activity that is being authorized.">subject</span> <a name="RegulatedAuthorization.subject"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="medicinalproductdefinition.html">MedicinalProductDefinition</a> | <a href="biologicallyderivedproduct.html">BiologicallyDerivedProduct</a> | <a href="nutritionproduct.html">NutritionProduct</a> | <a href="packagedproductdefinition.html">PackagedProductDefinition</a> | <a href="manufactureditemdefinition.html">ManufacturedItemDefinition</a> | <a href="ingredient.html">Ingredient</a> | <a href="substancedefinition.html">SubstanceDefinition</a> | <a href="devicedefinition.html">DeviceDefinition</a> | <a href="researchstudy.html">ResearchStudy</a> | <a href="activitydefinition.html">ActivityDefinition</a> | <a href="plandefinition.html">PlanDefinition</a> | <a href="observationdefinition.html">ObservationDefinition</a> | <a href="practitioner.html">Practitioner</a> | <a href="organization.html">Organization</a> | <a href="location.html">Location</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The product type, treatment, facility or activity that is being authorized <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.type : Overall type of this authorization, for example drug marketing approval, orphan drug designation.">type</span> <a name="RegulatedAuthorization.type"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Overall type of this authorization, for example drug marketing approval, orphan drug designation <br/> Binding: <a href="valueset-regulated-authorization-type.html">Regulated Authorization Type</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <span title="RegulatedAuthorization.description : General textual supporting information.">description</span> <a name="RegulatedAuthorization.description"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#markdown">markdown</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">General textual supporting information <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.region : The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.">region</span> <a name="RegulatedAuthorization.region"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The territory in which the authorization has been granted <br/> Binding: <a href="valueset-jurisdiction.html">Jurisdiction ValueSet</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.status : The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.">status</span> <a name="RegulatedAuthorization.status"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications <br/> Binding: <a href="valueset-publication-status.html">PublicationStatus</a> ( <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.">Preferred</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/> <span title="RegulatedAuthorization.statusDate : The date at which the current status was assigned.">statusDate</span> <a name="RegulatedAuthorization.statusDate"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The date at which the current status was assigned <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.validityPeriod : 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.">validityPeriod</span> <a name="RegulatedAuthorization.validityPeriod"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Period">Period</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">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 <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="RegulatedAuthorization.indication : Condition for which the use of the regulated product applies.">indication</span> <a name="RegulatedAuthorization.indication"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#CodeableReference">CodeableReference</a> ( <a href="clinicalusedefinition.html">ClinicalUseDefinition</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Condition for which the use of the regulated product applies <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.intendedUse : The intended use of the product, e.g. prevention, treatment, diagnosis.">intendedUse</span> <a name="RegulatedAuthorization.intendedUse"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The intended use of the product, e.g. prevention, treatment <br/> Binding: <a href="valueset-product-intended-use.html">Product Intended Use</a> ( <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.">Preferred</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.basis : The legal or regulatory framework against which this authorization is granted, or other reasons for it.">basis</span> <a name="RegulatedAuthorization.basis"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The legal/regulatory framework or reasons under which this authorization is granted <br/> Binding: <a href="valueset-regulated-authorization-basis.html">Regulated Authorization Basis</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="RegulatedAuthorization.holder : The organization that has been granted this authorization, by some authoritative body (the 'regulator').">holder</span> <a name="RegulatedAuthorization.holder"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="organization.html">Organization</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The organization that has been granted this authorization, by the regulator <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="RegulatedAuthorization.regulator : The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.">regulator</span> <a name="RegulatedAuthorization.regulator"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="organization.html">Organization</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The regulatory authority or authorizing body granting the authorization <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj 9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="RegulatedAuthorization.attachedDocument : Additional information or supporting documentation about the authorization.">attachedDocument</span> <a name="RegulatedAuthorization.attachedDocument"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="documentreference.html">DocumentReference</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Additional information or supporting documentation about the authorization <br/> <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAg DsHd9/w4EQIOamFnaBgAA4MMKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Element"/> <span title="RegulatedAuthorization.case : 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).">case</span> <a name="RegulatedAuthorization.case"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="types.html#BackBoneElement">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">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) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALElEQVR4Xu3IsQ0AIAwEsez6+89AqKGGJj7JzVWS+m m3zgcAAMxwDQAAgFcaYAVAgNGLTjgAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.case.identifier : Identifier by which this case can be referenced.">identifier</span> <a name="RegulatedAuthorization.case.identifier"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Identifier">Identifier</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Identifier by which this case can be referenced <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALElEQVR4Xu3IsQ0AIAw Esez6+89AqKGGJj7JzVWS+mm3zgcAAMxwDQAAgFcaYAVAgNGLTjgAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.case.type : The defining type of case.">type</span> <a name="RegulatedAuthorization.case.type"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The defining type of case <br/> Binding: <a href="valueset-regulated-authorization-case-type.html">Regulated Authorization Case Type</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALElEQVR4Xu3IsQ0AIAwEsez6+89AqKGGJj7JzVWS+m m3zgcAAMxwDQAAgFcaYAVAgNGLTjgAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="RegulatedAuthorization.case.status : The status associated with the case.">status</span> <a name="RegulatedAuthorization.case.status"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The status associated with the case <br/> Binding: <a href="valueset-publication-status.html">PublicationStatus</a> ( <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.">Preferred</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALElEQVR4Xu3IsQ0AIAw Esez6+89AqKGGJj7JzVWS+mm3zgcAAMxwDQAAgFcaYAVAgNGLTjgAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Choice of Types"/> <span title="RegulatedAuthorization.case.date[x] : Relevant date for this case.">date[x]</span> <a name="RegulatedAuthorization.case.date_x_"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Relevant date for this case <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LsQkAIBRDwb9r9p9BrbUSUZsLXPMgla ReGmtz23H6BwAA/lkCAADALR1gq0BWueJ34gAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="A time period defined by a start and end date and optionally time.">datePeriod</span> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Period">Period</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALElEQVR4Xu3IsQ0AIAw Esez6+89AqKGGJj7JzVWS+mm3zgcAAMxwDQAAgFcaYAVAgNGLTjgAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type"/> <span title="A date, date-time or partial date (e.g. just year or year + month). If hours and minutes are specified, a UTC offset SHALL be populated. The format is a union of the schema types gYear, gYearMonth, date and dateTime. Seconds must be provided due to schema type constraints but may be zero-filled and may be ignored. Dates SHALL be valid dates.">dateDateTime</span> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#dateTime">dateTime</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAgDsHd9/w4EQIOamFnaBgAA4M MKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:(snipped in html view)" style="background-color: white; background-color: inherit" title="Reference to another Element"/> <span title="RegulatedAuthorization.case.application : 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.">application</span> <a name="RegulatedAuthorization.case.application"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">see <a href="#RegulatedAuthorization.case" title="RegulatedAuthorization.case">case</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure <br/> <br/> </td> </tr> <tr> <td class="hierarchy" colspan="5"> <br/> <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"> <img alt="doco" src="data:(snipped in html view)" style="background-color: inherit"/> Documentation for this format </a> </td> </tr> </table> </div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-category"> <valueString value="Specialized.Medication Definition"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="trial-use"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="2"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category"> <valueCode value="anonymous"/> </extension> <url value="http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization"/> <version value="6.0.0-ballot1"/> <name value="RegulatedAuthorization"/> <status value="draft"/> <experimental value="false"/> <date value="2023-12-18T15:12:07+11:00"/> <publisher value="HL7 International / Biomedical Research and Regulation"/> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/fiwg"/> </telecom> </contact> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/rcrim"/> </telecom> </contact> <description value="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."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <fhirVersion value="6.0.0-ballot1"/> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <mapping> <identity value="idmp"/> <uri value="https://www.iso.org/obp/ui/#iso:std:iso:11615"/> <name value="IDMP Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="RegulatedAuthorization"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> <derivation value="specialization"/> <snapshot> <element id="RegulatedAuthorization"> <path value="RegulatedAuthorization"/> <short value="Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product"/> <definition value="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."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="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"/> <expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofTy pe(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('unmat ched', id).empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-5"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> <expression value="contained.meta.security.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="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."/> </extension> <key value="dom-6"/> <severity value="warning"/> <human value="A resource should have narrative for robust management"/> <expression value="text.`div`.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity, Role, or Act"/> </mapping> <mapping> <identity value="w5"/> <map value="administrative.medication"/> </mapping> <mapping> <identity value="idmp"/> <map value="Marketing Authorization, Clinical Trial Authorization"/> </mapping> </element> <element id="RegulatedAuthorization.id"> <path value="RegulatedAuthorization.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comment value="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."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="RegulatedAuthorization.meta"> <path value="RegulatedAuthorization.meta"/> <short value="Metadata about the resource"/> <definition value="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."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="RegulatedAuthorization.implicitRules"> <path value="RegulatedAuthorization.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="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."/> <comment value="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."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="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 value="true"/> </element> <element id="RegulatedAuthorization.language"> <path value="RegulatedAuthorization.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="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)."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="required"/> <description value="IETF language tag for a human language"/> <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot1"/> <additional> <purpose value="starter"/> <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> </additional> </binding> </element> <element id="RegulatedAuthorization.text"> <path value="RegulatedAuthorization.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="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."/> <comment value="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."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <condition value="dom-6"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="RegulatedAuthorization.contained"> <path value="RegulatedAuthorization.contained"/> <short value="Contained, inline Resources"/> <definition value="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."/> <comment value="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."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <condition value="dom-2"/> <condition value="dom-4"/> <condition value="dom-3"/> <condition value="dom-5"/> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="RegulatedAuthorization.extension"> <path value="RegulatedAuthorization.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="RegulatedAuthorization.modifierExtension"> <path value="RegulatedAuthorization.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="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)."/> <comment value="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."/> <requirements value="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)."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="RegulatedAuthorization.identifier"> <path value="RegulatedAuthorization.identifier"/> <short value="Business identifier for the authorization, typically assigned by the authorizing body"/> <definition value="Business identifier for the authorization, typically assigned by the authorizing body."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Number"/> </mapping> </element> <element id="RegulatedAuthorization.subject"> <path value="RegulatedAuthorization.subject"/> <short value="The product type, treatment, facility or activity that is being authorized"/> <definition value="The product type, treatment, facility or activity that is being authorized."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization.subject"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/NutritionProduct"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Ingredient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ObservationDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="(the link to Medicinal Product or Packaged Medicinal Product)"/> </mapping> </element> <element id="RegulatedAuthorization.type"> <path value="RegulatedAuthorization.type"/> <short value="Overall type of this authorization, for example drug marketing approval, orphan drug designation"/> <definition value="Overall type of this authorization, for example drug marketing approval, orphan drug designation."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="RegulatedAuthorizationType"/> </extension> <strength value="example"/> <description value="Overall type of this authorization."/> <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-type"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.description"> <path value="RegulatedAuthorization.description"/> <short value="General textual supporting information"/> <definition value="General textual supporting information."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.description"/> <min value="0"/> <max value="1"/> </base> <type> <code value="markdown"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.region"> <path value="RegulatedAuthorization.region"/> <short value="The territory in which the authorization has been granted"/> <definition value="The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization.region"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="example"/> <description value="Jurisdiction codes"/> <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Country"/> </mapping> </element> <element id="RegulatedAuthorization.status"> <path value="RegulatedAuthorization.status"/> <short value="The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications"/> <definition value="The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.status"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PublicationStatus"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="preferred"/> <description value="The lifecycle status of an artifact."/> <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Authorization Status"/> </mapping> </element> <element id="RegulatedAuthorization.statusDate"> <path value="RegulatedAuthorization.statusDate"/> <short value="The date at which the current status was assigned"/> <definition value="The date at which the current status was assigned."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.statusDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Authorization Status Date"/> </mapping> </element> <element id="RegulatedAuthorization.validityPeriod"> <path value="RegulatedAuthorization.validityPeriod"/> <short value="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"/> <definition value="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."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.validityPeriod"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End"/> </mapping> </element> <element id="RegulatedAuthorization.indication"> <path value="RegulatedAuthorization.indication"/> <short value="Condition for which the use of the regulated product applies"/> <definition value="Condition for which the use of the regulated product applies."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization.indication"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.intendedUse"> <path value="RegulatedAuthorization.intendedUse"/> <short value="The intended use of the product, e.g. prevention, treatment"/> <definition value="The intended use of the product, e.g. prevention, treatment, diagnosis."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.intendedUse"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ProductIntendedUse"/> </extension> <strength value="preferred"/> <description value="The overall intended use of a product."/> <valueSet value="http://hl7.org/fhir/ValueSet/product-intended-use"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.basis"> <path value="RegulatedAuthorization.basis"/> <short value="The legal/regulatory framework or reasons under which this authorization is granted"/> <definition value="The legal or regulatory framework against which this authorization is granted, or other reasons for it."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization.basis"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="RegulatedAuthorizationBasis"/> </extension> <strength value="example"/> <description value="A legal or regulatory framework against which an authorization is granted, or other reasons for it."/> <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-basis"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Status Reasons.Legal Grounds"/> </mapping> </element> <element id="RegulatedAuthorization.holder"> <path value="RegulatedAuthorization.holder"/> <short value="The organization that has been granted this authorization, by the regulator"/> <definition value="The organization that has been granted this authorization, by some authoritative body (the 'regulator')."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.holder"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Holder (Organisation)"/> </mapping> </element> <element id="RegulatedAuthorization.regulator"> <path value="RegulatedAuthorization.regulator"/> <short value="The regulatory authority or authorizing body granting the authorization"/> <definition value="The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.regulator"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Medicines Regulatory Agency (Organisation)"/> </mapping> </element> <element id="RegulatedAuthorization.attachedDocument"> <path value="RegulatedAuthorization.attachedDocument"/> <short value="Additional information or supporting documentation about the authorization"/> <definition value="Additional information or supporting documentation about the authorization."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization.attachedDocument"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.case"> <path value="RegulatedAuthorization.case"/> <short value="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)"/> <definition value="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)."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.case"/> <min value="0"/> <max value="1"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application"/> </mapping> </element> <element id="RegulatedAuthorization.case.id"> <path value="RegulatedAuthorization.case.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.case.extension"> <path value="RegulatedAuthorization.case.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.case.modifierExtension"> <path value="RegulatedAuthorization.case.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="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)."/> <comment value="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."/> <requirements value="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)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="RegulatedAuthorization.case.identifier"> <path value="RegulatedAuthorization.case.identifier"/> <short value="Identifier by which this case can be referenced"/> <definition value="Identifier by which this case can be referenced."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.case.identifier"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number"/> </mapping> </element> <element id="RegulatedAuthorization.case.type"> <path value="RegulatedAuthorization.case.type"/> <short value="The defining type of case"/> <definition value="The defining type of case."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.case.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="RegulatedAuthorizationCaseType"/> </extension> <strength value="example"/> <description value="The type of a case involved in an application."/> <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Applica tion Type"/> </mapping> </element> <element id="RegulatedAuthorization.case.status"> <path value="RegulatedAuthorization.case.status"/> <short value="The status associated with the case"/> <definition value="The status associated with the case."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.case.status"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PublicationStatus"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="preferred"/> <description value="The lifecycle status of an artifact."/> <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.case.date[x]"> <path value="RegulatedAuthorization.case.date[x]"/> <short value="Relevant date for this case"/> <definition value="Relevant date for this case."/> <min value="0"/> <max value="1"/> <base> <path value="RegulatedAuthorization.case.date[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date"/> </mapping> </element> <element id="RegulatedAuthorization.case.application"> <path value="RegulatedAuthorization.case.application"/> <short value="Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure"/> <definition value="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."/> <min value="0"/> <max value="*"/> <base> <path value="RegulatedAuthorization.case.application"/> <min value="0"/> <max value="*"/> </base> <contentReference value="#RegulatedAuthorization.case"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Application"/> </mapping> </element> </snapshot> <differential> <element id="RegulatedAuthorization"> <path value="RegulatedAuthorization"/> <short value="Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product"/> <definition value="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."/> <min value="0"/> <max value="*"/> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="w5"/> <map value="administrative.medication"/> </mapping> <mapping> <identity value="idmp"/> <map value="Marketing Authorization, Clinical Trial Authorization"/> </mapping> </element> <element id="RegulatedAuthorization.identifier"> <path value="RegulatedAuthorization.identifier"/> <short value="Business identifier for the authorization, typically assigned by the authorizing body"/> <definition value="Business identifier for the authorization, typically assigned by the authorizing body."/> <min value="0"/> <max value="*"/> <type> <code value="Identifier"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Number"/> </mapping> </element> <element id="RegulatedAuthorization.subject"> <path value="RegulatedAuthorization.subject"/> <short value="The product type, treatment, facility or activity that is being authorized"/> <definition value="The product type, treatment, facility or activity that is being authorized."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/NutritionProduct"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Ingredient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ObservationDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="(the link to Medicinal Product or Packaged Medicinal Product)"/> </mapping> </element> <element id="RegulatedAuthorization.type"> <path value="RegulatedAuthorization.type"/> <short value="Overall type of this authorization, for example drug marketing approval, orphan drug designation"/> <definition value="Overall type of this authorization, for example drug marketing approval, orphan drug designation."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="RegulatedAuthorizationType"/> </extension> <strength value="example"/> <description value="Overall type of this authorization."/> <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-type"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.description"> <path value="RegulatedAuthorization.description"/> <short value="General textual supporting information"/> <definition value="General textual supporting information."/> <min value="0"/> <max value="1"/> <type> <code value="markdown"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.region"> <path value="RegulatedAuthorization.region"/> <short value="The territory in which the authorization has been granted"/> <definition value="The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="example"/> <description value="Jurisdiction codes"/> <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Country"/> </mapping> </element> <element id="RegulatedAuthorization.status"> <path value="RegulatedAuthorization.status"/> <short value="The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications"/> <definition value="The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PublicationStatus"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="preferred"/> <description value="The lifecycle status of an artifact."/> <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Authorization Status"/> </mapping> </element> <element id="RegulatedAuthorization.statusDate"> <path value="RegulatedAuthorization.statusDate"/> <short value="The date at which the current status was assigned"/> <definition value="The date at which the current status was assigned."/> <min value="0"/> <max value="1"/> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Authorization Status Date"/> </mapping> </element> <element id="RegulatedAuthorization.validityPeriod"> <path value="RegulatedAuthorization.validityPeriod"/> <short value="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"/> <definition value="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."/> <min value="0"/> <max value="1"/> <type> <code value="Period"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End"/> </mapping> </element> <element id="RegulatedAuthorization.indication"> <path value="RegulatedAuthorization.indication"/> <short value="Condition for which the use of the regulated product applies"/> <definition value="Condition for which the use of the regulated product applies."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.intendedUse"> <path value="RegulatedAuthorization.intendedUse"/> <short value="The intended use of the product, e.g. prevention, treatment"/> <definition value="The intended use of the product, e.g. prevention, treatment, diagnosis."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ProductIntendedUse"/> </extension> <strength value="preferred"/> <description value="The overall intended use of a product."/> <valueSet value="http://hl7.org/fhir/ValueSet/product-intended-use"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.basis"> <path value="RegulatedAuthorization.basis"/> <short value="The legal/regulatory framework or reasons under which this authorization is granted"/> <definition value="The legal or regulatory framework against which this authorization is granted, or other reasons for it."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="RegulatedAuthorizationBasis"/> </extension> <strength value="example"/> <description value="A legal or regulatory framework against which an authorization is granted, or other reasons for it."/> <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-basis"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Status Reasons.Legal Grounds"/> </mapping> </element> <element id="RegulatedAuthorization.holder"> <path value="RegulatedAuthorization.holder"/> <short value="The organization that has been granted this authorization, by the regulator"/> <definition value="The organization that has been granted this authorization, by some authoritative body (the 'regulator')."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Holder (Organisation)"/> </mapping> </element> <element id="RegulatedAuthorization.regulator"> <path value="RegulatedAuthorization.regulator"/> <short value="The regulatory authority or authorizing body granting the authorization"/> <definition value="The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Medicines Regulatory Agency (Organisation)"/> </mapping> </element> <element id="RegulatedAuthorization.attachedDocument"> <path value="RegulatedAuthorization.attachedDocument"/> <short value="Additional information or supporting documentation about the authorization"/> <definition value="Additional information or supporting documentation about the authorization."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.case"> <path value="RegulatedAuthorization.case"/> <short value="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)"/> <definition value="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)."/> <min value="0"/> <max value="1"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application"/> </mapping> </element> <element id="RegulatedAuthorization.case.identifier"> <path value="RegulatedAuthorization.case.identifier"/> <short value="Identifier by which this case can be referenced"/> <definition value="Identifier by which this case can be referenced."/> <min value="0"/> <max value="1"/> <type> <code value="Identifier"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number"/> </mapping> </element> <element id="RegulatedAuthorization.case.type"> <path value="RegulatedAuthorization.case.type"/> <short value="The defining type of case"/> <definition value="The defining type of case."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="RegulatedAuthorizationCaseType"/> </extension> <strength value="example"/> <description value="The type of a case involved in an application."/> <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Applica tion Type"/> </mapping> </element> <element id="RegulatedAuthorization.case.status"> <path value="RegulatedAuthorization.case.status"/> <short value="The status associated with the case"/> <definition value="The status associated with the case."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PublicationStatus"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="preferred"/> <description value="The lifecycle status of an artifact."/> <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="RegulatedAuthorization.case.date[x]"> <path value="RegulatedAuthorization.case.date[x]"/> <short value="Relevant date for this case"/> <definition value="Relevant date for this case."/> <min value="0"/> <max value="1"/> <type> <code value="Period"/> </type> <type> <code value="dateTime"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date"/> </mapping> </element> <element id="RegulatedAuthorization.case.application"> <path value="RegulatedAuthorization.case.application"/> <short value="Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure"/> <definition value="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."/> <min value="0"/> <max value="*"/> <contentReference value="#RegulatedAuthorization.case"/> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Marketing Authorization Application"/> </mapping> </element> </differential> </StructureDefinition>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot1 generated on Mon, Dec 18, 2023 15:18+1100.
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