Release 5 Ballot
Medication DefinitionThis page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for regulatedauthorization
{
"resourceType" : "StructureDefinition",
"id" : "RegulatedAuthorization",
"meta" : {
"lastUpdated" : "2022-09-07T10:58:29.429+10:00"
},
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
"valueString" : "Specialized.Medication Definition"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 2
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
"valueCode" : "anonymous"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}],
"url" : "http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization",
"version" : "5.0.0-ballot",
"name" : "RegulatedAuthorization",
"status" : "draft",
"experimental" : false,
"date" : "2022-09-07T10:58:29+10:00",
"publisher" : "Health Level Seven International (Biomedical Research and Regulation)",
"contact" : [{
"telecom" : [{
"system" : "url",
"value" : "http://hl7.org/fhir"
}]
},
{
"telecom" : [{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim/index.cfm"
}]
}],
"description" : "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.",
"fhirVersion" : "5.0.0-ballot",
"mapping" : [{
"identity" : "idmp",
"uri" : "https://en.wikipedia.org/wiki/Identification_of_medicinal_products",
"name" : "IDMP Mapping"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "RegulatedAuthorization",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "RegulatedAuthorization",
"path" : "RegulatedAuthorization",
"short" : "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product",
"definition" : "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization",
"min" : 0,
"max" : "*"
},
"constraint" : [{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"xpath" : "not(parent::f:contained and f:contained)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"xpath" : "not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:security))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "idmp",
"map" : "Marketing Authorisation, Clinical Trial Authorisation"
},
{
"identity" : "w5",
"map" : "administrative.medication"
}]
},
{
"id" : "RegulatedAuthorization.id",
"path" : "RegulatedAuthorization.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "RegulatedAuthorization.meta",
"path" : "RegulatedAuthorization.meta",
"short" : "Metadata about the resource",
"definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Meta"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "RegulatedAuthorization.implicitRules",
"path" : "RegulatedAuthorization.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
"isSummary" : true
},
{
"id" : "RegulatedAuthorization.language",
"path" : "RegulatedAuthorization.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "IETF language tag",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id" : "RegulatedAuthorization.text",
"path" : "RegulatedAuthorization.text",
"short" : "Text summary of the resource, for human interpretation",
"definition" : "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"comment" : "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"alias" : ["narrative",
"html",
"xhtml",
"display"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Narrative"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "RegulatedAuthorization.contained",
"path" : "RegulatedAuthorization.contained",
"short" : "Contained, inline Resources",
"definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"comment" : "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
"alias" : ["inline resources",
"anonymous resources",
"contained resources"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Resource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "RegulatedAuthorization.extension",
"path" : "RegulatedAuthorization.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, 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" : "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" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "RegulatedAuthorization.modifierExtension",
"path" : "RegulatedAuthorization.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "RegulatedAuthorization.identifier",
"path" : "RegulatedAuthorization.identifier",
"short" : "Business identifier for the authorization, typically assigned by the authorizing body",
"definition" : "Business identifier for the authorization, typically assigned by the authorizing body.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.class"
},
{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Number"
}]
},
{
"id" : "RegulatedAuthorization.subject",
"path" : "RegulatedAuthorization.subject",
"short" : "The product type, treatment, facility or activity that is being authorized",
"definition" : "The product type, treatment, facility or activity that is being authorized.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization.subject",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition",
"http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct",
"http://hl7.org/fhir/StructureDefinition/NutritionProduct",
"http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition",
"http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition",
"http://hl7.org/fhir/StructureDefinition/Ingredient",
"http://hl7.org/fhir/StructureDefinition/SubstanceDefinition",
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"http://hl7.org/fhir/StructureDefinition/ActivityDefinition",
"http://hl7.org/fhir/StructureDefinition/PlanDefinition",
"http://hl7.org/fhir/StructureDefinition/ObservationDefinition",
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/Organization",
"http://hl7.org/fhir/StructureDefinition/Location"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(the link to Medicinal Product or Packaged Medicinal Product)"
}]
},
{
"id" : "RegulatedAuthorization.type",
"path" : "RegulatedAuthorization.type",
"short" : "Overall type of this authorization, for example drug marketing approval, orphan drug designation",
"definition" : "Overall type of this authorization, for example drug marketing approval, orphan drug designation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RegulatedAuthorizationType"
}],
"strength" : "example",
"description" : "Overall type of this authorization.",
"valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.description",
"path" : "RegulatedAuthorization.description",
"short" : "General textual supporting information",
"definition" : "General textual supporting information.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.description",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.region",
"path" : "RegulatedAuthorization.region",
"short" : "The territory in which the authorization has been granted",
"definition" : "The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization.region",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "example",
"description" : "Jurisdiction codes",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Country"
}]
},
{
"id" : "RegulatedAuthorization.status",
"path" : "RegulatedAuthorization.status",
"short" : "The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications",
"definition" : "The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.status",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "The lifecycle status of an artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Authorisation Status"
}]
},
{
"id" : "RegulatedAuthorization.statusDate",
"path" : "RegulatedAuthorization.statusDate",
"short" : "The date at which the current status was assigned",
"definition" : "The date at which the current status was assigned.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.statusDate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Authorisation Status Date"
}]
},
{
"id" : "RegulatedAuthorization.validityPeriod",
"path" : "RegulatedAuthorization.validityPeriod",
"short" : "The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date",
"definition" : "The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.validityPeriod",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Validity Period Start, Marketing Authorisation.Validity Period End"
}]
},
{
"id" : "RegulatedAuthorization.indication",
"path" : "RegulatedAuthorization.indication",
"short" : "Condition for which the use of the regulated product applies",
"definition" : "Condition for which the use of the regulated product applies.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization.indication",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.intendedUse",
"path" : "RegulatedAuthorization.intendedUse",
"short" : "The intended use of the product, e.g. prevention, treatment",
"definition" : "The intended use of the product, e.g. prevention, treatment, diagnosis.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.intendedUse",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ProductIntendedUse"
}],
"strength" : "preferred",
"description" : "The overall intended use of a product.",
"valueSet" : "http://hl7.org/fhir/ValueSet/product-intended-use"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.basis",
"path" : "RegulatedAuthorization.basis",
"short" : "The legal/regulatory framework or reasons under which this authorization is granted",
"definition" : "The legal or regulatory framework against which this authorization is granted, or other reasons for it.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization.basis",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RegulatedAuthorizationBasis"
}],
"strength" : "example",
"description" : "A legal or regulatory framework against which an authorization is granted, or other reasons for it.",
"valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-basis"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Status Reasons.Legal Grounds"
}]
},
{
"id" : "RegulatedAuthorization.holder",
"path" : "RegulatedAuthorization.holder",
"short" : "The organization that has been granted this authorization, by the regulator",
"definition" : "The organization that has been granted this authorization, by some authoritative body (the 'regulator').",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.holder",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Holder (Organisation)"
}]
},
{
"id" : "RegulatedAuthorization.regulator",
"path" : "RegulatedAuthorization.regulator",
"short" : "The regulatory authority or authorizing body granting the authorization",
"definition" : "The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.regulator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Medicines Regulatory Agency (Organisation)"
}]
},
{
"id" : "RegulatedAuthorization.attachedDocument",
"path" : "RegulatedAuthorization.attachedDocument",
"short" : "Additional information or supporting documentation about the authorization",
"definition" : "Additional information or supporting documentation about the authorization.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization.attachedDocument",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DocumentReference"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.case",
"path" : "RegulatedAuthorization.case",
"short" : "The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)",
"definition" : "The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.case",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Procedure, Marketing Authorisation Procedure.Marketing Authorisation Application"
}]
},
{
"id" : "RegulatedAuthorization.case.id",
"path" : "RegulatedAuthorization.case.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.case.extension",
"path" : "RegulatedAuthorization.case.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, 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" : "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" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.case.modifierExtension",
"path" : "RegulatedAuthorization.case.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "RegulatedAuthorization.case.identifier",
"path" : "RegulatedAuthorization.case.identifier",
"short" : "Identifier by which this case can be referenced",
"definition" : "Identifier by which this case can be referenced.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.case.identifier",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation Procedure.Procedure Identifier / Number, Marketing Authorisation Application.Application Identifier / Number"
}]
},
{
"id" : "RegulatedAuthorization.case.type",
"path" : "RegulatedAuthorization.case.type",
"short" : "The defining type of case",
"definition" : "The defining type of case.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.case.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RegulatedAuthorizationCaseType"
}],
"strength" : "example",
"description" : "The type of a case involved in an application.",
"valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation Procedure.Procedure Type, Marketing Authorisation Application.Application Type"
}]
},
{
"id" : "RegulatedAuthorization.case.status",
"path" : "RegulatedAuthorization.case.status",
"short" : "The status associated with the case",
"definition" : "The status associated with the case.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.case.status",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "The lifecycle status of an artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.case.date[x]",
"path" : "RegulatedAuthorization.case.date[x]",
"short" : "Relevant date for this case",
"definition" : "Relevant date for this case.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "RegulatedAuthorization.case.date[x]",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
},
{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation Procedure.Procedure Date Start, Marketing Authorisation Procedure.Procedure Date End, Marketing Authorisation Application.Application Date"
}]
},
{
"id" : "RegulatedAuthorization.case.application",
"path" : "RegulatedAuthorization.case.application",
"short" : "Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure",
"definition" : "A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "RegulatedAuthorization.case.application",
"min" : 0,
"max" : "*"
},
"contentReference" : "#RegulatedAuthorization.case",
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Application"
}]
}]
},
"differential" : {
"element" : [{
"id" : "RegulatedAuthorization",
"path" : "RegulatedAuthorization",
"short" : "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product",
"definition" : "Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.",
"min" : 0,
"max" : "*",
"mustSupport" : false,
"isModifier" : false,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation, Clinical Trial Authorisation"
},
{
"identity" : "w5",
"map" : "administrative.medication"
}]
},
{
"id" : "RegulatedAuthorization.identifier",
"path" : "RegulatedAuthorization.identifier",
"short" : "Business identifier for the authorization, typically assigned by the authorizing body",
"definition" : "Business identifier for the authorization, typically assigned by the authorizing body.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.class"
},
{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Number"
}]
},
{
"id" : "RegulatedAuthorization.subject",
"path" : "RegulatedAuthorization.subject",
"short" : "The product type, treatment, facility or activity that is being authorized",
"definition" : "The product type, treatment, facility or activity that is being authorized.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition",
"http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct",
"http://hl7.org/fhir/StructureDefinition/NutritionProduct",
"http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition",
"http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition",
"http://hl7.org/fhir/StructureDefinition/Ingredient",
"http://hl7.org/fhir/StructureDefinition/SubstanceDefinition",
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"http://hl7.org/fhir/StructureDefinition/ActivityDefinition",
"http://hl7.org/fhir/StructureDefinition/PlanDefinition",
"http://hl7.org/fhir/StructureDefinition/ObservationDefinition",
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/Organization",
"http://hl7.org/fhir/StructureDefinition/Location"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(the link to Medicinal Product or Packaged Medicinal Product)"
}]
},
{
"id" : "RegulatedAuthorization.type",
"path" : "RegulatedAuthorization.type",
"short" : "Overall type of this authorization, for example drug marketing approval, orphan drug designation",
"definition" : "Overall type of this authorization, for example drug marketing approval, orphan drug designation.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RegulatedAuthorizationType"
}],
"strength" : "example",
"description" : "Overall type of this authorization.",
"valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.description",
"path" : "RegulatedAuthorization.description",
"short" : "General textual supporting information",
"definition" : "General textual supporting information.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.region",
"path" : "RegulatedAuthorization.region",
"short" : "The territory in which the authorization has been granted",
"definition" : "The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "example",
"description" : "Jurisdiction codes",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Country"
}]
},
{
"id" : "RegulatedAuthorization.status",
"path" : "RegulatedAuthorization.status",
"short" : "The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications",
"definition" : "The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "The lifecycle status of an artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Authorisation Status"
}]
},
{
"id" : "RegulatedAuthorization.statusDate",
"path" : "RegulatedAuthorization.statusDate",
"short" : "The date at which the current status was assigned",
"definition" : "The date at which the current status was assigned.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Authorisation Status Date"
}]
},
{
"id" : "RegulatedAuthorization.validityPeriod",
"path" : "RegulatedAuthorization.validityPeriod",
"short" : "The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date",
"definition" : "The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Validity Period Start, Marketing Authorisation.Validity Period End"
}]
},
{
"id" : "RegulatedAuthorization.indication",
"path" : "RegulatedAuthorization.indication",
"short" : "Condition for which the use of the regulated product applies",
"definition" : "Condition for which the use of the regulated product applies.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.intendedUse",
"path" : "RegulatedAuthorization.intendedUse",
"short" : "The intended use of the product, e.g. prevention, treatment",
"definition" : "The intended use of the product, e.g. prevention, treatment, diagnosis.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ProductIntendedUse"
}],
"strength" : "preferred",
"description" : "The overall intended use of a product.",
"valueSet" : "http://hl7.org/fhir/ValueSet/product-intended-use"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.basis",
"path" : "RegulatedAuthorization.basis",
"short" : "The legal/regulatory framework or reasons under which this authorization is granted",
"definition" : "The legal or regulatory framework against which this authorization is granted, or other reasons for it.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RegulatedAuthorizationBasis"
}],
"strength" : "example",
"description" : "A legal or regulatory framework against which an authorization is granted, or other reasons for it.",
"valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-basis"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Status Reasons.Legal Grounds"
}]
},
{
"id" : "RegulatedAuthorization.holder",
"path" : "RegulatedAuthorization.holder",
"short" : "The organization that has been granted this authorization, by the regulator",
"definition" : "The organization that has been granted this authorization, by some authoritative body (the 'regulator').",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Holder (Organisation)"
}]
},
{
"id" : "RegulatedAuthorization.regulator",
"path" : "RegulatedAuthorization.regulator",
"short" : "The regulatory authority or authorizing body granting the authorization",
"definition" : "The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Medicines Regulatory Agency (Organisation)"
}]
},
{
"id" : "RegulatedAuthorization.attachedDocument",
"path" : "RegulatedAuthorization.attachedDocument",
"short" : "Additional information or supporting documentation about the authorization",
"definition" : "Additional information or supporting documentation about the authorization.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DocumentReference"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.case",
"path" : "RegulatedAuthorization.case",
"short" : "The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)",
"definition" : "The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Procedure, Marketing Authorisation Procedure.Marketing Authorisation Application"
}]
},
{
"id" : "RegulatedAuthorization.case.identifier",
"path" : "RegulatedAuthorization.case.identifier",
"short" : "Identifier by which this case can be referenced",
"definition" : "Identifier by which this case can be referenced.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation Procedure.Procedure Identifier / Number, Marketing Authorisation Application.Application Identifier / Number"
}]
},
{
"id" : "RegulatedAuthorization.case.type",
"path" : "RegulatedAuthorization.case.type",
"short" : "The defining type of case",
"definition" : "The defining type of case.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "RegulatedAuthorizationCaseType"
}],
"strength" : "example",
"description" : "The type of a case involved in an application.",
"valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation Procedure.Procedure Type, Marketing Authorisation Application.Application Type"
}]
},
{
"id" : "RegulatedAuthorization.case.status",
"path" : "RegulatedAuthorization.case.status",
"short" : "The status associated with the case",
"definition" : "The status associated with the case.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "The lifecycle status of an artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "RegulatedAuthorization.case.date[x]",
"path" : "RegulatedAuthorization.case.date[x]",
"short" : "Relevant date for this case",
"definition" : "Relevant date for this case.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
},
{
"code" : "dateTime"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation Procedure.Procedure Date Start, Marketing Authorisation Procedure.Procedure Date End, Marketing Authorisation Application.Application Date"
}]
},
{
"id" : "RegulatedAuthorization.case.application",
"path" : "RegulatedAuthorization.case.application",
"short" : "Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure",
"definition" : "A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.",
"min" : 0,
"max" : "*",
"contentReference" : "#RegulatedAuthorization.case",
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Marketing Authorisation Application"
}]
}]
}
}
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 R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Wed, Sep 7, 2022 11:11+1000.
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