R4 Ballot #2 (Mixed Normative/Trial use)
MedicationsThis page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this 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 | Ballot Status: Informative | Compartments: Not linked to any defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for medicinalproductauthorization
{
"resourceType" : "StructureDefinition",
"id" : "MedicinalProductAuthorization",
"meta" : {
"lastUpdated" : "2018-08-19T21:48:56.559+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",
"valueString" : "Trial Use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 0
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}],
"url" : "http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization",
"name" : "MedicinalProductAuthorization",
"status" : "draft",
"date" : "2018-08-19T21:48:56+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" : "The regulatory authorization of a medicinal product.",
"fhirVersion" : "3.5.0",
"mapping" : [{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "MedicinalProductAuthorization",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "MedicinalProductAuthorization",
"path" : "MedicinalProductAuthorization",
"short" : "The regulatory authorization of a medicinal product",
"definition" : "The regulatory authorization of a medicinal product.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization",
"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" : "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" : "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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(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(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
"source" : "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 guman 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" : "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" : "DomainResource"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity. Role, or Act"
}]
},
{
"id" : "MedicinalProductAuthorization.id",
"path" : "MedicinalProductAuthorization.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" : "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "id"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.meta",
"path" : "MedicinalProductAuthorization.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"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.implicitRules",
"path" : "MedicinalProductAuthorization.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"
}],
"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" : "MedicinalProductAuthorization.language",
"path" : "MedicinalProductAuthorization.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"
}],
"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" : "A human language.",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id" : "MedicinalProductAuthorization.text",
"path" : "MedicinalProductAuthorization.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 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"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "MedicinalProductAuthorization.contained",
"path" : "MedicinalProductAuthorization.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, and nor can they have their own independent transaction scope.",
"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"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProductAuthorization.extension",
"path" : "MedicinalProductAuthorization.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"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProductAuthorization.modifierExtension",
"path" : "MedicinalProductAuthorization.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. 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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProductAuthorization.identifier",
"path" : "MedicinalProductAuthorization.identifier",
"short" : "Business identifier for the marketing authorization, as assigned by a regulator",
"definition" : "Business identifier for the marketing authorization, as assigned by a regulator.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.subject",
"path" : "MedicinalProductAuthorization.subject",
"short" : "The medicinal product that is being authorized",
"definition" : "The medicinal product that is being authorized.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.subject",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProduct",
"http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged"]
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.country",
"path" : "MedicinalProductAuthorization.country",
"short" : "The country in which the marketing authorization has been granted",
"definition" : "The country in which the marketing authorization has been granted.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization.country",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdiction",
"path" : "MedicinalProductAuthorization.jurisdiction",
"short" : "Jurisdiction within a country",
"definition" : "Jurisdiction within a country.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization.jurisdiction",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.legalStatusOfSupply",
"path" : "MedicinalProductAuthorization.legalStatusOfSupply",
"short" : "The legal status of supply of the medicinal product as classified by the regulator",
"definition" : "The legal status of supply of the medicinal product as classified by the regulator.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.legalStatusOfSupply",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.status",
"path" : "MedicinalProductAuthorization.status",
"short" : "The status of the marketing authorization",
"definition" : "The status of the marketing authorization.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.status",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.statusDate",
"path" : "MedicinalProductAuthorization.statusDate",
"short" : "The date at which the given status has become applicable",
"definition" : "The date at which the given status has become applicable.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.statusDate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.restoreDate",
"path" : "MedicinalProductAuthorization.restoreDate",
"short" : "The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored",
"definition" : "The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.restoreDate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.validityPeriod",
"path" : "MedicinalProductAuthorization.validityPeriod",
"short" : "The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format",
"definition" : "The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.validityPeriod",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.dataExclusivityPeriod",
"path" : "MedicinalProductAuthorization.dataExclusivityPeriod",
"short" : "A period of time after authorization before generic product applicatiosn can be submitted",
"definition" : "A period of time after authorization before generic product applicatiosn can be submitted.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.dataExclusivityPeriod",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.dateOfFirstAuthorization",
"path" : "MedicinalProductAuthorization.dateOfFirstAuthorization",
"short" : "The date when the first authorization was granted by a Medicines Regulatory Agency",
"definition" : "The date when the first authorization was granted by a Medicines Regulatory Agency.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.dateOfFirstAuthorization",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.internationalBirthDate",
"path" : "MedicinalProductAuthorization.internationalBirthDate",
"short" : "Date of first marketing authorization for a company's new medicinal product in any country in the World",
"definition" : "Date of first marketing authorization for a company's new medicinal product in any country in the World.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.internationalBirthDate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.legalBasis",
"path" : "MedicinalProductAuthorization.legalBasis",
"short" : "The legal framework against which this authorization is granted",
"definition" : "The legal framework against which this authorization is granted.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.legalBasis",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization",
"short" : "Authorization in areas within a country",
"definition" : "Authorization in areas within a country.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization",
"min" : 0,
"max" : "*"
},
"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" : "Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.id",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.id",
"representation" : ["xmlAttr"],
"short" : "xml:id (or equivalent in JSON)",
"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" : [{
"code" : "string"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.extension",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.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"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.modifierExtension",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.modifierExtension",
"short" : "Extensions that cannot be ignored 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. 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.",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "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" : "MedicinalProductAuthorization.jurisdictionalAuthorization.identifier",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.identifier",
"short" : "The assigned number for the marketing authorization",
"definition" : "The assigned number for the marketing authorization.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"short" : "Country of authorization",
"definition" : "Country of authorization.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"short" : "Jurisdiction within a country",
"definition" : "Jurisdiction within a country.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply",
"short" : "The legal status of supply in a jurisdiction or region",
"definition" : "The legal status of supply in a jurisdiction or region.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod",
"short" : "The start and expected end date of the authorization",
"definition" : "The start and expected end date of the authorization.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.holder",
"path" : "MedicinalProductAuthorization.holder",
"short" : "Marketing Authorization Holder",
"definition" : "Marketing Authorization Holder.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.holder",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.regulator",
"path" : "MedicinalProductAuthorization.regulator",
"short" : "Medicines Regulatory Agency",
"definition" : "Medicines Regulatory Agency.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.regulator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure",
"path" : "MedicinalProductAuthorization.procedure",
"short" : "The regulatory procedure for granting or amending a marketing authorization",
"definition" : "The regulatory procedure for granting or amending a marketing authorization.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.procedure",
"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" : "Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.id",
"path" : "MedicinalProductAuthorization.procedure.id",
"representation" : ["xmlAttr"],
"short" : "xml:id (or equivalent in JSON)",
"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" : [{
"code" : "string"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProductAuthorization.procedure.extension",
"path" : "MedicinalProductAuthorization.procedure.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"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProductAuthorization.procedure.modifierExtension",
"path" : "MedicinalProductAuthorization.procedure.modifierExtension",
"short" : "Extensions that cannot be ignored 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. 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.",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "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" : "MedicinalProductAuthorization.procedure.identifier",
"path" : "MedicinalProductAuthorization.procedure.identifier",
"short" : "Identifier for this procedure",
"definition" : "Identifier for this procedure.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.procedure.identifier",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Identifier"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.type",
"path" : "MedicinalProductAuthorization.procedure.type",
"short" : "Type of procedure",
"definition" : "Type of procedure.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.procedure.type",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.date[x]",
"path" : "MedicinalProductAuthorization.procedure.date[x]",
"short" : "Date of procedure",
"definition" : "Date of procedure.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProductAuthorization.procedure.date[x]",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
},
{
"code" : "dateTime"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.application",
"path" : "MedicinalProductAuthorization.procedure.application",
"short" : "Applcations submitted to obtain a marketing authorization",
"definition" : "Applcations submitted to obtain a marketing authorization.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProductAuthorization.procedure.application",
"min" : 0,
"max" : "*"
},
"contentReference" : "#MedicinalProductAuthorization.procedure",
"isModifier" : false,
"isSummary" : true
}]
},
"differential" : {
"element" : [{
"id" : "MedicinalProductAuthorization",
"path" : "MedicinalProductAuthorization",
"short" : "The regulatory authorization of a medicinal product",
"definition" : "The regulatory authorization of a medicinal product.",
"min" : 0,
"max" : "*"
},
{
"id" : "MedicinalProductAuthorization.identifier",
"path" : "MedicinalProductAuthorization.identifier",
"short" : "Business identifier for the marketing authorization, as assigned by a regulator",
"definition" : "Business identifier for the marketing authorization, as assigned by a regulator.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.subject",
"path" : "MedicinalProductAuthorization.subject",
"short" : "The medicinal product that is being authorized",
"definition" : "The medicinal product that is being authorized.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProduct",
"http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.country",
"path" : "MedicinalProductAuthorization.country",
"short" : "The country in which the marketing authorization has been granted",
"definition" : "The country in which the marketing authorization has been granted.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdiction",
"path" : "MedicinalProductAuthorization.jurisdiction",
"short" : "Jurisdiction within a country",
"definition" : "Jurisdiction within a country.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.legalStatusOfSupply",
"path" : "MedicinalProductAuthorization.legalStatusOfSupply",
"short" : "The legal status of supply of the medicinal product as classified by the regulator",
"definition" : "The legal status of supply of the medicinal product as classified by the regulator.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.status",
"path" : "MedicinalProductAuthorization.status",
"short" : "The status of the marketing authorization",
"definition" : "The status of the marketing authorization.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.statusDate",
"path" : "MedicinalProductAuthorization.statusDate",
"short" : "The date at which the given status has become applicable",
"definition" : "The date at which the given status has become applicable.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.restoreDate",
"path" : "MedicinalProductAuthorization.restoreDate",
"short" : "The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored",
"definition" : "The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.validityPeriod",
"path" : "MedicinalProductAuthorization.validityPeriod",
"short" : "The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format",
"definition" : "The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.dataExclusivityPeriod",
"path" : "MedicinalProductAuthorization.dataExclusivityPeriod",
"short" : "A period of time after authorization before generic product applicatiosn can be submitted",
"definition" : "A period of time after authorization before generic product applicatiosn can be submitted.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.dateOfFirstAuthorization",
"path" : "MedicinalProductAuthorization.dateOfFirstAuthorization",
"short" : "The date when the first authorization was granted by a Medicines Regulatory Agency",
"definition" : "The date when the first authorization was granted by a Medicines Regulatory Agency.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.internationalBirthDate",
"path" : "MedicinalProductAuthorization.internationalBirthDate",
"short" : "Date of first marketing authorization for a company's new medicinal product in any country in the World",
"definition" : "Date of first marketing authorization for a company's new medicinal product in any country in the World.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.legalBasis",
"path" : "MedicinalProductAuthorization.legalBasis",
"short" : "The legal framework against which this authorization is granted",
"definition" : "The legal framework against which this authorization is granted.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization",
"short" : "Authorization in areas within a country",
"definition" : "Authorization in areas within a country.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.identifier",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.identifier",
"short" : "The assigned number for the marketing authorization",
"definition" : "The assigned number for the marketing authorization.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"short" : "Country of authorization",
"definition" : "Country of authorization.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"short" : "Jurisdiction within a country",
"definition" : "Jurisdiction within a country.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply",
"short" : "The legal status of supply in a jurisdiction or region",
"definition" : "The legal status of supply in a jurisdiction or region.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod",
"path" : "MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod",
"short" : "The start and expected end date of the authorization",
"definition" : "The start and expected end date of the authorization.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.holder",
"path" : "MedicinalProductAuthorization.holder",
"short" : "Marketing Authorization Holder",
"definition" : "Marketing Authorization Holder.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.regulator",
"path" : "MedicinalProductAuthorization.regulator",
"short" : "Medicines Regulatory Agency",
"definition" : "Medicines Regulatory Agency.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure",
"path" : "MedicinalProductAuthorization.procedure",
"short" : "The regulatory procedure for granting or amending a marketing authorization",
"definition" : "The regulatory procedure for granting or amending a marketing authorization.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "BackboneElement"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.identifier",
"path" : "MedicinalProductAuthorization.procedure.identifier",
"short" : "Identifier for this procedure",
"definition" : "Identifier for this procedure.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.type",
"path" : "MedicinalProductAuthorization.procedure.type",
"short" : "Type of procedure",
"definition" : "Type of procedure.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.date[x]",
"path" : "MedicinalProductAuthorization.procedure.date[x]",
"short" : "Date of procedure",
"definition" : "Date of procedure.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
},
{
"code" : "dateTime"
}],
"isSummary" : true
},
{
"id" : "MedicinalProductAuthorization.procedure.application",
"path" : "MedicinalProductAuthorization.procedure.application",
"short" : "Applcations submitted to obtain a marketing authorization",
"definition" : "Applcations submitted to obtain a marketing authorization.",
"min" : 0,
"max" : "*",
"contentReference" : "#MedicinalProductAuthorization.procedure",
"isSummary" : true
}]
}
}
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.
®© HL7.org 2011+. FHIR Mixed Nomative/Trial Use Ballot #2 (v3.5.0-14907) generated on Sun, Aug 19, 2018 21:53+1000. QA Page
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