R4
Ballot
#1
#2
(Mixed
Normative/Trial
use)
Medications
This
page
is
part
of
the
FHIR
Specification
(v3.3.0:
(v3.5.0:
R4
Ballot
2).
#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": "2018-04-03T12:05:46.262+10:00"
"resourceType" : "StructureDefinition",
"id" : "MedicinalProductAuthorization",
"meta" : {
"lastUpdated" : "2018-08-19T21:48:56.559+10:00"
},
"text": {
"status": "generated",
"div": "<div>!-- Snipped for Brevity --></div>"
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-ballot-status",
"valueString": "Draft"
},
{
"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": "2018-04-03T12:05:46+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": "3.3.0",
"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-1",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain any narrative",
"expression": "contained.text.empty()",
"xpath": "not(parent::f:contained and f:text)",
"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.all(('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists())",
"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"
}
],
"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",
"valueReference": {
"reference": "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": "extensible",
"description": "A human language.",
"valueSetCanonical": "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 in formation is added later.",
"alias": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"condition": [
"dom-1"
],
"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.",
"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.",
"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": "Not known why this is labelled a modifier",
"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": "1",
"base": {
"path": "MedicinalProductAuthorization.identifier",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"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": 1,
"max": "*",
"base": {
"path": "MedicinalProductAuthorization.country",
"min": 1,
"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": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.legalStatusOfSupply",
"min": 1,
"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": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.status",
"min": 1,
"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": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.statusDate",
"min": 1,
"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": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.validityPeriod",
"min": 1,
"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": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.internationalBirthDate",
"min": 1,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"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() | (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"
}
]
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.jurisdictionalAuthorization.modifierExtension",
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.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 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.",
"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": "modifierExtension is reserved for use where modifier extensions must be used",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
"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"
},
{
"id": "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"short": "Country of authorization",
"definition": "Country of authorization.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"short": "Jurisdiction within a country",
"definition": "Jurisdiction within a country.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.jurisdictionalAuthorization.number",
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.number",
"short": "The assigned number for the marketing authorization",
"definition": "The assigned number for the marketing authorization.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.number",
"min": 0,
"max": "1"
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
"type": [
{
"code": "Identifier"
}
],
"isModifier": false,
"isSummary": 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"
},
{
"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
"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"
},
{
"id": "MedicinalProductAuthorization.holder",
"path": "MedicinalProductAuthorization.holder",
"short": "Marketing Authorization Holder",
"definition": "Marketing Authorization Holder.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.holder",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.regulator",
"path": "MedicinalProductAuthorization.regulator",
"short": "Medicines Regulatory Agency",
"definition": "Medicines Regulatory Agency.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.regulator",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"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": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.procedure",
"min": 1,
"max": "1"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"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" : "code"
}],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
},
"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": "*"
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
{
"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"
},
{
"id": "MedicinalProductAuthorization.procedure.modifierExtension",
"path": "MedicinalProductAuthorization.procedure.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 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.",
"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": "modifierExtension is reserved for use where modifier extensions must be used",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.procedure.number",
"path": "MedicinalProductAuthorization.procedure.number",
"short": "Identifier for this procedure",
"definition": "Identifier for this procedure.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.procedure.number",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"isModifier": false,
"isSummary": true
"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" : "*"
},
{
"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
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.procedure.date",
"path": "MedicinalProductAuthorization.procedure.date",
"short": "Date of procedure",
"definition": "Date of procedure.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.procedure.date",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
}
],
"isModifier": false,
"isSummary": true
"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" : "*"
},
{
"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": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.procedure.application.id",
"path": "MedicinalProductAuthorization.procedure.application.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"
}
]
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.procedure.application.extension",
"path": "MedicinalProductAuthorization.procedure.application.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"
}
]
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.procedure.application.modifierExtension",
"path": "MedicinalProductAuthorization.procedure.application.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 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.",
"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": "modifierExtension is reserved for use where modifier extensions must be used",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
"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"
},
{
"id": "MedicinalProductAuthorization.procedure.application.number",
"path": "MedicinalProductAuthorization.procedure.application.number",
"short": "A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency",
"definition": "A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.procedure.application.number",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.procedure.application.type",
"path": "MedicinalProductAuthorization.procedure.application.type",
"short": "The type of the application",
"definition": "The type of the application.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.procedure.application.type",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.procedure.application.date",
"path": "MedicinalProductAuthorization.procedure.application.date",
"short": "Date that the application was made",
"definition": "Date that the application was made.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductAuthorization.procedure.application.date",
"min": 1,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"isModifier": false,
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.marketingStatus",
"path": "MedicinalProductAuthorization.marketingStatus",
"short": "Marketing status of the medicinal product, in contrast to marketing authorizaton",
"definition": "Marketing status of the medicinal product, in contrast to marketing authorizaton.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductAuthorization.marketingStatus",
"min": 0,
"max": "*"
},
"type": [
{
"code": "MarketingStatus"
}
],
"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": "*"
"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"
},
{
"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": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
"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"
},
{
"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": 1,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
"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"
},
{
"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": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.status",
"path": "MedicinalProductAuthorization.status",
"short": "The status of the marketing authorization",
"definition": "The status of the marketing authorization.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
"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"
},
{
"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": 1,
"max": "1",
"type": [
{
"code": "dateTime"
}
],
"isSummary": true
"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" : "*"
},
{
"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
"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"
},
{
"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": 1,
"max": "1",
"type": [
{
"code": "Period"
}
],
"isSummary": true
"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" : "*"
},
{
"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
"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" : "*"
},
{
"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
"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" : "*"
},
{
"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": 1,
"max": "1",
"type": [
{
"code": "dateTime"
}
],
"isSummary": true
"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"
},
{
"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
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.country",
"short": "Country of authorization",
"definition": "Country of authorization.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction",
"short": "Jurisdiction within a country",
"definition": "Jurisdiction within a country.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.jurisdictionalAuthorization.number",
"path": "MedicinalProductAuthorization.jurisdictionalAuthorization.number",
"short": "The assigned number for the marketing authorization",
"definition": "The assigned number for the marketing authorization.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
"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"
},
{
"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
"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"
},
{
"id": "MedicinalProductAuthorization.holder",
"path": "MedicinalProductAuthorization.holder",
"short": "Marketing Authorization Holder",
"definition": "Marketing Authorization Holder.",
"min": 1,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.regulator",
"path": "MedicinalProductAuthorization.regulator",
"short": "Medicines Regulatory Agency",
"definition": "Medicines Regulatory Agency.",
"min": 1,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isSummary": true
"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"
},
{
"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": 1,
"max": "1",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.procedure.number",
"path": "MedicinalProductAuthorization.procedure.number",
"short": "Identifier for this procedure",
"definition": "Identifier for this procedure.",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
"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" : "*"
},
{
"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
"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"
},
{
"id": "MedicinalProductAuthorization.procedure.date",
"path": "MedicinalProductAuthorization.procedure.date",
"short": "Date of procedure",
"definition": "Date of procedure.",
"min": 0,
"max": "1",
"type": [
{
"code": "Period"
}
],
"isSummary": true
"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"
},
{
"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": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.procedure.application.number",
"path": "MedicinalProductAuthorization.procedure.application.number",
"short": "A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency",
"definition": "A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency.",
"min": 1,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
"type" : [{
"code" : "Period"
},
{
"id": "MedicinalProductAuthorization.procedure.application.type",
"path": "MedicinalProductAuthorization.procedure.application.type",
"short": "The type of the application",
"definition": "The type of the application.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
"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" : "*"
},
{
"id": "MedicinalProductAuthorization.procedure.application.date",
"path": "MedicinalProductAuthorization.procedure.application.date",
"short": "Date that the application was made",
"definition": "Date that the application was made.",
"min": 1,
"max": "1",
"type": [
{
"code": "dateTime"
}
],
"isSummary": true
"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"
},
{
"id": "MedicinalProductAuthorization.marketingStatus",
"path": "MedicinalProductAuthorization.marketingStatus",
"short": "Marketing status of the medicinal product, in contrast to marketing authorizaton",
"definition": "Marketing status of the medicinal product, in contrast to marketing authorizaton.",
"min": 0,
"max": "*",
"type": [
{
"code": "MarketingStatus"
}
],
"isSummary": true
}
]
"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
(v3.3.0-13671)
#2
(v3.5.0-14907)
generated
on
Tue,
Apr
3,
Sun,
Aug
19,
2018
12:16+1000.
21:53+1000.
QA
Page
Links:
Search
|
Version
History
|
Table
of
Contents
|
Credits
|
Compare
to
DSTU3
|
Ballot
Comparison
|
|
Propose
a
change