Medications| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for medicinalproduct
{
"resourceType" : "StructureDefinition",
"id" : "MedicinalProduct",
"meta" : {
"lastUpdated" : "2021-01-21T15:34:20.265+00:00"
},
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 0
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
"valueCode" : "anonymous"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}],
"url" : "http://hl7.org/fhir/StructureDefinition/MedicinalProduct",
"version" : "4.0.1",
"name" : "MedicinalProduct",
"status" : "draft",
"date" : "2021-01-21T15:34:20+00:00",
"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" : "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).",
"fhirVersion" : "4.0.1",
"mapping" : [{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "MedicinalProduct",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "MedicinalProduct",
"path" : "MedicinalProduct",
"short" : "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)",
"definition" : "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct",
"min" : 0,
"max" : "*"
},
"constraint" : [{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"xpath" : "not(parent::f:contained and f:contained)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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 $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:security))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "Когда у ресурса нет описания, только системы, которые полностью понимают данные, могут безопасно отображать ресурс для человека. Включение удобочитаемого представления в ресурс делает экосистему гораздо более надежной и удешевляет обработку ресурсов промежуточными системами. Некоторые экосистемы ограничивают распределение ресурсов только теми системами, которые полностью понимают ресурсы, и, как следствие, разработчики могут считать, что повествование излишне. Однако опыт показывает, что такие экосистемы часто открываются для новых участников со временем."
}],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity. Role, or Act"
}]
},
{
"id" : "MedicinalProduct.id",
"path" : "MedicinalProduct.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" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.meta",
"path" : "MedicinalProduct.meta",
"short" : "Metadata about the resource",
"definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Meta"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.implicitRules",
"path" : "MedicinalProduct.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"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" : "MedicinalProduct.language",
"path" : "MedicinalProduct.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"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" : "MedicinalProduct.text",
"path" : "MedicinalProduct.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"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "MedicinalProduct.contained",
"path" : "MedicinalProduct.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" : "MedicinalProduct.extension",
"path" : "MedicinalProduct.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProduct.modifierExtension",
"path" : "MedicinalProduct.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"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" : "MedicinalProduct.identifier",
"path" : "MedicinalProduct.identifier",
"short" : "Business identifier for this product. Could be an MPID",
"definition" : "Business identifier for this product. Could be an MPID.",
"alias" : ["MPID"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.type",
"path" : "MedicinalProduct.type",
"short" : "Regulatory type, e.g. Investigational or Authorized",
"definition" : "Regulatory type, e.g. Investigational or Authorized.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.domain",
"path" : "MedicinalProduct.domain",
"short" : "If this medicine applies to human or veterinary uses",
"definition" : "If this medicine applies to human or veterinary uses.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.domain",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Coding"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.combinedPharmaceuticalDoseForm",
"path" : "MedicinalProduct.combinedPharmaceuticalDoseForm",
"short" : "The dose form for a single part product, or combined form of a multiple part product",
"definition" : "The dose form for a single part product, or combined form of a multiple part product.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.combinedPharmaceuticalDoseForm",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.legalStatusOfSupply",
"path" : "MedicinalProduct.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" : "MedicinalProduct.legalStatusOfSupply",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.additionalMonitoringIndicator",
"path" : "MedicinalProduct.additionalMonitoringIndicator",
"short" : "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons",
"definition" : "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.additionalMonitoringIndicator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialMeasures",
"path" : "MedicinalProduct.specialMeasures",
"short" : "Whether the Medicinal Product is subject to special measures for regulatory reasons",
"definition" : "Whether the Medicinal Product is subject to special measures for regulatory reasons.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.specialMeasures",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.paediatricUseIndicator",
"path" : "MedicinalProduct.paediatricUseIndicator",
"short" : "If authorised for use in children",
"definition" : "If authorised for use in children.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.paediatricUseIndicator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.productClassification",
"path" : "MedicinalProduct.productClassification",
"short" : "Allows the product to be classified by various systems",
"definition" : "Allows the product to be classified by various systems.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.productClassification",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.marketingStatus",
"path" : "MedicinalProduct.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" : "MedicinalProduct.marketingStatus",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "MarketingStatus"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.pharmaceuticalProduct",
"path" : "MedicinalProduct.pharmaceuticalProduct",
"short" : "Pharmaceutical aspects of product",
"definition" : "Pharmaceutical aspects of product.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.pharmaceuticalProduct",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.packagedMedicinalProduct",
"path" : "MedicinalProduct.packagedMedicinalProduct",
"short" : "Package representation for the product",
"definition" : "Package representation for the product.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.packagedMedicinalProduct",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.attachedDocument",
"path" : "MedicinalProduct.attachedDocument",
"short" : "Supporting documentation, typically for regulatory submission",
"definition" : "Supporting documentation, typically for regulatory submission.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.attachedDocument",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DocumentReference"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.masterFile",
"path" : "MedicinalProduct.masterFile",
"short" : "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)",
"definition" : "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.masterFile",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DocumentReference"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.contact",
"path" : "MedicinalProduct.contact",
"short" : "A product specific contact, person (in a role), or an organization",
"definition" : "A product specific contact, person (in a role), or an organization.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.contact",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.clinicalTrial",
"path" : "MedicinalProduct.clinicalTrial",
"short" : "Clinical trials or studies that this product is involved in",
"definition" : "Clinical trials or studies that this product is involved in.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.clinicalTrial",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name",
"path" : "MedicinalProduct.name",
"short" : "The product's name, including full name and possibly coded parts",
"definition" : "The product's name, including full name and possibly coded parts.",
"min" : 1,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.name",
"min" : 1,
"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" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.id",
"path" : "MedicinalProduct.name.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.name.extension",
"path" : "MedicinalProduct.name.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.name.modifierExtension",
"path" : "MedicinalProduct.name.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProduct.name.productName",
"path" : "MedicinalProduct.name.productName",
"short" : "The full product name",
"definition" : "The full product name.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.name.productName",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.namePart",
"path" : "MedicinalProduct.name.namePart",
"short" : "Coding words or phrases of the name",
"definition" : "Coding words or phrases of the name.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.name.namePart",
"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" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.namePart.id",
"path" : "MedicinalProduct.name.namePart.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.name.namePart.extension",
"path" : "MedicinalProduct.name.namePart.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.name.namePart.modifierExtension",
"path" : "MedicinalProduct.name.namePart.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProduct.name.namePart.part",
"path" : "MedicinalProduct.name.namePart.part",
"short" : "A fragment of a product name",
"definition" : "A fragment of a product name.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.name.namePart.part",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.namePart.type",
"path" : "MedicinalProduct.name.namePart.type",
"short" : "Idenifying type for this part of the name (e.g. strength part)",
"definition" : "Idenifying type for this part of the name (e.g. strength part).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.name.namePart.type",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Coding"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage",
"path" : "MedicinalProduct.name.countryLanguage",
"short" : "Country where the name applies",
"definition" : "Country where the name applies.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.name.countryLanguage",
"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" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage.id",
"path" : "MedicinalProduct.name.countryLanguage.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.name.countryLanguage.extension",
"path" : "MedicinalProduct.name.countryLanguage.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.name.countryLanguage.modifierExtension",
"path" : "MedicinalProduct.name.countryLanguage.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProduct.name.countryLanguage.country",
"path" : "MedicinalProduct.name.countryLanguage.country",
"short" : "Country code for where this name applies",
"definition" : "Country code for where this name applies.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.name.countryLanguage.country",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage.jurisdiction",
"path" : "MedicinalProduct.name.countryLanguage.jurisdiction",
"short" : "Jurisdiction code for where this name applies",
"definition" : "Jurisdiction code for where this name applies.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.name.countryLanguage.jurisdiction",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage.language",
"path" : "MedicinalProduct.name.countryLanguage.language",
"short" : "Language code for this name",
"definition" : "Language code for this name.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.name.countryLanguage.language",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.crossReference",
"path" : "MedicinalProduct.crossReference",
"short" : "Reference to another product, e.g. for linking authorised to investigational product",
"definition" : "Reference to another product, e.g. for linking authorised to investigational product.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.crossReference",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation",
"path" : "MedicinalProduct.manufacturingBusinessOperation",
"short" : "An operation applied to the product, for manufacturing or adminsitrative purpose",
"definition" : "An operation applied to the product, for manufacturing or adminsitrative purpose.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.manufacturingBusinessOperation",
"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" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.id",
"path" : "MedicinalProduct.manufacturingBusinessOperation.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.extension",
"path" : "MedicinalProduct.manufacturingBusinessOperation.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.modifierExtension",
"path" : "MedicinalProduct.manufacturingBusinessOperation.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.operationType",
"path" : "MedicinalProduct.manufacturingBusinessOperation.operationType",
"short" : "The type of manufacturing operation",
"definition" : "The type of manufacturing operation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.manufacturingBusinessOperation.operationType",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"path" : "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"short" : "Regulatory authorization reference number",
"definition" : "Regulatory authorization reference number.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"path" : "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"short" : "Regulatory authorization date",
"definition" : "Regulatory authorization date.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"path" : "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"short" : "To indicate if this proces is commercially confidential",
"definition" : "To indicate if this proces is commercially confidential.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"path" : "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"short" : "The manufacturer or establishment associated with the process",
"definition" : "The manufacturer or establishment associated with the process.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.regulator",
"path" : "MedicinalProduct.manufacturingBusinessOperation.regulator",
"short" : "A regulator which oversees the operation",
"definition" : "A regulator which oversees the operation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.manufacturingBusinessOperation.regulator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation",
"path" : "MedicinalProduct.specialDesignation",
"short" : "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease",
"definition" : "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.specialDesignation",
"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" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.id",
"path" : "MedicinalProduct.specialDesignation.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.specialDesignation.extension",
"path" : "MedicinalProduct.specialDesignation.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "MedicinalProduct.specialDesignation.modifierExtension",
"path" : "MedicinalProduct.specialDesignation.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "MedicinalProduct.specialDesignation.identifier",
"path" : "MedicinalProduct.specialDesignation.identifier",
"short" : "Identifier for the designation, or procedure number",
"definition" : "Identifier for the designation, or procedure number.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "MedicinalProduct.specialDesignation.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.type",
"path" : "MedicinalProduct.specialDesignation.type",
"short" : "The type of special designation, e.g. orphan drug, minor use",
"definition" : "The type of special designation, e.g. orphan drug, minor use.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.specialDesignation.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.intendedUse",
"path" : "MedicinalProduct.specialDesignation.intendedUse",
"short" : "The intended use of the product, e.g. prevention, treatment",
"definition" : "The intended use of the product, e.g. prevention, treatment.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.specialDesignation.intendedUse",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.indication[x]",
"path" : "MedicinalProduct.specialDesignation.indication[x]",
"short" : "Condition for which the medicinal use applies",
"definition" : "Condition for which the medicinal use applies.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.specialDesignation.indication[x]",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
},
{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductIndication"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.status",
"path" : "MedicinalProduct.specialDesignation.status",
"short" : "For example granted, pending, expired or withdrawn",
"definition" : "For example granted, pending, expired or withdrawn.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.specialDesignation.status",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.date",
"path" : "MedicinalProduct.specialDesignation.date",
"short" : "Date when the designation was granted",
"definition" : "Date when the designation was granted.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.specialDesignation.date",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.species",
"path" : "MedicinalProduct.specialDesignation.species",
"short" : "Animal species for which this applies",
"definition" : "Animal species for which this applies.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "MedicinalProduct.specialDesignation.species",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : true
}]
},
"differential" : {
"element" : [{
"id" : "MedicinalProduct",
"path" : "MedicinalProduct",
"short" : "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)",
"definition" : "Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).",
"min" : 0,
"max" : "*"
},
{
"id" : "MedicinalProduct.identifier",
"path" : "MedicinalProduct.identifier",
"short" : "Business identifier for this product. Could be an MPID",
"definition" : "Business identifier for this product. Could be an MPID.",
"alias" : ["MPID"],
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.type",
"path" : "MedicinalProduct.type",
"short" : "Regulatory type, e.g. Investigational or Authorized",
"definition" : "Regulatory type, e.g. Investigational or Authorized.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.domain",
"path" : "MedicinalProduct.domain",
"short" : "If this medicine applies to human or veterinary uses",
"definition" : "If this medicine applies to human or veterinary uses.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Coding"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.combinedPharmaceuticalDoseForm",
"path" : "MedicinalProduct.combinedPharmaceuticalDoseForm",
"short" : "The dose form for a single part product, or combined form of a multiple part product",
"definition" : "The dose form for a single part product, or combined form of a multiple part product.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.legalStatusOfSupply",
"path" : "MedicinalProduct.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" : "MedicinalProduct.additionalMonitoringIndicator",
"path" : "MedicinalProduct.additionalMonitoringIndicator",
"short" : "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons",
"definition" : "Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialMeasures",
"path" : "MedicinalProduct.specialMeasures",
"short" : "Whether the Medicinal Product is subject to special measures for regulatory reasons",
"definition" : "Whether the Medicinal Product is subject to special measures for regulatory reasons.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "string"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.paediatricUseIndicator",
"path" : "MedicinalProduct.paediatricUseIndicator",
"short" : "If authorised for use in children",
"definition" : "If authorised for use in children.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.productClassification",
"path" : "MedicinalProduct.productClassification",
"short" : "Allows the product to be classified by various systems",
"definition" : "Allows the product to be classified by various systems.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.marketingStatus",
"path" : "MedicinalProduct.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
},
{
"id" : "MedicinalProduct.pharmaceuticalProduct",
"path" : "MedicinalProduct.pharmaceuticalProduct",
"short" : "Pharmaceutical aspects of product",
"definition" : "Pharmaceutical aspects of product.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.packagedMedicinalProduct",
"path" : "MedicinalProduct.packagedMedicinalProduct",
"short" : "Package representation for the product",
"definition" : "Package representation for the product.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.attachedDocument",
"path" : "MedicinalProduct.attachedDocument",
"short" : "Supporting documentation, typically for regulatory submission",
"definition" : "Supporting documentation, typically for regulatory submission.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DocumentReference"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.masterFile",
"path" : "MedicinalProduct.masterFile",
"short" : "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)",
"definition" : "A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DocumentReference"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.contact",
"path" : "MedicinalProduct.contact",
"short" : "A product specific contact, person (in a role), or an organization",
"definition" : "A product specific contact, person (in a role), or an organization.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.clinicalTrial",
"path" : "MedicinalProduct.clinicalTrial",
"short" : "Clinical trials or studies that this product is involved in",
"definition" : "Clinical trials or studies that this product is involved in.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name",
"path" : "MedicinalProduct.name",
"short" : "The product's name, including full name and possibly coded parts",
"definition" : "The product's name, including full name and possibly coded parts.",
"min" : 1,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.productName",
"path" : "MedicinalProduct.name.productName",
"short" : "The full product name",
"definition" : "The full product name.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "string"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.namePart",
"path" : "MedicinalProduct.name.namePart",
"short" : "Coding words or phrases of the name",
"definition" : "Coding words or phrases of the name.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.namePart.part",
"path" : "MedicinalProduct.name.namePart.part",
"short" : "A fragment of a product name",
"definition" : "A fragment of a product name.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "string"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.namePart.type",
"path" : "MedicinalProduct.name.namePart.type",
"short" : "Idenifying type for this part of the name (e.g. strength part)",
"definition" : "Idenifying type for this part of the name (e.g. strength part).",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Coding"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage",
"path" : "MedicinalProduct.name.countryLanguage",
"short" : "Country where the name applies",
"definition" : "Country where the name applies.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage.country",
"path" : "MedicinalProduct.name.countryLanguage.country",
"short" : "Country code for where this name applies",
"definition" : "Country code for where this name applies.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage.jurisdiction",
"path" : "MedicinalProduct.name.countryLanguage.jurisdiction",
"short" : "Jurisdiction code for where this name applies",
"definition" : "Jurisdiction code for where this name applies.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.name.countryLanguage.language",
"path" : "MedicinalProduct.name.countryLanguage.language",
"short" : "Language code for this name",
"definition" : "Language code for this name.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.crossReference",
"path" : "MedicinalProduct.crossReference",
"short" : "Reference to another product, e.g. for linking authorised to investigational product",
"definition" : "Reference to another product, e.g. for linking authorised to investigational product.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation",
"path" : "MedicinalProduct.manufacturingBusinessOperation",
"short" : "An operation applied to the product, for manufacturing or adminsitrative purpose",
"definition" : "An operation applied to the product, for manufacturing or adminsitrative purpose.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.operationType",
"path" : "MedicinalProduct.manufacturingBusinessOperation.operationType",
"short" : "The type of manufacturing operation",
"definition" : "The type of manufacturing operation.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"path" : "MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber",
"short" : "Regulatory authorization reference number",
"definition" : "Regulatory authorization reference number.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"path" : "MedicinalProduct.manufacturingBusinessOperation.effectiveDate",
"short" : "Regulatory authorization date",
"definition" : "Regulatory authorization date.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"path" : "MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator",
"short" : "To indicate if this proces is commercially confidential",
"definition" : "To indicate if this proces is commercially confidential.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"path" : "MedicinalProduct.manufacturingBusinessOperation.manufacturer",
"short" : "The manufacturer or establishment associated with the process",
"definition" : "The manufacturer or establishment associated with the process.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.manufacturingBusinessOperation.regulator",
"path" : "MedicinalProduct.manufacturingBusinessOperation.regulator",
"short" : "A regulator which oversees the operation",
"definition" : "A regulator which oversees the operation.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation",
"path" : "MedicinalProduct.specialDesignation",
"short" : "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease",
"definition" : "Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.identifier",
"path" : "MedicinalProduct.specialDesignation.identifier",
"short" : "Identifier for the designation, or procedure number",
"definition" : "Identifier for the designation, or procedure number.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.type",
"path" : "MedicinalProduct.specialDesignation.type",
"short" : "The type of special designation, e.g. orphan drug, minor use",
"definition" : "The type of special designation, e.g. orphan drug, minor use.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.intendedUse",
"path" : "MedicinalProduct.specialDesignation.intendedUse",
"short" : "The intended use of the product, e.g. prevention, treatment",
"definition" : "The intended use of the product, e.g. prevention, treatment.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.indication[x]",
"path" : "MedicinalProduct.specialDesignation.indication[x]",
"short" : "Condition for which the medicinal use applies",
"definition" : "Condition for which the medicinal use applies.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
},
{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductIndication"]
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.status",
"path" : "MedicinalProduct.specialDesignation.status",
"short" : "For example granted, pending, expired or withdrawn",
"definition" : "For example granted, pending, expired or withdrawn.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.date",
"path" : "MedicinalProduct.specialDesignation.date",
"short" : "Date when the designation was granted",
"definition" : "Date when the designation was granted.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"isSummary" : true
},
{
"id" : "MedicinalProduct.specialDesignation.species",
"path" : "MedicinalProduct.specialDesignation.species",
"short" : "Animal species for which this applies",
"definition" : "Animal species for which this applies.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"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 Release 4 (Technical Correction #1) (v4.0.1) generated on Thu, Jan 21, 2021 15:38+0000. QA Page
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