Release 4B
Medication DefinitionThis page is part of the FHIR Specification (v4.3.0: R4B - STU). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for packagedproductdefinition
{
"resourceType" : "StructureDefinition",
"id" : "PackagedProductDefinition",
"meta" : {
"lastUpdated" : "2022-05-28T12:47:40.239+10:00"
},
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
"valueString" : "Specialized.Medication Definition"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 1
},
{
"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/PackagedProductDefinition",
"version" : "4.3.0",
"name" : "PackagedProductDefinition",
"status" : "draft",
"experimental" : false,
"date" : "2022-05-28T12:47:40+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" : "A medically related item or items, in a container or package.",
"fhirVersion" : "4.3.0",
"mapping" : [{
"identity" : "idmp",
"uri" : "https://en.wikipedia.org/wiki/Identification_of_medicinal_products",
"name" : "IDMP Mapping"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "PackagedProductDefinition",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "PackagedProductDefinition",
"path" : "PackagedProductDefinition",
"short" : "A medically related item or items, in a container or package",
"definition" : "A medically related item or items, in a container or package.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition",
"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.exists() and ('#'+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(uri) = '#').exists()).not()).trace('unmatched', id).empty()",
"xpath" : "not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:security))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "idmp",
"map" : "Packaged Medicinal Product"
},
{
"identity" : "w5",
"map" : "administrative.medication"
}]
},
{
"id" : "PackagedProductDefinition.id",
"path" : "PackagedProductDefinition.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" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.meta",
"path" : "PackagedProductDefinition.meta",
"short" : "Metadata about the resource",
"definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Meta"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.implicitRules",
"path" : "PackagedProductDefinition.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.language",
"path" : "PackagedProductDefinition.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "IETF language tag",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id" : "PackagedProductDefinition.text",
"path" : "PackagedProductDefinition.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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "PackagedProductDefinition.contained",
"path" : "PackagedProductDefinition.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"
}],
"constraint" : [{
"key" : "dom-r4b",
"severity" : "warning",
"human" : "Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems",
"expression" : "($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)",
"xpath" : "not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:PackagedProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedAuthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citation|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDefinition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingredient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic)",
"source" : "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "PackagedProductDefinition.extension",
"path" : "PackagedProductDefinition.extension",
"short" : "Additional content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "PackagedProductDefinition.modifierExtension",
"path" : "PackagedProductDefinition.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements" : "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "PackagedProductDefinition.identifier",
"path" : "PackagedProductDefinition.identifier",
"short" : "A unique identifier for this package as whole",
"definition" : "A unique identifier for this package as whole. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.PCID"
}]
},
{
"id" : "PackagedProductDefinition.name",
"path" : "PackagedProductDefinition.name",
"short" : "A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc",
"definition" : "A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.name",
"min" : 0,
"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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.type",
"path" : "PackagedProductDefinition.type",
"short" : "A high level category e.g. medicinal product, raw material, shipping container etc",
"definition" : "A high level category e.g. medicinal product, raw material, shipping/transport container, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageType"
}],
"strength" : "example",
"description" : "A high level categorisation of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.packageFor",
"path" : "PackagedProductDefinition.packageFor",
"short" : "The product that this is a pack for",
"definition" : "The product that this is a pack for.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.packageFor",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(the link from Packaged Medicinal Product to Medicinal Product)"
}]
},
{
"id" : "PackagedProductDefinition.status",
"path" : "PackagedProductDefinition.status",
"short" : "The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status",
"definition" : "The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.status",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid",
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "The lifecycle status of an artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.statusDate",
"path" : "PackagedProductDefinition.statusDate",
"short" : "The date at which the given status became applicable",
"definition" : "The date at which the given status became applicable.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.statusDate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity",
"path" : "PackagedProductDefinition.containedItemQuantity",
"short" : "A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size",
"definition" : "A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.containedItemQuantity",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Quantity"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.description",
"path" : "PackagedProductDefinition.description",
"short" : "Textual description. Note that this is not the name of the package or product",
"definition" : "Textual description. Note that this is not the name of the package or product.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.description",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.description"
}]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply",
"path" : "PackagedProductDefinition.legalStatusOfSupply",
"short" : "The legal status of supply of the packaged item as classified by the regulator",
"definition" : "The legal status of supply of the packaged item as classified by the regulator.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.legalStatusOfSupply",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children unless an empty Parameters resource",
"expression" : "hasValue() or (children().count() > id.count()) or $this is Parameters",
"xpath" : "@value|f:*|h:div|self::f:Parameters",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Legal Status of Supply (for a package)"
}]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.id",
"path" : "PackagedProductDefinition.legalStatusOfSupply.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" : "PackagedProductDefinition.legalStatusOfSupply.extension",
"path" : "PackagedProductDefinition.legalStatusOfSupply.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" : "PackagedProductDefinition.legalStatusOfSupply.modifierExtension",
"path" : "PackagedProductDefinition.legalStatusOfSupply.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" : "PackagedProductDefinition.legalStatusOfSupply.code",
"path" : "PackagedProductDefinition.legalStatusOfSupply.code",
"short" : "The actual status of supply. In what situation this package type may be supplied for use",
"definition" : "The actual status of supply. Conveys in what situation this package type may be supplied for use.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.legalStatusOfSupply.code",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "LegalStatusOfSupply"
}],
"strength" : "example",
"description" : "The prescription supply types appropriate to a medicinal product",
"valueSet" : "http://hl7.org/fhir/ValueSet/legal-status-of-supply"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Legal Status of Supply (for a package)"
}]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"short" : "The place where the legal status of supply applies",
"definition" : "The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.legalStatusOfSupply.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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "example",
"description" : "Jurisdiction codes",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.marketingStatus",
"path" : "PackagedProductDefinition.marketingStatus",
"short" : "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated",
"definition" : "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.Marketing Status"
}]
},
{
"id" : "PackagedProductDefinition.characteristic",
"path" : "PackagedProductDefinition.characteristic",
"short" : "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\"",
"definition" : "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\", \"calendar pack\".",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.characteristic",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageCharacteristic"
}],
"strength" : "example",
"description" : "A characteristic of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-characteristic"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.copackagedIndicator",
"path" : "PackagedProductDefinition.copackagedIndicator",
"short" : "If the drug product is supplied with another item such as a diluent or adjuvant",
"definition" : "States whether a drug product is supplied with another item such as a diluent or adjuvant.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.copackagedIndicator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "boolean"
}],
"meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made",
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.manufacturer",
"path" : "PackagedProductDefinition.manufacturer",
"short" : "Manufacturer of this package type (multiple means these are all possible manufacturers)",
"definition" : "Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.Manufacturer / Establishment (Organisation)"
}]
},
{
"id" : "PackagedProductDefinition.package",
"path" : "PackagedProductDefinition.package",
"short" : "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap",
"definition" : "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children unless an empty Parameters resource",
"expression" : "hasValue() or (children().count() > id.count()) or $this is Parameters",
"xpath" : "@value|f:*|h:div|self::f:Parameters",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)"
}]
},
{
"id" : "PackagedProductDefinition.package.id",
"path" : "PackagedProductDefinition.package.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" : "PackagedProductDefinition.package.extension",
"path" : "PackagedProductDefinition.package.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" : "PackagedProductDefinition.package.modifierExtension",
"path" : "PackagedProductDefinition.package.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" : "PackagedProductDefinition.package.identifier",
"path" : "PackagedProductDefinition.package.identifier",
"short" : "An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier",
"definition" : "An identifier that is specific to this particular part of the packaging. Including possibly Data Carrier Identifier (a GS1 barcode).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Data Carrier Identifier"
}]
},
{
"id" : "PackagedProductDefinition.package.type",
"path" : "PackagedProductDefinition.package.type",
"short" : "The physical type of the container of the items",
"definition" : "The physical type of the container of the items.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackagingType"
}],
"strength" : "example",
"description" : "A high level categorisation of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/packaging-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Package Item (Container) Type"
}]
},
{
"id" : "PackagedProductDefinition.package.quantity",
"path" : "PackagedProductDefinition.package.quantity",
"short" : "The quantity of this level of packaging in the package that contains it (with the outermost level being 1)",
"definition" : "The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.quantity",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "integer"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Package Item (Container) Quantity"
}]
},
{
"id" : "PackagedProductDefinition.package.material",
"path" : "PackagedProductDefinition.package.material",
"short" : "Material type of the package item",
"definition" : "Material type of the package item.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.material",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageMaterial"
}],
"strength" : "example",
"description" : "A material used in the construction of packages and their components.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-material"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Material"
}]
},
{
"id" : "PackagedProductDefinition.package.alternateMaterial",
"path" : "PackagedProductDefinition.package.alternateMaterial",
"short" : "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material",
"definition" : "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.alternateMaterial",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageMaterial"
}],
"strength" : "example",
"description" : "A material used in the construction of packages and their components.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-material"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Alternate Material"
}]
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage",
"path" : "PackagedProductDefinition.package.shelfLifeStorage",
"short" : "Shelf Life and storage information",
"definition" : "Shelf Life and storage information.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.shelfLifeStorage",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children unless an empty Parameters resource",
"expression" : "hasValue() or (children().count() > id.count()) or $this is Parameters",
"xpath" : "@value|f:*|h:div|self::f:Parameters",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Shelf Life / Storage"
}]
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage.id",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.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" : "PackagedProductDefinition.package.shelfLifeStorage.extension",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.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" : "PackagedProductDefinition.package.shelfLifeStorage.modifierExtension",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.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" : "PackagedProductDefinition.package.shelfLifeStorage.type",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.type",
"short" : "This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified",
"definition" : "This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.shelfLifeStorage.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage.period[x]",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.period[x]",
"short" : "The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used",
"definition" : "The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.shelfLifeStorage.period[x]",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Duration"
},
{
"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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage",
"short" : "Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified",
"definition" : "Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.package.manufacturer",
"path" : "PackagedProductDefinition.package.manufacturer",
"short" : "Manufacturer of this package Item (multiple means these are all possible manufacturers)",
"definition" : "Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Manufacturer / Establishment (Organisation)"
}]
},
{
"id" : "PackagedProductDefinition.package.property",
"path" : "PackagedProductDefinition.package.property",
"short" : "General characteristics of this item",
"definition" : "General characteristics of this item.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.property",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children unless an empty Parameters resource",
"expression" : "hasValue() or (children().count() > id.count()) or $this is Parameters",
"xpath" : "@value|f:*|h:div|self::f:Parameters",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Physical Characteristics"
}]
},
{
"id" : "PackagedProductDefinition.package.property.id",
"path" : "PackagedProductDefinition.package.property.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" : "PackagedProductDefinition.package.property.extension",
"path" : "PackagedProductDefinition.package.property.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" : "PackagedProductDefinition.package.property.modifierExtension",
"path" : "PackagedProductDefinition.package.property.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" : "PackagedProductDefinition.package.property.type",
"path" : "PackagedProductDefinition.package.property.type",
"short" : "A code expressing the type of characteristic",
"definition" : "A code expressing the type of characteristic.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.property.type",
"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"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ProductCharacteristic"
}],
"strength" : "example",
"description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
"valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Physical Characteristics, all attributes"
}]
},
{
"id" : "PackagedProductDefinition.package.property.value[x]",
"path" : "PackagedProductDefinition.package.property.value[x]",
"short" : "A value for the characteristic",
"definition" : "A value for the characteristic.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.property.value[x]",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
},
{
"code" : "Quantity"
},
{
"code" : "date"
},
{
"code" : "boolean"
},
{
"code" : "Attachment"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Physical Characteristics, attribute's value"
}]
},
{
"id" : "PackagedProductDefinition.package.containedItem",
"path" : "PackagedProductDefinition.package.containedItem",
"short" : "The item(s) within the packaging",
"definition" : "The item(s) within the packaging.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.containedItem",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children unless an empty Parameters resource",
"expression" : "hasValue() or (children().count() > id.count()) or $this is Parameters",
"xpath" : "@value|f:*|h:div|self::f:Parameters",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Manufactured Item, Package Item (Container).Device"
}]
},
{
"id" : "PackagedProductDefinition.package.containedItem.id",
"path" : "PackagedProductDefinition.package.containedItem.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" : "PackagedProductDefinition.package.containedItem.extension",
"path" : "PackagedProductDefinition.package.containedItem.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" : "PackagedProductDefinition.package.containedItem.modifierExtension",
"path" : "PackagedProductDefinition.package.containedItem.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" : "PackagedProductDefinition.package.containedItem.item",
"path" : "PackagedProductDefinition.package.containedItem.item",
"short" : "The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package",
"definition" : "The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.containedItem.item",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition",
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition",
"http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct",
"http://hl7.org/fhir/StructureDefinition/NutritionProduct"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device"
}]
},
{
"id" : "PackagedProductDefinition.package.containedItem.amount",
"path" : "PackagedProductDefinition.package.containedItem.amount",
"short" : "The number of this type of item within this packaging",
"definition" : "The number of this type of item within this packaging.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "PackagedProductDefinition.package.containedItem.amount",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Quantity"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Manufactured Item.Manufactured Item Quantity"
}]
},
{
"id" : "PackagedProductDefinition.package.package",
"path" : "PackagedProductDefinition.package.package",
"short" : "Allows containers (and parts of containers) within containers, still a single packaged product",
"definition" : "Allows containers (and parts of containers) parwithin containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "PackagedProductDefinition.package.package",
"min" : 0,
"max" : "*"
},
"contentReference" : "#PackagedProductDefinition.package",
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(link from Package Item (Container) to itself)"
}]
}]
},
"differential" : {
"element" : [{
"id" : "PackagedProductDefinition",
"path" : "PackagedProductDefinition",
"short" : "A medically related item or items, in a container or package",
"definition" : "A medically related item or items, in a container or package.",
"min" : 0,
"max" : "*",
"mustSupport" : false,
"isModifier" : false,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product"
},
{
"identity" : "w5",
"map" : "administrative.medication"
}]
},
{
"id" : "PackagedProductDefinition.identifier",
"path" : "PackagedProductDefinition.identifier",
"short" : "A unique identifier for this package as whole",
"definition" : "A unique identifier for this package as whole. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.PCID"
}]
},
{
"id" : "PackagedProductDefinition.name",
"path" : "PackagedProductDefinition.name",
"short" : "A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc",
"definition" : "A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.type",
"path" : "PackagedProductDefinition.type",
"short" : "A high level category e.g. medicinal product, raw material, shipping container etc",
"definition" : "A high level category e.g. medicinal product, raw material, shipping/transport container, etc.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageType"
}],
"strength" : "example",
"description" : "A high level categorisation of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.packageFor",
"path" : "PackagedProductDefinition.packageFor",
"short" : "The product that this is a pack for",
"definition" : "The product that this is a pack for.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(the link from Packaged Medicinal Product to Medicinal Product)"
}]
},
{
"id" : "PackagedProductDefinition.status",
"path" : "PackagedProductDefinition.status",
"short" : "The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status",
"definition" : "The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid",
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "The lifecycle status of an artifact.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.statusDate",
"path" : "PackagedProductDefinition.statusDate",
"short" : "The date at which the given status became applicable",
"definition" : "The date at which the given status became applicable.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.containedItemQuantity",
"path" : "PackagedProductDefinition.containedItemQuantity",
"short" : "A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size",
"definition" : "A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Quantity"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.description",
"path" : "PackagedProductDefinition.description",
"short" : "Textual description. Note that this is not the name of the package or product",
"definition" : "Textual description. Note that this is not the name of the package or product.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.description"
}]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply",
"path" : "PackagedProductDefinition.legalStatusOfSupply",
"short" : "The legal status of supply of the packaged item as classified by the regulator",
"definition" : "The legal status of supply of the packaged item as classified by the regulator.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Legal Status of Supply (for a package)"
}]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.code",
"path" : "PackagedProductDefinition.legalStatusOfSupply.code",
"short" : "The actual status of supply. In what situation this package type may be supplied for use",
"definition" : "The actual status of supply. Conveys in what situation this package type may be supplied for use.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "LegalStatusOfSupply"
}],
"strength" : "example",
"description" : "The prescription supply types appropriate to a medicinal product",
"valueSet" : "http://hl7.org/fhir/ValueSet/legal-status-of-supply"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Marketing Authorisation.Legal Status of Supply (for a package)"
}]
},
{
"id" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"path" : "PackagedProductDefinition.legalStatusOfSupply.jurisdiction",
"short" : "The place where the legal status of supply applies",
"definition" : "The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "example",
"description" : "Jurisdiction codes",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.marketingStatus",
"path" : "PackagedProductDefinition.marketingStatus",
"short" : "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated",
"definition" : "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "MarketingStatus"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.Marketing Status"
}]
},
{
"id" : "PackagedProductDefinition.characteristic",
"path" : "PackagedProductDefinition.characteristic",
"short" : "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\"",
"definition" : "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\", \"calendar pack\".",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageCharacteristic"
}],
"strength" : "example",
"description" : "A characteristic of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-characteristic"
},
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.copackagedIndicator",
"path" : "PackagedProductDefinition.copackagedIndicator",
"short" : "If the drug product is supplied with another item such as a diluent or adjuvant",
"definition" : "States whether a drug product is supplied with another item such as a diluent or adjuvant.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "boolean"
}],
"meaningWhenMissing" : "If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made",
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "n/a"
}]
},
{
"id" : "PackagedProductDefinition.manufacturer",
"path" : "PackagedProductDefinition.manufacturer",
"short" : "Manufacturer of this package type (multiple means these are all possible manufacturers)",
"definition" : "Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.Manufacturer / Establishment (Organisation)"
}]
},
{
"id" : "PackagedProductDefinition.package",
"path" : "PackagedProductDefinition.package",
"short" : "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap",
"definition" : "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)"
}]
},
{
"id" : "PackagedProductDefinition.package.identifier",
"path" : "PackagedProductDefinition.package.identifier",
"short" : "An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier",
"definition" : "An identifier that is specific to this particular part of the packaging. Including possibly Data Carrier Identifier (a GS1 barcode).",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Data Carrier Identifier"
}]
},
{
"id" : "PackagedProductDefinition.package.type",
"path" : "PackagedProductDefinition.package.type",
"short" : "The physical type of the container of the items",
"definition" : "The physical type of the container of the items.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackagingType"
}],
"strength" : "example",
"description" : "A high level categorisation of a package.",
"valueSet" : "http://hl7.org/fhir/ValueSet/packaging-type"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Package Item (Container) Type"
}]
},
{
"id" : "PackagedProductDefinition.package.quantity",
"path" : "PackagedProductDefinition.package.quantity",
"short" : "The quantity of this level of packaging in the package that contains it (with the outermost level being 1)",
"definition" : "The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "integer"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Package Item (Container) Quantity"
}]
},
{
"id" : "PackagedProductDefinition.package.material",
"path" : "PackagedProductDefinition.package.material",
"short" : "Material type of the package item",
"definition" : "Material type of the package item.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageMaterial"
}],
"strength" : "example",
"description" : "A material used in the construction of packages and their components.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-material"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Material"
}]
},
{
"id" : "PackagedProductDefinition.package.alternateMaterial",
"path" : "PackagedProductDefinition.package.alternateMaterial",
"short" : "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material",
"definition" : "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PackageMaterial"
}],
"strength" : "example",
"description" : "A material used in the construction of packages and their components.",
"valueSet" : "http://hl7.org/fhir/ValueSet/package-material"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Alternate Material"
}]
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage",
"path" : "PackagedProductDefinition.package.shelfLifeStorage",
"short" : "Shelf Life and storage information",
"definition" : "Shelf Life and storage information.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Shelf Life / Storage"
}]
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage.type",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.type",
"short" : "This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified",
"definition" : "This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage.period[x]",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.period[x]",
"short" : "The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used",
"definition" : "The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Duration"
},
{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage",
"path" : "PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage",
"short" : "Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified",
"definition" : "Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "PackagedProductDefinition.package.manufacturer",
"path" : "PackagedProductDefinition.package.manufacturer",
"short" : "Manufacturer of this package Item (multiple means these are all possible manufacturers)",
"definition" : "Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Manufacturer / Establishment (Organisation)"
}]
},
{
"id" : "PackagedProductDefinition.package.property",
"path" : "PackagedProductDefinition.package.property",
"short" : "General characteristics of this item",
"definition" : "General characteristics of this item.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Physical Characteristics"
}]
},
{
"id" : "PackagedProductDefinition.package.property.type",
"path" : "PackagedProductDefinition.package.property.type",
"short" : "A code expressing the type of characteristic",
"definition" : "A code expressing the type of characteristic.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ProductCharacteristic"
}],
"strength" : "example",
"description" : "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.",
"valueSet" : "http://hl7.org/fhir/ValueSet/product-characteristic-codes"
},
"mapping" : [{
"identity" : "idmp",
"map" : "Physical Characteristics, all attributes"
}]
},
{
"id" : "PackagedProductDefinition.package.property.value[x]",
"path" : "PackagedProductDefinition.package.property.value[x]",
"short" : "A value for the characteristic",
"definition" : "A value for the characteristic.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
},
{
"code" : "Quantity"
},
{
"code" : "date"
},
{
"code" : "boolean"
},
{
"code" : "Attachment"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Physical Characteristics, attribute's value"
}]
},
{
"id" : "PackagedProductDefinition.package.containedItem",
"path" : "PackagedProductDefinition.package.containedItem",
"short" : "The item(s) within the packaging",
"definition" : "The item(s) within the packaging.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Package Item (Container).Manufactured Item, Package Item (Container).Device"
}]
},
{
"id" : "PackagedProductDefinition.package.containedItem.item",
"path" : "PackagedProductDefinition.package.containedItem.item",
"short" : "The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package",
"definition" : "The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package).",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition",
"http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition",
"http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct",
"http://hl7.org/fhir/StructureDefinition/NutritionProduct"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device"
}]
},
{
"id" : "PackagedProductDefinition.package.containedItem.amount",
"path" : "PackagedProductDefinition.package.containedItem.amount",
"short" : "The number of this type of item within this packaging",
"definition" : "The number of this type of item within this packaging.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Quantity"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "Manufactured Item.Manufactured Item Quantity"
}]
},
{
"id" : "PackagedProductDefinition.package.package",
"path" : "PackagedProductDefinition.package.package",
"short" : "Allows containers (and parts of containers) within containers, still a single packaged product",
"definition" : "Allows containers (and parts of containers) parwithin containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition).",
"min" : 0,
"max" : "*",
"contentReference" : "#PackagedProductDefinition.package",
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "idmp",
"map" : "(link from Package Item (Container) to itself)"
}]
}]
}
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR Release 4B (v4.3.0) hl7.fhir.r4b.core#4.3.0 generated on Sat, May 28, 2022 12:56+1000.
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