R4 Ballot #1 (Mixed Normative/Trial use)
MedicationsThis page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Not linked to any defined compartments |
StructureDefinition for medicinalproductpackaged
{
"resourceType": "StructureDefinition",
"id": "MedicinalProductPackaged",
"meta": {
"lastUpdated": "2018-04-03T12:05:46.262+10:00"
},
"text": {
"status": "generated",
"div": "<div>!-- Snipped for Brevity --></div>"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-ballot-status",
"valueString": "Draft"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
}
],
"url": "http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged",
"name": "MedicinalProductPackaged",
"status": "draft",
"date": "2018-04-03T12:05:46+10:00",
"publisher": "Health Level Seven International (Biomedical Research and Regulation)",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "http://hl7.org/fhir"
}
]
},
{
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim/index.cfm"
}
]
}
],
"description": "A medicinal product in a container or package.",
"fhirVersion": "3.3.0",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "MedicinalProductPackaged",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation": "specialization",
"snapshot": {
"element": [
{
"id": "MedicinalProductPackaged",
"path": "MedicinalProductPackaged",
"short": "A medicinal product in a container or package",
"definition": "A medicinal product in a container or package.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged",
"min": 0,
"max": "*"
},
"constraint": [
{
"key": "dom-2",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression": "contained.contained.empty()",
"xpath": "not(parent::f:contained and f:contained)",
"source": "DomainResource"
},
{
"key": "dom-1",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain any narrative",
"expression": "contained.text.empty()",
"xpath": "not(parent::f:contained and f:text)",
"source": "DomainResource"
},
{
"key": "dom-4",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source": "DomainResource"
},
{
"key": "dom-3",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression": "contained.all(('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists())",
"xpath": "not(exists(for $contained in f:contained return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
"source": "DomainResource"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Entity. Role, or Act"
}
]
},
{
"id": "MedicinalProductPackaged.id",
"path": "MedicinalProductPackaged.id",
"short": "Logical id of this artifact",
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "id"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.meta",
"path": "MedicinalProductPackaged.meta",
"short": "Metadata about the resource",
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.meta",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Meta"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.implicitRules",
"path": "MedicinalProductPackaged.implicitRules",
"short": "A set of rules under which this content was created",
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.",
"min": 0,
"max": "1",
"base": {
"path": "Resource.implicitRules",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"isModifier": true,
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
"isSummary": true
},
{
"id": "MedicinalProductPackaged.language",
"path": "MedicinalProductPackaged.language",
"short": "Language of the resource content",
"definition": "The base language in which the resource is written.",
"comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min": 0,
"max": "1",
"base": {
"path": "Resource.language",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueReference": {
"reference": "http://hl7.org/fhir/ValueSet/all-languages"
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean": true
}
],
"strength": "extensible",
"description": "A human language.",
"valueSetCanonical": "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id": "MedicinalProductPackaged.text",
"path": "MedicinalProductPackaged.text",
"short": "Text summary of the resource, for human interpretation",
"definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"comment": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded in formation is added later.",
"alias": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"condition": [
"dom-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Act.text?"
}
]
},
{
"id": "MedicinalProductPackaged.contained",
"path": "MedicinalProductPackaged.contained",
"short": "Contained, inline Resources",
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.",
"alias": [
"inline resources",
"anonymous resources",
"contained resources"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.contained",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Resource"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProductPackaged.extension",
"path": "MedicinalProductPackaged.extension",
"short": "Additional Content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProductPackaged.modifierExtension",
"path": "MedicinalProductPackaged.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isModifierReason": "Not known why this is labelled a modifier",
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProductPackaged.identifier",
"path": "MedicinalProductPackaged.identifier",
"short": "Unique identifier",
"definition": "Unique identifier.",
"alias": [
"PCID"
],
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.identifier",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.description",
"path": "MedicinalProductPackaged.description",
"short": "Textual description",
"definition": "Textual description.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.description",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.marketingStatus",
"path": "MedicinalProductPackaged.marketingStatus",
"short": "Marketing information",
"definition": "Marketing information.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.marketingStatus",
"min": 0,
"max": "*"
},
"type": [
{
"code": "MarketingStatus"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.batchIdentifier",
"path": "MedicinalProductPackaged.batchIdentifier",
"short": "Batch numbering",
"definition": "Batch numbering.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.batchIdentifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.batchIdentifier.id",
"path": "MedicinalProductPackaged.batchIdentifier.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProductPackaged.batchIdentifier.extension",
"path": "MedicinalProductPackaged.batchIdentifier.extension",
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProductPackaged.batchIdentifier.modifierExtension",
"path": "MedicinalProductPackaged.batchIdentifier.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isModifierReason": "modifierExtension is reserved for use where modifier extensions must be used",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProductPackaged.batchIdentifier.outerPackaging",
"path": "MedicinalProductPackaged.batchIdentifier.outerPackaging",
"short": "A number appearing on the outer packaging of a specific batch",
"definition": "A number appearing on the outer packaging of a specific batch.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.batchIdentifier.outerPackaging",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.batchIdentifier.immediatePackaging",
"path": "MedicinalProductPackaged.batchIdentifier.immediatePackaging",
"short": "A number appearing on the immediate packaging (and not the outer packaging)",
"definition": "A number appearing on the immediate packaging (and not the outer packaging).",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.batchIdentifier.immediatePackaging",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Identifier"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem",
"path": "MedicinalProductPackaged.packageItem",
"short": "A packaging item, as a contained for medicine, possibly with other packaging items within",
"definition": "A packaging item, as a contained for medicine, possibly with other packaging items within.",
"min": 1,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem",
"min": 1,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.id",
"path": "MedicinalProductPackaged.packageItem.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProductPackaged.packageItem.extension",
"path": "MedicinalProductPackaged.packageItem.extension",
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProductPackaged.packageItem.modifierExtension",
"path": "MedicinalProductPackaged.packageItem.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isModifierReason": "modifierExtension is reserved for use where modifier extensions must be used",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProductPackaged.packageItem.identifier",
"path": "MedicinalProductPackaged.packageItem.identifier",
"short": "Including possibly Data Carrier Identifier",
"definition": "Including possibly Data Carrier Identifier.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.identifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Identifier"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.type",
"path": "MedicinalProductPackaged.packageItem.type",
"short": "The physical type of the container of the medicine",
"definition": "The physical type of the container of the medicine.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.packageItem.type",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.quantity",
"path": "MedicinalProductPackaged.packageItem.quantity",
"short": "The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1",
"definition": "The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.packageItem.quantity",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.material",
"path": "MedicinalProductPackaged.packageItem.material",
"short": "Material type of the package item",
"definition": "Material type of the package item.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.material",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.alternateMaterial",
"path": "MedicinalProductPackaged.packageItem.alternateMaterial",
"short": "A possible alternate material for the packaging",
"definition": "A possible alternate material for the packaging.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.alternateMaterial",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturer",
"path": "MedicinalProductPackaged.packageItem.manufacturer",
"short": "Manufacturer of this Package Item",
"definition": "Manufacturer of this Package Item.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturer",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.device",
"path": "MedicinalProductPackaged.packageItem.device",
"short": "A device accompanying a medicinal product",
"definition": "A device accompanying a medicinal product.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.device",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/MedicinalProductDeviceSpec"
]
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem",
"short": "The manufactured item as contained in the packaged medicinal product",
"definition": "The manufactured item as contained in the packaged medicinal product.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturedItem",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() | (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "Element"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.id",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.id",
"representation": [
"xmlAttr"
],
"short": "xml:id (or equivalent in JSON)",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.extension",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.extension",
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.modifierExtension",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"isModifier": true,
"isModifierReason": "modifierExtension is reserved for use where modifier extensions must be used",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm",
"short": "Dose form as manufactured and before any transformation into the pharmaceutical product",
"definition": "Dose form as manufactured and before any transformation into the pharmaceutical product.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation",
"short": "The “real world” units in which the quantity of the manufactured item is described",
"definition": "The “real world” units in which the quantity of the manufactured item is described.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.quantity",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.quantity",
"short": "The quantity or \"count number\" of the manufactured item",
"definition": "The quantity or \"count number\" of the manufactured item.",
"min": 1,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.quantity",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Quantity"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer",
"short": "Manufacturer of the item (Note that this should be named \"manufacturer\" but it currently causes technical issues)",
"definition": "Manufacturer of the item (Note that this should be named \"manufacturer\" but it currently causes technical issues).",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.ingredient",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.ingredient",
"short": "Ingredient",
"definition": "Ingredient.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.ingredient",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/MedicinalProductIngredient"
]
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics",
"short": "Dimensions, color etc.",
"definition": "Dimensions, color etc.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics",
"min": 0,
"max": "1"
},
"type": [
{
"code": "ProdCharacteristic"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.otherCharacteristics",
"path": "MedicinalProductPackaged.packageItem.otherCharacteristics",
"short": "Other codeable characteristics",
"definition": "Other codeable characteristics.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.otherCharacteristics",
"min": 0,
"max": "*"
},
"type": [
{
"code": "CodeableConcept"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.packageItem",
"path": "MedicinalProductPackaged.packageItem.packageItem",
"short": "Allows containers within containers",
"definition": "Allows containers within containers.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.packageItem",
"min": 0,
"max": "*"
},
"contentReference": "#MedicinalProductPackaged.packageItem",
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.physicalCharacteristics",
"path": "MedicinalProductPackaged.packageItem.physicalCharacteristics",
"short": "Dimensions, color etc.",
"definition": "Dimensions, color etc.",
"min": 0,
"max": "1",
"base": {
"path": "MedicinalProductPackaged.packageItem.physicalCharacteristics",
"min": 0,
"max": "1"
},
"type": [
{
"code": "ProdCharacteristic"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.shelfLifeStorage",
"path": "MedicinalProductPackaged.packageItem.shelfLifeStorage",
"short": "Shelf Life and storage information",
"definition": "Shelf Life and storage information.",
"min": 0,
"max": "*",
"base": {
"path": "MedicinalProductPackaged.packageItem.shelfLifeStorage",
"min": 0,
"max": "*"
},
"type": [
{
"code": "ProductShelfLife"
}
],
"isModifier": false,
"isSummary": true
}
]
},
"differential": {
"element": [
{
"id": "MedicinalProductPackaged",
"path": "MedicinalProductPackaged",
"short": "A medicinal product in a container or package",
"definition": "A medicinal product in a container or package.",
"min": 0,
"max": "*"
},
{
"id": "MedicinalProductPackaged.identifier",
"path": "MedicinalProductPackaged.identifier",
"short": "Unique identifier",
"definition": "Unique identifier.",
"alias": [
"PCID"
],
"min": 1,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.description",
"path": "MedicinalProductPackaged.description",
"short": "Textual description",
"definition": "Textual description.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.marketingStatus",
"path": "MedicinalProductPackaged.marketingStatus",
"short": "Marketing information",
"definition": "Marketing information.",
"min": 0,
"max": "*",
"type": [
{
"code": "MarketingStatus"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.batchIdentifier",
"path": "MedicinalProductPackaged.batchIdentifier",
"short": "Batch numbering",
"definition": "Batch numbering.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.batchIdentifier.outerPackaging",
"path": "MedicinalProductPackaged.batchIdentifier.outerPackaging",
"short": "A number appearing on the outer packaging of a specific batch",
"definition": "A number appearing on the outer packaging of a specific batch.",
"min": 1,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.batchIdentifier.immediatePackaging",
"path": "MedicinalProductPackaged.batchIdentifier.immediatePackaging",
"short": "A number appearing on the immediate packaging (and not the outer packaging)",
"definition": "A number appearing on the immediate packaging (and not the outer packaging).",
"min": 0,
"max": "1",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem",
"path": "MedicinalProductPackaged.packageItem",
"short": "A packaging item, as a contained for medicine, possibly with other packaging items within",
"definition": "A packaging item, as a contained for medicine, possibly with other packaging items within.",
"min": 1,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.identifier",
"path": "MedicinalProductPackaged.packageItem.identifier",
"short": "Including possibly Data Carrier Identifier",
"definition": "Including possibly Data Carrier Identifier.",
"min": 0,
"max": "*",
"type": [
{
"code": "Identifier"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.type",
"path": "MedicinalProductPackaged.packageItem.type",
"short": "The physical type of the container of the medicine",
"definition": "The physical type of the container of the medicine.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.quantity",
"path": "MedicinalProductPackaged.packageItem.quantity",
"short": "The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1",
"definition": "The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1.",
"min": 1,
"max": "1",
"type": [
{
"code": "Quantity"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.material",
"path": "MedicinalProductPackaged.packageItem.material",
"short": "Material type of the package item",
"definition": "Material type of the package item.",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.alternateMaterial",
"path": "MedicinalProductPackaged.packageItem.alternateMaterial",
"short": "A possible alternate material for the packaging",
"definition": "A possible alternate material for the packaging.",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturer",
"path": "MedicinalProductPackaged.packageItem.manufacturer",
"short": "Manufacturer of this Package Item",
"definition": "Manufacturer of this Package Item.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.device",
"path": "MedicinalProductPackaged.packageItem.device",
"short": "A device accompanying a medicinal product",
"definition": "A device accompanying a medicinal product.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/MedicinalProductDeviceSpec"
]
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem",
"short": "The manufactured item as contained in the packaged medicinal product",
"definition": "The manufactured item as contained in the packaged medicinal product.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm",
"short": "Dose form as manufactured and before any transformation into the pharmaceutical product",
"definition": "Dose form as manufactured and before any transformation into the pharmaceutical product.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation",
"short": "The “real world” units in which the quantity of the manufactured item is described",
"definition": "The “real world” units in which the quantity of the manufactured item is described.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.quantity",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.quantity",
"short": "The quantity or \"count number\" of the manufactured item",
"definition": "The quantity or \"count number\" of the manufactured item.",
"min": 1,
"max": "1",
"type": [
{
"code": "Quantity"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer",
"short": "Manufacturer of the item (Note that this should be named \"manufacturer\" but it currently causes technical issues)",
"definition": "Manufacturer of the item (Note that this should be named \"manufacturer\" but it currently causes technical issues).",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.ingredient",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.ingredient",
"short": "Ingredient",
"definition": "Ingredient.",
"min": 0,
"max": "*",
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/MedicinalProductIngredient"
]
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics",
"path": "MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics",
"short": "Dimensions, color etc.",
"definition": "Dimensions, color etc.",
"min": 0,
"max": "1",
"type": [
{
"code": "ProdCharacteristic"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.otherCharacteristics",
"path": "MedicinalProductPackaged.packageItem.otherCharacteristics",
"short": "Other codeable characteristics",
"definition": "Other codeable characteristics.",
"min": 0,
"max": "*",
"type": [
{
"code": "CodeableConcept"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.packageItem",
"path": "MedicinalProductPackaged.packageItem.packageItem",
"short": "Allows containers within containers",
"definition": "Allows containers within containers.",
"min": 0,
"max": "*",
"contentReference": "#MedicinalProductPackaged.packageItem",
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.physicalCharacteristics",
"path": "MedicinalProductPackaged.packageItem.physicalCharacteristics",
"short": "Dimensions, color etc.",
"definition": "Dimensions, color etc.",
"min": 0,
"max": "1",
"type": [
{
"code": "ProdCharacteristic"
}
],
"isSummary": true
},
{
"id": "MedicinalProductPackaged.packageItem.shelfLifeStorage",
"path": "MedicinalProductPackaged.packageItem.shelfLifeStorage",
"short": "Shelf Life and storage information",
"definition": "Shelf Life and storage information.",
"min": 0,
"max": "*",
"type": [
{
"code": "ProductShelfLife"
}
],
"isSummary": true
}
]
}
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
®© HL7.org 2011+. FHIR Mixed Nomative/Trial Use Ballot (v3.3.0-13671) generated on Tue, Apr 3, 2018 12:16+1000. QA Page
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