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| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No defined compartments |
ShEx statement for packagedproductdefinition
PREFIX fhir: <http://hl7.org/fhir/>
PREFIX fhirvs: <http://hl7.org/fhir/ValueSet/>
PREFIX xsd: <http://www.w3.org/2001/XMLSchema#>
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#>
IMPORT <date.shex>
IMPORT <string.shex>
IMPORT <boolean.shex>
IMPORT <integer.shex>
IMPORT <dateTime.shex>
IMPORT <Quantity.shex>
IMPORT <markdown.shex>
IMPORT <Identifier.shex>
IMPORT <Attachment.shex>
IMPORT <Organization.shex>
IMPORT <DomainResource.shex>
IMPORT <CodeableConcept.shex>
IMPORT <MarketingStatus.shex>
IMPORT <BackboneElement.shex>
IMPORT <ProductShelfLife.shex>
IMPORT <CodeableReference.shex>
IMPORT <DocumentReference.shex>
IMPORT <MedicinalProductDefinition.shex>
start=@<PackagedProductDefinition> AND {fhir:nodeRole [fhir:treeRoot]}
# A medically related item or items, in a container or package
<PackagedProductDefinition> EXTENDS @<DomainResource> CLOSED {
a [fhir:PackagedProductDefinition]?;fhir:nodeRole [fhir:treeRoot]?;
fhir:identifier @<OneOrMore_Identifier>?; # A unique identifier for this
# package as whole - not for the
# content of the package
fhir:name @<string>?; # A name for this package. Typically
# as listed in a drug formulary,
# catalogue, inventory etc
fhir:type @<CodeableConcept>?; # A high level category e.g.
# medicinal product, raw material,
# shipping container etc
fhir:packageFor @<OneOrMore_Reference_MedicinalProductDefinition>?; # The product that this is a pack for
fhir:status @<CodeableConcept>?; # The status within the lifecycle of
# this item. High level - not
# intended to duplicate details
# elsewhere e.g. legal status, or
# authorization/marketing status
fhir:statusDate @<dateTime>?; # The date at which the given status
# became applicable
fhir:containedItemQuantity @<OneOrMore_Quantity>?; # 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. See also
# packaging.containedItem.amount
# (especially the long definition)
fhir:description @<markdown>?; # Textual description. Note that
# this is not the name of the
# package or product
fhir:legalStatusOfSupply @<OneOrMore_PackagedProductDefinition.legalStatusOfSupply>?; # The legal status of supply of the
# packaged item as classified by the
# regulator
fhir:marketingStatus @<OneOrMore_MarketingStatus>?; # Allows specifying that an item is
# on the market for sale, or that it
# is not available, and the dates
# and locations associated
fhir:copackagedIndicator @<boolean>?; # Identifies if the drug product is
# supplied with another item such as
# a diluent or adjuvant
fhir:manufacturer @<OneOrMore_Reference_Organization>?; # Manufacturer of this package type
# (multiple means these are all
# possible manufacturers)
fhir:attachedDocument @<OneOrMore_Reference_DocumentReference>?; # Additional information or
# supporting documentation about the
# packaged product
fhir:packaging @<PackagedProductDefinition.packaging>?; # A packaging item, as a container
# for medically related items,
# possibly with other packaging
# items within, or a packaging
# component, such as bottle cap
fhir:characteristic @<OneOrMore_PackagedProductDefinition.packaging.property>?; # Allows the key features to be
# recorded, such as "hospital pack",
# "nurse prescribable"
}
# A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
<PackagedProductDefinition.packaging> EXTENDS @<BackboneElement> CLOSED {
fhir:identifier @<OneOrMore_Identifier>?; # An identifier that is specific to
# this particular part of the
# packaging. Including possibly a
# Data Carrier Identifier
fhir:type @<CodeableConcept>?; # The physical type of the container
# of the items
fhir:componentPart @<boolean>?; # Is this a part of the packaging
# (e.g. a cap or bottle stopper),
# rather than the packaging itself
# (e.g. a bottle or vial)
fhir:quantity @<integer>?; # The quantity of this level of
# packaging in the package that
# contains it (with the outermost
# level being 1)
fhir:material @<OneOrMore_CodeableConcept>?; # Material type of the package item
fhir:alternateMaterial @<OneOrMore_CodeableConcept>?; # A possible alternate material for
# this part of the packaging, that
# is allowed to be used instead of
# the usual material
fhir:shelfLifeStorage @<OneOrMore_ProductShelfLife>?; # Shelf Life and storage information
fhir:manufacturer @<OneOrMore_Reference_Organization>?; # Manufacturer of this packaging
# item (multiple means these are all
# potential manufacturers)
fhir:property @<OneOrMore_PackagedProductDefinition.packaging.property>?; # General characteristics of this
# item
fhir:containedItem @<OneOrMore_PackagedProductDefinition.packaging.containedItem>?; # The item(s) within the packaging
fhir:packaging @<OneOrMore_PackagedProductDefinition.packaging>?; # Allows containers (and parts of
# containers) within containers,
# still as a part of single packaged
# product
}
# The legal status of supply of the packaged item as classified by the regulator
<PackagedProductDefinition.legalStatusOfSupply> EXTENDS @<BackboneElement> CLOSED {
fhir:code @<CodeableConcept>?; # The actual status of supply. In
# what situation this package type
# may be supplied for use
fhir:jurisdiction @<CodeableConcept>?; # The place where the legal status
# of supply applies
}
# Allows containers (and parts of containers) within containers, still as a part of single packaged product
<PackagedProductDefinition.packaging.packagingnull> CLOSED {
}
# General characteristics of this item
<PackagedProductDefinition.packaging.property> EXTENDS @<BackboneElement> CLOSED {
fhir:type @<CodeableConcept>; # A code expressing the type of
# characteristic
fhir:value @<CodeableConcept> OR
@<Quantity> OR
@<date> OR
@<boolean> OR
@<Attachment> ?; # A value for the characteristic
}
# The item(s) within the packaging
<PackagedProductDefinition.packaging.containedItem> EXTENDS @<BackboneElement> CLOSED {
fhir:item @<CodeableReference>; # 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
fhir:amount @<Quantity>?; # The number of this type of item
# within this packaging or for
# continuous items such as liquids
# it is the quantity (for example
# 25ml). See also
# PackagedProductDefinition.contai-
# nedItemQuantity (especially the
# long definition)
}
#---------------------- Cardinality Types (OneOrMore) -------------------
<OneOrMore_Identifier> CLOSED {
rdf:first @<Identifier> ;
rdf:rest [rdf:nil] OR @<OneOrMore_Identifier>
}
<OneOrMore_Reference_MedicinalProductDefinition> CLOSED {
rdf:first @<Reference> AND {fhir:link
@<MedicinalProductDefinition> } ;
rdf:rest [rdf:nil] OR @<OneOrMore_Reference_MedicinalProductDefinition>
}
<OneOrMore_Quantity> CLOSED {
rdf:first @<Quantity> ;
rdf:rest [rdf:nil] OR @<OneOrMore_Quantity>
}
<OneOrMore_PackagedProductDefinition.legalStatusOfSupply> CLOSED {
rdf:first @<PackagedProductDefinition.legalStatusOfSupply> ;
rdf:rest [rdf:nil] OR @<OneOrMore_PackagedProductDefinition.legalStatusOfSupply>
}
<OneOrMore_MarketingStatus> CLOSED {
rdf:first @<MarketingStatus> ;
rdf:rest [rdf:nil] OR @<OneOrMore_MarketingStatus>
}
<OneOrMore_Reference_Organization> CLOSED {
rdf:first @<Reference> AND {fhir:link
@<Organization> } ;
rdf:rest [rdf:nil] OR @<OneOrMore_Reference_Organization>
}
<OneOrMore_Reference_DocumentReference> CLOSED {
rdf:first @<Reference> AND {fhir:link
@<DocumentReference> } ;
rdf:rest [rdf:nil] OR @<OneOrMore_Reference_DocumentReference>
}
<OneOrMore_PackagedProductDefinition.packaging.property> CLOSED {
rdf:first @<PackagedProductDefinition.packaging.property> ;
rdf:rest [rdf:nil] OR @<OneOrMore_PackagedProductDefinition.packaging.property>
}
<OneOrMore_CodeableConcept> CLOSED {
rdf:first @<CodeableConcept> ;
rdf:rest [rdf:nil] OR @<OneOrMore_CodeableConcept>
}
<OneOrMore_ProductShelfLife> CLOSED {
rdf:first @<ProductShelfLife> ;
rdf:rest [rdf:nil] OR @<OneOrMore_ProductShelfLife>
}
<OneOrMore_PackagedProductDefinition.packaging.containedItem> CLOSED {
rdf:first @<PackagedProductDefinition.packaging.containedItem> ;
rdf:rest [rdf:nil] OR @<OneOrMore_PackagedProductDefinition.packaging.containedItem>
}
<OneOrMore_PackagedProductDefinition.packaging> CLOSED {
rdf:first @<PackagedProductDefinition.packaging> ;
rdf:rest [rdf:nil] OR @<OneOrMore_PackagedProductDefinition.packaging>
}
Usage note: every effort has been made to ensure that the ShEx files are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot3 generated on Thu, Oct 23, 2025 19:47+0000.
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