Generated Narrative: StructureDefinition emaWriteApiPackagedProductDefinition Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> PackagedProductDefinition EmaWriteApiPackagedProductDefinitionRestrictions Slices for identifier C 0..2 Identifier A unique identifier for this package as whole - not for the content of the package Slice: Unordered, Closed by value:system onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present identifier:emaPcIdentifier 0..1 EmaPcIdentifier A unique identifier for this package as whole - not for the content of the package system 1..1 uri The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pcId identifier:dataCarrierGs1 0..1 Identifier A unique identifier for this package as whole - not for the content of the package system 1..1 uri The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575 identifier:dataCarrierPharmacy 0..1 Identifier A unique identifier for this package as whole - not for the content of the package system 1..1 uri The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029 identifier:dataCarrierNationalTrade 0..1 Identifier A unique identifier for this package as whole - not for the content of the package system 1..1 uri The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030 packageFor 1..1 Reference(EMA Write API MedicinalProductDefinition) The product that this is a pack for status 1..1 EmaRefTermCodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: Record Status (required) containedItemQuantity value 1..1 decimal Numerical value (with implicit precision) system 1..1 uri System that defines coded unit form Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000014 code 1..1 code Coded form of the unit Binding: Units of Presentation (required) description 1..1 markdown Textual description. Note that this is not the name of the package or product extension 1..1 EmaCoding Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) legalStatusOfSupply code 0..1 EmaRefTermCodeableConcept The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status of Supply (required) marketingStatus 1..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated Slices for extension Content/Rules for all slices extension:riskOfSupplyShortage 0..1 boolean Risk of Supply Shortage URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage extension:riskOfSupplyShortageComment 0..1 string Risk of Supply Shortage Comment URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment extension:marketingStatusReason 0..1 EmaCoding Marketing Status Reason URL: http://ema.europa.eu/fhir/extension/marketingStatusReason Binding: Marketing Status Reason (required) country 1..1 EmaRefTermCodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: Country (required) status 1..1 EmaRefTermCodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: Marketing Status (required) dateRange start 1..1 dateTime Starting time with inclusive boundary manufacturer extension 1..* Reference(EMA Write API ActivityDefinition) The Operation Extension URL: http://ema.europa.eu/fhir/extension/operation packaging type 1..1 EmaRefTermCodeableConcept The physical type of the container of the items Binding: Packaging (required) quantity extension 1..1 Coding The Comparator Extension URL: http://ema.europa.eu/fhir/extension/comparator Binding: Quantity Operator (required) material 1..* EmaRefTermCodeableConcept Material type of the package item Binding: Material (required) shelfLifeStorage type 1..1 EmaRefTermCodeableConcept 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 Binding: Shelf Life Type (required) period[x] 1..1 EmaDuration 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 specialPrecautionsForStorage 0..* EmaRefTermCodeableConcept 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 Binding: Special Precautions For Storage (required) manufacturer extension 1..* Extension Extension extension 0..0 Slices for value[x] 0..1 base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta Value of extension Slice: Unordered, Open by type:$this value[x]:valueReference 0..1 Reference(EMA Write API ActivityDefinition) Value of extension containedItem item 1..1 CodeableReference(DeviceDefinition | ManufacturedItemDefinition) 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 amount 1..1 EmaQuantity 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.containedItemQuantity (especially the long definition) <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
Defines the rules a PackagedProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
A medically related item or items, in a container or package
A medically related item or items, in a container or package.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
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
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
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.
A resource should have narrative for robust management
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
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.
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 its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
Contained resources do not have a 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.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
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.
Must have either extensions or value[x], not both
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Slice defining 2 different types of identifiers (closed)
A unique identifier for this package as whole - not for the content of the package
A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.
Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
Additional content defined by implementations
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 managable, 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.
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.
A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.
A high level category e.g. medicinal product, raw material, shipping container etc
A high level category e.g. medicinal product, raw material, shipping/transport container, etc.
A high level categorisation of a package.
The product this package model relates to, not the contents of the package (for which see package.containedItem).
(the link from Packaged Medicinal Product to Medicinal Product)
The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
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.
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
The date at which the given status became applicable
The date at which the given status became applicable.
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)
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.
Numerical value (with implicit precision)
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Precision is handled implicitly in almost all cases of measurement.
PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
< | <= | >= | > | ad - how to understand the value
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
If there is no comparator, then there is no modification of the value
This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
How the Quantity should be understood and represented.
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
The identification of the system that provides the coded form of the unit.
Need to know the system that defines the coded form of the unit.
CO.codeSystem, PQ.translation.codeSystem
A computer processable form of the unit in some unit representation system.
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
PQ.code, MO.currency, PQ.translation.code
Textual description. Note that this is not the name of the package or product
Textual description. Note that this is not the name of the package or product.
unique id for the element within a resource (for internal references)
The legal status of supply of the packaged item as classified by the regulator
The legal status of supply of the packaged item as classified by the regulator.
Marketing Authorization.Legal Status of Supply (for a package)
Extensions that cannot be ignored even if unrecognized
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 managable, 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The actual status of supply. In what situation this package type may be supplied for use
The actual status of supply. Conveys in what situation this package type may be supplied for use.
The place where the legal status of supply applies
The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.
Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.
Packaged Medicinal Product.Marketing Status
The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.
Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.
This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.
The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.
The start of the period. The boundary is inclusive.
If the low element is missing, the meaning is that the low boundary is not known.
End time with inclusive boundary, if not ongoing
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
If the end of the period is missing, it means that the period is ongoing
Identifies if the drug product is supplied with another item such as a diluent or adjuvant
Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.
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
Manufacturer of this package type (multiple means these are all possible manufacturers)
Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.
Packaged Medicinal Product.Manufacturer / Establishment (Organisation)
Literal reference, Relative, internal or absolute URL
A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
Type the reference refers to (e.g. "Patient") - must be a resource in resources
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Aa resource (or, for logical models, the URI of the logical model).
Logical reference, when literal reference is not known
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Plain text narrative that identifies the resource in addition to the resource reference.
This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
Additional information or supporting documentation about the packaged product
Additional information or supporting documentation about the packaged product.
A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
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).
Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)
An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode).
Package Item (Container).Data Carrier Identifier
The physical type of the container of the items
The physical type of the container of the items.
Package Item (Container).Package Item (Container) Type
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)
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). The latter type are designed be a container, but the former are not.
If absent, it cannot be assumed that the item is packaging (a container) or a part of the packaging - it is just 'packaging'. Systems can sometimes infer this from the packaging.type (e.g. bottles are containers, bottle caps are not), or from the fact that a container will usually have other items within it (though it is possible that these exist but are not mentioned). Often the distinction is not critical - and can easily be understood by humans - but if that is necessary for machine processing it is recommended that this attribute is given a value.
Whether this packaging item corresponds to an Package Item (Container), if false, or a Package (Component), when true
The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2.
Package Item (Container).Package Item (Container) Quantity
A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
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).
A material used in the construction of packages and their components.
Package Item (Container).Alternate Material
Package Item (Container).Shelf Life / Storage
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
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.
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
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.
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
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.
Manufacturer of this packaging item (multiple means these are all potential manufacturers)
Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item.
Package Item (Container).Manufacturer / Establishment (Organisation)
Source of the definition for the extension code - a logical name or a URL.
The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).
Package Item (Container).Physical Characteristics
A code expressing the type of characteristic
A code expressing the type of characteristic.
This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Physical Characteristics, all attributes
Physical Characteristics, attribute's value
Package Item (Container).Manufactured Item, Package Item (Container).Device
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
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.packaging.packaging).
(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device
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.containedItemQuantity (especially the long definition)
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.containedItemQuantity (especially the long definition).
Manufactured Item.Manufactured Item Quantity
Allows containers (and parts of containers) within containers, still as a part of single packaged product
Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).
(link from Package Item (Container) to itself)
Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".