EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EmaWriteApiPackagedProductDefinition - Detailed Descriptions

Draft as of 2025-04-04

Definitions for the emaWriteApiPackagedProductDefinition resource profile.

Guidance on how to interpret the contents of this table can be found here

0. PackagedProductDefinition
Definition

A medically related item or items, in a container or package.

ShortA medically related item or items, in a container or package
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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())
dom-4: 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())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. PackagedProductDefinition.implicitRules
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.

ShortA set of rules under which this content was created
Comments

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.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. PackagedProductDefinition.contained
Definition

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.

ShortContained, inline Resources
Comments

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.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. PackagedProductDefinition.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. PackagedProductDefinition.identifier
Definition

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.

ShortA unique identifier for this package as whole - not for the content of the package
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier(EMA PC Identifier)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. PackagedProductDefinition.packageFor
Definition

The product this package model relates to, not the contents of the package (for which see package.containedItem).

ShortThe product that this is a pack for
Control10..1*
TypeReference(EMA Write API MedicinalProductDefinition, MedicinalProductDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. PackagedProductDefinition.status
Definition

The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.

ShortThe status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Control0..1
BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status
(preferred to http://hl7.org/fhir/ValueSet/publication-status)

The lifecycle status of an artifact.

TypeCodeableConcept
Is Modifiertrue because 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
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. PackagedProductDefinition.containedItemQuantity
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.

ShortA 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)
Control10..*
TypeQuantity
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. PackagedProductDefinition.containedItemQuantity.value
Definition

The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortNumerical value (with implicit precision)
Comments

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).

Control10..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. PackagedProductDefinition.containedItemQuantity.comparator
Definition

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.

Short< | <= | >= | > | ad - how to understand the value
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

How the Quantity should be understood and represented.

Typecode
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

Meaning if MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. PackagedProductDefinition.containedItemQuantity.system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control10..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000014
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. PackagedProductDefinition.containedItemQuantity.code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded form of the unit
Comments

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.

Control10..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from For codes, see Units of Presentation
(required to http://ema.europa.eu/fhir/vs/unitsOfPresentation)
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. PackagedProductDefinition.description
Definition

Textual description. Note that this is not the name of the package or product.

ShortTextual description. Note that this is not the name of the package or product
Control10..1
Typemarkdown
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. PackagedProductDefinition.description.extension
Definition

Language using the EMA SPOR codes


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.

ShortLanguage
Comments

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.

Control1..1
TypeExtension(Language) (Extension Type: Coding(EMA Coding))
Is Modifierfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
28. PackagedProductDefinition.marketingStatus
Definition

Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.

ShortAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Control10..*
TypeMarketingStatus
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage
Slice NameriskOfSupplyShortage
Definition

Risk of Supply Shortage

ShortRisk of Supply Shortage
Control0..1
TypeExtension(Risk of Supply Shortage) (Extension Type: boolean)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
32. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment
Slice NameriskOfSupplyShortageComment
Definition

Risk of Supply Shortage Comment

ShortRisk of Supply Shortage Comment
Control0..1
TypeExtension(Risk of Supply Shortage Comment) (Extension Type: string)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
34. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason
Slice NamemarketingStatusReason
Definition

Marketing Status Reason

ShortMarketing Status Reason
Control0..1
TypeExtension(Marketing Status Reason) (Extension Type: Coding(EMA Coding))
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
36. PackagedProductDefinition.marketingStatus.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
38. PackagedProductDefinition.marketingStatus.country
Definition

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.

ShortThe 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
Control10..1
BindingThe codes SHALL be taken from For codes, see Country
(required to http://ema.europa.eu/fhir/vs/country)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. PackagedProductDefinition.marketingStatus.status
Definition

This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

ShortThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
Control1..1
BindingThe codes SHALL be taken from For codes, see Marketing Status
(required to http://ema.europa.eu/fhir/vs/marketingStatus)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. PackagedProductDefinition
2. PackagedProductDefinition.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier(EMA PC Identifier)
4. PackagedProductDefinition.packageFor
Control1..1
TypeReference(EMA Write API MedicinalProductDefinition)
6. PackagedProductDefinition.containedItemQuantity
Control1..?
8. PackagedProductDefinition.containedItemQuantity.value
Control1..?
10. PackagedProductDefinition.containedItemQuantity.system
Control1..?
Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000014
12. PackagedProductDefinition.containedItemQuantity.code
Control1..?
BindingThe codes SHALL be taken from Units of Presentation
(required to http://ema.europa.eu/fhir/vs/unitsOfPresentation)
14. PackagedProductDefinition.description
Control1..?
16. PackagedProductDefinition.description.extension
Control1..1
TypeExtension(Language) (Extension Type: Coding(EMA Coding))
18. PackagedProductDefinition.legalStatusOfSupply
20. PackagedProductDefinition.legalStatusOfSupply.code
BindingThe codes SHALL be taken from Legal Status of Supply
(required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
22. PackagedProductDefinition.marketingStatus
Control1..?
24. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage
Slice NameriskOfSupplyShortage
Control0..1
TypeExtension(Risk of Supply Shortage) (Extension Type: boolean)
26. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment
Slice NameriskOfSupplyShortageComment
Control0..1
TypeExtension(Risk of Supply Shortage Comment) (Extension Type: string)
28. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason
Slice NamemarketingStatusReason
Control0..1
TypeExtension(Marketing Status Reason) (Extension Type: Coding(EMA Coding))
30. PackagedProductDefinition.marketingStatus.country
Control1..?
BindingThe codes SHALL be taken from Country
(required to http://ema.europa.eu/fhir/vs/country)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
32. PackagedProductDefinition.marketingStatus.status
BindingThe codes SHALL be taken from Marketing Status
(required to http://ema.europa.eu/fhir/vs/marketingStatus)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
34. PackagedProductDefinition.marketingStatus.dateRange
36. PackagedProductDefinition.marketingStatus.dateRange.start
Control1..?
38. PackagedProductDefinition.marketingStatus.dateRange.end
Control1..?
40. PackagedProductDefinition.packaging
42. PackagedProductDefinition.packaging.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
TypeIdentifier(EMA Data Carrier Identifier)
44. PackagedProductDefinition.packaging.type
Control1..?
BindingThe codes SHALL be taken from Packaging
(required to http://ema.europa.eu/fhir/vs/packaging)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
46. PackagedProductDefinition.packaging.quantity
48. PackagedProductDefinition.packaging.quantity.extension
Control1..1
TypeExtension(The Comparator Extension) (Extension Type: Choice of: 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)
50. PackagedProductDefinition.packaging.material
Control1..?
BindingThe codes SHALL be taken from Material
(required to http://ema.europa.eu/fhir/vs/material)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
52. PackagedProductDefinition.packaging.shelfLifeStorage
54. PackagedProductDefinition.packaging.shelfLifeStorage.type
Control1..?
BindingThe codes SHALL be taken from Shelf Life Type
(required to http://ema.europa.eu/fhir/vs/shelfLifeType)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
56. PackagedProductDefinition.packaging.shelfLifeStorage.period[x]
Control1..?
TypeDuration(EMA Duration)
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
58. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage
BindingThe codes SHALL be taken from Special Precautions For Storage
(required to http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage)
TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
60. PackagedProductDefinition.packaging.manufacturer
62. PackagedProductDefinition.packaging.manufacturer.extension
Control1..?
64. PackagedProductDefinition.packaging.manufacturer.extension.extension
Control0..0
66. PackagedProductDefinition.packaging.manufacturer.extension.value[x]
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
SlicingThis element introduces a set of slices on PackagedProductDefinition.packaging.manufacturer.extension.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
  • 68. PackagedProductDefinition.packaging.manufacturer.extension.value[x]:valueReference
    Slice NamevalueReference
    Control0..1
    TypeReference(EMA Write API ActivityDefinition)
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    70. PackagedProductDefinition.packaging.containedItem
    72. PackagedProductDefinition.packaging.containedItem.item
    TypeCodeableReference(DeviceDefinition, ManufacturedItemDefinition)
    74. PackagedProductDefinition.packaging.containedItem.amount
    Control1..?
    TypeQuantity(EMA Quantity)
    76. PackagedProductDefinition.packaging.packaging
    Control1..1

    Guidance on how to interpret the contents of this table can be found here

    0. PackagedProductDefinition
    Definition

    A medically related item or items, in a container or package.

    ShortA medically related item or items, in a container or package
    Control0..*
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-3: 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())
    dom-4: 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())
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
    dom-6: A resource should have narrative for robust management (text.`div`.exists())
    2. PackagedProductDefinition.id
    Definition

    The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

    ShortLogical id of this artifact
    Comments

    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.

    Control0..1
    Typeid
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    4. PackagedProductDefinition.meta
    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.

    ShortMetadata about the resource
    Control0..1
    TypeMeta
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. PackagedProductDefinition.implicitRules
    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.

    ShortA set of rules under which this content was created
    Comments

    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.

    Control0..1
    Typeuri
    Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    8. PackagedProductDefinition.language
    Definition

    The base language in which the resource is written.

    ShortLanguage of the resource content
    Comments

    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).

    Control0..1
    BindingThe codes SHALL be taken from AllLanguages
    (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

    IETF language tag for a human language

    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. PackagedProductDefinition.text
    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.

    ShortText summary of the resource, for human interpretation
    Comments

    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.

    Control0..1
    This element is affected by the following invariants: dom-6
    TypeNarrative
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Alternate Namesnarrative, html, xhtml, display
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. PackagedProductDefinition.contained
    Definition

    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.

    ShortContained, inline Resources
    Comments

    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.

    Control0..*
    This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
    TypeResource
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Alternate Namesinline resources, anonymous resources, contained resources
    14. PackagedProductDefinition.extension
    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 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.

    ShortAdditional content defined by implementations
    Comments

    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.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    16. PackagedProductDefinition.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, 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.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored
    Comments

    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.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Must Supportfalse
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    18. PackagedProductDefinition.identifier
    Definition

    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.

    ShortA unique identifier for this package as whole - not for the content of the package
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1
    TypeIdentifier(EMA PC Identifier)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. PackagedProductDefinition.name
    Definition

    A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.

    ShortA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
    Control0..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. PackagedProductDefinition.type
    Definition

    A high level category e.g. medicinal product, raw material, shipping/transport container, etc.

    ShortA high level category e.g. medicinal product, raw material, shipping container etc
    Control0..1
    BindingFor example codes, see PackageType
    (example to http://hl7.org/fhir/ValueSet/package-type)

    A high level categorisation of a package.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. PackagedProductDefinition.packageFor
    Definition

    The product this package model relates to, not the contents of the package (for which see package.containedItem).

    ShortThe product that this is a pack for
    Control1..1
    TypeReference(EMA Write API MedicinalProductDefinition)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. PackagedProductDefinition.status
    Definition

    The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.

    ShortThe status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
    Control0..1
    BindingThe codes SHOULD be taken from PublicationStatus
    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

    The lifecycle status of an artifact.

    TypeCodeableConcept
    Is Modifiertrue because 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
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. PackagedProductDefinition.statusDate
    Definition

    The date at which the given status became applicable.

    ShortThe date at which the given status became applicable
    Control0..1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. PackagedProductDefinition.containedItemQuantity
    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.

    ShortA 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)
    Control1..*
    TypeQuantity
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. PackagedProductDefinition.containedItemQuantity.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    This element is affected by the following invariants: ele-1
    Typeid
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    34. PackagedProductDefinition.containedItemQuantity.extension
    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 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.

    ShortAdditional content defined by implementations
    Comments

    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.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on PackagedProductDefinition.containedItemQuantity.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 36. PackagedProductDefinition.containedItemQuantity.value
      Definition

      The value of the measured amount. The value includes an implicit precision in the presentation of the value.

      ShortNumerical value (with implicit precision)
      Comments

      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).

      Control1..1
      Typedecimal
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Precision is handled implicitly in almost all cases of measurement.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. PackagedProductDefinition.containedItemQuantity.comparator
      Definition

      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.

      Short< | <= | >= | > | ad - how to understand the value
      Control0..1
      BindingThe codes SHALL be taken from QuantityComparator
      (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

      How the Quantity should be understood and represented.

      Typecode
      Is Modifiertrue because 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
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

      Meaning if MissingIf there is no comparator, then there is no modification of the value
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. PackagedProductDefinition.containedItemQuantity.unit
      Definition

      A human-readable form of the unit.

      ShortUnit representation
      Control0..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. PackagedProductDefinition.containedItemQuantity.system
      Definition

      The identification of the system that provides the coded form of the unit.

      ShortSystem that defines coded unit form
      Control1..1
      This element is affected by the following invariants: qty-3
      Typeuri
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Need to know the system that defines the coded form of the unit.

      Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000014
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. PackagedProductDefinition.containedItemQuantity.code
      Definition

      A computer processable form of the unit in some unit representation system.

      ShortCoded form of the unit
      Comments

      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.

      Control1..1
      This element is affected by the following invariants: qty-3
      BindingThe codes SHALL be taken from Units of Presentation
      (required to http://ema.europa.eu/fhir/vs/unitsOfPresentation)
      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      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.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. PackagedProductDefinition.description
      Definition

      Textual description. Note that this is not the name of the package or product.

      ShortTextual description. Note that this is not the name of the package or product
      Control1..1
      Typemarkdown
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. PackagedProductDefinition.description.id
      Definition

      unique id for the element within a resource (for internal references)

      Shortxml:id (or equivalent in JSON)
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      50. PackagedProductDefinition.description.extension
      Definition

      Language using the EMA SPOR codes

      ShortLanguage
      Control1..1
      TypeExtension(Language) (Extension Type: Coding(EMA Coding))
      Is Modifierfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      52. PackagedProductDefinition.description.value
      Definition

      Primitive value for markdown

      ShortPrimitive value for markdown
      Control0..1
      Typemarkdown
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      54. PackagedProductDefinition.legalStatusOfSupply
      Definition

      The legal status of supply of the packaged item as classified by the regulator.

      ShortThe legal status of supply of the packaged item as classified by the regulator
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      56. PackagedProductDefinition.legalStatusOfSupply.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      58. PackagedProductDefinition.legalStatusOfSupply.extension
      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 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.

      ShortAdditional content defined by implementations
      Comments

      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.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      60. PackagedProductDefinition.legalStatusOfSupply.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      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.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      62. PackagedProductDefinition.legalStatusOfSupply.code
      Definition

      The actual status of supply. Conveys in what situation this package type may be supplied for use.

      ShortThe actual status of supply. In what situation this package type may be supplied for use
      Control0..1
      BindingThe codes SHALL be taken from Legal Status of Supply
      (required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply)
      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      64. PackagedProductDefinition.legalStatusOfSupply.jurisdiction
      Definition

      The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.

      ShortThe place where the legal status of supply applies
      Control0..1
      BindingFor example codes, see JurisdictionValueSet
      (example to http://hl7.org/fhir/ValueSet/jurisdiction)

      Jurisdiction codes

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      66. PackagedProductDefinition.marketingStatus
      Definition

      Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.

      ShortAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
      Control1..*
      TypeMarketingStatus
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      68. PackagedProductDefinition.marketingStatus.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typeid
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      70. PackagedProductDefinition.marketingStatus.extension
      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 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.

      ShortAdditional content defined by implementations
      Comments

      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.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on PackagedProductDefinition.marketingStatus.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 72. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage
        Slice NameriskOfSupplyShortage
        Definition

        Risk of Supply Shortage

        ShortRisk of Supply Shortage
        Control0..1
        TypeExtension(Risk of Supply Shortage) (Extension Type: boolean)
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        74. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment
        Slice NameriskOfSupplyShortageComment
        Definition

        Risk of Supply Shortage Comment

        ShortRisk of Supply Shortage Comment
        Control0..1
        TypeExtension(Risk of Supply Shortage Comment) (Extension Type: string)
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        76. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason
        Slice NamemarketingStatusReason
        Definition

        Marketing Status Reason

        ShortMarketing Status Reason
        Control0..1
        TypeExtension(Marketing Status Reason) (Extension Type: Coding(EMA Coding))
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        78. PackagedProductDefinition.marketingStatus.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        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.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        80. PackagedProductDefinition.marketingStatus.country
        Definition

        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.

        ShortThe 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
        Control1..1
        BindingThe codes SHALL be taken from Country
        (required to http://ema.europa.eu/fhir/vs/country)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        82. PackagedProductDefinition.marketingStatus.jurisdiction
        Definition

        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.

        ShortWhere 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
        Control0..1
        TypeCodeableConcept
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        84. PackagedProductDefinition.marketingStatus.status
        Definition

        This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

        ShortThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
        Control1..1
        BindingThe codes SHALL be taken from Marketing Status
        (required to http://ema.europa.eu/fhir/vs/marketingStatus)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        86. PackagedProductDefinition.marketingStatus.dateRange
        Definition

        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.

        ShortThe 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
        Control0..1
        TypePeriod
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        88. PackagedProductDefinition.marketingStatus.dateRange.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeid
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        90. PackagedProductDefinition.marketingStatus.dateRange.extension
        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 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.

        ShortAdditional content defined by implementations
        Comments

        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.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on PackagedProductDefinition.marketingStatus.dateRange.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 92. PackagedProductDefinition.marketingStatus.dateRange.start
          Definition

          The start of the period. The boundary is inclusive.

          ShortStarting time with inclusive boundary
          Comments

          If the low element is missing, the meaning is that the low boundary is not known.

          Control1..1
          This element is affected by the following invariants: per-1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          94. PackagedProductDefinition.marketingStatus.dateRange.end
          Definition

          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.

          ShortEnd time with inclusive boundary, if not ongoing
          Comments

          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.

          Control1..1
          This element is affected by the following invariants: per-1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          96. PackagedProductDefinition.marketingStatus.restoreDate
          Definition

          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.

          ShortThe 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
          Control0..1
          TypedateTime
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          98. PackagedProductDefinition.copackagedIndicator
          Definition

          Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.

          ShortIdentifies if the drug product is supplied with another item such as a diluent or adjuvant
          Control0..1
          Typeboolean
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Meaning if MissingIf this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          100. PackagedProductDefinition.manufacturer
          Definition

          Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.

          ShortManufacturer of this package type (multiple means these are all possible manufacturers)
          Control0..*
          TypeReference(Organization)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          102. PackagedProductDefinition.attachedDocument
          Definition

          Additional information or supporting documentation about the packaged product.

          ShortAdditional information or supporting documentation about the packaged product
          Control0..*
          TypeReference(DocumentReference)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          104. PackagedProductDefinition.packaging
          Definition

          A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).

          ShortA packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
          Control0..1
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          106. PackagedProductDefinition.packaging.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          108. PackagedProductDefinition.packaging.extension
          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 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.

          ShortAdditional content defined by implementations
          Comments

          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.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          110. PackagedProductDefinition.packaging.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          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.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          112. PackagedProductDefinition.packaging.identifier
          Definition

          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).

          ShortAn identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control1..1
          TypeIdentifier(EMA Data Carrier Identifier)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          114. PackagedProductDefinition.packaging.type
          Definition

          The physical type of the container of the items.

          ShortThe physical type of the container of the items
          Control1..1
          BindingThe codes SHALL be taken from Packaging
          (required to http://ema.europa.eu/fhir/vs/packaging)
          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          116. PackagedProductDefinition.packaging.componentPart
          Definition

          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.

          ShortIs this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
          Control0..1
          Typeboolean
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Meaning if MissingIf 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.
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          118. PackagedProductDefinition.packaging.quantity
          Definition

          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.

          ShortThe quantity of this level of packaging in the package that contains it (with the outermost level being 1)
          Control0..1
          Typeinteger
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          120. PackagedProductDefinition.packaging.quantity.id
          Definition

          unique id for the element within a resource (for internal references)

          Shortxml:id (or equivalent in JSON)
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          122. PackagedProductDefinition.packaging.quantity.extension
          Definition

          The Comparator Extension

          ShortThe Comparator Extension
          Control1..1
          TypeExtension(The Comparator Extension) (Extension Type: Choice of: 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)
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          124. PackagedProductDefinition.packaging.quantity.value
          Definition

          The actual value

          ShortPrimitive value for integer
          Control0..1
          Typeinteger
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Min Value-2147483648
          Max Value2147483647
          126. PackagedProductDefinition.packaging.material
          Definition

          Material type of the package item.

          ShortMaterial type of the package item
          Control1..*
          BindingThe codes SHALL be taken from Material
          (required to http://ema.europa.eu/fhir/vs/material)
          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          128. PackagedProductDefinition.packaging.alternateMaterial
          Definition

          A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).

          ShortA possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
          Control0..*
          BindingFor example codes, see PackageMaterial
          (example to http://hl7.org/fhir/ValueSet/package-material)

          A material used in the construction of packages and their components.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          130. PackagedProductDefinition.packaging.shelfLifeStorage
          Definition

          Shelf Life and storage information.

          ShortShelf Life and storage information
          Control0..*
          TypeProductShelfLife
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          132. PackagedProductDefinition.packaging.shelfLifeStorage.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeid
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          134. PackagedProductDefinition.packaging.shelfLifeStorage.extension
          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 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.

          ShortAdditional content defined by implementations
          Comments

          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.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on PackagedProductDefinition.packaging.shelfLifeStorage.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 136. PackagedProductDefinition.packaging.shelfLifeStorage.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            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.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            138. PackagedProductDefinition.packaging.shelfLifeStorage.type
            Definition

            This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.

            ShortThis 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
            Control1..1
            BindingThe codes SHALL be taken from Shelf Life Type
            (required to http://ema.europa.eu/fhir/vs/shelfLifeType)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            140. PackagedProductDefinition.packaging.shelfLifeStorage.period[x]
            Definition

            The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.

            ShortThe 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
            Control1..1
            TypeDuration(EMA Duration)
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            142. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage
            Definition

            Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.

            ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
            Control0..*
            BindingThe codes SHALL be taken from Special Precautions For Storage
            (required to http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            144. PackagedProductDefinition.packaging.manufacturer
            Definition

            Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item.

            ShortManufacturer of this packaging item (multiple means these are all potential manufacturers)
            Control0..*
            TypeReference(Organization)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            146. PackagedProductDefinition.packaging.manufacturer.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            This element is affected by the following invariants: ele-1
            Typeid
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            148. PackagedProductDefinition.packaging.manufacturer.extension
            Definition

            An Extension

            ShortExtension
            Control1..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on PackagedProductDefinition.packaging.manufacturer.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 150. PackagedProductDefinition.packaging.manufacturer.extension.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              152. PackagedProductDefinition.packaging.manufacturer.extension.extension
              Definition

              An Extension

              ShortExtension
              Control0..0
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on PackagedProductDefinition.packaging.manufacturer.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 154. PackagedProductDefinition.packaging.manufacturer.extension.url
                Definition

                Source of the definition for the extension code - a logical name or a URL.

                Shortidentifies the meaning of the extension
                Comments

                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.

                Control1..1
                Typeuri
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                156. PackagedProductDefinition.packaging.manufacturer.extension.value[x]
                Definition

                Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                ShortValue of extension
                Control0..1
                This element is affected by the following invariants: ext-1
                TypeChoice of: 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
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summaryfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                SlicingThis element introduces a set of slices on PackagedProductDefinition.packaging.manufacturer.extension.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • type @ $this
                • 158. PackagedProductDefinition.packaging.manufacturer.extension.value[x]:valueReference
                  Slice NamevalueReference
                  Definition

                  Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                  ShortValue of extension
                  Control0..1
                  This element is affected by the following invariants: ext-1
                  TypeReference(EMA Write API ActivityDefinition)
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  160. PackagedProductDefinition.packaging.manufacturer.reference
                  Definition

                  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.

                  ShortLiteral reference, Relative, internal or absolute URL
                  Comments

                  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.

                  Control0..1
                  This element is affected by the following invariants: ref-2, ref-1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  162. PackagedProductDefinition.packaging.manufacturer.type
                  Definition

                  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).

                  ShortType the reference refers to (e.g. "Patient") - must be a resource in resources
                  Comments

                  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.

                  Control0..1
                  BindingUnless not suitable, these codes SHALL be taken from ResourceType
                  (extensible to http://hl7.org/fhir/ValueSet/resource-types)

                  Aa resource (or, for logical models, the URI of the logical model).

                  Typeuri
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  164. PackagedProductDefinition.packaging.manufacturer.identifier
                  Definition

                  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.

                  ShortLogical reference, when literal reference is not known
                  Comments

                  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 extension.

                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  This element is affected by the following invariants: ref-2
                  TypeIdentifier
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  166. PackagedProductDefinition.packaging.manufacturer.display
                  Definition

                  Plain text narrative that identifies the resource in addition to the resource reference.

                  ShortText alternative for the resource
                  Comments

                  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.

                  Control0..1
                  This element is affected by the following invariants: ref-2
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  168. PackagedProductDefinition.packaging.property
                  Definition

                  General characteristics of this item.

                  ShortGeneral characteristics of this item
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  170. PackagedProductDefinition.packaging.property.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  172. PackagedProductDefinition.packaging.property.extension
                  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 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.

                  ShortAdditional content defined by implementations
                  Comments

                  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.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  174. PackagedProductDefinition.packaging.property.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  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.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  176. PackagedProductDefinition.packaging.property.type
                  Definition

                  A code expressing the type of characteristic.

                  ShortA code expressing the type of characteristic
                  Control1..1
                  BindingFor example codes, see ProductCharacteristic
                  (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                  This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  178. PackagedProductDefinition.packaging.property.value[x]
                  Definition

                  A value for the characteristic.

                  ShortA value for the characteristic
                  Control0..1
                  TypeChoice of: CodeableConcept, Quantity, date, boolean, Attachment
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  180. PackagedProductDefinition.packaging.containedItem
                  Definition

                  The item(s) within the packaging.

                  ShortThe item(s) within the packaging
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  182. PackagedProductDefinition.packaging.containedItem.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  184. PackagedProductDefinition.packaging.containedItem.extension
                  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 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.

                  ShortAdditional content defined by implementations
                  Comments

                  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.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  186. PackagedProductDefinition.packaging.containedItem.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  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.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  188. PackagedProductDefinition.packaging.containedItem.item
                  Definition

                  The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.packaging.packaging).

                  ShortThe 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
                  Control1..1
                  TypeCodeableReference(DeviceDefinition, ManufacturedItemDefinition)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  190. PackagedProductDefinition.packaging.containedItem.amount
                  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).

                  ShortThe 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)
                  Control1..1
                  TypeQuantity(EMA Quantity)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  192. PackagedProductDefinition.packaging.packaging
                  Definition

                  Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).

                  ShortAllows containers (and parts of containers) within containers, still as a part of single packaged product
                  Control1..1
                  TypeSeettp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  194. PackagedProductDefinition.characteristic
                  Definition

                  Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".

                  ShortAllows the key features to be recorded, such as "hospital pack", "nurse prescribable"
                  Control0..*
                  TypeSeettp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))