0.1.0 - ci-build

AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: AT_MedicinalProduct_PackagedProductDefinition - Detailed Descriptions

Draft as of 2024-05-24

Definitions for the at-medprod-packagedProductDefinition resource profile.

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

0. PackagedProductDefinition
2. PackagedProductDefinition.identifier
ShortPharmaceutical registration number (Pharmazentralnummer (PZN))
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
TypeIdentifier(Identifier)
4. PackagedProductDefinition.identifier.system
Pattern Valuehttps://argepharma.fcio.at
6. PackagedProductDefinition.packageFor
Control1..1
TypeReference(Medicinal Product Definition)
8. PackagedProductDefinition.containedItemQuantity
ShortSize / Weight of the package
Control1..1
10. PackagedProductDefinition.containedItemQuantity.value
Control1..?
12. PackagedProductDefinition.containedItemQuantity.system
Control1..?
14. PackagedProductDefinition.containedItemQuantity.code
Control1..?
BindingThe codes SHALL be taken from The Units of Presentation Value Set
(required to https://ema.europa.eu/fhir/vs/unitsOfPresentation)
16. PackagedProductDefinition.marketingStatus
ShortDelivery state of the package
Control1..1
18. PackagedProductDefinition.marketingStatus.status
BindingThe codes SHALL be taken from The Marketing Status value Set
(required to https://ema.europa.eu/fhir/vs/marketingStatus)
TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
20. PackagedProductDefinition.packaging
22. PackagedProductDefinition.packaging.type
ShortPackage type container
BindingThe codes SHALL be taken from The Packaging Value Set
(required to https://ema.europa.eu/fhir/vs/packaging)
TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)

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

An identifier - identifies some entity uniquely and unambiguously. Typically this is used for business identifiers.


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.

ShortPharmaceutical registration number (Pharmazentralnummer (PZN))A unique identifier for this package as whole - not for the content of the package
Comments

The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..1*
TypeIdentifier(Identifier)
Is Modifierfalse
Must Supportfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason (value.exists())
10. PackagedProductDefinition.identifier.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

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

Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

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

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Pattern Valuehttps://argepharma.fcio.at
Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. PackagedProductDefinition.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control10..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. 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(Medicinal Product Definition, MedicinalProductDefinition)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. 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()))
20. 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.

ShortSize / Weight of the packageA 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..1*
TypeQuantity
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. 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()))
24. 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()))
26. 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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. 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 The Units of Presentation Value Set
(required to https://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()))
30. 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.

ShortDelivery state of the packageAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Control10..1*
TypeMarketingStatus
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. 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())
34. PackagedProductDefinition.marketingStatus.status
Definition

A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.


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

ShortConcept - reference to a terminology or just textThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Control1..1
BindingThe codes SHALL be taken from For codes, see The Marketing Status value Set
(required to https://ema.europa.eu/fhir/vs/marketingStatus)
TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
Is Modifierfalse
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
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

An identifier - identifies some entity uniquely and unambiguously. Typically this is used for business identifiers.

ShortPharmaceutical registration number (Pharmazentralnummer (PZN))
Comments

The rules of the identifier.type determine if a check digit is part of the ID value or sent separately, such as through the checkDigit extension.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
TypeIdentifier(Identifier)
Is Modifierfalse
Must Supportfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason (value.exists())
20. PackagedProductDefinition.identifier.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
22. PackagedProductDefinition.identifier.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.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 24. PackagedProductDefinition.identifier.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUse
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

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

    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

    ShortDescription of identifier
    Comments

    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

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

    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

    TypeCodeableConcept
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows users to make use of identifiers when the identifier system is not known.

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

    Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

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

    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

    Pattern Valuehttps://argepharma.fcio.at
    Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. PackagedProductDefinition.identifier.value
    Definition

    The portion of the identifier typically relevant to the user and which is unique within the context of the system.

    ShortThe value that is unique
    Comments

    If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

    Control1..1
    This element is affected by the following invariants: ident-1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Example<br/><b>General</b>:123456
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. PackagedProductDefinition.identifier.period
    Definition

    Time period during which identifier is/was valid for use.

    ShortTime period when id is/was valid for use
    Control0..1
    TypePeriod
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. PackagedProductDefinition.identifier.assigner
    Definition

    Organization that issued/manages the identifier.

    ShortOrganization that issued id (may be just text)
    Comments

    The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

    Control0..1
    TypeReference(Organization)
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. 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()))
    38. 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()))
    40. 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(Medicinal Product Definition)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. 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()))
    44. 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()))
    46. 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.

    ShortSize / Weight of the package
    Control1..1
    TypeQuantity
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    48. 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
    50. 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
    • 52. 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()))
      54. 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()))
      56. 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()))
      58. 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.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. 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 The Units of Presentation Value Set
      (required to https://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()))
      62. 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
      Control0..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()))
      64. 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()))
      66. 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
      68. 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())
      70. 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())
      72. 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
      BindingFor example codes, see LegalStatusOfSupply
      (example to http://hl7.org/fhir/ValueSet/legal-status-of-supply)

      The prescription supply types appropriate to a medicinal product

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      74. 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()))
      76. 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.

      ShortDelivery state of the package
      Control1..1
      TypeMarketingStatus
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      78. 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
      80. 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
      • 82. 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())
        84. 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
        Control0..1
        TypeCodeableConcept
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        86. 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()))
        88. PackagedProductDefinition.marketingStatus.status
        Definition

        A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

        ShortConcept - reference to a terminology or just text
        Comments

        Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

        Control1..1
        BindingThe codes SHALL be taken from The Marketing Status value Set
        (required to https://ema.europa.eu/fhir/vs/marketingStatus)
        TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
        Is Modifierfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        90. 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()))
        92. 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()))
        94. 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()))
        96. 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()))
        98. 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()))
        100. 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()))
        102. 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
        104. 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())
        106. 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())
        108. 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)
        Control0..*
        TypeIdentifier
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        110. PackagedProductDefinition.packaging.type
        Definition

        A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.

        ShortPackage type container
        Comments

        Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

        Control0..1
        BindingThe codes SHALL be taken from The Packaging Value Set
        (required to https://ema.europa.eu/fhir/vs/packaging)
        TypeCodeableConcept(Generic ReferentialTerm CodeableConcept)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        112. 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()))
        114. 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()))
        116. PackagedProductDefinition.packaging.material
        Definition

        Material type of the package item.

        ShortMaterial type of the package item
        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()))
        118. 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()))
        120. 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()))
        122. 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()))
        124. 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()))
        126. 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
        128. 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())
        130. 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())
        132. 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()))
        134. 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()))
        136. 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()))
        138. 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
        140. 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())
        142. 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())
        144. 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(ManufacturedItemDefinition, DeviceDefinition, PackagedProductDefinition, BiologicallyDerivedProduct, NutritionProduct)
        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.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)
        Control0..1
        TypeQuantity
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        148. 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
        Control0..*
        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()))
        150. 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()))