This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
Page standards status: Trial-use | Maturity Level: 2 |
Definitions for the PackagedProductDefinition-uv-epi resource profile.
Guidance on how to interpret the contents of this table can be found here.
1. PackagedProductDefinition | |
2. PackagedProductDefinition.identifier | |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..? |
3. PackagedProductDefinition.identifier.system | |
Control | 1..? |
4. PackagedProductDefinition.identifier.value | |
Control | 1..? |
5. PackagedProductDefinition.name | |
Control | 10..1 |
6. PackagedProductDefinition.type | |
7. PackagedProductDefinition.packageFor | |
Type | Reference(MedicinalProductDefinitionUvEpi|MedicinalProductDefinition) |
8. PackagedProductDefinition.statusDate | |
Example | Example of a status date:2015-02-07T13:28:17Z |
9. PackagedProductDefinition.description | |
10. PackagedProductDefinition.legalStatusOfSupply | |
11. PackagedProductDefinition.legalStatusOfSupply.jurisdiction | |
Binding | The codes SHOULD be taken from ISO Country two letter codeFor example codes, see JurisdictionValueSet |
12. PackagedProductDefinition.marketingStatus | |
13. PackagedProductDefinition.marketingStatus.jurisdiction | |
Control | 0..? |
Binding | The codes SHOULD be taken from ISO Country two letter code |
14. PackagedProductDefinition.copackagedIndicator | |
15. PackagedProductDefinition.manufacturer | |
Type | Reference(OrganizationUvEpi|Organization) |
16. PackagedProductDefinition.packaging | |
Control | 0..? |
17. PackagedProductDefinition.packaging.identifier | |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 10..* |
18. PackagedProductDefinition.packaging.identifier.system | |
Control | 1..? |
19. PackagedProductDefinition.packaging.identifier.value | |
Control | 1..? |
20. PackagedProductDefinition.packaging.material | |
Control | 0..1* |
21. PackagedProductDefinition.packaging.shelfLifeStorage | |
22. PackagedProductDefinition.packaging.shelfLifeStorage.period[x] | |
Control | 0..? |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Slicing | This element introduces a set of slices on PackagedProductDefinition.packaging.shelfLifeStorage.period[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
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23. PackagedProductDefinition.packaging.shelfLifeStorage.period[x]:periodDuration | |
SliceName | periodDuration |
Control | 0..1 |
Type | Duration |
[x] Note | See Choice of Data Types for further information about how to use [x] |
24. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | |
Control | 0..1 |
25. PackagedProductDefinition.packaging.manufacturer | |
Type | Reference(OrganizationUvEpi|Organization) |
26. PackagedProductDefinition.packaging.containedItem | |
Control | 0..? |
27. PackagedProductDefinition.packaging.containedItem.item | |
Type | CodeableReference(ManufacturedItemDefinitionUvEpi|DeviceDefinition|ManufacturedItemDefinition|PackagedProductDefinition|BiologicallyDerivedProduct|NutritionProduct) |
Guidance on how to interpret the contents of this table can be found here.
1. PackagedProductDefinition | |
Definition | A medically related item or items, in a container or package. |
Control | 0..* |
Summary | false |
Invariants | Defined on this element dom-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. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
3. 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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained 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. |
4. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
5. PackagedProductDefinition.name | |
Definition | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc. |
Control | 10..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
6. PackagedProductDefinition.type | |
Definition | A high level category e.g. medicinal product, raw material, shipping/transport container, etc. |
Control | 0..1 |
Binding | For example codes, see PackageType A high level categorisation of a package. |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
7. PackagedProductDefinition.packageFor | |
Definition | The product this package model relates to, not the contents of the package (for which see package.containedItem). |
Control | 0..* |
Type | Reference(MedicinalProductDefinitionUvEpi|MedicinalProductDefinition) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
8. 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. |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatus The lifecycle status of an artifact. |
Type | CodeableConcept |
Is Modifier | true |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
9. PackagedProductDefinition.statusDate | |
Definition | The date at which the given status became applicable. |
Control | 0..1 |
Type | dateTime |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Example | Example of a status date:2015-02-07T13:28:17Z |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
10. PackagedProductDefinition.description | |
Definition | Textual description. Note that this is not the name of the package or product. |
Control | 0..1 |
Type | markdown |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
11. PackagedProductDefinition.legalStatusOfSupply | |
Definition | The legal status of supply of the packaged item as classified by the regulator. |
Control | 0..* |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
12. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-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()) |
13. PackagedProductDefinition.legalStatusOfSupply.jurisdiction | |
Definition | The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context. |
Control | 0..1 |
Binding | The codes SHOULD be taken from ISO Country two letter codeFor example codes, see JurisdictionValueSet |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
14. 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. |
Control | 0..* |
Type | MarketingStatus |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
15. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-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.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. |
Control | 0..1 |
Binding | The codes SHOULD be taken from ISO Country two letter codeFor codes, see (unbound) |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
17. PackagedProductDefinition.marketingStatus.status | |
Definition | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples. |
Control | 1..1 |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
18. 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. |
Control | 0..1 |
Type | boolean |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Meaning if Missing | If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
19. PackagedProductDefinition.manufacturer | |
Definition | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers. |
Control | 0..* |
Type | Reference(OrganizationUvEpi|Organization) |
Summary | true |
Invariants | Defined on this element ele-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.
1. PackagedProductDefinition | |
Definition | A medically related item or items, in a container or package. |
Control | 0..* |
Summary | false |
2. PackagedProductDefinition.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Control | 0..1 |
Type | id |
Summary | true |
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. |
3. 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. |
Control | 0..1 |
Type | Meta |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
4. 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. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
5. PackagedProductDefinition.language | |
Definition | The base language in which the resource is written. |
Control | 0..1 |
Binding | The codes SHALL be taken from AllLanguages IETF language tag for a human languag |
Type | code |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | false |
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). |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
6. 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. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Summary | false |
Alternate Names | narrative, html, xhtml, display |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
7. 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. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained 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. |
8. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
9. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
10. PackagedProductDefinition.identifier | |
Definition | A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
11. 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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
12. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
Slicing | This element introduces a set of slices on PackagedProductDefinition.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
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13. PackagedProductDefinition.identifier.use | |
Definition | The purpose of this identifier. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known |
Type | code |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
14. PackagedProductDefinition.identifier.type | |
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierTypeCodes; other codes may be used where these codes are not suitable A coded type for an identifier that can be used to determine which identifier to use for a specific purpose |
Type | CodeableConcept |
Summary | true |
Requirements | Allows users to make use of identifiers when the identifier system is not known. |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
15. PackagedProductDefinition.identifier.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Control | 1..1 |
Type | uri |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Comments | Identifier.system is always case sensitive. |
Example | General:http://www.acme.com/identifiers/patient |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
16. PackagedProductDefinition.identifier.value | |
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
Control | 1..1 This element is affected by the following invariants: ident-1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Example | General:123456 |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
17. PackagedProductDefinition.identifier.period | |
Definition | Time period during which identifier is/was valid for use. |
Control | 0..1 |
Type | Period |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
18. PackagedProductDefinition.identifier.assigner | |
Definition | Organization that issued/manages the identifier. |
Control | 0..1 |
Type | Reference(Organization) |
Summary | true |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
19. PackagedProductDefinition.name | |
Definition | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc. |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
20. PackagedProductDefinition.type | |
Definition | A high level category e.g. medicinal product, raw material, shipping/transport container, etc. |
Control | 0..1 |
Binding | For example codes, see PackageType A high level categorisation of a package |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
21. PackagedProductDefinition.packageFor | |
Definition | The product this package model relates to, not the contents of the package (for which see package.containedItem). |
Control | 0..* |
Type | Reference(MedicinalProductDefinitionUvEpi) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
22. 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. |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatus The lifecycle status of an artifact |
Type | CodeableConcept |
Is Modifier | true |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
23. PackagedProductDefinition.statusDate | |
Definition | The date at which the given status became applicable. |
Control | 0..1 |
Type | dateTime |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Example | Example of a status date:2015-02-07T13:28:17Z |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
24. 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. |
Control | 0..* |
Type | Quantity |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
25. PackagedProductDefinition.description | |
Definition | Textual description. Note that this is not the name of the package or product. |
Control | 0..1 |
Type | markdown |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
26. PackagedProductDefinition.legalStatusOfSupply | |
Definition | The legal status of supply of the packaged item as classified by the regulator. |
Control | 0..* |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
27. 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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
28. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
29. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-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()) |
30. PackagedProductDefinition.legalStatusOfSupply.code | |
Definition | The actual status of supply. Conveys in what situation this package type may be supplied for use. |
Control | 0..1 |
Binding | For example codes, see LegalStatusOfSupply The prescription supply types appropriate to a medicinal produc |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
31. PackagedProductDefinition.legalStatusOfSupply.jurisdiction | |
Definition | The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context. |
Control | 0..1 |
Binding | The codes SHOULD be taken from ISO Country two letter code |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
32. 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. |
Control | 0..* |
Type | MarketingStatus |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
33. 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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
34. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
Slicing | This element introduces a set of slices on PackagedProductDefinition.marketingStatus.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
35. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
36. PackagedProductDefinition.marketingStatus.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. |
Control | 0..1 |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
37. 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. |
Control | 0..1 |
Binding | The codes SHOULD be taken from ISO Country two letter code |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
38. PackagedProductDefinition.marketingStatus.status | |
Definition | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples. |
Control | 1..1 |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
39. 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. |
Control | 0..1 |
Type | Period |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
40. 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. |
Control | 0..1 |
Type | dateTime |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
41. 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. |
Control | 0..1 |
Type | boolean |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Meaning if Missing | If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
42. PackagedProductDefinition.manufacturer | |
Definition | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers. |
Control | 0..* |
Type | Reference(OrganizationUvEpi) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
43. PackagedProductDefinition.attachedDocument | |
Definition | Additional information or supporting documentation about the packaged product. |
Control | 0..* |
Type | Reference(DocumentReference) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
44. 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). |
Control | 0..1 |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
45. 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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
46. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
47. 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-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()) |
48. 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). |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..* |
Type | Identifier |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
49. PackagedProductDefinition.packaging.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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
50. PackagedProductDefinition.packaging.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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
Slicing | This element introduces a set of slices on PackagedProductDefinition.packaging.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
51. PackagedProductDefinition.packaging.identifier.use | |
Definition | The purpose of this identifier. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known |
Type | code |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
52. PackagedProductDefinition.packaging.identifier.type | |
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierTypeCodes; other codes may be used where these codes are not suitable A coded type for an identifier that can be used to determine which identifier to use for a specific purpose |
Type | CodeableConcept |
Summary | true |
Requirements | Allows users to make use of identifiers when the identifier system is not known. |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
53. PackagedProductDefinition.packaging.identifier.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Control | 1..1 |
Type | uri |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Comments | Identifier.system is always case sensitive. |
Example | General:http://www.acme.com/identifiers/patient |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
54. PackagedProductDefinition.packaging.identifier.value | |
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
Control | 1..1 This element is affected by the following invariants: ident-1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Example | General:123456 |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
55. PackagedProductDefinition.packaging.identifier.period | |
Definition | Time period during which identifier is/was valid for use. |
Control | 0..1 |
Type | Period |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
56. PackagedProductDefinition.packaging.identifier.assigner | |
Definition | Organization that issued/manages the identifier. |
Control | 0..1 |
Type | Reference(Organization) |
Summary | true |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
57. PackagedProductDefinition.packaging.type | |
Definition | The physical type of the container of the items. |
Control | 0..1 |
Binding | For example codes, see PackagingType A high level categorisation of a package |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
58. 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. |
Control | 0..1 |
Type | boolean |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Meaning if Missing | If absent, it cannot be assumed that the item is packaging (a container) or a part of the packaging - it is just 'packaging'. Systems can sometimes infer this from the packaging.type (e.g. bottles are containers, bottle caps are not), or from the fact that a container will usually have other items within it (though it is possible that these exist but are not mentioned). Often the distinction is not critical - and can easily be understood by humans - but if that is necessary for machine processing it is recommended that this attribute is given a value. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
59. 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. |
Control | 0..1 |
Type | integer |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
60. PackagedProductDefinition.packaging.material | |
Definition | Material type of the package item. |
Control | 0..1 |
Binding | For example codes, see PackageMaterial A material used in the construction of packages and their components |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
61. 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). |
Control | 0..* |
Binding | For example codes, see PackageMaterial A material used in the construction of packages and their components |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
62. PackagedProductDefinition.packaging.shelfLifeStorage | |
Definition | Shelf Life and storage information. |
Control | 0..* |
Type | ProductShelfLife |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
63. PackagedProductDefinition.packaging.shelfLifeStorage.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
64. PackagedProductDefinition.packaging.shelfLifeStorage.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-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()) |
Slicing | This element introduces a set of slices on PackagedProductDefinition.packaging.shelfLifeStorage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
65. PackagedProductDefinition.packaging.shelfLifeStorage.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-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()) |
66. PackagedProductDefinition.packaging.shelfLifeStorage.type | |
Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified. |
Control | 0..1 |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
67. PackagedProductDefinition.packaging.shelfLifeStorage.period[x] | |
Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used. |
Control | 0..1 |
Type | Choice of: Duration, string |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
Slicing | This element introduces a set of slices on PackagedProductDefinition.packaging.shelfLifeStorage.period[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
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68. PackagedProductDefinition.packaging.shelfLifeStorage.period[x]:periodDuration | |
SliceName | periodDuration |
Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used. |
Control | 0..1 |
Type | Duration |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
69. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | |
Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified. |
Control | 0..1 |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
70. PackagedProductDefinition.packaging.manufacturer | |
Definition | Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item. |
Control | 0..* |
Type | Reference(OrganizationUvEpi) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
71. PackagedProductDefinition.packaging.property | |
Definition | General characteristics of this item. |
Control | 0..* |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
72. 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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
73. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
74. PackagedProductDefinition.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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-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()) |
75. PackagedProductDefinition.packaging.property.type | |
Definition | A code expressing the type of characteristic. |
Control | 1..1 |
Binding | For example codes, see ProductCharacteristic This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set |
Type | CodeableConcept |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
76. PackagedProductDefinition.packaging.property.value[x] | |
Definition | A value for the characteristic. |
Control | 0..1 |
Type | Choice of: CodeableConcept, Quantity, date, boolean, Attachment |
[x] Note | See Choice of Data Types for further information about how to use [x] |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
77. PackagedProductDefinition.packaging.containedItem | |
Definition | The item(s) within the packaging. |
Control | 0..* |
Type | BackboneElement |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
78. 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. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
XML Representation | In the XML format, this property is represented as an attribute. |
Summary | false |
79. 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. |
Control | 0..* |
Type | Extension |
Summary | false |
Alternate Names | extensions, user content |
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. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
80. PackagedProductDefinition.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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
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 Names | extensions, user content, modifiers |
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. |
Invariants | Defined on this element ele-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()) |
81. 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). |
Control | 1..1 |
Type | CodeableReference(ManufacturedItemDefinitionUvEpi|DeviceDefinition) |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
82. 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). |
Control | 0..1 |
Type | Quantity |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
83. 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). |
Control | 0..* |
Type | See ttp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
84. PackagedProductDefinition.characteristic | |
Definition | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack". |
Control | 0..* |
Type | See ttp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property |
Summary | true |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |