Left: | PackagedProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi) |
Right: | PackagedProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi) |
Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot' vs '1.0.0' |
Information | StructureDefinition.date | Values for date differ: '2022-12-04T18:49:33+00:00' vs '2023-07-26T13:32:34+00:00' |
Warning | StructureDefinition.fhirVersion | Values for fhirVersion differ: '5.0.0-ballot' vs '5.0.0' |
Warning | PackagedProductDefinition.implicitRules | Elements differ in 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 it's narrative along with other profiles, value sets, etc.' vs '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.' |
Warning | PackagedProductDefinition.language | Elements differ in binding.description: 'IETF language tag' vs 'IETF language tag for a human language' |
Warning | PackagedProductDefinition.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.modifierExtension | Elements differ in 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 manageable, 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).' vs '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).' |
Warning | PackagedProductDefinition.identifier.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.identifier.system | Elements differ in definition: 'Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.' vs 'Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.' |
Warning | PackagedProductDefinition.identifier.value | Elements differ in 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 [Rendered Value extension]. 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.' vs '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.' |
Information | PackagedProductDefinition.name | Element minimum cardinalities differ: '0' vs '1' |
Information | PackagedProductDefinition.type | Example/preferred bindings differ at PackagedProductDefinition.type using binding from PackagedProductDefinitionUvEpi |
Warning | PackagedProductDefinition.containedItemQuantity | Elements differ in short: 'Number of items in this overall pack' vs 'A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)' |
Warning | PackagedProductDefinition.legalStatusOfSupply.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.legalStatusOfSupply.modifierExtension | Elements differ in 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 manageable, 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).' vs '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).' |
Information | PackagedProductDefinition.legalStatusOfSupply.code | Example/preferred bindings differ at PackagedProductDefinition.legalStatusOfSupply.code using binding from PackagedProductDefinitionUvEpi |
Information | PackagedProductDefinition.legalStatusOfSupply.jurisdiction | Example/preferred bindings differ at PackagedProductDefinition.legalStatusOfSupply.jurisdiction using binding from PackagedProductDefinitionUvEpi |
Warning | PackagedProductDefinition.marketingStatus.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.marketingStatus.modifierExtension | Elements differ in 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 manageable, 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).' vs '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).' |
Warning | PackagedProductDefinition.marketingStatus.country | Elements differ in short: 'The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements' vs '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' |
Warning | PackagedProductDefinition.marketingStatus.country | Elements differ in definition: 'The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.' vs '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.' |
Warning | PackagedProductDefinition.marketingStatus.jurisdiction | Elements differ in short: 'Where a Medicines Regulatory Agency has granted a marketing authorisation 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' vs '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' |
Warning | PackagedProductDefinition.marketingStatus.jurisdiction | Elements differ in definition: 'Where a Medicines Regulatory Agency has granted a marketing authorisation 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.' vs '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.' |
Warning | PackagedProductDefinition.marketingStatus.dateRange | Elements differ in short: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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' vs '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' |
Warning | PackagedProductDefinition.marketingStatus.dateRange | Elements differ in definition: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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.' vs '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.' |
Warning | PackagedProductDefinition.marketingStatus.restoreDate | Elements differ in short: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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' vs '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' |
Warning | PackagedProductDefinition.marketingStatus.restoreDate | Elements differ in definition: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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.' vs '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.' |
Error | PackagedProductDefinition.characteristic | Type Mismatch: CodeableConcept vs |
Warning | PackagedProductDefinition.packaging.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.packaging.modifierExtension | Elements differ in 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 manageable, 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).' vs '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).' |
Warning | PackagedProductDefinition.packaging.identifier.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.packaging.identifier.system | Elements differ in definition: 'Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.' vs 'Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.' |
Warning | PackagedProductDefinition.packaging.identifier.value | Elements differ in 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 [Rendered Value extension]. 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.' vs '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.' |
Information | PackagedProductDefinition.packaging.type | Example/preferred bindings differ at PackagedProductDefinition.packaging.type using binding from PackagedProductDefinitionUvEpi |
Information | PackagedProductDefinition.packaging.material | Element maximum cardinalities differ: '2147483647' vs '1' |
Information | PackagedProductDefinition.packaging.material | Example/preferred bindings differ at PackagedProductDefinition.packaging.material using binding from PackagedProductDefinitionUvEpi |
Warning | PackagedProductDefinition.packaging.shelfLifeStorage.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.packaging.shelfLifeStorage.modifierExtension | Elements differ in 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 manageable, 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).' vs '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).' |
Information | PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | Element maximum cardinalities differ: '2147483647' vs '1' |
Warning | PackagedProductDefinition.packaging.property.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.packaging.property.modifierExtension | Elements differ in 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 manageable, 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).' vs '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).' |
Warning | PackagedProductDefinition.packaging.containedItem.extension | Elements differ in 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 manageable, 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.' vs '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.' |
Warning | PackagedProductDefinition.packaging.containedItem.modifierExtension | Elements differ in 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 manageable, 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).' vs '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).' |
Warning | PackagedProductDefinition.packaging.containedItem.amount | Elements differ in short: 'The number of this type of item within this packaging' vs '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)' |
Warning | PackagedProductDefinition.packaging.containedItem.amount | Elements differ in definition: 'The number of this type of item within this packaging.' vs '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).' |
Warning | PackagedProductDefinition.packaging.packaging | Elements differ in short: 'Used to nest layers of packaging; e.g., outside to inside with secondary package and then primary package)' vs 'Allows containers (and parts of containers) within containers, still as a part of single packaged product' |
Warning | PackagedProductDefinition.packaging.packaging | Elements differ in definition: 'Allows containers (and parts of containers) parwithin containers, still a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).' vs 'Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).' |
Name | Value | Comments | |
---|---|---|---|
abstract | false | ||
baseDefinition | http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition | ||
copyright | |||
date | 2022-12-04T18:49:33+00:00 | 2023-07-26T13:32:34+00:00 |
|
description | PackagedProductDefinition (ePI) | ||
experimental | |||
fhirVersion | 5.0.0-ballot | 5.0.0 |
|
jurisdiction | |||
jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 | ||
kind | resource | ||
name | PackagedProductDefinitionUvEpi | ||
publisher | HL7 International - Biomedical Research & Regulation Work Group |
| |
purpose | |||
status | active | ||
title | PackagedProductDefinition (ePI) | ||
type | PackagedProductDefinition | ||
url | http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi | ||
version | 1.0.0-ballot | 1.0.0 |
|
Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||||
id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||
meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| ||||
language | 0..1 | code | Language of the resource content Binding: ?? (preferred): IETF language tag
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language |
| ||||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||
contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||
extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
| ||||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| ||||
identifier | Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | |||||
id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
| ||||||
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required) | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known . | |||||
type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible) | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | |||||
system | Σ | 1..1 | uri | The namespace for the identifier value Binding: ?? (extensible) Example General: http://www.acme.com/identifiers/patient | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| ||||
value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| ||||
period | Σ | 0..1 | Period | Time period when id is/was valid for use | Σ | 0..1 | Period | Time period when id is/was valid for use | |||||
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | |||||
name | Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc Example name: 3 ml cartridge (glass) in a pre-filled pen | Σ | 1..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
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type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: ?? (example): A high level categorisation of a package. |
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packageFor | Σ | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | Σ | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | |||||
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: ?? (preferred): The lifecycle status of an artifact. Example Example Status: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]} | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: ?? (preferred): The lifecycle status of an artifact. | |||||
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable Example statusDate: 2015-02-07T13:28:17Z | Σ | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z | |||||
containedItemQuantity | Σ | 0..* | Quantity | Number of items in this overall pack | Σ | 0..* | Quantity | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition) |
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description | Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | |||||
legalStatusOfSupply | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | |||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
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modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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code | Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: ?? (example): The prescription supply types appropriate to a medicinal product |
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jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ?? (preferred) |
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marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | |||||
id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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country | Σ | 0..1 | CodeableConcept | The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | 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 |
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jurisdiction | Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorisation 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 | Σ | 0..1 | CodeableConcept | 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 Binding: ?? (preferred) |
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status | Σ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: ?? (preferred) | Σ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples | |||||
dateRange | Σ | 0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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 | Σ | 0..1 | Period | 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 |
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restoreDate | Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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 | Σ | 0..1 | dateTime | 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 |
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characteristic | Σ | 0..* | CodeableConcept | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" Binding: ?? (example): A characteristic of a package. | Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" |
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copackagedIndicator | Σ | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | Σ | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | |||||
manufacturer | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this package type (multiple means these are all possible manufacturers) | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this package type (multiple means these are all possible manufacturers) | |||||
attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | |||||
packaging | Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | |||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
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modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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identifier | Σ | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | Σ | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | |||||
id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required) | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known . | |||||
type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible) | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | |||||
system | Σ | 1..1 | uri | The namespace for the identifier value Binding: ?? (preferred) Example General: http://www.acme.com/identifiers/patient | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
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value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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period | Σ | 0..1 | Period | Time period when id is/was valid for use | Σ | 0..1 | Period | Time period when id is/was valid for use | |||||
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | |||||
type | Σ | 0..1 | CodeableConcept | The physical type of the container of the items Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | The physical type of the container of the items Binding: ?? (example): A high level categorisation of a package. |
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quantity | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | |||||
material | Σ | 0..* | CodeableConcept | Material type of the package item Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | Material type of the package item Binding: ?? (example): A material used in the construction of packages and their components. |
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alternateMaterial | Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: ?? (example): A material used in the construction of packages and their components. | Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: ?? (example): A material used in the construction of packages and their components. | |||||
shelfLifeStorage | Σ | 0..* | ProductShelfLife | Shelf Life and storage information. | Σ | 0..* | ProductShelfLife | Shelf Life and storage information. | |||||
id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
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modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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type | Σ | 0..1 | CodeableConcept | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | 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 | |||||
Slices for period[x] | Σ | 0..1 | Duration, string | 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 Slice: Unordered, Open by type:$this | Σ | 0..1 | Duration, string | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used Slice: Unordered, Open by type:$this | |||||
specialPrecautionsForStorage | Σ | 0..* | CodeableConcept | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: ?? (preferred) | Σ | 0..1 | CodeableConcept | 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 |
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manufacturer | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | |||||
property | Σ | 0..* | BackboneElement | General characteristics of this item | Σ | 0..* | BackboneElement | General characteristics of this item | |||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
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modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | |||||
value[x] | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, Attachment | A value for the characteristic | Σ | 0..1 | CodeableConcept, Quantity, date, boolean, Attachment | A value for the characteristic | |||||
containedItem | Σ | 0..* | BackboneElement | The item(s) within the packaging | Σ | 0..* | BackboneElement | The item(s) within the packaging | |||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
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modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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item | Σ | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | Σ | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | |||||
amount | Σ | 0..1 | Quantity | The number of this type of item within this packaging | Σ | 0..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) |
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packaging | Σ | 0..* | See packaging (PackagedProductDefinition) | Used to nest layers of packaging; e.g., outside to inside with secondary package and then primary package) | Σ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
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componentPart | Σ | 0..1 | boolean | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial) |
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Documentation for this format |