Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1
Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions
Draft as of 2024-08-20 |
Definitions for the PackagedProductD412 resource profile.
Guidance on how to interpret the contents of this table can be found here
0. PackagedProductDefinition | |
2. PackagedProductDefinition.identifier | |
Definition | Identifier for the packaged product: PCID, national code or other. |
Short | Identifier for the packaged product: PCID, national ID, or other |
Note | This is a business identifier, not a resource identifier (see discussion) |
Slicing | This element introduces a set of slices on PackagedProductDefinition.identifier . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
4. PackagedProductDefinition.identifier:pcid | |
Slice Name | pcid |
Definition | EMA IG 4.1 |
Short | PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
6. PackagedProductDefinition.identifier:pcid.system | |
Control | 1..? |
Pattern Value | http://ema.europa.eu/example/pcid |
8. PackagedProductDefinition.packageFor | |
Type | Reference(Medicinal Product) |
10. PackagedProductDefinition.containedItemQuantity | |
Definition | EMA IG 4.4 |
Short | Pack size. Repeated for combination packages. |
Binding | The codes SHALL be taken from EMA SPOR Unit of Presentation (required to http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs ) |
12. PackagedProductDefinition.description | |
Definition | EMA IG 4.2 |
14. PackagedProductDefinition.legalStatusOfSupply | |
Definition | EMA IG 4.5. Legal status of supply on the packaged product level. The same information can be repeated/differentiated on the medicinal product level |
Short | Legal status of supply on the packaged product level. |
Control | 0..1 |
16. PackagedProductDefinition.legalStatusOfSupply.code | |
Binding | The codes SHALL be taken from EMA SPOR Legal Status for the Supply (required to http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs ) |
18. PackagedProductDefinition.legalStatusOfSupply.jurisdiction | |
Binding | The codes SHALL be taken from EMA SPOR Country (required to http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs ) |
20. PackagedProductDefinition.marketingStatus | |
Definition | EMA IG 4.6 |
22. PackagedProductDefinition.marketingStatus.country | |
Binding | The codes SHALL be taken from EMA SPOR Country (required to http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs ) |
24. PackagedProductDefinition.marketingStatus.status | |
26. PackagedProductDefinition.marketingStatus.status.coding | |
28. PackagedProductDefinition.marketingStatus.status.coding.system | |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000072052 |
30. PackagedProductDefinition.packaging | |
32. PackagedProductDefinition.packaging.type | |
Definition | EMA IG 4.8.1 |
Short | Container type |
34. PackagedProductDefinition.packaging.type.coding | |
36. PackagedProductDefinition.packaging.type.coding.system | |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000073346 |
38. PackagedProductDefinition.packaging.quantity | |
Definition | EMA IG 4.8.5 |
40. PackagedProductDefinition.packaging.material | |
Definition | EMA IG 4.8.7 |
42. PackagedProductDefinition.packaging.shelfLifeStorage | |
Definition | EMA IG 4.12 |
44. PackagedProductDefinition.packaging.containedItem | |
Definition | EMA IG 4.9 or 4.8.3 |
Short | An item (inner package or manufactured item) within the packaging |
46. PackagedProductDefinition.packaging.containedItem.item | |
Type | CodeableReference(Packaged Product, Manufactured Item) |
48. PackagedProductDefinition.packaging.containedItem.amount | |
Definition | EMA IG 4.11.2 |
Short | Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition |
Guidance on how to interpret the contents of this table can be found here
0. PackagedProductDefinition | |
Definition | A medically related item or items, in a container or package. |
Short | A medically related item or items, in a container or package |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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. |
Short | A set of rules under which this content was created |
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
4. PackagedProductDefinition.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
6. PackagedProductDefinition.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
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 |
Invariants | 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()) |
8. PackagedProductDefinition.identifier | |
Definition | Identifier for the packaged product: PCID, national code or other. 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. |
Short | Identifier for the packaged product: PCID, national ID, or otherA unique identifier for this package as whole - not for the content of the package |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | 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.identifier . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
10. PackagedProductDefinition.identifier:pcid | |
Slice Name | pcid |
Definition | EMA IG 4.1 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. |
Short | PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.A unique identifier for this package as whole - not for the content of the package |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. PackagedProductDefinition.identifier:pcid.use | |
Definition | The purpose of this identifier. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 )Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
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. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
14. PackagedProductDefinition.identifier:pcid.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 10..1 |
Type | uri |
Is Modifier | false |
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. |
Pattern Value | http://ema.europa.eu/example/pcid |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
16. PackagedProductDefinition.packageFor | |
Definition | The product this package model relates to, not the contents of the package (for which see package.containedItem). |
Short | The product that this is a pack for |
Control | 0..* |
Type | Reference(Medicinal Product, MedicinalProductDefinition) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
18. PackagedProductDefinition.status | |
Definition | The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status. |
Short | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. |
Type | CodeableConcept |
Is Modifier | true because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
20. PackagedProductDefinition.containedItemQuantity | |
Definition | EMA IG 4.4 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. |
Short | Pack size. Repeated for combination packages.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) |
Control | 0..* |
Binding | The codes SHALL be taken from For codes, see EMA SPOR Unit of Presentation (required to http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs ) |
Type | Quantity |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
22. PackagedProductDefinition.description | |
Definition | EMA IG 4.2 Textual description. Note that this is not the name of the package or product. |
Short | Textual description. Note that this is not the name of the package or product |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. PackagedProductDefinition.legalStatusOfSupply | |
Definition | EMA IG 4.5. Legal status of supply on the packaged product level. The same information can be repeated/differentiated on the medicinal product level The legal status of supply of the packaged item as classified by the regulator. |
Short | Legal status of supply on the packaged product level.The legal status of supply of the packaged item as classified by the regulator |
Control | 0..1* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
26. 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). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
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 |
Invariants | 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()) |
28. PackagedProductDefinition.legalStatusOfSupply.code | |
Definition | The actual status of supply. Conveys in what situation this package type may be supplied for use. |
Short | The actual status of supply. In what situation this package type may be supplied for use |
Control | 0..1 |
Binding | The codes SHALL be taken from For example codes, see EMA SPOR Legal Status for the Supplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply (required to http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
30. PackagedProductDefinition.legalStatusOfSupply.jurisdiction | |
Definition | The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context. |
Short | The place where the legal status of supply applies |
Control | 0..1 |
Binding | The codes SHALL be taken from For example codes, see EMA SPOR Countryhttp://hl7.org/fhir/ValueSet/jurisdiction (required to http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
32. PackagedProductDefinition.marketingStatus | |
Definition | EMA IG 4.6 Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. |
Short | 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 |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
34. 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). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
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 |
Invariants | 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. |
Short | 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 |
Binding | The codes SHALL be taken from For codes, see EMA SPOR Country (required to http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Summary | true |
Invariants | 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. |
Short | 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 |
Is Modifier | false |
Summary | true |
Invariants | 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
0. PackagedProductDefinition | |
Definition | A medically related item or items, in a container or package. |
Short | A medically related item or items, in a container or package |
Control | 0..* |
Is Modifier | false |
Must Support | false |
Summary | false |
Invariants | 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.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Short | Logical id of this artifact |
Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
Control | 0..1 |
Type | id |
Is Modifier | false |
Must Support | false |
Summary | true |
4. PackagedProductDefinition.meta | |
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. |
Short | Metadata about the resource |
Control | 0..1 |
Type | Meta |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
6. PackagedProductDefinition.implicitRules | |
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
Short | A set of rules under which this content was created |
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
8. PackagedProductDefinition.language | |
Definition | The base language in which the resource is written. |
Short | Language of the resource content |
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). |
Control | 0..1 |
Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0 )IETF language tag for a human language |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
10. PackagedProductDefinition.text | |
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. |
Short | Text summary of the resource, for human interpretation |
Comments | Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | narrative, html, xhtml, display |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
12. PackagedProductDefinition.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
Short | Contained, inline Resources |
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. |
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
14. PackagedProductDefinition.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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.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). |
Short | Extensions that cannot be ignored |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
Must Support | false |
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 |
Invariants | 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() ) |
18. PackagedProductDefinition.identifier | |
Definition | Identifier for the packaged product: PCID, national code or other. |
Short | Identifier for the packaged product: PCID, national ID, or other |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | 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.identifier . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
20. PackagedProductDefinition.identifier:pcid | |
Slice Name | pcid |
Definition | EMA IG 4.1 |
Short | PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
22. PackagedProductDefinition.identifier:pcid.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
24. PackagedProductDefinition.identifier:pcid.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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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 areUnordered and Open, and can be differentiated using the following discriminators: |
26. PackagedProductDefinition.identifier:pcid.use | |
Definition | The purpose of this identifier. |
Short | usual | official | temp | secondary | old (If known) |
Comments | Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. |
Control | 0..1 |
Binding | The codes SHALL be taken from IdentifierUse (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 )Identifies the purpose for this identifier, if known . |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. |
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. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
28. PackagedProductDefinition.identifier:pcid.type | |
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
Short | Description of identifier |
Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. |
Control | 0..1 |
Binding | Unless not suitable, these codes SHALL be taken from IdentifierTypeCodes (extensible to http://hl7.org/fhir/ValueSet/identifier-type )A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
Type | CodeableConcept |
Is Modifier | false |
Summary | true |
Requirements | Allows users to make use of identifiers when the identifier system is not known. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
30. PackagedProductDefinition.identifier:pcid.system | |
Definition | Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique. |
Short | The namespace for the identifier value |
Comments | Identifier.system is always case sensitive. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
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. |
Pattern Value | http://ema.europa.eu/example/pcid |
Example | <br/><b>General</b>:http://www.acme.com/identifiers/patient |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
32. PackagedProductDefinition.identifier:pcid.value | |
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
Short | The value that is unique |
Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. |
Control | 0..1 This element is affected by the following invariants: ident-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Example | <br/><b>General</b>:123456 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
34. PackagedProductDefinition.identifier:pcid.period | |
Definition | Time period during which identifier is/was valid for use. |
Short | Time period when id is/was valid for use |
Control | 0..1 |
Type | Period |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
36. PackagedProductDefinition.identifier:pcid.assigner | |
Definition | Organization that issued/manages the identifier. |
Short | Organization that issued id (may be just text) |
Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. |
Control | 0..1 |
Type | Reference(Organization) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
38. PackagedProductDefinition.name | |
Definition | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc. |
Short | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
40. PackagedProductDefinition.type | |
Definition | A high level category e.g. medicinal product, raw material, shipping/transport container, etc. |
Short | A high level category e.g. medicinal product, raw material, shipping container etc |
Control | 0..1 |
Binding | For example codes, see PackageType (example to http://hl7.org/fhir/ValueSet/package-type )A high level categorisation of a package. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
42. PackagedProductDefinition.packageFor | |
Definition | The product this package model relates to, not the contents of the package (for which see package.containedItem). |
Short | The product that this is a pack for |
Control | 0..* |
Type | Reference(Medicinal Product) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
44. 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. |
Short | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status |
Control | 0..1 |
Binding | The codes SHOULD be taken from PublicationStatus (preferred to http://hl7.org/fhir/ValueSet/publication-status )The lifecycle status of an artifact. |
Type | CodeableConcept |
Is Modifier | true because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
46. PackagedProductDefinition.statusDate | |
Definition | The date at which the given status became applicable. |
Short | The date at which the given status became applicable |
Control | 0..1 |
Type | dateTime |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
48. PackagedProductDefinition.containedItemQuantity | |
Definition | EMA IG 4.4 |
Short | Pack size. Repeated for combination packages. |
Control | 0..* |
Binding | The codes SHALL be taken from EMA SPOR Unit of Presentation (required to http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs ) |
Type | Quantity |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
50. PackagedProductDefinition.description | |
Definition | EMA IG 4.2 |
Short | Textual description. Note that this is not the name of the package or product |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
52. PackagedProductDefinition.legalStatusOfSupply | |
Definition | EMA IG 4.5. Legal status of supply on the packaged product level. The same information can be repeated/differentiated on the medicinal product level |
Short | Legal status of supply on the packaged product level. |
Control | 0..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
54. 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. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
56. 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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
58. 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). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
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 |
Invariants | 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() ) |
60. PackagedProductDefinition.legalStatusOfSupply.code | |
Definition | The actual status of supply. Conveys in what situation this package type may be supplied for use. |
Short | The actual status of supply. In what situation this package type may be supplied for use |
Control | 0..1 |
Binding | The codes SHALL be taken from EMA SPOR Legal Status for the Supply (required to http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
62. PackagedProductDefinition.legalStatusOfSupply.jurisdiction | |
Definition | The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context. |
Short | The place where the legal status of supply applies |
Control | 0..1 |
Binding | The codes SHALL be taken from EMA SPOR Country (required to http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
64. PackagedProductDefinition.marketingStatus | |
Definition | EMA IG 4.6 |
Short | 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 |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
66. 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. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
68. 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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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 areUnordered and Open, and can be differentiated using the following discriminators: |
70. 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). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
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 |
Invariants | 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() ) |
72. 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. |
Short | 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 |
Binding | The codes SHALL be taken from EMA SPOR Country (required to http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
74. 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. |
Short | 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 |
Type | CodeableConcept |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
76. 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. |
Short | 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 |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
78. PackagedProductDefinition.marketingStatus.status.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
80. PackagedProductDefinition.marketingStatus.status.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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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.status.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
82. PackagedProductDefinition.marketingStatus.status.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
84. PackagedProductDefinition.marketingStatus.status.coding.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
86. PackagedProductDefinition.marketingStatus.status.coding.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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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.status.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
88. PackagedProductDefinition.marketingStatus.status.coding.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 0..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000072052 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
90. PackagedProductDefinition.marketingStatus.status.coding.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
92. PackagedProductDefinition.marketingStatus.status.coding.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
94. PackagedProductDefinition.marketingStatus.status.coding.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
96. PackagedProductDefinition.marketingStatus.status.coding.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
98. PackagedProductDefinition.marketingStatus.status.text | |
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. |
Short | Plain text representation of the concept |
Comments | Very often the text is the same as a displayName of one of the codings. |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
100. 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. |
Short | 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 |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
102. 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. |
Short | 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 |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
104. 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. |
Short | Identifies if the drug product is supplied with another item such as a diluent or adjuvant |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
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 | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
106. PackagedProductDefinition.manufacturer | |
Definition | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers. |
Short | Manufacturer of this package type (multiple means these are all possible manufacturers) |
Control | 0..* |
Type | Reference(Organization) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
108. PackagedProductDefinition.attachedDocument | |
Definition | Additional information or supporting documentation about the packaged product. |
Short | Additional information or supporting documentation about the packaged product |
Control | 0..* |
Type | Reference(DocumentReference) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
110. 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). |
Short | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
Control | 0..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
112. 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. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
114. 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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
116. 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). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
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 |
Invariants | 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() ) |
118. 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). |
Short | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
120. PackagedProductDefinition.packaging.type | |
Definition | EMA IG 4.8.1 |
Short | Container type |
Control | 0..1 |
Binding | For example codes, see PackagingType (example to http://hl7.org/fhir/ValueSet/packaging-type )A high level categorisation of a package. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
122. PackagedProductDefinition.packaging.type.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
124. PackagedProductDefinition.packaging.type.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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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.type.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
126. PackagedProductDefinition.packaging.type.coding | |
Definition | A reference to a code defined by a terminology system. |
Short | Code defined by a terminology system |
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
Control | 0..* |
Type | Coding |
Is Modifier | false |
Summary | true |
Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
128. PackagedProductDefinition.packaging.type.coding.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
130. PackagedProductDefinition.packaging.type.coding.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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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.type.coding.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
132. PackagedProductDefinition.packaging.type.coding.system | |
Definition | The identification of the code system that defines the meaning of the symbol in the code. |
Short | Identity of the terminology system |
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously. |
Control | 0..1 |
Type | uri |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Pattern Value | https://spor.ema.europa.eu/v1/lists/100000073346 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
134. PackagedProductDefinition.packaging.type.coding.version | |
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. |
Short | Version of the system - if relevant |
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. |
Note | This is a business version Id, not a resource version Id (see discussion) |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
136. PackagedProductDefinition.packaging.type.coding.code | |
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). |
Short | Symbol in syntax defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to refer to a particular code in the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
138. PackagedProductDefinition.packaging.type.coding.display | |
Definition | A representation of the meaning of the code in the system, following the rules of the system. |
Short | Representation defined by the system |
Control | 0..1 This element is affected by the following invariants: cod-1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
140. PackagedProductDefinition.packaging.type.coding.userSelected | |
Definition | Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). |
Short | If this coding was chosen directly by the user |
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
142. PackagedProductDefinition.packaging.type.text | |
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. |
Short | Plain text representation of the concept |
Comments | Very often the text is the same as a displayName of one of the codings. |
Control | 0..1 |
Type | string |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
144. 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. |
Short | 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) |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
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 | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
146. PackagedProductDefinition.packaging.quantity | |
Definition | EMA IG 4.8.5 |
Short | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
Control | 0..1 |
Type | integer |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
148. PackagedProductDefinition.packaging.material | |
Definition | EMA IG 4.8.7 |
Short | Material type of the package item |
Control | 0..* |
Binding | For example codes, see PackageMaterial (example to http://hl7.org/fhir/ValueSet/package-material )A material used in the construction of packages and their components. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
150. 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). |
Short | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material |
Control | 0..* |
Binding | For example codes, see PackageMaterial (example to http://hl7.org/fhir/ValueSet/package-material )A material used in the construction of packages and their components. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
152. PackagedProductDefinition.packaging.shelfLifeStorage | |
Definition | EMA IG 4.12 |
Short | Shelf Life and storage information |
Control | 0..* |
Type | ProductShelfLife |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
154. PackagedProductDefinition.packaging.manufacturer | |
Definition | Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item. |
Short | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
Control | 0..* |
Type | Reference(Organization) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
156. PackagedProductDefinition.packaging.property | |
Definition | General characteristics of this item. |
Short | General characteristics of this item |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
158. 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. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
160. 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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
162. 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). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
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 |
Invariants | 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() ) |
164. PackagedProductDefinition.packaging.property.type | |
Definition | A code expressing the type of characteristic. |
Short | A code expressing the type of characteristic |
Control | 1..1 |
Binding | For example codes, see ProductCharacteristic (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes )This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
166. PackagedProductDefinition.packaging.property.value[x] | |
Definition | A value for the characteristic. |
Short | A value for the characteristic |
Control | 0..1 |
Type | Choice of: CodeableConcept, Quantity, date, boolean, Attachment |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
168. PackagedProductDefinition.packaging.containedItem | |
Definition | EMA IG 4.9 or 4.8.3 |
Short | An item (inner package or manufactured item) within the packaging |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
170. 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. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
172. 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. |
Short | Additional content defined by implementations |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | 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() ) |
174. 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). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
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 |
Invariants | 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() ) |
176. 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). |
Short | 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 |
Control | 1..1 |
Type | CodeableReference(Packaged Product, Manufactured Item) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
178. PackagedProductDefinition.packaging.containedItem.amount | |
Definition | EMA IG 4.11.2 |
Short | Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition |
Control | 0..1 |
Type | Quantity |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
180. 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). |
Short | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
Control | 0..* |
Type | Seettp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
182. PackagedProductDefinition.characteristic | |
Definition | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack". |
Short | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" |
Control | 0..* |
Type | Seettp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |