EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Draft as of 2025-04-04 |
Definitions for the emaWriteApiPackagedProductDefinition resource profile.
Guidance on how to interpret the contents of this table can be found here
0. PackagedProductDefinition | |
Definition | A medically related item or items, in a container or package. |
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 | 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 | 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(EMA PC 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())) |
10. 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 | 10..1* |
Type | Reference(EMA Write API MedicinalProductDefinition, 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())) |
12. PackagedProductDefinition.status | |
Definition | The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status. |
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())) |
14. PackagedProductDefinition.containedItemQuantity | |
Definition | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource. |
Short | 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 | 10..* |
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())) |
16. PackagedProductDefinition.containedItemQuantity.value | |
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Numerical value (with implicit precision) |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 10..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
18. PackagedProductDefinition.containedItemQuantity.comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
20. PackagedProductDefinition.containedItemQuantity.system | |
Definition | The identification of the system that provides the coded form of the unit. |
Short | System that defines coded unit form |
Control | 10..1 This element is affected by the following invariants: qty-3 |
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 know the system that defines the coded form of the unit. |
Pattern Value | http://spor.ema.europa.eu/v1/lists/200000000014 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
22. PackagedProductDefinition.containedItemQuantity.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 10..1 This element is affected by the following invariants: qty-3 |
Binding | The codes SHALL be taken from For codes, see Units of Presentation (required to http://ema.europa.eu/fhir/vs/unitsOfPresentation ) |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. PackagedProductDefinition.description | |
Definition | Textual description. Note that this is not the name of the package or product. |
Short | Textual description. Note that this is not the name of the package or product |
Control | 10..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())) |
26. PackagedProductDefinition.description.extension | |
Definition | Language using the EMA SPOR codes May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
Short | Language |
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 | 1..1 |
Type | Extension(Language) (Extension Type: Coding(EMA Coding)) |
Is Modifier | 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()) |
28. PackagedProductDefinition.marketingStatus | |
Definition | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. |
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 | 10..* |
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())) |
30. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage | |
Slice Name | riskOfSupplyShortage |
Definition | Risk of Supply Shortage |
Short | Risk of Supply Shortage |
Control | 0..1 |
Type | Extension(Risk of Supply Shortage) (Extension Type: boolean) |
Is Modifier | false |
Summary | false |
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()) |
32. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment | |
Slice Name | riskOfSupplyShortageComment |
Definition | Risk of Supply Shortage Comment |
Short | Risk of Supply Shortage Comment |
Control | 0..1 |
Type | Extension(Risk of Supply Shortage Comment) (Extension Type: string) |
Is Modifier | false |
Summary | false |
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()) |
34. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason | |
Slice Name | marketingStatusReason |
Definition | Marketing Status Reason |
Short | Marketing Status Reason |
Control | 0..1 |
Type | Extension(Marketing Status Reason) (Extension Type: Coding(EMA Coding)) |
Is Modifier | false |
Summary | false |
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.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()) |
38. PackagedProductDefinition.marketingStatus.country | |
Definition | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements. |
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 | 10..1 |
Binding | The codes SHALL be taken from For codes, see Country (required to http://ema.europa.eu/fhir/vs/country ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
40. PackagedProductDefinition.marketingStatus.status | |
Definition | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples. |
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 |
Binding | The codes SHALL be taken from For codes, see Marketing Status (required to http://ema.europa.eu/fhir/vs/marketingStatus ) |
Type | CodeableConcept(EMA Generic ReferentialTerm 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 | |
2. PackagedProductDefinition.identifier | |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 |
Type | Identifier(EMA PC Identifier) |
4. PackagedProductDefinition.packageFor | |
Control | 1..1 |
Type | Reference(EMA Write API MedicinalProductDefinition) |
6. PackagedProductDefinition.containedItemQuantity | |
Control | 1..? |
8. PackagedProductDefinition.containedItemQuantity.value | |
Control | 1..? |
10. PackagedProductDefinition.containedItemQuantity.system | |
Control | 1..? |
Pattern Value | http://spor.ema.europa.eu/v1/lists/200000000014 |
12. PackagedProductDefinition.containedItemQuantity.code | |
Control | 1..? |
Binding | The codes SHALL be taken from Units of Presentation (required to http://ema.europa.eu/fhir/vs/unitsOfPresentation ) |
14. PackagedProductDefinition.description | |
Control | 1..? |
16. PackagedProductDefinition.description.extension | |
Control | 1..1 |
Type | Extension(Language) (Extension Type: Coding(EMA Coding)) |
18. PackagedProductDefinition.legalStatusOfSupply | |
20. PackagedProductDefinition.legalStatusOfSupply.code | |
Binding | The codes SHALL be taken from Legal Status of Supply (required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
22. PackagedProductDefinition.marketingStatus | |
Control | 1..? |
24. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage | |
Slice Name | riskOfSupplyShortage |
Control | 0..1 |
Type | Extension(Risk of Supply Shortage) (Extension Type: boolean) |
26. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment | |
Slice Name | riskOfSupplyShortageComment |
Control | 0..1 |
Type | Extension(Risk of Supply Shortage Comment) (Extension Type: string) |
28. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason | |
Slice Name | marketingStatusReason |
Control | 0..1 |
Type | Extension(Marketing Status Reason) (Extension Type: Coding(EMA Coding)) |
30. PackagedProductDefinition.marketingStatus.country | |
Control | 1..? |
Binding | The codes SHALL be taken from Country (required to http://ema.europa.eu/fhir/vs/country ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
32. PackagedProductDefinition.marketingStatus.status | |
Binding | The codes SHALL be taken from Marketing Status (required to http://ema.europa.eu/fhir/vs/marketingStatus ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
34. PackagedProductDefinition.marketingStatus.dateRange | |
36. PackagedProductDefinition.marketingStatus.dateRange.start | |
Control | 1..? |
38. PackagedProductDefinition.marketingStatus.dateRange.end | |
Control | 1..? |
40. PackagedProductDefinition.packaging | |
42. PackagedProductDefinition.packaging.identifier | |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | Identifier(EMA Data Carrier Identifier) |
44. PackagedProductDefinition.packaging.type | |
Control | 1..? |
Binding | The codes SHALL be taken from Packaging (required to http://ema.europa.eu/fhir/vs/packaging ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
46. PackagedProductDefinition.packaging.quantity | |
48. PackagedProductDefinition.packaging.quantity.extension | |
Control | 1..1 |
Type | Extension(The Comparator Extension) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta) |
50. PackagedProductDefinition.packaging.material | |
Control | 1..? |
Binding | The codes SHALL be taken from Material (required to http://ema.europa.eu/fhir/vs/material ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
52. PackagedProductDefinition.packaging.shelfLifeStorage | |
54. PackagedProductDefinition.packaging.shelfLifeStorage.type | |
Control | 1..? |
Binding | The codes SHALL be taken from Shelf Life Type (required to http://ema.europa.eu/fhir/vs/shelfLifeType ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
56. PackagedProductDefinition.packaging.shelfLifeStorage.period[x] | |
Control | 1..? |
Type | Duration(EMA Duration) |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
58. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | |
Binding | The codes SHALL be taken from Special Precautions For Storage (required to http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
60. PackagedProductDefinition.packaging.manufacturer | |
62. PackagedProductDefinition.packaging.manufacturer.extension | |
Control | 1..? |
64. PackagedProductDefinition.packaging.manufacturer.extension.extension | |
Control | 0..0 |
66. PackagedProductDefinition.packaging.manufacturer.extension.value[x] | |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Slicing | This element introduces a set of slices on PackagedProductDefinition.packaging.manufacturer.extension.value[x] . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
68. PackagedProductDefinition.packaging.manufacturer.extension.value[x]:valueReference | |
Slice Name | valueReference |
Control | 0..1 |
Type | Reference(EMA Write API ActivityDefinition) |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
70. PackagedProductDefinition.packaging.containedItem | |
72. PackagedProductDefinition.packaging.containedItem.item | |
Type | CodeableReference(DeviceDefinition, ManufacturedItemDefinition) |
74. PackagedProductDefinition.packaging.containedItem.amount | |
Control | 1..? |
Type | Quantity(EMA Quantity) |
76. PackagedProductDefinition.packaging.packaging | |
Control | 1..1 |
Guidance on how to interpret the contents of this table can be found here
0. PackagedProductDefinition | |
Definition | A medically related item or items, in a container or package. |
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 | 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 | 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(EMA PC 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()) ) |
20. 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()) ) |
22. 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()) ) |
24. 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 | 1..1 |
Type | Reference(EMA Write API 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()) ) |
26. PackagedProductDefinition.status | |
Definition | The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status. |
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()) ) |
28. 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()) ) |
30. PackagedProductDefinition.containedItemQuantity | |
Definition | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource. |
Short | 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 | 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()) ) |
32. PackagedProductDefinition.containedItemQuantity.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
34. PackagedProductDefinition.containedItemQuantity.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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.containedItemQuantity.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
36. PackagedProductDefinition.containedItemQuantity.value | |
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value. |
Short | Numerical value (with implicit precision) |
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books). |
Control | 1..1 |
Type | decimal |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Precision is handled implicitly in almost all cases of measurement. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
38. PackagedProductDefinition.containedItemQuantity.comparator | |
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value. |
Short | < | <= | >= | > | ad - how to understand the value |
Control | 0..1 |
Binding | The codes SHALL be taken from QuantityComparator (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 )How the Quantity should be understood and represented. |
Type | code |
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology. |
Meaning if Missing | If there is no comparator, then there is no modification of the value |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
40. PackagedProductDefinition.containedItemQuantity.unit | |
Definition | A human-readable form of the unit. |
Short | Unit representation |
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 | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
42. PackagedProductDefinition.containedItemQuantity.system | |
Definition | The identification of the system that provides the coded form of the unit. |
Short | System that defines coded unit form |
Control | 1..1 This element is affected by the following invariants: qty-3 |
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 know the system that defines the coded form of the unit. |
Pattern Value | http://spor.ema.europa.eu/v1/lists/200000000014 |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
44. PackagedProductDefinition.containedItemQuantity.code | |
Definition | A computer processable form of the unit in some unit representation system. |
Short | Coded form of the unit |
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system. |
Control | 1..1 This element is affected by the following invariants: qty-3 |
Binding | The codes SHALL be taken from Units of Presentation (required to http://ema.europa.eu/fhir/vs/unitsOfPresentation ) |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest. |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
46. PackagedProductDefinition.description | |
Definition | Textual description. Note that this is not the name of the package or product. |
Short | Textual description. Note that this is not the name of the package or product |
Control | 1..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()) ) |
48. PackagedProductDefinition.description.id | |
Definition | unique id for the element within a resource (for internal references) |
Short | xml:id (or equivalent in JSON) |
Control | 0..1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
50. PackagedProductDefinition.description.extension | |
Definition | Language using the EMA SPOR codes |
Short | Language |
Control | 1..1 |
Type | Extension(Language) (Extension Type: Coding(EMA Coding)) |
Is Modifier | false |
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() ) |
52. PackagedProductDefinition.description.value | |
Definition | Primitive value for markdown |
Short | Primitive value for markdown |
Control | 0..1 |
Type | markdown |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
54. PackagedProductDefinition.legalStatusOfSupply | |
Definition | The legal status of supply of the packaged item as classified by the regulator. |
Short | The legal status of supply of the packaged item as classified by the regulator |
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()) ) |
56. PackagedProductDefinition.legalStatusOfSupply.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
58. PackagedProductDefinition.legalStatusOfSupply.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
60. PackagedProductDefinition.legalStatusOfSupply.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
62. 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 Legal Status of Supply (required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply ) |
Type | CodeableConcept(EMA Generic ReferentialTerm 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.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 | For example codes, see JurisdictionValueSet (example to http://hl7.org/fhir/ValueSet/jurisdiction )Jurisdiction codes |
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()) ) |
66. PackagedProductDefinition.marketingStatus | |
Definition | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. |
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 | 1..* |
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()) ) |
68. PackagedProductDefinition.marketingStatus.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
70. PackagedProductDefinition.marketingStatus.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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: |
72. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage | |
Slice Name | riskOfSupplyShortage |
Definition | Risk of Supply Shortage |
Short | Risk of Supply Shortage |
Control | 0..1 |
Type | Extension(Risk of Supply Shortage) (Extension Type: boolean) |
Is Modifier | false |
Summary | false |
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() ) |
74. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment | |
Slice Name | riskOfSupplyShortageComment |
Definition | Risk of Supply Shortage Comment |
Short | Risk of Supply Shortage Comment |
Control | 0..1 |
Type | Extension(Risk of Supply Shortage Comment) (Extension Type: string) |
Is Modifier | false |
Summary | false |
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() ) |
76. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason | |
Slice Name | marketingStatusReason |
Definition | Marketing Status Reason |
Short | Marketing Status Reason |
Control | 0..1 |
Type | Extension(Marketing Status Reason) (Extension Type: Coding(EMA Coding)) |
Is Modifier | false |
Summary | false |
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() ) |
78. PackagedProductDefinition.marketingStatus.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
80. PackagedProductDefinition.marketingStatus.country | |
Definition | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements. |
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 | 1..1 |
Binding | The codes SHALL be taken from Country (required to http://ema.europa.eu/fhir/vs/country ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
82. PackagedProductDefinition.marketingStatus.jurisdiction | |
Definition | Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified. |
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()) ) |
84. PackagedProductDefinition.marketingStatus.status | |
Definition | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples. |
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 |
Binding | The codes SHALL be taken from Marketing Status (required to http://ema.europa.eu/fhir/vs/marketingStatus ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
86. PackagedProductDefinition.marketingStatus.dateRange | |
Definition | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. |
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()) ) |
88. PackagedProductDefinition.marketingStatus.dateRange.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
90. PackagedProductDefinition.marketingStatus.dateRange.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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.dateRange.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
92. PackagedProductDefinition.marketingStatus.dateRange.start | |
Definition | The start of the period. The boundary is inclusive. |
Short | Starting time with inclusive boundary |
Comments | If the low element is missing, the meaning is that the low boundary is not known. |
Control | 1..1 This element is affected by the following invariants: per-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()) ) |
94. PackagedProductDefinition.marketingStatus.dateRange.end | |
Definition | The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time. |
Short | End time with inclusive boundary, if not ongoing |
Comments | The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03. |
Control | 1..1 This element is affected by the following invariants: per-1 |
Type | dateTime |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
Meaning if Missing | If the end of the period is missing, it means that the period is ongoing |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
96. PackagedProductDefinition.marketingStatus.restoreDate | |
Definition | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. |
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()) ) |
98. PackagedProductDefinition.copackagedIndicator | |
Definition | Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant. |
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()) ) |
100. 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()) ) |
102. 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()) ) |
104. PackagedProductDefinition.packaging | |
Definition | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item). |
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()) ) |
106. PackagedProductDefinition.packaging.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
108. PackagedProductDefinition.packaging.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
110. PackagedProductDefinition.packaging.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
112. PackagedProductDefinition.packaging.identifier | |
Definition | A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode). |
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 | 1..1 |
Type | Identifier(EMA Data Carrier 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()) ) |
114. PackagedProductDefinition.packaging.type | |
Definition | The physical type of the container of the items. |
Short | The physical type of the container of the items |
Control | 1..1 |
Binding | The codes SHALL be taken from Packaging (required to http://ema.europa.eu/fhir/vs/packaging ) |
Type | CodeableConcept(EMA Generic ReferentialTerm 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()) ) |
116. PackagedProductDefinition.packaging.componentPart | |
Definition | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial). The latter type are designed be a container, but the former are not. |
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()) ) |
118. PackagedProductDefinition.packaging.quantity | |
Definition | The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2. |
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()) ) |
120. PackagedProductDefinition.packaging.quantity.id | |
Definition | unique id for the element within a resource (for internal references) |
Short | xml:id (or equivalent in JSON) |
Control | 0..1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
122. PackagedProductDefinition.packaging.quantity.extension | |
Definition | The Comparator Extension |
Short | The Comparator Extension |
Control | 1..1 |
Type | Extension(The Comparator Extension) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta) |
Is Modifier | false |
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() ) |
124. PackagedProductDefinition.packaging.quantity.value | |
Definition | The actual value |
Short | Primitive value for integer |
Control | 0..1 |
Type | integer |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
Min Value | -2147483648 |
Max Value | 2147483647 |
126. PackagedProductDefinition.packaging.material | |
Definition | Material type of the package item. |
Short | Material type of the package item |
Control | 1..* |
Binding | The codes SHALL be taken from Material (required to http://ema.europa.eu/fhir/vs/material ) |
Type | CodeableConcept(EMA Generic ReferentialTerm 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()) ) |
128. PackagedProductDefinition.packaging.alternateMaterial | |
Definition | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve). |
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()) ) |
130. PackagedProductDefinition.packaging.shelfLifeStorage | |
Definition | Shelf Life and storage information. |
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()) ) |
132. PackagedProductDefinition.packaging.shelfLifeStorage.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
134. PackagedProductDefinition.packaging.shelfLifeStorage.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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.shelfLifeStorage.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
136. PackagedProductDefinition.packaging.shelfLifeStorage.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
138. PackagedProductDefinition.packaging.shelfLifeStorage.type | |
Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified. |
Short | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified |
Control | 1..1 |
Binding | The codes SHALL be taken from Shelf Life Type (required to http://ema.europa.eu/fhir/vs/shelfLifeType ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
140. PackagedProductDefinition.packaging.shelfLifeStorage.period[x] | |
Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used. |
Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used |
Control | 1..1 |
Type | Duration(EMA Duration) |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
142. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | |
Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified. |
Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified |
Control | 0..* |
Binding | The codes SHALL be taken from Special Precautions For Storage (required to http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage ) |
Type | CodeableConcept(EMA Generic ReferentialTerm CodeableConcept) |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
144. PackagedProductDefinition.packaging.manufacturer | |
Definition | Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item. |
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()) ) |
146. PackagedProductDefinition.packaging.manufacturer.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
148. PackagedProductDefinition.packaging.manufacturer.extension | |
Definition | An Extension |
Short | Extension |
Control | 1..* |
Type | Extension |
Is Modifier | false |
Summary | false |
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.manufacturer.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
150. PackagedProductDefinition.packaging.manufacturer.extension.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
152. PackagedProductDefinition.packaging.manufacturer.extension.extension | |
Definition | An Extension |
Short | Extension |
Control | 0..0 |
Type | Extension |
Is Modifier | false |
Summary | false |
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.manufacturer.extension.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
154. PackagedProductDefinition.packaging.manufacturer.extension.url | |
Definition | Source of the definition for the extension code - a logical name or a URL. |
Short | identifies the meaning of the extension |
Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
Control | 1..1 |
Type | uri |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
156. PackagedProductDefinition.packaging.manufacturer.extension.value[x] | |
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
Short | Value of extension |
Control | 0..1 This element is affected by the following invariants: ext-1 |
Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta |
[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 |
Summary | false |
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.packaging.manufacturer.extension.value[x] . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
158. PackagedProductDefinition.packaging.manufacturer.extension.value[x]:valueReference | |
Slice Name | valueReference |
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
Short | Value of extension |
Control | 0..1 This element is affected by the following invariants: ext-1 |
Type | Reference(EMA Write API ActivityDefinition) |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
160. PackagedProductDefinition.packaging.manufacturer.reference | |
Definition | A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. |
Short | Literal reference, Relative, internal or absolute URL |
Comments | Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server. |
Control | 0..1 This element is affected by the following invariants: ref-2, ref-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()) ) |
162. PackagedProductDefinition.packaging.manufacturer.type | |
Definition | The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). |
Short | Type the reference refers to (e.g. "Patient") - must be a resource in resources |
Comments | This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference. |
Control | 0..1 |
Binding | Unless not suitable, these codes SHALL be taken from ResourceType (extensible to http://hl7.org/fhir/ValueSet/resource-types )Aa resource (or, for logical models, the URI of the logical model). |
Type | uri |
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()) ) |
164. PackagedProductDefinition.packaging.manufacturer.identifier | |
Definition | An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. |
Short | Logical reference, when literal reference is not known |
Comments | When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..1 This element is affected by the following invariants: ref-2 |
Type | Identifier |
Is Modifier | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
166. PackagedProductDefinition.packaging.manufacturer.display | |
Definition | Plain text narrative that identifies the resource in addition to the resource reference. |
Short | Text alternative for the resource |
Comments | This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it. |
Control | 0..1 This element is affected by the following invariants: ref-2 |
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()) ) |
168. 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()) ) |
170. PackagedProductDefinition.packaging.property.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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.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() ) |
174. PackagedProductDefinition.packaging.property.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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.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()) ) |
178. 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()) ) |
180. PackagedProductDefinition.packaging.containedItem | |
Definition | The item(s) within the packaging. |
Short | The item(s) 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()) ) |
182. PackagedProductDefinition.packaging.containedItem.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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 |
184. PackagedProductDefinition.packaging.containedItem.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
186. PackagedProductDefinition.packaging.containedItem.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
188. PackagedProductDefinition.packaging.containedItem.item | |
Definition | The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.packaging.packaging). |
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(DeviceDefinition, ManufacturedItemDefinition) |
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()) ) |
190. PackagedProductDefinition.packaging.containedItem.amount | |
Definition | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition). |
Short | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) |
Control | 1..1 |
Type | Quantity(EMA 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()) ) |
192. PackagedProductDefinition.packaging.packaging | |
Definition | Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition). |
Short | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
Control | 1..1 |
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()) ) |
194. 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()) ) |