EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Resource Profile: EMA Write API PackagedProductDefinition
| Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition | Version: 1.2.1 | |||
| Draft as of 2026-06-26 | Computable Name: EmaWriteApiPackagedProductDefinition | |||
Defines the rules a PackagedProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
Usages:
- Use this Profile: EMA Write PMS API Bundle
- Refer to this Profile: EMA Write API Regulated Authorization
You can also check for usages in the FHIR IG Statistics
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  PackagedProductDefinition |
0..* | EmaWriteApiPackagedProductDefinitionRestrictions | A medically related item or items, in a container or package | |
  Slices for identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package Slice: Unordered, Closed by value:system |
   identifier:emaPcIdentifier |
Σ | 0..1 | EmaPcIdentifier | A unique identifier for this package as whole - not for the content of the package |
   extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
 system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pcId |
 value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| identifier:dataCarrierGs1 |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575 |
| identifier:dataCarrierPharmacy |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029 |
| identifier:dataCarrierNationalTrade |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030 |
 identifier:xevmpd |
Σ | 0..* | EmaXevmpdIdentifier | A unique identifier for this package as whole - not for the content of the package |
 extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665 |
| value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
  packageFor |
Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition) | The product that this is a pack for |
 status |
?!Σ | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: Record Status (required) |
| description |
Σ | 1..1 | markdown | Textual description. Note that this is not the name of the package or product |
 extension |
1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
 marketingStatus |
Σ | 1..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| Slices for extension |
Content/Rules for all slices | |||
 extension:riskOfSupplyShortage |
0..1 | Coding | Risk of Supply Shortage URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage | |
| extension:riskOfSupplyShortageComment |
0..1 | string | Risk of Supply Shortage Comment URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment | |
 extension:reason |
0..1 | EmaCoding | Reason URL: http://ema.europa.eu/fhir/extension/reason Binding: Marketing Status Reason (required) | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| country |
Σ | 1..1 | EmaRefTermCodeableConcept | 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 Binding: Country (required) |
| status |
Σ | 1..1 | EmaRefTermCodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: Marketing Status (required) |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| PackagedProductDefinition.identifier:dataCarrierGs1.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierPharmacy.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierNationalTrade.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.status | Base | required | Record Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.country | Base | required | Country | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.status | Base | required | Marketing Status | 📦1.2.1 | This IG |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from EmaWriteApiPackagedProductDefinitionRestrictions
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| PackagedProductDefinition |
EmaWriteApiPackagedProductDefinitionRestrictions | |||
| Slices for identifier |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package Slice: Unordered, Closed by value:system | |
| identifier:emaPcIdentifier |
0..1 | EmaPcIdentifier | A unique identifier for this package as whole - not for the content of the package | |
 system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pcId | |
| identifier:dataCarrierGs1 |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575 | |
| identifier:dataCarrierPharmacy |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029 | |
| identifier:dataCarrierNationalTrade |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030 | |
| identifier:xevmpd |
0..* | EmaXevmpdIdentifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665 | |
| packageFor |
1..1 | Reference(EMA Write API MedicinalProductDefinition) | The product that this is a pack for | |
| status |
1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: Record Status (required) | |
| containedItemQuantity |
||||
| value |
1..1 | decimal | Numerical value (with implicit precision) | |
| system |
1..1 | uri | System that defines coded unit form Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000014 | |
| code |
1..1 | code | Coded form of the unit Binding: Units of Presentation (required) | |
| description |
1..1 | markdown | Textual description. Note that this is not the name of the package or product | |
| extension |
1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
| legalStatusOfSupply |
||||
| code |
0..1 | EmaRefTermCodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status of Supply (required) | |
| marketingStatus |
1..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:riskOfSupplyShortage |
0..1 | Coding | Risk of Supply Shortage URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage | |
| extension:riskOfSupplyShortageComment |
0..1 | string | Risk of Supply Shortage Comment URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment | |
| extension:reason |
0..1 | EmaCoding | Reason URL: http://ema.europa.eu/fhir/extension/reason Binding: Marketing Status Reason (required) | |
| country |
1..1 | EmaRefTermCodeableConcept | 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 Binding: Country (required) | |
| status |
1..1 | EmaRefTermCodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: Marketing Status (required) | |
| dateRange |
||||
| start |
1..1 | dateTime | Starting time with inclusive boundary | |
| manufacturer |
||||
 extension |
1..* | Reference(ActivityDefinition) | The Operation Extension URL: http://ema.europa.eu/fhir/extension/operation | |
| packaging |
||||
| type |
1..1 | EmaRefTermCodeableConcept | The physical type of the container of the items Binding: Packaging (required) | |
| quantity |
||||
| extension |
1..1 | Coding | The Comparator Extension URL: http://ema.europa.eu/fhir/extension/comparator Binding: Quantity Operator (required) | |
| material |
1..* | EmaRefTermCodeableConcept | Material type of the package item Binding: Material (required) | |
| shelfLifeStorage |
||||
| type |
1..1 | EmaRefTermCodeableConcept | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Shelf Life Type (required) | |
| period[x] |
1..1 | EmaDuration | 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 | |
| specialPrecautionsForStorage |
0..* | EmaRefTermCodeableConcept | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Special Precautions For Storage (required) | |
| manufacturer |
||||
| extension |
1..* | Extension | Extension | |
| extension |
0..0 | Extension | ||
| Slices for value[x] |
0..1 | 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 | Value of extension Slice: Unordered, Open by type:$this | |
| value[x]:valueReference |
0..1 | Reference(EMA Write API ActivityDefinition) | Value of extension | |
| containedItem |
||||
| item |
1..1 | CodeableReference(DeviceDefinition | ManufacturedItemDefinition) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | |
| amount |
1..1 | EmaQuantity | 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) | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Status | Usage | ValueSet | Version | Source |
| PackagedProductDefinition.status | Base | required | Record Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.containedItemQuantity.code | Base | required | Units of Presentation | 📦1.2.1 | This IG |
| PackagedProductDefinition.legalStatusOfSupply.code | Base | required | Legal Status of Supply | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.country | Base | required | Country | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.status | Base | required | Marketing Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.type | Base | required | Packaging | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.material | Base | required | Material | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.shelfLifeStorage.type | Base | required | Shelf Life Type | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | Base | required | Special Precautions For Storage | 📦1.2.1 | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | EmaWriteApiPackagedProductDefinitionRestrictions | A medically related item or items, in a container or package | |
| id |
Σ | 0..1 | id | Logical id of this artifact |
| Slices for identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package Slice: Unordered, Closed by value:system |
| identifier:emaPcIdentifier |
Σ | 0..1 | EmaPcIdentifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pcId |
| value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| identifier:dataCarrierGs1 |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575 |
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 |
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| identifier:dataCarrierPharmacy |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029 |
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 |
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| identifier:dataCarrierNationalTrade |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030 |
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 |
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| identifier:xevmpd |
Σ | 0..* | EmaXevmpdIdentifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665 |
| value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| packageFor |
Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition) | The product that this is a pack for |
| status |
?!Σ | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: Record Status (required) |
| containedItemQuantity |
Σ | 0..* | Quantity | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition) |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| value |
Σ | 1..1 | decimal | Numerical value (with implicit precision) |
| comparator |
?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit |
Σ | 0..1 | string | Unit representation |
| system |
ΣC | 1..1 | uri | System that defines coded unit form Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000014 |
| code |
ΣC | 1..1 | code | Coded form of the unit Binding: Units of Presentation (required) |
| description |
Σ | 1..1 | markdown | Textual description. Note that this is not the name of the package or product |
| id |
0..1 | string | xml:id (or equivalent in JSON) | |
| extension |
1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
| value |
0..1 | markdown | Primitive value for markdown | |
| legalStatusOfSupply |
Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
Σ | 0..1 | EmaRefTermCodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status of Supply (required) |
| jurisdiction |
Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes |
| marketingStatus |
Σ | 1..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| extension:riskOfSupplyShortage |
0..1 | Coding | Risk of Supply Shortage URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage | |
| extension:riskOfSupplyShortageComment |
0..1 | string | Risk of Supply Shortage Comment URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment | |
| extension:reason |
0..1 | EmaCoding | Reason URL: http://ema.europa.eu/fhir/extension/reason Binding: Marketing Status Reason (required) | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| country |
Σ | 1..1 | EmaRefTermCodeableConcept | 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 Binding: Country (required) |
| jurisdiction |
Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified |
| status |
Σ | 1..1 | EmaRefTermCodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: Marketing Status (required) |
| dateRange |
Σ | 0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| start |
ΣC | 1..1 | dateTime | Starting time with inclusive boundary |
| end |
ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| restoreDate |
Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
1..* | Reference(ActivityDefinition) | The Operation Extension URL: http://ema.europa.eu/fhir/extension/operation Slice: Unordered, Open by value:url | |
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
| identifier |
ΣC | 0..1 | Identifier | Logical reference, when literal reference is not known |
| display |
ΣC | 0..1 | string | Text alternative for the resource |
| packaging |
Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier |
Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
| type |
Σ | 1..1 | EmaRefTermCodeableConcept | The physical type of the container of the items Binding: Packaging (required) |
| componentPart |
Σ | 0..1 | boolean | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial) |
| quantity |
Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| id |
0..1 | string | xml:id (or equivalent in JSON) | |
| extension |
1..1 | Coding | The Comparator Extension URL: http://ema.europa.eu/fhir/extension/comparator Binding: Quantity Operator (required) | |
| value |
0..1 | integer | Primitive value for integer | |
| material |
Σ | 1..* | EmaRefTermCodeableConcept | Material type of the package item Binding: Material (required) |
| alternateMaterial |
Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. |
| shelfLifeStorage |
Σ | 0..* | ProductShelfLife | Shelf Life and storage information |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
Σ | 1..1 | EmaRefTermCodeableConcept | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Shelf Life Type (required) |
| period[x] |
Σ | 1..1 | EmaDuration | 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 |
| specialPrecautionsForStorage |
Σ | 0..* | EmaRefTermCodeableConcept | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Special Precautions For Storage (required) |
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:All Slices |
Content/Rules for all slices | |||
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | identifies the meaning of the extension | |
| Slices for value[x] |
0..1 | Value of extension Slice: Unordered, Open by type:$this | ||
| valueBase64Binary |
base64Binary | |||
| valueBoolean |
boolean | |||
| valueCanonical |
canonical(Any) | |||
| valueCode |
code | |||
| valueDate |
date | |||
| valueDateTime |
dateTime | |||
| valueDecimal |
decimal | |||
| valueId |
id | |||
| valueInstant |
instant | |||
| valueInteger |
integer | |||
| valueInteger64 |
integer64 | |||
| valueMarkdown |
markdown | |||
| valueOid |
oid | |||
| valuePositiveInt |
positiveInt | |||
| valueString |
string | |||
| valueTime |
time | |||
| valueUnsignedInt |
unsignedInt | |||
| valueUri |
uri | |||
| valueUrl |
url | |||
| valueUuid |
uuid | |||
| valueAddress |
Address | |||
| valueAge |
Age | |||
| valueAnnotation |
Annotation | |||
| valueAttachment |
Attachment | |||
| valueCodeableConcept |
CodeableConcept | |||
| valueCodeableReference |
CodeableReference | |||
| valueCoding |
Coding | |||
| valueContactPoint |
ContactPoint | |||
| valueCount |
Count | |||
| valueDistance |
Distance | |||
| valueDuration |
Duration | |||
| valueHumanName |
HumanName | |||
| valueIdentifier |
Identifier | |||
| valueMoney |
Money | |||
| valuePeriod |
Period | |||
| valueQuantity |
Quantity | |||
| valueRange |
Range | |||
| valueRatio |
Ratio | |||
| valueRatioRange |
RatioRange | |||
| valueReference |
Reference(Any) | |||
| valueSampledData |
SampledData | |||
| valueSignature |
Signature | |||
| valueTiming |
Timing | |||
| valueContactDetail |
ContactDetail | |||
| valueDataRequirement |
DataRequirement | |||
| valueExpression |
Expression | |||
| valueParameterDefinition |
ParameterDefinition | |||
| valueRelatedArtifact |
RelatedArtifact | |||
| valueTriggerDefinition |
TriggerDefinition | |||
| valueUsageContext |
UsageContext | |||
| valueAvailability |
Availability | |||
| valueExtendedContactDetail |
ExtendedContactDetail | |||
| valueDosage |
Dosage | |||
| valueMeta |
Meta | |||
| value[x]:valueReference |
0..1 | Reference(EMA Write API ActivityDefinition) | Value of extension | |
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
| identifier |
ΣC | 0..1 | Identifier | Logical reference, when literal reference is not known |
| display |
ΣC | 0..1 | string | Text alternative for the resource |
| property |
Σ | 0..* | BackboneElement | General characteristics of this item |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
 value[x] |
Σ | 0..1 | A value for the characteristic | |
| valueCodeableConcept |
CodeableConcept | |||
| valueQuantity |
Quantity | |||
| valueDate |
date | |||
| valueBoolean |
boolean | |||
| valueAttachment |
Attachment | |||
| containedItem |
Σ | 0..* | BackboneElement | The item(s) within the packaging |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item |
Σ | 1..1 | CodeableReference(DeviceDefinition | ManufacturedItemDefinition) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package |
| amount |
Σ | 1..1 | EmaQuantity | 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) |
| packaging |
Σ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| PackagedProductDefinition.identifier:dataCarrierGs1.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierGs1.type | Base | extensible | Identifier Type Codes | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierPharmacy.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierPharmacy.type | Base | extensible | Identifier Type Codes | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierNationalTrade.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierNationalTrade.type | Base | extensible | Identifier Type Codes | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.status | Base | required | Record Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.containedItemQuantity.comparator | Base | required | QuantityComparator | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.containedItemQuantity.code | Base | required | Units of Presentation | 📦1.2.1 | This IG |
| PackagedProductDefinition.legalStatusOfSupply.code | Base | required | Legal Status of Supply | 📦1.2.1 | This IG |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | Base | example | Jurisdiction ValueSet | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.marketingStatus.country | Base | required | Country | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.status | Base | required | Marketing Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.manufacturer.type | Base | extensible | Resource Types | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.packaging.type | Base | required | Packaging | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.material | Base | required | Material | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.alternateMaterial | Base | example | Package Material | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.packaging.shelfLifeStorage.type | Base | required | Shelf Life Type | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | Base | required | Special Precautions For Storage | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.manufacturer.type | Base | extensible | Resource Types | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.packaging.property.type | Base | example | Product Characteristic | 📍5.0.0 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from EmaWriteApiPackagedProductDefinitionRestrictions
Summary
Mandatory: 6 elements(17 nested mandatory elements)
Prohibited: 1 element
Structures
This structure refers to these other structures:
- EMA PC Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaPcIdentifier)
- EMA xEVMPD Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaXevmpdIdentifier)
- EMA Write API MedicinalProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition)
- EMA Generic ReferentialTerm CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept)
- EMA Duration (http://ema.europa.eu/fhir/StructureDefinition/emaDuration)
- EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
- EMA Quantity (http://ema.europa.eu/fhir/StructureDefinition/emaQuantity)
Extensions
This structure refers to these extensions:
- http://ema.europa.eu/fhir/extension/language
- http://ema.europa.eu/fhir/extension/riskOfSupplyShortage
- http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment
- http://ema.europa.eu/fhir/extension/reason
- http://ema.europa.eu/fhir/extension/operation
- http://ema.europa.eu/fhir/extension/comparator
Slices
This structure defines the following Slices:
- The element 1 is sliced based on the value of PackagedProductDefinition.identifier (Closed)
- The element 1 is sliced based on the value of PackagedProductDefinition.packaging.manufacturer.extension.value[x]
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | EmaWriteApiPackagedProductDefinitionRestrictions | A medically related item or items, in a container or package | |
| Slices for identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package Slice: Unordered, Closed by value:system |
| identifier:emaPcIdentifier |
Σ | 0..1 | EmaPcIdentifier | A unique identifier for this package as whole - not for the content of the package |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pcId |
| value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| identifier:dataCarrierGs1 |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575 |
| identifier:dataCarrierPharmacy |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029 |
| identifier:dataCarrierNationalTrade |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030 |
| identifier:xevmpd |
Σ | 0..* | EmaXevmpdIdentifier | A unique identifier for this package as whole - not for the content of the package |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665 |
| value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| packageFor |
Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition) | The product that this is a pack for |
| status |
?!Σ | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: Record Status (required) |
| description |
Σ | 1..1 | markdown | Textual description. Note that this is not the name of the package or product |
| extension |
1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
| marketingStatus |
Σ | 1..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| Slices for extension |
Content/Rules for all slices | |||
| extension:riskOfSupplyShortage |
0..1 | Coding | Risk of Supply Shortage URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage | |
| extension:riskOfSupplyShortageComment |
0..1 | string | Risk of Supply Shortage Comment URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment | |
| extension:reason |
0..1 | EmaCoding | Reason URL: http://ema.europa.eu/fhir/extension/reason Binding: Marketing Status Reason (required) | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| country |
Σ | 1..1 | EmaRefTermCodeableConcept | 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 Binding: Country (required) |
| status |
Σ | 1..1 | EmaRefTermCodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: Marketing Status (required) |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| PackagedProductDefinition.identifier:dataCarrierGs1.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierPharmacy.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierNationalTrade.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.status | Base | required | Record Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.country | Base | required | Country | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.status | Base | required | Marketing Status | 📦1.2.1 | This IG |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
This structure is derived from EmaWriteApiPackagedProductDefinitionRestrictions
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| PackagedProductDefinition |
EmaWriteApiPackagedProductDefinitionRestrictions | |||
| Slices for identifier |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package Slice: Unordered, Closed by value:system | |
| identifier:emaPcIdentifier |
0..1 | EmaPcIdentifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pcId | |
| identifier:dataCarrierGs1 |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575 | |
| identifier:dataCarrierPharmacy |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029 | |
| identifier:dataCarrierNationalTrade |
0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030 | |
| identifier:xevmpd |
0..* | EmaXevmpdIdentifier | A unique identifier for this package as whole - not for the content of the package | |
| system |
1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665 | |
| packageFor |
1..1 | Reference(EMA Write API MedicinalProductDefinition) | The product that this is a pack for | |
| status |
1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: Record Status (required) | |
| containedItemQuantity |
||||
| value |
1..1 | decimal | Numerical value (with implicit precision) | |
| system |
1..1 | uri | System that defines coded unit form Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000014 | |
| code |
1..1 | code | Coded form of the unit Binding: Units of Presentation (required) | |
| description |
1..1 | markdown | Textual description. Note that this is not the name of the package or product | |
| extension |
1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
| legalStatusOfSupply |
||||
| code |
0..1 | EmaRefTermCodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status of Supply (required) | |
| marketingStatus |
1..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:riskOfSupplyShortage |
0..1 | Coding | Risk of Supply Shortage URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage | |
| extension:riskOfSupplyShortageComment |
0..1 | string | Risk of Supply Shortage Comment URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment | |
| extension:reason |
0..1 | EmaCoding | Reason URL: http://ema.europa.eu/fhir/extension/reason Binding: Marketing Status Reason (required) | |
| country |
1..1 | EmaRefTermCodeableConcept | 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 Binding: Country (required) | |
| status |
1..1 | EmaRefTermCodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: Marketing Status (required) | |
| dateRange |
||||
| start |
1..1 | dateTime | Starting time with inclusive boundary | |
| manufacturer |
||||
| extension |
1..* | Reference(ActivityDefinition) | The Operation Extension URL: http://ema.europa.eu/fhir/extension/operation | |
| packaging |
||||
| type |
1..1 | EmaRefTermCodeableConcept | The physical type of the container of the items Binding: Packaging (required) | |
| quantity |
||||
| extension |
1..1 | Coding | The Comparator Extension URL: http://ema.europa.eu/fhir/extension/comparator Binding: Quantity Operator (required) | |
| material |
1..* | EmaRefTermCodeableConcept | Material type of the package item Binding: Material (required) | |
| shelfLifeStorage |
||||
| type |
1..1 | EmaRefTermCodeableConcept | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Shelf Life Type (required) | |
| period[x] |
1..1 | EmaDuration | 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 | |
| specialPrecautionsForStorage |
0..* | EmaRefTermCodeableConcept | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Special Precautions For Storage (required) | |
| manufacturer |
||||
| extension |
1..* | Extension | Extension | |
| extension |
0..0 | Extension | ||
| Slices for value[x] |
0..1 | 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 | Value of extension Slice: Unordered, Open by type:$this | |
| value[x]:valueReference |
0..1 | Reference(EMA Write API ActivityDefinition) | Value of extension | |
| containedItem |
||||
| item |
1..1 | CodeableReference(DeviceDefinition | ManufacturedItemDefinition) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | |
| amount |
1..1 | EmaQuantity | 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) | |
| Documentation for this format | ||||
Terminology Bindings (Differential)
| Path | Status | Usage | ValueSet | Version | Source |
| PackagedProductDefinition.status | Base | required | Record Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.containedItemQuantity.code | Base | required | Units of Presentation | 📦1.2.1 | This IG |
| PackagedProductDefinition.legalStatusOfSupply.code | Base | required | Legal Status of Supply | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.country | Base | required | Country | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.status | Base | required | Marketing Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.type | Base | required | Packaging | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.material | Base | required | Material | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.shelfLifeStorage.type | Base | required | Shelf Life Type | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | Base | required | Special Precautions For Storage | 📦1.2.1 | This IG |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | EmaWriteApiPackagedProductDefinitionRestrictions | A medically related item or items, in a container or package | |
| id |
Σ | 0..1 | id | Logical id of this artifact |
| Slices for identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package Slice: Unordered, Closed by value:system |
| identifier:emaPcIdentifier |
Σ | 0..1 | EmaPcIdentifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/pcId |
| value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| identifier:dataCarrierGs1 |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575 |
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 |
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| identifier:dataCarrierPharmacy |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029 |
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 |
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| identifier:dataCarrierNationalTrade |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| use |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
| type |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030 |
| value |
ΣC | 0..1 | string | The value that is unique Example General: 123456 |
| period |
Σ | 0..1 | Period | Time period when id is/was valid for use |
| assigner |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
| identifier:xevmpd |
Σ | 0..* | EmaXevmpdIdentifier | A unique identifier for this package as whole - not for the content of the package |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| system |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665 |
| value |
ΣC | 1..1 | string | The value that is unique Example General: 123456 |
| packageFor |
Σ | 1..1 | Reference(EMA Write API MedicinalProductDefinition) | The product that this is a pack for |
| status |
?!Σ | 1..1 | EmaRefTermCodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: Record Status (required) |
| containedItemQuantity |
Σ | 0..* | Quantity | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition) |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| value |
Σ | 1..1 | decimal | Numerical value (with implicit precision) |
| comparator |
?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented. |
| unit |
Σ | 0..1 | string | Unit representation |
| system |
ΣC | 1..1 | uri | System that defines coded unit form Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000014 |
| code |
ΣC | 1..1 | code | Coded form of the unit Binding: Units of Presentation (required) |
| description |
Σ | 1..1 | markdown | Textual description. Note that this is not the name of the package or product |
| id |
0..1 | string | xml:id (or equivalent in JSON) | |
| extension |
1..1 | EmaCoding | Language URL: http://ema.europa.eu/fhir/extension/language Binding: Language (required) | |
| value |
0..1 | markdown | Primitive value for markdown | |
| legalStatusOfSupply |
Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| code |
Σ | 0..1 | EmaRefTermCodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status of Supply (required) |
| jurisdiction |
Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes |
| marketingStatus |
Σ | 1..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| id |
0..1 | id | Unique id for inter-element referencing | |
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| extension:riskOfSupplyShortage |
0..1 | Coding | Risk of Supply Shortage URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage | |
| extension:riskOfSupplyShortageComment |
0..1 | string | Risk of Supply Shortage Comment URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment | |
| extension:reason |
0..1 | EmaCoding | Reason URL: http://ema.europa.eu/fhir/extension/reason Binding: Marketing Status Reason (required) | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| country |
Σ | 1..1 | EmaRefTermCodeableConcept | 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 Binding: Country (required) |
| jurisdiction |
Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified |
| status |
Σ | 1..1 | EmaRefTermCodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: Marketing Status (required) |
| dateRange |
Σ | 0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| start |
ΣC | 1..1 | dateTime | Starting time with inclusive boundary |
| end |
ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| restoreDate |
Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
1..* | Reference(ActivityDefinition) | The Operation Extension URL: http://ema.europa.eu/fhir/extension/operation Slice: Unordered, Open by value:url | |
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
| identifier |
ΣC | 0..1 | Identifier | Logical reference, when literal reference is not known |
| display |
ΣC | 0..1 | string | Text alternative for the resource |
| packaging |
Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier |
Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
| type |
Σ | 1..1 | EmaRefTermCodeableConcept | The physical type of the container of the items Binding: Packaging (required) |
| componentPart |
Σ | 0..1 | boolean | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial) |
| quantity |
Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| id |
0..1 | string | xml:id (or equivalent in JSON) | |
| extension |
1..1 | Coding | The Comparator Extension URL: http://ema.europa.eu/fhir/extension/comparator Binding: Quantity Operator (required) | |
| value |
0..1 | integer | Primitive value for integer | |
| material |
Σ | 1..* | EmaRefTermCodeableConcept | Material type of the package item Binding: Material (required) |
| alternateMaterial |
Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. |
| shelfLifeStorage |
Σ | 0..* | ProductShelfLife | Shelf Life and storage information |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
Σ | 1..1 | EmaRefTermCodeableConcept | This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Shelf Life Type (required) |
| period[x] |
Σ | 1..1 | EmaDuration | 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 |
| specialPrecautionsForStorage |
Σ | 0..* | EmaRefTermCodeableConcept | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified Binding: Special Precautions For Storage (required) |
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:All Slices |
Content/Rules for all slices | |||
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | Extension Slice: Unordered, Open by value:url | ||
| url |
1..1 | uri | identifies the meaning of the extension | |
| Slices for value[x] |
0..1 | Value of extension Slice: Unordered, Open by type:$this | ||
| valueBase64Binary |
base64Binary | |||
| valueBoolean |
boolean | |||
| valueCanonical |
canonical(Any) | |||
| valueCode |
code | |||
| valueDate |
date | |||
| valueDateTime |
dateTime | |||
| valueDecimal |
decimal | |||
| valueId |
id | |||
| valueInstant |
instant | |||
| valueInteger |
integer | |||
| valueInteger64 |
integer64 | |||
| valueMarkdown |
markdown | |||
| valueOid |
oid | |||
| valuePositiveInt |
positiveInt | |||
| valueString |
string | |||
| valueTime |
time | |||
| valueUnsignedInt |
unsignedInt | |||
| valueUri |
uri | |||
| valueUrl |
url | |||
| valueUuid |
uuid | |||
| valueAddress |
Address | |||
| valueAge |
Age | |||
| valueAnnotation |
Annotation | |||
| valueAttachment |
Attachment | |||
| valueCodeableConcept |
CodeableConcept | |||
| valueCodeableReference |
CodeableReference | |||
| valueCoding |
Coding | |||
| valueContactPoint |
ContactPoint | |||
| valueCount |
Count | |||
| valueDistance |
Distance | |||
| valueDuration |
Duration | |||
| valueHumanName |
HumanName | |||
| valueIdentifier |
Identifier | |||
| valueMoney |
Money | |||
| valuePeriod |
Period | |||
| valueQuantity |
Quantity | |||
| valueRange |
Range | |||
| valueRatio |
Ratio | |||
| valueRatioRange |
RatioRange | |||
| valueReference |
Reference(Any) | |||
| valueSampledData |
SampledData | |||
| valueSignature |
Signature | |||
| valueTiming |
Timing | |||
| valueContactDetail |
ContactDetail | |||
| valueDataRequirement |
DataRequirement | |||
| valueExpression |
Expression | |||
| valueParameterDefinition |
ParameterDefinition | |||
| valueRelatedArtifact |
RelatedArtifact | |||
| valueTriggerDefinition |
TriggerDefinition | |||
| valueUsageContext |
UsageContext | |||
| valueAvailability |
Availability | |||
| valueExtendedContactDetail |
ExtendedContactDetail | |||
| valueDosage |
Dosage | |||
| valueMeta |
Meta | |||
| value[x]:valueReference |
0..1 | Reference(EMA Write API ActivityDefinition) | Value of extension | |
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL |
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
| identifier |
ΣC | 0..1 | Identifier | Logical reference, when literal reference is not known |
| display |
ΣC | 0..1 | string | Text alternative for the resource |
| property |
Σ | 0..* | BackboneElement | General characteristics of this item |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
| value[x] |
Σ | 0..1 | A value for the characteristic | |
| valueCodeableConcept |
CodeableConcept | |||
| valueQuantity |
Quantity | |||
| valueDate |
date | |||
| valueBoolean |
boolean | |||
| valueAttachment |
Attachment | |||
| containedItem |
Σ | 0..* | BackboneElement | The item(s) within the packaging |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item |
Σ | 1..1 | CodeableReference(DeviceDefinition | ManufacturedItemDefinition) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package |
| amount |
Σ | 1..1 | EmaQuantity | 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) |
| packaging |
Σ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| PackagedProductDefinition.identifier:dataCarrierGs1.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierGs1.type | Base | extensible | Identifier Type Codes | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierPharmacy.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierPharmacy.type | Base | extensible | Identifier Type Codes | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierNationalTrade.use | Base | required | IdentifierUse | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.identifier:dataCarrierNationalTrade.type | Base | extensible | Identifier Type Codes | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.status | Base | required | Record Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.containedItemQuantity.comparator | Base | required | QuantityComparator | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.containedItemQuantity.code | Base | required | Units of Presentation | 📦1.2.1 | This IG |
| PackagedProductDefinition.legalStatusOfSupply.code | Base | required | Legal Status of Supply | 📦1.2.1 | This IG |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | Base | example | Jurisdiction ValueSet | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.marketingStatus.country | Base | required | Country | 📦1.2.1 | This IG |
| PackagedProductDefinition.marketingStatus.status | Base | required | Marketing Status | 📦1.2.1 | This IG |
| PackagedProductDefinition.manufacturer.type | Base | extensible | Resource Types | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.packaging.type | Base | required | Packaging | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.material | Base | required | Material | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.alternateMaterial | Base | example | Package Material | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.packaging.shelfLifeStorage.type | Base | required | Shelf Life Type | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | Base | required | Special Precautions For Storage | 📦1.2.1 | This IG |
| PackagedProductDefinition.packaging.manufacturer.type | Base | extensible | Resource Types | 📍5.0.0 | FHIR Std. |
| PackagedProductDefinition.packaging.property.type | Base | example | Product Characteristic | 📍5.0.0 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from EmaWriteApiPackagedProductDefinitionRestrictions
Summary
Mandatory: 6 elements(17 nested mandatory elements)
Prohibited: 1 element
Structures
This structure refers to these other structures:
- EMA PC Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaPcIdentifier)
- EMA xEVMPD Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaXevmpdIdentifier)
- EMA Write API MedicinalProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition)
- EMA Generic ReferentialTerm CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept)
- EMA Duration (http://ema.europa.eu/fhir/StructureDefinition/emaDuration)
- EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
- EMA Quantity (http://ema.europa.eu/fhir/StructureDefinition/emaQuantity)
Extensions
This structure refers to these extensions:
- http://ema.europa.eu/fhir/extension/language
- http://ema.europa.eu/fhir/extension/riskOfSupplyShortage
- http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment
- http://ema.europa.eu/fhir/extension/reason
- http://ema.europa.eu/fhir/extension/operation
- http://ema.europa.eu/fhir/extension/comparator
Slices
This structure defines the following Slices:
- The element 1 is sliced based on the value of PackagedProductDefinition.identifier (Closed)
- The element 1 is sliced based on the value of PackagedProductDefinition.packaging.manufacturer.extension.value[x]
Other representations of profile: CSV, Excel, Schematron