EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) 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: 1.2.0
Draft as of 2025-08-08 Computable Name: EmaWriteApiPackagedProductDefinition

Defines the rules a PackagedProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* EmaWriteApiPackagedProductDefinitionRestrictions A medically related item or items, in a container or package
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... Slices for identifier ΣC 0..2 Identifier A unique identifier for this package as whole - not for the content of the package
Slice: Unordered, Closed by value:system
ele-1: All FHIR elements must have a @value or children
onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
.... identifier:emaPcIdentifier Σ 0..1 EmaPcIdentifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/pcId
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:dataCarrierGs1 Σ 0..1 Identifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575
.... identifier:dataCarrierPharmacy Σ 0..1 Identifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029
.... identifier:dataCarrierNationalTrade Σ 0..1 Identifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030
... packageFor Σ 1..1 Reference(EMA Write API MedicinalProductDefinition) The product that this is a pack for
ele-1: All FHIR elements must have a @value or children
... 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)
ele-1: All FHIR elements must have a @value or children
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... 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
ele-1: All FHIR elements must have a @value or children
.... Slices for extension Content/Rules for all slices
..... extension:riskOfSupplyShortage 0..1 boolean Risk of Supply Shortage
URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... extension:riskOfSupplyShortageComment 0..1 string Risk of Supply Shortage Comment
URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... extension:marketingStatusReason 0..1 EmaCoding Marketing Status Reason
URL: http://ema.europa.eu/fhir/extension/marketingStatusReason
Binding: Marketing Status Reason (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... 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)
ele-1: All FHIR elements must have a @value or children
.... 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)
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier:dataCarrierGs1.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierPharmacy.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierNationalTrade.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.statusrequiredRecordStatusVs (a valid code from Record Status)
http://ema.europa.eu/fhir/vs/recordStatus
from this IG
PackagedProductDefinition.marketingStatus.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
PackagedProductDefinition.marketingStatus.statusrequiredMarketingStatusVs (a valid code from Marketing Status)
http://ema.europa.eu/fhir/vs/marketingStatus
from this IG

Constraints

IdGradePath(s)DetailsRequirements
onlyOneDataCarrierIdentifiererrorPackagedProductDefinition.identifierOnly one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
: exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1

This structure is derived from EmaWriteApiPackagedProductDefinitionRestrictions

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition EmaWriteApiPackagedProductDefinitionRestrictions
... Slices for identifier C 0..2 Identifier A unique identifier for this package as whole - not for the content of the package
Slice: Unordered, Closed by value:system
onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
.... 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..1 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..1 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..1 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
... 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)
.... 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 boolean 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:marketingStatusReason 0..1 EmaCoding Marketing Status Reason
URL: http://ema.europa.eu/fhir/extension/marketingStatusReason
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(EMA Write API 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
...... 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)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.statusrequiredRecordStatusVs (a valid code from Record Status)
http://ema.europa.eu/fhir/vs/recordStatus
from this IG
PackagedProductDefinition.containedItemQuantity.coderequiredUnitsOfPresentationVs (a valid code from Units Of Presentation)
http://ema.europa.eu/fhir/vs/unitsOfPresentation
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
PackagedProductDefinition.marketingStatus.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
PackagedProductDefinition.marketingStatus.statusrequiredMarketingStatusVs (a valid code from Marketing Status)
http://ema.europa.eu/fhir/vs/marketingStatus
from this IG
PackagedProductDefinition.packaging.typerequiredPackagingVs (a valid code from Packaging)
http://ema.europa.eu/fhir/vs/packaging
from this IG
PackagedProductDefinition.packaging.materialrequiredMaterialVs (a valid code from Material)
http://ema.europa.eu/fhir/vs/material
from this IG
PackagedProductDefinition.packaging.shelfLifeStorage.typerequiredShelfLifeTypeVs (a valid code from Shelf Life Type)
http://ema.europa.eu/fhir/vs/shelfLifeType
from this IG
PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStoragerequiredSpecialPrecautionsForStorageVs (a valid code from Special Precautions for Storage)
http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage
from this IG

Constraints

IdGradePath(s)DetailsRequirements
onlyOneDataCarrierIdentifiererrorPackagedProductDefinition.identifierOnly one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
: exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 ΣC 0..2 Identifier A unique identifier for this package as whole - not for the content of the package
Slice: Unordered, Closed by value:system
onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
.... 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
..... 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..1 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..1 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..1 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)
... packageFor Σ 1..1 Reference(EMA Write API MedicinalProductDefinition) The product that this is a pack for
... 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 boolean 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:marketingStatusReason 0..1 EmaCoding Marketing Status Reason
URL: http://ema.europa.eu/fhir/extension/marketingStatusReason
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(EMA Write API 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
....... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier:dataCarrierGs1.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierGs1.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierPharmacy.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierPharmacy.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierNationalTrade.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierNationalTrade.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
PackagedProductDefinition.statusrequiredRecordStatusVs (a valid code from Record Status)
http://ema.europa.eu/fhir/vs/recordStatus
from this IG
PackagedProductDefinition.containedItemQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.coderequiredUnitsOfPresentationVs (a valid code from Units Of Presentation)
http://ema.europa.eu/fhir/vs/unitsOfPresentation
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.marketingStatus.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
PackagedProductDefinition.marketingStatus.statusrequiredMarketingStatusVs (a valid code from Marketing Status)
http://ema.europa.eu/fhir/vs/marketingStatus
from this IG
PackagedProductDefinition.manufacturer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
PackagedProductDefinition.packaging.typerequiredPackagingVs (a valid code from Packaging)
http://ema.europa.eu/fhir/vs/packaging
from this IG
PackagedProductDefinition.packaging.materialrequiredMaterialVs (a valid code from Material)
http://ema.europa.eu/fhir/vs/material
from this IG
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.shelfLifeStorage.typerequiredShelfLifeTypeVs (a valid code from Shelf Life Type)
http://ema.europa.eu/fhir/vs/shelfLifeType
from this IG
PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStoragerequiredSpecialPrecautionsForStorageVs (a valid code from Special Precautions for Storage)
http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage
from this IG
PackagedProductDefinition.packaging.manufacturer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
onlyOneDataCarrierIdentifiererrorPackagedProductDefinition.identifierOnly one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
: exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* EmaWriteApiPackagedProductDefinitionRestrictions A medically related item or items, in a container or package
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... Slices for identifier ΣC 0..2 Identifier A unique identifier for this package as whole - not for the content of the package
Slice: Unordered, Closed by value:system
ele-1: All FHIR elements must have a @value or children
onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
.... identifier:emaPcIdentifier Σ 0..1 EmaPcIdentifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/pcId
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:dataCarrierGs1 Σ 0..1 Identifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575
.... identifier:dataCarrierPharmacy Σ 0..1 Identifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029
.... identifier:dataCarrierNationalTrade Σ 0..1 Identifier A unique identifier for this package as whole - not for the content of the package
ele-1: All FHIR elements must have a @value or children
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .


ele-1: All FHIR elements must have a @value or children
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030
... packageFor Σ 1..1 Reference(EMA Write API MedicinalProductDefinition) The product that this is a pack for
ele-1: All FHIR elements must have a @value or children
... 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)
ele-1: All FHIR elements must have a @value or children
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... 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
ele-1: All FHIR elements must have a @value or children
.... Slices for extension Content/Rules for all slices
..... extension:riskOfSupplyShortage 0..1 boolean Risk of Supply Shortage
URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortage
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... extension:riskOfSupplyShortageComment 0..1 string Risk of Supply Shortage Comment
URL: http://ema.europa.eu/fhir/extension/riskOfSupplyShortageComment
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... extension:marketingStatusReason 0..1 EmaCoding Marketing Status Reason
URL: http://ema.europa.eu/fhir/extension/marketingStatusReason
Binding: Marketing Status Reason (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... 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)
ele-1: All FHIR elements must have a @value or children
.... 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)
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier:dataCarrierGs1.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierPharmacy.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierNationalTrade.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.statusrequiredRecordStatusVs (a valid code from Record Status)
http://ema.europa.eu/fhir/vs/recordStatus
from this IG
PackagedProductDefinition.marketingStatus.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
PackagedProductDefinition.marketingStatus.statusrequiredMarketingStatusVs (a valid code from Marketing Status)
http://ema.europa.eu/fhir/vs/marketingStatus
from this IG

Constraints

IdGradePath(s)DetailsRequirements
onlyOneDataCarrierIdentifiererrorPackagedProductDefinition.identifierOnly one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
: exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1

Differential View

This structure is derived from EmaWriteApiPackagedProductDefinitionRestrictions

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition EmaWriteApiPackagedProductDefinitionRestrictions
... Slices for identifier C 0..2 Identifier A unique identifier for this package as whole - not for the content of the package
Slice: Unordered, Closed by value:system
onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
.... 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..1 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..1 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..1 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
... 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)
.... 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 boolean 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:marketingStatusReason 0..1 EmaCoding Marketing Status Reason
URL: http://ema.europa.eu/fhir/extension/marketingStatusReason
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(EMA Write API 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
...... 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)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.statusrequiredRecordStatusVs (a valid code from Record Status)
http://ema.europa.eu/fhir/vs/recordStatus
from this IG
PackagedProductDefinition.containedItemQuantity.coderequiredUnitsOfPresentationVs (a valid code from Units Of Presentation)
http://ema.europa.eu/fhir/vs/unitsOfPresentation
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
PackagedProductDefinition.marketingStatus.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
PackagedProductDefinition.marketingStatus.statusrequiredMarketingStatusVs (a valid code from Marketing Status)
http://ema.europa.eu/fhir/vs/marketingStatus
from this IG
PackagedProductDefinition.packaging.typerequiredPackagingVs (a valid code from Packaging)
http://ema.europa.eu/fhir/vs/packaging
from this IG
PackagedProductDefinition.packaging.materialrequiredMaterialVs (a valid code from Material)
http://ema.europa.eu/fhir/vs/material
from this IG
PackagedProductDefinition.packaging.shelfLifeStorage.typerequiredShelfLifeTypeVs (a valid code from Shelf Life Type)
http://ema.europa.eu/fhir/vs/shelfLifeType
from this IG
PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStoragerequiredSpecialPrecautionsForStorageVs (a valid code from Special Precautions for Storage)
http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage
from this IG

Constraints

IdGradePath(s)DetailsRequirements
onlyOneDataCarrierIdentifiererrorPackagedProductDefinition.identifierOnly one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
: exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 ΣC 0..2 Identifier A unique identifier for this package as whole - not for the content of the package
Slice: Unordered, Closed by value:system
onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
.... 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
..... 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..1 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..1 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..1 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)
... packageFor Σ 1..1 Reference(EMA Write API MedicinalProductDefinition) The product that this is a pack for
... 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 boolean 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:marketingStatusReason 0..1 EmaCoding Marketing Status Reason
URL: http://ema.europa.eu/fhir/extension/marketingStatusReason
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(EMA Write API 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
....... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier:dataCarrierGs1.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierGs1.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierPharmacy.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierPharmacy.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierNationalTrade.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:dataCarrierNationalTrade.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
PackagedProductDefinition.statusrequiredRecordStatusVs (a valid code from Record Status)
http://ema.europa.eu/fhir/vs/recordStatus
from this IG
PackagedProductDefinition.containedItemQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.coderequiredUnitsOfPresentationVs (a valid code from Units Of Presentation)
http://ema.europa.eu/fhir/vs/unitsOfPresentation
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.marketingStatus.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
PackagedProductDefinition.marketingStatus.statusrequiredMarketingStatusVs (a valid code from Marketing Status)
http://ema.europa.eu/fhir/vs/marketingStatus
from this IG
PackagedProductDefinition.manufacturer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
PackagedProductDefinition.packaging.typerequiredPackagingVs (a valid code from Packaging)
http://ema.europa.eu/fhir/vs/packaging
from this IG
PackagedProductDefinition.packaging.materialrequiredMaterialVs (a valid code from Material)
http://ema.europa.eu/fhir/vs/material
from this IG
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.shelfLifeStorage.typerequiredShelfLifeTypeVs (a valid code from Shelf Life Type)
http://ema.europa.eu/fhir/vs/shelfLifeType
from this IG
PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStoragerequiredSpecialPrecautionsForStorageVs (a valid code from Special Precautions for Storage)
http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage
from this IG
PackagedProductDefinition.packaging.manufacturer.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
onlyOneDataCarrierIdentifiererrorPackagedProductDefinition.identifierOnly one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present
: exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1

 

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