Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build
Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build
Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/vulcan-epi/StructureDefinition/PackagedProductDefinition-uv-epi | Version: 0.1.0 | |||
| Active as of 2022-09-02 | Computable Name: PackagedProductDefinitionUvEpi | |||
PackagedProductDefinition (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 3 elements (3 nested mandatory elements)
Structures
This structure refers to these other structures:
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
  identifier | 1..* | Identifier | Unique identifier | |
  system | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) | |
 value | 1..1 | string | The value that is unique | |
| name | 0..1 | string | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc Example null: 3 ml cartridge (glass) in a pre-filled pen | |
| type | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping/transport container, etc Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000155527","display":"Chemical Medicinal Product"}]} | |
 packageFor | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | |
| status | 0..1 | CodeableConcept | The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]} | |
| statusDate | 0..1 | dateTime | The date at which the given status became applicable Example null: 2015-02-07T13:28:17Z | |
| containedItemQuantity | 0..* | Quantity | A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource Example null: {"value":3,"unit":"ml"} | |
| description | 0..1 | markdown | Textual description. Note that this is not the name of the package or product Example null: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen. | |
| legalStatusOfSupply | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | |
| marketingStatus | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | |
| copackagedIndicator | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | |
| manufacturer | 0..* | Reference(Organization (ePI)) | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers | |
 package | ||||
 identifier | 1..* | Identifier | Including possibly Data Carrier Identifier | |
| system | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) | |
| value | 1..1 | string | The value that is unique | |
| type | 0..1 | CodeableConcept | The physical type of the container of the items Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073543","display":"Pre-filled pen"}]} | |
| quantity | 0..1 | integer | The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1 Example null: 3 | |
| material | 0..* | CodeableConcept | Material type of the package item Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000003204","display":"Glass type I"}]} | |
| containedItem | ||||
| item | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition | PackagedProductDefinition (ePI) | BiologicallyDerivedProduct | NutritionProduct) | The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package) | |
| package | 0..* | Allows containers (and parts of containers) within containers, still a single packaged product. | ||
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
 id | Σ | 0..1 | id | Logical id of this artifact | ||||
 meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 1..* | Identifier | Unique identifier | ||||
| id | 0..1 | string | 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ||||
| period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| name | Σ | 0..1 | string | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc Example null: 3 ml cartridge (glass) in a pre-filled pen | ||||
| type | Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping/transport container, etc Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000155527","display":"Chemical Medicinal Product"}]} | ||||
| packageFor | Σ | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | ||||
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status Binding: PublicationStatus (preferred): Identifies the level of importance to be assigned to actioning the request. Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]} | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable Example null: 2015-02-07T13:28:17Z | ||||
| containedItemQuantity | Σ | 0..* | Quantity | A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource Example null: {"value":3,"unit":"ml"} | ||||
| description | Σ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product Example null: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen. | ||||
| legalStatusOfSupply | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | ||||
| id | 0..1 | id | 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 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context | ||||
| marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | ||||
| characteristic | Σ | 0..* | CodeableConcept | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack" | ||||
| copackagedIndicator | Σ | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | ||||
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers | ||||
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| package | 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 (which is not a device or a medication manufactured item) | ||||
| id | 0..1 | id | 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 | 1..* | Identifier | Including possibly Data Carrier Identifier | ||||
| id | 0..1 | string | 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ||||
| period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| type | Σ | 0..1 | CodeableConcept | The physical type of the container of the items Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073543","display":"Pre-filled pen"}]} | ||||
| quantity | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1 Example null: 3 | ||||
| material | Σ | 0..* | CodeableConcept | Material type of the package item Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000003204","display":"Glass type I"}]} | ||||
| alternateMaterial | Σ | 0..* | CodeableConcept | A possible alternate material for the packaging | ||||
| shelfLifeStorage | Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers | ||||
| property | Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| id | 0..1 | id | 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 | ||||
 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 | id | 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(ManufacturedItemDefinition (ePI) | DeviceDefinition | PackagedProductDefinition (ePI) | BiologicallyDerivedProduct | NutritionProduct) | The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package) | ||||
| amount | Σ | 0..1 | Quantity | The number of this type of item within this packaging | ||||
| package | Σ | 0..* | See package (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still a single packaged product. | ||||
| Documentation for this format | ||||||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
| Documentation for this format | ||||
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 3 elements (3 nested mandatory elements)
Structures
This structure refers to these other structures:
Differential View
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
| identifier | 1..* | Identifier | Unique identifier | |
| system | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) | |
| value | 1..1 | string | The value that is unique | |
| name | 0..1 | string | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc Example null: 3 ml cartridge (glass) in a pre-filled pen | |
| type | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping/transport container, etc Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000155527","display":"Chemical Medicinal Product"}]} | |
| packageFor | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | |
| status | 0..1 | CodeableConcept | The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]} | |
| statusDate | 0..1 | dateTime | The date at which the given status became applicable Example null: 2015-02-07T13:28:17Z | |
| containedItemQuantity | 0..* | Quantity | A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource Example null: {"value":3,"unit":"ml"} | |
| description | 0..1 | markdown | Textual description. Note that this is not the name of the package or product Example null: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen. | |
| legalStatusOfSupply | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | |
| marketingStatus | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | |
| copackagedIndicator | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | |
| manufacturer | 0..* | Reference(Organization (ePI)) | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers | |
| package | ||||
| identifier | 1..* | Identifier | Including possibly Data Carrier Identifier | |
| system | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) | |
| value | 1..1 | string | The value that is unique | |
| type | 0..1 | CodeableConcept | The physical type of the container of the items Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073543","display":"Pre-filled pen"}]} | |
| quantity | 0..1 | integer | The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1 Example null: 3 | |
| material | 0..* | CodeableConcept | Material type of the package item Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000003204","display":"Glass type I"}]} | |
| containedItem | ||||
| item | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition | PackagedProductDefinition (ePI) | BiologicallyDerivedProduct | NutritionProduct) | The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package) | |
| package | 0..* | Allows containers (and parts of containers) within containers, still a single packaged product. | ||
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 1..* | Identifier | Unique identifier | ||||
| id | 0..1 | string | 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ||||
| period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| name | Σ | 0..1 | string | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc Example null: 3 ml cartridge (glass) in a pre-filled pen | ||||
| type | Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping/transport container, etc Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000155527","display":"Chemical Medicinal Product"}]} | ||||
| packageFor | Σ | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | ||||
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status Binding: PublicationStatus (preferred): Identifies the level of importance to be assigned to actioning the request. Example null: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]} | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable Example null: 2015-02-07T13:28:17Z | ||||
| containedItemQuantity | Σ | 0..* | Quantity | A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource Example null: {"value":3,"unit":"ml"} | ||||
| description | Σ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product Example null: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen. | ||||
| legalStatusOfSupply | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | ||||
| id | 0..1 | id | 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 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context | ||||
| marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | ||||
| characteristic | Σ | 0..* | CodeableConcept | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack" | ||||
| copackagedIndicator | Σ | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | ||||
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers | ||||
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| package | 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 (which is not a device or a medication manufactured item) | ||||
| id | 0..1 | id | 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 | 1..* | Identifier | Including possibly Data Carrier Identifier | ||||
| id | 0..1 | string | 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Binding: PackagedProductDefinition identifier systems (extensible) Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 | ||||
| period | Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| type | Σ | 0..1 | CodeableConcept | The physical type of the container of the items Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"100000073543","display":"Pre-filled pen"}]} | ||||
| quantity | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1 Example null: 3 | ||||
| material | Σ | 0..* | CodeableConcept | Material type of the package item Example null: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi","code":"200000003204","display":"Glass type I"}]} | ||||
| alternateMaterial | Σ | 0..* | CodeableConcept | A possible alternate material for the packaging | ||||
| shelfLifeStorage | Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers | ||||
| property | Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| id | 0..1 | id | 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 | ||||
| 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 | id | 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(ManufacturedItemDefinition (ePI) | DeviceDefinition | PackagedProductDefinition (ePI) | BiologicallyDerivedProduct | NutritionProduct) | The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package) | ||||
| amount | Σ | 0..1 | Quantity | The number of this type of item within this packaging | ||||
| package | Σ | 0..* | See package (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still a single packaged product. | ||||
| Documentation for this format | ||||||||
Other representations of profile: CSV, Excel, Schematron
| Path | Conformance | ValueSet |
| PackagedProductDefinition.language | preferred | CommonLanguages Max Binding: AllLanguages |
| PackagedProductDefinition.identifier.use | required | IdentifierUse |
| PackagedProductDefinition.identifier.type | extensible | Identifier Type Codes |
| PackagedProductDefinition.identifier.system | extensible | VsPackagedProductIdSystems |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.package.identifier.use | required | IdentifierUse |
| PackagedProductDefinition.package.identifier.type | extensible | Identifier Type Codes |
| PackagedProductDefinition.package.identifier.system | extensible | VsPackagedProductIdSystems |
IG © 2021+ . Package hl7.fhir.uv.vulcan-epi#0.1.0 based on FHIR 5.0.0-snapshot1. Generated 2022-09-02
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