Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi | Version: 1.0.0-ballot | |||
| Active as of 2022-12-04 | Computable Name: PackagedProductDefinitionUvEpi | |||
PackagedProductDefinition (ePI)
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
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 | ||||
  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 as listed in a drug formulary, catalogue, inventory etc Example name: 3 ml cartridge (glass) in a pre-filled pen | |
| type | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: High level Pack Type (preferred) | |
 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. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Example Example Status: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]} | |
| statusDate | 0..1 | dateTime | The date at which the given status became applicable Example statusDate: 2015-02-07T13:28:17Z | |
| containedItemQuantity | 0..* | Quantity | Number of items in this overall pack | |
| description | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | |
| legalStatusOfSupply | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | |
| code | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status for the Supply (preferred) | |
| jurisdiction | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Country2 (preferred) | |
| 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. | |
| country | 0..1 | CodeableConcept | The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: Country2 (preferred) | |
| status | 1..1 | CodeableConcept | 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 (preferred) | |
| 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 (multiple means these are all possible manufacturers) | |
 packaging | ||||
 identifier | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | |
| system | 1..1 | uri | The namespace for the identifier value Binding: Data Carrier Identifiers (preferred) | |
| value | 1..1 | string | The value that is unique | |
| type | 0..1 | CodeableConcept | The physical type of the container of the items Binding: Pack Type (preferred) | |
| material | 0..* | CodeableConcept | Material type of the package item Binding: Package Material (preferred) | |
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information. | |
| type | 0..1 | CodeableConcept | 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 (preferred) | |
 periodDuration | 0..1 | Duration | 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 | |
| code | 0..1 | code | Coded form of the unit Binding: Units of Measure (preferred) | |
| specialPrecautionsForStorage | 0..* | CodeableConcept | 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 (preferred) | |
| manufacturer | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | |
| containedItem | ||||
| item | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition) | 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 | |
| packaging | 0..* | Used to nest layers of packaging; e.g., outside to inside with secondary package and then primary package) | ||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.identifier.system | extensible | VsPackagedProductIdSystems |
| PackagedProductDefinition.type | preferred | VsPackageType |
| PackagedProductDefinition.legalStatusOfSupply.code | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.country | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| PackagedProductDefinition.packaging.identifier.system | preferred | VsDataCarrierIdSystem |
| PackagedProductDefinition.packaging.type | preferred | VsSecondaryPrimaryPackType (a valid code from http://example.org) |
| PackagedProductDefinition.packaging.material | preferred | VsPackageMaterial (a valid code from https://spor.ema.europa.eu/omswi) |
| PackagedProductDefinition.packaging.shelfLifeStorage.type | preferred | VsShelfLifeType (a valid code from https://spor.ema.europa.eu/omswi) |
| PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.code | preferred | VsUnitofMeasure |
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | preferred | VsSpecialPrecautionsForStorage (a valid code from https://spor.ema.europa.eu/rmswi/100000073344) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| name | Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc Example name: 3 ml cartridge (glass) in a pre-filled pen |
| type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: High level Pack Type (preferred) |
| 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. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Example Example Status: {"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 statusDate: 2015-02-07T13:28:17Z |
| containedItemQuantity | Σ | 0..* | Quantity | Number of items in this overall pack |
| description | Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack |
| legalStatusOfSupply | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. |
| 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 Binding: Legal Status for the Supply (preferred) |
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Country2 (preferred) |
| 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. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| country | Σ | 0..1 | CodeableConcept | The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: Country2 (preferred) |
| status | Σ | 1..1 | CodeableConcept | 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 (preferred) |
| 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 (multiple means these are all possible manufacturers) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.type | preferred | VsPackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.code | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.country | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| 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 | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) | ||||
| 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 as listed in a drug formulary, catalogue, inventory etc Example name: 3 ml cartridge (glass) in a pre-filled pen | ||||
| type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: High level Pack Type (preferred) | ||||
| 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. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Example Example Status: {"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 statusDate: 2015-02-07T13:28:17Z | ||||
| containedItemQuantity | Σ | 0..* | Quantity | Number of items in this overall pack | ||||
| description | Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | ||||
| 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 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status for the Supply (preferred) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Country2 (preferred) | ||||
| 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. | ||||
| 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 | ||||
| country | Σ | 0..1 | CodeableConcept | The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: Country2 (preferred) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorisation 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 | CodeableConcept | 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 (preferred) | ||||
| dateRange | Σ | 0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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 | ||||
| restoreDate | Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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 | ||||
| characteristic | Σ | 0..* | CodeableConcept | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" Binding: PackageCharacteristic (example): A characteristic of a package. | ||||
| 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 (multiple means these are all possible manufacturers) | ||||
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| 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 | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
| 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) | ||||
| 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: Data Carrier Identifiers (preferred) 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 Binding: Pack Type (preferred) | ||||
| quantity | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material | Σ | 0..* | CodeableConcept | Material type of the package item Binding: Package Material (preferred) | ||||
| 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 | 0..1 | CodeableConcept | 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 (preferred) | ||||
 Slices for period[x] | Σ | 0..1 | 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 Slice: Unordered, Open by type:$this | |||||
 periodDuration | Duration | |||||||
| periodString | string | |||||||
  period[x]:periodDuration | Σ | 0..1 | Duration | 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 | ||||
 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 | 0..1 | decimal | Numerical value (with implicit precision) | ||||
| comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required) | ||||
| unit | Σ | 0..1 | string | Unit representation | ||||
| system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
 code | Σ | 0..1 | code | Coded form of the unit Binding: Units of Measure (preferred) | ||||
| specialPrecautionsForStorage | Σ | 0..* | CodeableConcept | 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 (preferred) | ||||
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| 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(ManufacturedItemDefinition (ePI) | DeviceDefinition) | 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 | 0..1 | Quantity | The number of this type of item within this packaging | ||||
| packaging | Σ | 0..* | See packaging (PackagedProductDefinition) | Used to nest layers of packaging; e.g., outside to inside with secondary package and then primary package) | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| PackagedProductDefinition.language | preferred | CommonLanguages
| ||||
| PackagedProductDefinition.identifier.use | required | IdentifierUse | ||||
| PackagedProductDefinition.identifier.type | extensible | Identifier Type Codes | ||||
| PackagedProductDefinition.identifier.system | extensible | VsPackagedProductIdSystems | ||||
| PackagedProductDefinition.type | preferred | VsPackageType | ||||
| PackagedProductDefinition.status | preferred | PublicationStatus | ||||
| PackagedProductDefinition.legalStatusOfSupply.code | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) | ||||
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | Country2 | ||||
| PackagedProductDefinition.marketingStatus.country | preferred | Country2 | ||||
| PackagedProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) | ||||
| PackagedProductDefinition.characteristic | example | PackageCharacteristic | ||||
| PackagedProductDefinition.packaging.identifier.use | required | IdentifierUse | ||||
| PackagedProductDefinition.packaging.identifier.type | extensible | Identifier Type Codes | ||||
| PackagedProductDefinition.packaging.identifier.system | preferred | VsDataCarrierIdSystem | ||||
| PackagedProductDefinition.packaging.type | preferred | VsSecondaryPrimaryPackType (a valid code from http://example.org) | ||||
| PackagedProductDefinition.packaging.material | preferred | VsPackageMaterial (a valid code from https://spor.ema.europa.eu/omswi) | ||||
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterial | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.type | preferred | VsShelfLifeType (a valid code from https://spor.ema.europa.eu/omswi) | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.period[x]:periodDuration.comparator | required | QuantityComparator | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.period[x]:periodDuration.code | preferred | VsUnitofMeasure | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | preferred | VsSpecialPrecautionsForStorage (a valid code from https://spor.ema.europa.eu/rmswi/100000073344) | ||||
| PackagedProductDefinition.packaging.property.type | example | ProductCharacteristic |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 0 element (5 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 | ||||
| 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 as listed in a drug formulary, catalogue, inventory etc Example name: 3 ml cartridge (glass) in a pre-filled pen | |
| type | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: High level Pack Type (preferred) | |
| 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. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Example Example Status: {"coding":[{"system":"http://hl7.org/fhir/publication-status","code":"active"}]} | |
| statusDate | 0..1 | dateTime | The date at which the given status became applicable Example statusDate: 2015-02-07T13:28:17Z | |
| containedItemQuantity | 0..* | Quantity | Number of items in this overall pack | |
| description | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | |
| legalStatusOfSupply | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | |
| code | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status for the Supply (preferred) | |
| jurisdiction | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Country2 (preferred) | |
| 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. | |
| country | 0..1 | CodeableConcept | The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: Country2 (preferred) | |
| status | 1..1 | CodeableConcept | 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 (preferred) | |
| 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 (multiple means these are all possible manufacturers) | |
| packaging | ||||
| identifier | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | |
| system | 1..1 | uri | The namespace for the identifier value Binding: Data Carrier Identifiers (preferred) | |
| value | 1..1 | string | The value that is unique | |
| type | 0..1 | CodeableConcept | The physical type of the container of the items Binding: Pack Type (preferred) | |
| material | 0..* | CodeableConcept | Material type of the package item Binding: Package Material (preferred) | |
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information. | |
| type | 0..1 | CodeableConcept | 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 (preferred) | |
| periodDuration | 0..1 | Duration | 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 | |
| code | 0..1 | code | Coded form of the unit Binding: Units of Measure (preferred) | |
| specialPrecautionsForStorage | 0..* | CodeableConcept | 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 (preferred) | |
| manufacturer | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | |
| containedItem | ||||
| item | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition) | 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 | |
| packaging | 0..* | Used to nest layers of packaging; e.g., outside to inside with secondary package and then primary package) | ||
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.identifier.system | extensible | VsPackagedProductIdSystems |
| PackagedProductDefinition.type | preferred | VsPackageType |
| PackagedProductDefinition.legalStatusOfSupply.code | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.country | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
| PackagedProductDefinition.packaging.identifier.system | preferred | VsDataCarrierIdSystem |
| PackagedProductDefinition.packaging.type | preferred | VsSecondaryPrimaryPackType (a valid code from http://example.org) |
| PackagedProductDefinition.packaging.material | preferred | VsPackageMaterial (a valid code from https://spor.ema.europa.eu/omswi) |
| PackagedProductDefinition.packaging.shelfLifeStorage.type | preferred | VsShelfLifeType (a valid code from https://spor.ema.europa.eu/omswi) |
| PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.code | preferred | VsUnitofMeasure |
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | preferred | VsSpecialPrecautionsForStorage (a valid code from https://spor.ema.europa.eu/rmswi/100000073344) |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| name | Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc Example name: 3 ml cartridge (glass) in a pre-filled pen |
| type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: High level Pack Type (preferred) |
| 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. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Example Example Status: {"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 statusDate: 2015-02-07T13:28:17Z |
| containedItemQuantity | Σ | 0..* | Quantity | Number of items in this overall pack |
| description | Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack |
| legalStatusOfSupply | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. |
| 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 Binding: Legal Status for the Supply (preferred) |
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Country2 (preferred) |
| 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. |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| country | Σ | 0..1 | CodeableConcept | The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: Country2 (preferred) |
| status | Σ | 1..1 | CodeableConcept | 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 (preferred) |
| 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 (multiple means these are all possible manufacturers) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.type | preferred | VsPackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.code | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.country | preferred | Country2 |
| PackagedProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) |
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 | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) | ||||
| 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 as listed in a drug formulary, catalogue, inventory etc Example name: 3 ml cartridge (glass) in a pre-filled pen | ||||
| type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: High level Pack Type (preferred) | ||||
| 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. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Example Example Status: {"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 statusDate: 2015-02-07T13:28:17Z | ||||
| containedItemQuantity | Σ | 0..* | Quantity | Number of items in this overall pack | ||||
| description | Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | ||||
| 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 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status for the Supply (preferred) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Country2 (preferred) | ||||
| 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. | ||||
| 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 | ||||
| country | Σ | 0..1 | CodeableConcept | The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: Country2 (preferred) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorisation 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 | CodeableConcept | 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 (preferred) | ||||
| dateRange | Σ | 0..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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 | ||||
| restoreDate | Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorisation 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 | ||||
| characteristic | Σ | 0..* | CodeableConcept | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" Binding: PackageCharacteristic (example): A characteristic of a package. | ||||
| 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 (multiple means these are all possible manufacturers) | ||||
| attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| 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 | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
| 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) | ||||
| 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: Data Carrier Identifiers (preferred) 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 Binding: Pack Type (preferred) | ||||
| quantity | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material | Σ | 0..* | CodeableConcept | Material type of the package item Binding: Package Material (preferred) | ||||
| 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 | 0..1 | CodeableConcept | 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 (preferred) | ||||
| Slices for period[x] | Σ | 0..1 | 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 Slice: Unordered, Open by type:$this | |||||
| periodDuration | Duration | |||||||
| periodString | string | |||||||
| period[x]:periodDuration | Σ | 0..1 | Duration | 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 | ||||
| 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 | 0..1 | decimal | Numerical value (with implicit precision) | ||||
| comparator | ?!Σ | 0..1 | code | < | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required) | ||||
| unit | Σ | 0..1 | string | Unit representation | ||||
| system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code | Σ | 0..1 | code | Coded form of the unit Binding: Units of Measure (preferred) | ||||
| specialPrecautionsForStorage | Σ | 0..* | CodeableConcept | 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 (preferred) | ||||
| manufacturer | Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| 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(ManufacturedItemDefinition (ePI) | DeviceDefinition) | 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 | 0..1 | Quantity | The number of this type of item within this packaging | ||||
| packaging | Σ | 0..* | See packaging (PackagedProductDefinition) | Used to nest layers of packaging; e.g., outside to inside with secondary package and then primary package) | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| PackagedProductDefinition.language | preferred | CommonLanguages
| ||||
| PackagedProductDefinition.identifier.use | required | IdentifierUse | ||||
| PackagedProductDefinition.identifier.type | extensible | Identifier Type Codes | ||||
| PackagedProductDefinition.identifier.system | extensible | VsPackagedProductIdSystems | ||||
| PackagedProductDefinition.type | preferred | VsPackageType | ||||
| PackagedProductDefinition.status | preferred | PublicationStatus | ||||
| PackagedProductDefinition.legalStatusOfSupply.code | preferred | VsLegalStatusOfSupply (a valid code from https://spor.ema.europa.eu/rmswi/100000072051) | ||||
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | Country2 | ||||
| PackagedProductDefinition.marketingStatus.country | preferred | Country2 | ||||
| PackagedProductDefinition.marketingStatus.status | preferred | VsMarketingStatus (a valid code from https://spor.ema.europa.eu/rmswi/100000072052) | ||||
| PackagedProductDefinition.characteristic | example | PackageCharacteristic | ||||
| PackagedProductDefinition.packaging.identifier.use | required | IdentifierUse | ||||
| PackagedProductDefinition.packaging.identifier.type | extensible | Identifier Type Codes | ||||
| PackagedProductDefinition.packaging.identifier.system | preferred | VsDataCarrierIdSystem | ||||
| PackagedProductDefinition.packaging.type | preferred | VsSecondaryPrimaryPackType (a valid code from http://example.org) | ||||
| PackagedProductDefinition.packaging.material | preferred | VsPackageMaterial (a valid code from https://spor.ema.europa.eu/omswi) | ||||
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterial | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.type | preferred | VsShelfLifeType (a valid code from https://spor.ema.europa.eu/omswi) | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.period[x]:periodDuration.comparator | required | QuantityComparator | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.period[x]:periodDuration.code | preferred | VsUnitofMeasure | ||||
| PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage | preferred | VsSpecialPrecautionsForStorage (a valid code from https://spor.ema.europa.eu/rmswi/100000073344) | ||||
| PackagedProductDefinition.packaging.property.type | example | ProductCharacteristic |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 0 element (5 nested mandatory elements)
Structures
This structure refers to these other structures:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ . Package hl7.fhir.uv.emedicinal-product-info#1.0.0-ballot based on FHIR 5.0.0-ballot. Generated 2022-12-04
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