Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). 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 | |||
| Standards status: Trial-use | Maturity Level: 2 | 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 | |
 value | 1..1 | string | The value that is unique | |
| name | 1..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc | |
| type | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. | |
 packageFor | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | |
| statusDate | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z | |
| 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. | |
| jurisdiction | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (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. | |
| jurisdiction | 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 Binding: ISO Country two letter code (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 | |
| value | 1..1 | string | The value that is unique | |
| material | 0..1 | CodeableConcept | Material type of the package item | |
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information. | |
 Slices for period[x] | 0..1 | Duration, string | 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 | |
  period[x]: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 | |
| specialPrecautionsForStorage | 0..1 | 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 | |
| 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 | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountry |
| 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 |
| contained | 0..* | Resource | Contained, inline Resources | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| name | Σ | 1..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
 type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package. |
| 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. |
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z |
| 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 |
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (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 |
| 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 Binding: ISO Country two letter code (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 |
| 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 | example | PackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountry |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| 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: AllLanguages (required): IETF language tag for a human language | |
| 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): 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 Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 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 | 1..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
| type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package. |
| 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. |
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z |
| 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) |
| 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: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product |
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (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 authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements |
| 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 Binding: ISO Country two letter code (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 |
| 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 |
| 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 |
| 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): 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 Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 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: PackagingType (example): A high level categorisation of a package. |
| 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) |
| material | Σ | 0..1 | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. |
| 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 |
| 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 |
| specialPrecautionsForStorage | Σ | 0..1 | 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 |
| 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 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 |
| characteristic | Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.language | required | AllLanguages |
| PackagedProductDefinition.identifier.use | required | IdentifierUse |
| PackagedProductDefinition.identifier.type | extensible | IdentifierTypeCodes |
| PackagedProductDefinition.type | example | PackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupply |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.packaging.identifier.use | required | IdentifierUse |
| PackagedProductDefinition.packaging.identifier.type | extensible | IdentifierTypeCodes |
| PackagedProductDefinition.packaging.type | example | PackagingType |
| PackagedProductDefinition.packaging.material | example | PackageMaterial |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | ProductCharacteristic |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 1 element (5 nested mandatory elements)
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Maturity: 2
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 | |
| value | 1..1 | string | The value that is unique | |
| name | 1..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc | |
| type | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. | |
| packageFor | 0..* | Reference(MedicinalProductDefinition (ePI)) | The product that this is a pack for | |
| statusDate | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z | |
| 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. | |
| jurisdiction | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (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. | |
| jurisdiction | 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 Binding: ISO Country two letter code (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 | |
| value | 1..1 | string | The value that is unique | |
| material | 0..1 | CodeableConcept | Material type of the package item | |
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information. | |
| Slices for period[x] | 0..1 | Duration, string | 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 | |
| period[x]: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 | |
| specialPrecautionsForStorage | 0..1 | 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 | |
| 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 | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountry |
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 |
| contained | 0..* | Resource | Contained, inline Resources | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| name | Σ | 1..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
| type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package. |
| 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. |
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z |
| 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 |
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (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 |
| 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 Binding: ISO Country two letter code (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 |
| 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 | example | PackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountry |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
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: AllLanguages (required): IETF language tag for a human language | |
| 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): 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 Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 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 | 1..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
| type | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package. |
| 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. |
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z |
| 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) |
| 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: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product |
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (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 authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements |
| 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 Binding: ISO Country two letter code (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 |
| 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 |
| 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 |
| 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): 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 Example General: http://www.acme.com/identifiers/patient |
| value | ΣC | 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: PackagingType (example): A high level categorisation of a package. |
| 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) |
| material | Σ | 0..1 | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. |
| 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 |
| 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 |
| specialPrecautionsForStorage | Σ | 0..1 | 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 |
| 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 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 |
| characteristic | Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.language | required | AllLanguages |
| PackagedProductDefinition.identifier.use | required | IdentifierUse |
| PackagedProductDefinition.identifier.type | extensible | IdentifierTypeCodes |
| PackagedProductDefinition.type | example | PackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupply |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountry |
| PackagedProductDefinition.packaging.identifier.use | required | IdentifierUse |
| PackagedProductDefinition.packaging.identifier.type | extensible | IdentifierTypeCodes |
| PackagedProductDefinition.packaging.type | example | PackagingType |
| PackagedProductDefinition.packaging.material | example | PackageMaterial |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | ProductCharacteristic |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 1 element (5 nested mandatory elements)
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
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