This is the set of resources that conform to either of the profiles PackagedProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi) and PackagedProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi). E.g. what you have to deal with if you get resources conforming to one of them
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() | 0..* | A medically related item or items, in a container or package | ||
![]() ![]() | Σ | 0..1 | Meta | Metadata about the resource |
![]() ![]() | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language | |
![]() ![]() | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |
![]() ![]() | 0..* | Resource | Contained, inline Resources | |
![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() | Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
![]() ![]() ![]() | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
![]() ![]() ![]() | Σ | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() ![]() | Σ | 0..1 | Period | Time period when id is/was valid for use |
![]() ![]() ![]() | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
![]() ![]() | Σ | 0..1 | string | left: A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc; right: A name for this package. |
![]() ![]() | Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: ?? (example): A high level categorisation of a package. |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() | Σ | 0..* | Reference(MedicinalProductDefinition (ePI) | #sd+3-MedicinalProductDefinition-uv-epi-MedicinalProductDefinition-uv-epi) | The product that this is a pack for |
![]() ![]() | ?!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: ?? (preferred): The lifecycle status of an artifact. |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() | Σ | 0..1 | dateTime | left: The date at which the given status became applicable; right: The date at which the given status became applicable. Example Example of a status date: 2015-02-07T13:28:17Z |
![]() ![]() | Σ | 0..* | Quantity | left: 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); right: A count of the contained items. |
![]() ![]() | Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack |
![]() ![]() | Σ | 0..* | BackboneElement | left: The legal status of supply of the packaged item as classified by the regulator.; right: The legal status of supply of the packaged item as classified by the regulator |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: ?? (example): The prescription supply types appropriate to a medicinal product |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ?? (preferred): Jurisdiction codes |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() | Σ | 0..* | MarketingStatus | left: Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.; right: Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() | 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 |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() | 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: ?? (example) |
![]() ![]() ![]() | 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 |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() | 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 |
![]() ![]() ![]() | 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 |
![]() ![]() | Σ | 0..1 | boolean | left: If the drug product is supplied with another item such as a diluent; right: If the drug product is supplied with another item such as a diluent or adjuvant. |
![]() ![]() | Σ | 0..* | Reference(Organization (ePI) | #sd+29-Organization-uv-epi-Organization-uv-epi) | Manufacturer of this package type (multiple means these are all possible manufacturers) |
![]() ![]() | Σ | 0..* | Reference(DocumentReference) | left: Additional information or supporting documentation about the packaged product; right: Pack artwork images or other related documents associated with this package. |
![]() ![]() | Σ | 0..1 | BackboneElement | left: A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap; right: A packaging item, as a container for medically related items, possibly with other packaging items within. |
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() | Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. |
![]() ![]() ![]() ![]() | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
![]() ![]() ![]() ![]() | Σ | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() ![]() ![]() | Σ | 0..1 | Period | Time period when id is/was valid for use |
![]() ![]() ![]() ![]() | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) |
![]() ![]() ![]() | Σ | 0..1 | CodeableConcept | The physical type of the container of the items Binding: ?? (example): A high level categorisation of a package. |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() | 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) |
![]() ![]() ![]() | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
![]() ![]() ![]() | Σ | 0..* | CodeableConcept | Material type of the package item Binding: ?? (example): A material used in the construction of packages and their components. |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() | 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: ?? (example): A material used in the construction of packages and their components. |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() | Σ | 0..* | ProductShelfLife | left: Shelf Life and storage information.; right: Shelf Life and storage information |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() | 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 |
![]() ![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() ![]() | 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 | |
![]() ![]() ![]() ![]() ![]() | Duration | |||
![]() ![]() ![]() ![]() ![]() | string | |||
![]() ![]() ![]() ![]() | 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 |
![]() ![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() | Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
![]() ![]() ![]() | Σ | 0..* | BackboneElement | General characteristics of this item |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
![]() ![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
![]() ![]() ![]() ![]() ![]() | Σ | 1..1 | Coding | Code defined by a terminology system |
![]() ![]() ![]() ![]() ![]() | Σ | 0..1 | string | Plain text representation of the concept |
![]() ![]() ![]() ![]() | Σ | 0..1 | A value for the characteristic | |
![]() ![]() ![]() ![]() ![]() | CodeableConcept | |||
![]() ![]() ![]() ![]() ![]() | Quantity | |||
![]() ![]() ![]() ![]() ![]() | date | |||
![]() ![]() ![]() ![]() ![]() | boolean | |||
![]() ![]() ![]() ![]() ![]() | Attachment | |||
![]() ![]() ![]() | Σ | 0..* | BackboneElement | The item(s) within the packaging |
![]() ![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
![]() ![]() ![]() ![]() | Σ | 1..1 | CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) | 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 |
![]() ![]() ![]() ![]() | 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) |
![]() ![]() ![]() | Σ | 0..* | left: Allows containers (and parts of containers) within containers, still as a part of single packaged product; right: Nested packaging. | |
![]() ![]() | Σ | 0..* | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" | |
Documentation for this format | ||||