{ "resourceType": "StructureDefinition", "id": "PackagedProductDefinition", "meta": { "lastUpdated": "2021-01-01T21:58:31.578+00:00" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category", "valueString": "Specialized.Medication Definition" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 1 }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category", "valueCode": "anonymous" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status", "valueCode": ".status=entered-in-error" } ], "url": "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition", "version": "4.6.0", "name": "PackagedProductDefinition", "status": "draft", "date": "2021-01-01T21:58:31+00:00", "publisher": "Health Level Seven International (Biomedical Research and Regulation)", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/fhir" } ] }, { "telecom": [ { "system": "url", "value": "http://www.hl7.org/Special/committees/rcrim/index.cfm" } ] } ], "description": "A medically related item or items, in a container or package.", "fhirVersion": "4.6.0", "mapping": [ { "identity": "idmp", "uri": "https://en.wikipedia.org/wiki/Identification_of_medicinal_products", "name": "IDMP Mapping" }, { "identity": "w5", "uri": "http://hl7.org/fhir/fivews", "name": "FiveWs Pattern Mapping" }, { "identity": "rim", "uri": "http://hl7.org/v3", "name": "RIM Mapping" } ], "kind": "resource", "abstract": false, "type": "PackagedProductDefinition", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource", "derivation": "specialization", "differential": { "element": [ { "id": "PackagedProductDefinition", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "0,0" } ], "path": "PackagedProductDefinition", "short": "A medically related item or items, in a container or package", "definition": "A medically related item or items, in a container or package.", "min": 0, "max": "*", "mapping": [ { "identity": "idmp", "map": "Packaged Medicinal Product" }, { "identity": "w5", "map": "administrative.medication" } ] }, { "id": "PackagedProductDefinition.identifier", "path": "PackagedProductDefinition.identifier", "short": "A unique identifier for this package as whole", "definition": "A unique identifier for this package as whole. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.", "min": 0, "max": "*", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Packaged Medicinal Product.PCID" } ] }, { "id": "PackagedProductDefinition.name", "path": "PackagedProductDefinition.name", "short": "A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc", "definition": "A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.", "min": 0, "max": "1", "type": [ { "code": "string" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.type", "path": "PackagedProductDefinition.type", "short": "A high level category e.g. medicinal product, raw material, shipping container etc", "definition": "A high level category e.g. medicinal product, raw material, shipping/transport container, etc.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PackageType" } ], "strength": "example", "description": "A high level categorisation of a package.", "valueSet": "http://hl7.org/fhir/ValueSet/package-type" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.packageFor", "path": "PackagedProductDefinition.packageFor", "short": "The product that this is a pack for", "definition": "The product that this is a pack for.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(the link from Packaged Medicinal Product to Medicinal Product)" } ] }, { "id": "PackagedProductDefinition.status", "path": "PackagedProductDefinition.status", "short": "The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status", "definition": "The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isModifier": true, "isModifierReason": "This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PublicationStatus" } ], "strength": "preferred", "description": "The lifecycle status of an artifact.", "valueSet": "http://hl7.org/fhir/ValueSet/publication-status" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.statusDate", "path": "PackagedProductDefinition.statusDate", "short": "The date at which the given status became applicable", "definition": "The date at which the given status became applicable.", "min": 0, "max": "1", "type": [ { "code": "dateTime" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.containedItemQuantity", "path": "PackagedProductDefinition.containedItemQuantity", "short": "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", "definition": "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. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.", "min": 0, "max": "*", "type": [ { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.description", "path": "PackagedProductDefinition.description", "short": "Textual description. Note that this is not the name of the package or product", "definition": "Textual description. Note that this is not the name of the package or product.", "min": 0, "max": "1", "type": [ { "code": "markdown" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Packaged Medicinal Product.description" } ] }, { "id": "PackagedProductDefinition.legalStatusOfSupply", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "0,250" } ], "path": "PackagedProductDefinition.legalStatusOfSupply", "short": "The legal status of supply of the packaged item as classified by the regulator", "definition": "The legal status of supply of the packaged item as classified by the regulator.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Marketing Authorisation.Legal Status of Supply (for a package)" } ] }, { "id": "PackagedProductDefinition.legalStatusOfSupply.code", "path": "PackagedProductDefinition.legalStatusOfSupply.code", "short": "The actual status of supply. In what situation this package type may be supplied for use", "definition": "The actual status of supply. Conveys in what situation this package type may be supplied for use.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "LegalStatusOfSupply" } ], "strength": "example", "description": "The prescription supply types appropriate to a medicinal product", "valueSet": "http://hl7.org/fhir/ValueSet/legal-status-of-supply" }, "mapping": [ { "identity": "idmp", "map": "Marketing Authorisation.Legal Status of Supply (for a package)" } ] }, { "id": "PackagedProductDefinition.legalStatusOfSupply.jurisdiction", "path": "PackagedProductDefinition.legalStatusOfSupply.jurisdiction", "short": "The place where the legal status of supply applies", "definition": "The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Jurisdiction" } ], "strength": "example", "description": "Jurisdiction codes", "valueSet": "http://hl7.org/fhir/ValueSet/jurisdiction" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.marketingStatus", "path": "PackagedProductDefinition.marketingStatus", "short": "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated", "definition": "Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.", "min": 0, "max": "*", "type": [ { "code": "MarketingStatus" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Packaged Medicinal Product.Marketing Status" } ] }, { "id": "PackagedProductDefinition.characteristic", "path": "PackagedProductDefinition.characteristic", "short": "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\"", "definition": "Allows the key features to be recorded, such as \"hospital pack\", \"nurse prescribable\", \"calendar pack\".", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PackageCharacteristic" } ], "strength": "example", "description": "A characteristic of a package.", "valueSet": "http://hl7.org/fhir/ValueSet/package-characteristic" }, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.copackagedIndicator", "path": "PackagedProductDefinition.copackagedIndicator", "short": "If the drug product is supplied with another item such as a diluent or adjuvant", "definition": "States whether a drug product is supplied with another item such as a diluent or adjuvant.", "min": 0, "max": "1", "type": [ { "code": "boolean" } ], "meaningWhenMissing": "If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made", "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.manufacturer", "path": "PackagedProductDefinition.manufacturer", "short": "Manufacturer of this package type (multiple means these are all possible manufacturers)", "definition": "Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Packaged Medicinal Product.Manufacturer / Establishment (Organisation)" } ] }, { "id": "PackagedProductDefinition.attachedDocument", "path": "PackagedProductDefinition.attachedDocument", "short": "Additional information or supporting documentation about the packaged product", "definition": "Additional information or supporting documentation about the packaged product.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DocumentReference" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "n/a" } ] }, { "id": "PackagedProductDefinition.package", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "403,29" } ], "path": "PackagedProductDefinition.package", "short": "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap", "definition": "A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).", "min": 0, "max": "1", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)" } ] }, { "id": "PackagedProductDefinition.package.identifier", "path": "PackagedProductDefinition.package.identifier", "short": "An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier", "definition": "An identifier that is specific to this particular part of the packaging. Including possibly Data Carrier Identifier (a GS1 barcode).", "min": 0, "max": "*", "type": [ { "code": "Identifier" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Data Carrier Identifier" } ] }, { "id": "PackagedProductDefinition.package.type", "path": "PackagedProductDefinition.package.type", "short": "The physical type of the container of the items", "definition": "The physical type of the container of the items.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PackagingType" } ], "strength": "example", "description": "A high level categorisation of a package.", "valueSet": "http://hl7.org/fhir/ValueSet/packaging-type" }, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Package Item (Container) Type" } ] }, { "id": "PackagedProductDefinition.package.quantity", "path": "PackagedProductDefinition.package.quantity", "short": "The quantity of this level of packaging in the package that contains it (with the outermost level being 1)", "definition": "The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1.", "min": 0, "max": "1", "type": [ { "code": "integer" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Package Item (Container) Quantity" } ] }, { "id": "PackagedProductDefinition.package.material", "path": "PackagedProductDefinition.package.material", "short": "Material type of the package item", "definition": "Material type of the package item.", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PackageMaterial" } ], "strength": "example", "description": "A material used in the construction of packages and their components.", "valueSet": "http://hl7.org/fhir/ValueSet/package-material" }, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Material" } ] }, { "id": "PackagedProductDefinition.package.alternateMaterial", "path": "PackagedProductDefinition.package.alternateMaterial", "short": "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material", "definition": "A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).", "min": 0, "max": "*", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "PackageMaterial" } ], "strength": "example", "description": "A material used in the construction of packages and their components.", "valueSet": "http://hl7.org/fhir/ValueSet/package-material" }, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Alternate Material" } ] }, { "id": "PackagedProductDefinition.package.shelfLifeStorage", "path": "PackagedProductDefinition.package.shelfLifeStorage", "short": "Shelf Life and storage information", "definition": "Shelf Life and storage information.", "min": 0, "max": "*", "type": [ { "code": "ProductShelfLife" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Shelf Life / Storage" } ] }, { "id": "PackagedProductDefinition.package.manufacturer", "path": "PackagedProductDefinition.package.manufacturer", "short": "Manufacturer of this package Item (multiple means these are all possible manufacturers)", "definition": "Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers.", "min": 0, "max": "*", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Manufacturer / Establishment (Organisation)" } ] }, { "id": "PackagedProductDefinition.package.property", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "300,250" } ], "path": "PackagedProductDefinition.package.property", "short": "General characteristics of this item", "definition": "General characteristics of this item.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Physical Characteristics" } ] }, { "id": "PackagedProductDefinition.package.property.type", "path": "PackagedProductDefinition.package.property.type", "short": "A code expressing the type of characteristic", "definition": "A code expressing the type of characteristic.", "min": 1, "max": "1", "type": [ { "code": "CodeableConcept" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ProductCharacteristic" } ], "strength": "example", "description": "This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.", "valueSet": "http://hl7.org/fhir/ValueSet/product-characteristic-codes" }, "mapping": [ { "identity": "idmp", "map": "Physical Characteristics, all attributes" } ] }, { "id": "PackagedProductDefinition.package.property.value[x]", "path": "PackagedProductDefinition.package.property.value[x]", "short": "A value for the characteristic", "definition": "A value for the characteristic.", "min": 0, "max": "1", "type": [ { "code": "CodeableConcept" }, { "code": "Quantity" }, { "code": "date" }, { "code": "boolean" }, { "code": "Attachment" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Physical Characteristics, attribute's value" } ] }, { "id": "PackagedProductDefinition.package.containedItem", "extension": [ { "url": "http://hl7.org/fhir/build/StructureDefinition/svg", "valueCode": "610,250" } ], "path": "PackagedProductDefinition.package.containedItem", "short": "The item(s) within the packaging", "definition": "The item(s) within the packaging.", "min": 0, "max": "*", "type": [ { "code": "BackboneElement" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Package Item (Container).Manufactured Item, Package Item (Container).Device" } ] }, { "id": "PackagedProductDefinition.package.containedItem.item", "path": "PackagedProductDefinition.package.containedItem.item", "short": "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", "definition": "The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package).", "min": 1, "max": "1", "type": [ { "code": "CodeableReference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition", "http://hl7.org/fhir/StructureDefinition/DeviceDefinition", "http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition", "http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct", "http://hl7.org/fhir/StructureDefinition/NutritionProduct" ] } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device" } ] }, { "id": "PackagedProductDefinition.package.containedItem.amount", "path": "PackagedProductDefinition.package.containedItem.amount", "short": "The number of this type of item within this packaging", "definition": "The number of this type of item within this packaging.", "min": 0, "max": "1", "type": [ { "code": "Quantity" } ], "isSummary": true, "mapping": [ { "identity": "idmp", "map": "Manufactured Item.Manufactured Item Quantity" } ] }, { "id": "PackagedProductDefinition.package.package", "path": "PackagedProductDefinition.package.package", "short": "Allows containers (and parts of containers) within containers, still a single packaged product", "definition": "Allows containers (and parts of containers) parwithin containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition).", "min": 0, "max": "*", "contentReference": "#PackagedProductDefinition.package", "isSummary": true, "mapping": [ { "identity": "idmp", "map": "(link from Package Item (Container) to itself)" } ] } ] } }