Medicinal Product Packaged

The medicinal product packaged profile has been adapted from the MedicinalProductPackaged FHIR resource. It contains the following elements:

idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
maHolderOrManufacturerI0..1Extension(string)
repackagingManufacturerI0..1Extension(CodeableConcept)
modifierExtension?! I0..*Extension
id0..1string
extensionI0..*Extension
useΣ ?!0..0codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uri
valueΣ1..1string
periodΣ I0..1Period
assignerΣ I0..0Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..0codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uri
valueΣ1..1string
periodΣ I0..1Period
assignerΣ I0..0Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..0codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uri
valueΣ1..1string
periodΣ I0..1Period
assignerΣ I0..0Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..0codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uri
valueΣ1..1string
periodΣ I0..1Period
assignerΣ I0..0Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..0codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uri
valueΣ1..1string
periodΣ I0..1Period
assignerΣ I0..0Reference(Organization)
id0..1string
extensionI0..*Extension
referenceΣ I1..1string
typeΣ1..1uriBinding
identifierΣ0..0Identifier
displayΣ0..0string
descriptionΣ0..1string
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uri
versionΣ0..0string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..0boolean
textΣ0..1string
marketingStatusΣ0..*MarketingStatus
marketingAuthorizationΣ I0..0Reference(MedicinalProductAuthorization)
manufacturerΣ I0..0Reference(Organization)
id0..1string
propertyI0..1Extension(Complex)
containedItemI0..*Extension(Complex)
modifierExtensionΣ ?! I0..*Extension
id0..1string
extensionI0..*Extension
useΣ ?!0..0codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uri
valueΣ1..1string
periodΣ I0..1Period
assignerΣ I0..0Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..0codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uri
valueΣ1..1string
periodΣ I0..1Period
assignerΣ I0..0Reference(Organization)
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uri
versionΣ0..0string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..0boolean
textΣ0..1string
quantityΣ I1..1Quantity
materialΣ0..0CodeableConcept
alternateMaterialΣ0..0CodeableConcept
deviceΣ I0..0Reference(DeviceDefinition)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ1..1uri
versionΣ0..0string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..0boolean
textΣ0..1string
quantityΣ I1..1Quantity
materialΣ0..0CodeableConcept
alternateMaterialΣ0..0CodeableConcept
deviceΣ I0..0Reference(DeviceDefinition)
physicalCharacteristicsΣ0..0ProdCharacteristic
otherCharacteristicsΣ0..0CodeableConcept
shelfLifeStorageΣ0..0ProductShelfLife
manufacturerΣ I0..0Reference(Organization)
physicalCharacteristicsΣ0..0ProdCharacteristic
otherCharacteristicsΣ0..0CodeableConcept
shelfLifeStorageΣ0..0ProductShelfLife
manufacturerΣ I0..0Reference(Organization)

extension

repackagingManufacturer

The repackagingManufacturer extension is implemented in order to specify the repackager of the package, if there is one. The url of the extension is: https://simplifier.net/safest/medicinalproductpackaged-repackaging-manufacturer-safest

It contains coding for the SAFEST Simplifier code system for repackagers in Norway, url: https://simplifier.net/safest/repackagingmanufacturersafest

maHolderOrManufacturer

The maHolderOrManufacturer extension is implemented in order to specify the marketing authorization holder of the package. If there is no marketing authorization holder, then the manufacturer of the package will be specified instead. It is a string containing a company name. The url of the extension is: https://simplifier.net/safest/medicinalproductpackaged-ma-holder-or-manufacturer-safest

identifier

legemiddelPakningID

The legemiddelPakningID identifier contains the legemiddelPakningID FEST identifier, in order to carry it over to SAFEST. Identifier URL: http://legemiddelverket.no/FEST/LegemiddelPakningID

safestPackagedProductID

The safestPackagedProductID identifier is mandatory. It is generated by SAFEST for every Medicinal Product Packaged. Identifier URL: http://legemiddelverket.no/fhir/SAFEST/SafestPackagedProductID

nordicArticleNumber

The nordicArticleNumber identifier contains the identification code for a specific article of medicine with marketing authorisation in the Nordic countries. Identifier URL: ​https://farmalogg.no/varenummer​

legemiddeldoseId

The legemiddeldoseId identifier is implemented in order to carry over the legemiddeldose FEST identifier to SAFEST. It is mandatory. Identifier URL: http://legemiddelverket.no/FEST/LegemiddeldoseID

lmrNummer

The lmrNummer identifier is implemented in order to carry over the LMRnummer FEST identifier to SAFEST. It is mandatory. Identifier URL: http://legemiddelverket.no/FEST/lmrNummer​

description

The description element contains a string with a description of the contents of the package.

legalStatusOfSupply

The legalStatusOfSupply element contains the legal status of supply of the package. If all the packages connected to the medicinal product has the same status, then the legal status of supply will be defined on the medicinal product and this element will be empty.

Contains coding for SAFEST Simplifier code system for legal status of supply, url: https://simplifier.net/safest/legalstatusofsupplysafest

marketingStatus

The marketingStatus element contains the marketing status of the package. For each marketing status on the package, there is a coding to the code system for marketing status, coding to the corresponding SPOR code system (if there is one), and a period specifying when the status applies.

packageItem

extension

containedItem

The containedItem extension was implemented in order to be compatible with FHIR version R5. It contains two sub-extensions:

  • item Item contains a reference referencing a Medicinal Product Manufactured contained within the package. The reference object consists of the absolute URL of the FHIR resource (must be on the same FHIR server) and the type of the FHIR resource, which in this case is MedicinalProductManufactured. Extension url: item
  • amount Amount contains a quantity describing the quantity of the containedItem. Extension url: amount

The url of the extension is: https://simplifier.net/safest/containeditem-safest

property

The property extension was implemented in order to be compatible with FHIR version R5.

It contains two sub-extensions:

The url of the extension is: https://simplifier.net/safest/property-safest

Identifier

safestPackagedItemID

The safestPackageID identifier is mandatory. It is generated for every packageItem. Identifier URL: http://legemiddelverket.no/fhir/SAFEST/SafestPackagedItemID​

dataCarrierIdentifier

The dataCarrierIdentifier identifier contains product codes from Farmalogg. Identifier URL: https​://farmalogg.no/produktkode​

type

The type element contains a coding to the Volven code system for package types, url: https://volven.no/toolws/index.asmx/wsAppInfoSchema?strKveKode=7449

quantity

The quantity element specifies the quantity of this type of packageItem at the current level of packaging.

subject

The subject element contains references to the Medicinal Products connected to the package. The references consist of the absolute URL of the FHIR resource (must be on the same FHIR server) and the type of the FHIR resource, which in this case is MedicinalProduct