Generated Narrative: StructureDefinition DEU-ePIL-PackagedProductDefinition Name Flags Card. Type Description & Constraints PackagedProductDefinition PackagedProductDefinition #xD; id 1..1 id Technical ID of this packaged product #xD; Slices for identifier 0..* Identifier Package identifiers (all optional) Slice: Unordered, Open by value:type.coding.system, value:type.coding.code #xD; identifier:All Slices Content/Rules for all slices #xD; type 0..1 CodeableConcept Description of identifier Binding: DEU ePIL Identifier Type ValueSet (extensible) #xD; identifier:gtin 0..1 Identifier GTIN (Global Trade Item Number) - Optional #xD; type 1..1 CodeableConcept Description of identifier #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: 100000167575 #xD; display 0..1 string Representation defined by the system Required Pattern: GS1 Global Trade Item Number #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; identifier:ntin 0..1 Identifier NTIN (National Trade Item Number) #xD; type 1..1 CodeableConcept Description of identifier #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: 200000027030 #xD; display 0..1 string Representation defined by the system Required Pattern: National Trade Item Number #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; identifier:ppn 0..1 Identifier PPN (Pharmacy Product Number) #xD; type 1..1 CodeableConcept Description of identifier #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: 200000027029 #xD; display 0..1 string Representation defined by the system Required Pattern: Pharmacy Product Number #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; identifier:pzn 0..1 Identifier PZN (Pharmaceutical Central Number) #xD; type #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: PZN #xD; display 0..1 string Representation defined by the system Required Pattern: Pharmazentralnummer #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; identifier:pcid 0..1 Identifier PCID (Packaged Medicinal Product Identifier) #xD; type 1..1 CodeableConcept Description of identifier #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: PCID #xD; display 0..1 string Representation defined by the system Required Pattern: Packaged Medicinal Product Identifier #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; name 0..1 string Package name #xD; packageFor S 1..1 Reference(03 - DEU ePIL Medicinal Product Definition) Packaged for Medicinal Product #xD; containedItemQuantity S 0..* Quantity Contained Quantity #xD; manufacturer S 0..1 Reference(02 - DEU ePIL Organization) Manufacturer #xD; Documentation for this format
04 - DEU ePIL Packaged Product Definition
Defines the PackagedProductDefinition resource, including optional packaging identifiers (GTIN, NTIN, PPN, PZN, PCID), name, and quantity of contained items.
A medically related item or items, in a container or package
A medically related item or items, in a container or package.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
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()
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()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Mandatory technical identifier for this PackagedProductDefinition resource. Used for referencing this resource within the Bundle and FHIR system. This is the resource's technical ID (called 'logical id' in FHIR terminology).
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Must have either extensions or value[x], not both
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Package identifiers such as GTIN, NTIN, PPN, PZN, or PCID. All identifiers are optional.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
GTIN (Global Trade Item Number) - Optional
GTIN identifier (e.g., 04150004540432). Optional identifier that can be provided in addition to NTIN, PPN, or PZN.
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
The identification of the code system that defines the meaning of the symbol in the code.
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
National Trade Item Number for German market.
PCID (Packaged Medicinal Product Identifier)
Unique identifier for the packaged medicinal product
Optional name of the package. When not provided, the package can be identified by its identifiers (GTIN, PZN, etc.).
A high level category e.g. medicinal product, raw material, shipping container etc
A high level category e.g. medicinal product, raw material, shipping/transport container, etc.
A high level categorisation of a package.
Reference to the MedicinalProductDefinition resource (DEU_ePIL_MedicinalProductDefinition profile) for which this package is intended.
(the link from Packaged Medicinal Product to Medicinal Product)
The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
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.
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
The date at which the given status became applicable
The date at which the given status became applicable.
The quantity of items within the package, e.g., 100 Filmtabletten, 500 Gramm, or 200 Milliliters. Optional when quantity information is not applicable or available.
Textual description. Note that this is not the name of the package or product
Textual description. Note that this is not the name of the package or product.
The legal status of supply of the packaged item as classified by the regulator
The legal status of supply of the packaged item as classified by the regulator.
Marketing Authorization.Legal Status of Supply (for a package)
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The actual status of supply. In what situation this package type may be supplied for use
The actual status of supply. Conveys in what situation this package type may be supplied for use.
The prescription supply types appropriate to a medicinal product
The place where the legal status of supply applies
The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.
Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.
Packaged Medicinal Product.Marketing Status
Identifies if the drug product is supplied with another item such as a diluent or adjuvant
Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.
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
Optional reference to the manufacturer organization (DEU_ePIL_Organization profile). When not provided, manufacturer information may be available through other resources or contexts.
Packaged Medicinal Product.Manufacturer / Establishment (Organisation)
Additional information or supporting documentation about the packaged product
Additional information or supporting documentation about the packaged product.
A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
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).
Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)
An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode).
Package Item (Container).Data Carrier Identifier
The physical type of the container of the items
The physical type of the container of the items.
Package Item (Container).Package Item (Container) Type
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)
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). The latter type are designed be a container, but the former are not.
If absent, it cannot be assumed that the item is packaging (a container) or a part of the packaging - it is just 'packaging'. Systems can sometimes infer this from the packaging.type (e.g. bottles are containers, bottle caps are not), or from the fact that a container will usually have other items within it (though it is possible that these exist but are not mentioned). Often the distinction is not critical - and can easily be understood by humans - but if that is necessary for machine processing it is recommended that this attribute is given a value.
Whether this packaging item corresponds to an Package Item (Container), if false, or a Package (Component), when true
The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2.
Package Item (Container).Package Item (Container) Quantity
A material used in the construction of packages and their components.
A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
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).
Package Item (Container).Alternate Material
Package Item (Container).Shelf Life / Storage
Manufacturer of this packaging item (multiple means these are all potential manufacturers)
Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item.
Package Item (Container).Manufacturer / Establishment (Organisation)
Package Item (Container).Physical Characteristics
A code expressing the type of characteristic
A code expressing the type of characteristic.
This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Physical Characteristics, all attributes
Physical Characteristics, attribute's value
Package Item (Container).Manufactured Item, Package Item (Container).Device
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
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.packaging.packaging).
(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device
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)
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).
Manufactured Item.Manufactured Item Quantity
Allows containers (and parts of containers) within containers, still as a part of single packaged product
Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).
(link from Package Item (Container) to itself)
Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".