Generated Narrative: StructureDefinition ManufacturedItemDefinition-uv-epi Language: en Name Flags Card. Type Description & Constraints ManufacturedItemDefinition 0..* ManufacturedItemDefinition The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product #xD; identifier 1..* Identifier Unique identifier #xD; system 1..1 uri The namespace for the identifier value #xD; value 1..1 string The value that is unique #xD; status 1..1 code draft|active|retired|unknown #xD; name 0..1 string A descriptive name given to this item. #xD; manufacturedDoseForm #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; unitOfPresentation #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; manufacturer 0..* Reference(Organization (ePI)) Manufacturer of the item, one of several possible #xD; Slices for property 0..* BackboneElement General characteristics of this item. Slice: Unordered, Open by value:type.coding.code #xD; property:color 0..* BackboneElement General characteristics of this item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: color #xD; value[x] 0..1 CodeableConcept A value for the characteristic #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; property:flavor 0..* BackboneElement General characteristics of this item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: flavor #xD; value[x] 0..1 CodeableConcept A value for the characteristic #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; property:score 0..* BackboneElement General characteristics of this item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: score #xD; value[x] 0..1 CodeableConcept A value for the characteristic #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; property:shape 0..* BackboneElement General characteristics of this item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: shape #xD; value[x] 0..1 CodeableConcept A value for the characteristic #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; property:surfaceForm 0..* BackboneElement General characteristics of this item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: surfaceform #xD; value[x] 0..1 CodeableConcept A value for the characteristic #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; property:size 0..* BackboneElement General characteristics of this item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: size #xD; value[x] 0..1 CodeableConcept A value for the characteristic #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; property:image 0..* BackboneElement General characteristics of this item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: image #xD; value[x] 0..1 CodeableConcept A value for the characteristic #xD; coding 1..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system #xD; code 1..1 code Symbol in syntax defined by the system #xD; display 1..1 string Representation defined by the system #xD; property:imprint 0..* BackboneElement Imprint on the item #xD; type 1..1 CodeableConcept A code expressing the type of characteristic Required Pattern: At least the following #xD; coding Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig #xD; code 1..1 code Symbol in syntax defined by the system Required Pattern: imprint #xD; value[x] 0..1 markdown A value for the characteristic #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.
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
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
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
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.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
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
The status of this item. Enables tracking the life-cycle of the content.
Allows filtering of manufactured items that are appropriate for use versus not.
This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
A descriptive name applied to this item.
Dose form as manufactured (before any necessary transformation)
Dose form as manufactured and before any transformation into the pharmaceutical product.
Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
Manufactured Item.Manufactured Dose Form
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
The “real-world” units in which the quantity of the item is described
The “real-world” units in which the quantity of the manufactured item is described.
The presentation type in which an administrable medicinal product is given to a patient.
Manufacturer of the item, one of several possible
Manufacturer of the item, one of several possible.
Manufactured Item.Manufacturer / Establishment (Organisation)
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.
The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.
This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Manufactured Item.Ingredient (see also FHIR Ingredient resource)
Manufactured Item.Physical Characteristics
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
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
Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup.
Defining type of the component e.g. shell, layer, ink
Defining type of the component e.g. shell, layer, ink.
The function of this component within the item e.g. delivers active ingredient, masks taste
The function of this component within the item e.g. delivers active ingredient, masks taste.
The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient).
The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
The physical location of the constituent/ingredient within the component
The physical location of the constituent/ingredient within the component. Example – if the component is the bead in the capsule, then the location would be where the ingredient resides within the product part – intragranular, extra-granular, etc.
The function of this constituent within the component e.g. binder
The function of this constituent within the component e.g. binder.
The ingredient that is the constituent of the given component
The ingredient that is the constituent of the given component.
General characteristics of this component
General characteristics of this component.
A component that this component contains or is made from
A component that this component contains or is made from.