Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Resource Profile: BatchFormula - Detailed Descriptions

Page standards status: Trial-use | Maturity Level: 2

Definitions for the pqcmc-product-batch-formula resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

0. ManufacturedItemDefinition
Definition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.
Short | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: 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()) dom-4: 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()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ManufacturedItemDefinition.implicitRules
Definition | 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.
Short | A set of rules under which this content was created
Comments | 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.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ManufacturedItemDefinition.contained
Definition | 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.
Short | Contained, inline Resources
Comments | 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.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
6. ManufacturedItemDefinition.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
Requirements | 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.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. ManufacturedItemDefinition.identifier
Definition | Unique identifier.
Short | optional user designated identifierUnique identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1*
Type | Identifier
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ManufacturedItemDefinition.status
Definition | The status of this item. Enables tracking the life-cycle of the content.
Short | draft | active | retired | unknown
Comments | Allows filtering of manufactured items that are appropriate for use versus not.
Control | 1..1
Binding | The codes SHALL be taken from PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 (required to `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` ) The lifecycle status of an artifact.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. ManufacturedItemDefinition.name
Definition | A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined] A descriptive name applied to this item.
Short | Product Non-proprietary NameA descriptive name applied to this item
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. ManufacturedItemDefinition.manufacturedDoseForm
Definition | Dose form as manufactured and before any transformation into the pharmaceutical product.
Short | Dose form as manufactured (before any necessary transformation)
Control | 1..1
Binding | The codes SHALL be taken from For example codes, see Manufactured Dose Form Terminology http://hl7.org/fhir/ValueSet/manufactured-dose-form (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. ManufacturedItemDefinition.manufacturer
Definition | Manufacturer of the item, one of several possible.
Short | Manufacturer of the item, one of several possible
Control | 0..*
Type | Reference(Literal Reference)(Basic Organization, Organization)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. ManufacturedItemDefinition.property
Definition | General characteristics of this item.
Short | General characteristics of this item
Control | 20..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type.text
20. ManufacturedItemDefinition.property.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
22. ManufacturedItemDefinition.property.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. ManufacturedItemDefinition.property.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. ManufacturedItemDefinition.property:BatchSize
Slice Name | BatchSize
Definition | The amount of material in a specific batch size [Source: SME Defined] Example: 1000 kg General characteristics of this item.
Short | Batch QuantityGeneral characteristics of this item
Control | 10..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ManufacturedItemDefinition.property:BatchSize.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
30. ManufacturedItemDefinition.property:BatchSize.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. ManufacturedItemDefinition.property:BatchSize.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Batch Quantity`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. ManufacturedItemDefinition.property:BatchSize.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 10..1
Binding | The codes SHALL be taken from For codes, see Units Of Measure (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` )
Type | Quantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. ManufacturedItemDefinition.property:BatchSize.value[x].value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. ManufacturedItemDefinition.property:BatchSize.value[x].comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. ManufacturedItemDefinition.property:BatchSize.value[x].code
Definition | A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709] A computer processable form of the unit in some unit representation system.
Short | Quantity UOMCoded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 0..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. ManufacturedItemDefinition.property:BatchUtil
Slice Name | BatchUtil
Definition | A categorization of the batch that identifies its usage. [Source: SME Defined] Examples: commercial, development. General characteristics of this item.
Short | Batch UtilizationGeneral characteristics of this item
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. ManufacturedItemDefinition.property:BatchUtil.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
46. ManufacturedItemDefinition.property:BatchUtil.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. ManufacturedItemDefinition.property:BatchUtil.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Batch Utilization`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. ManufacturedItemDefinition.property:BatchUtil.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 10..1
Binding | The codes SHALL be taken from For codes, see Batch utilization Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` )
Type | CodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. ManufacturedItemDefinition.property:AddInfo
Slice Name | AddInfo
Definition | A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes. General characteristics of this item.
Short | Batch Formula Additional InformationGeneral characteristics of this item
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. ManufacturedItemDefinition.property:AddInfo.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
56. ManufacturedItemDefinition.property:AddInfo.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ManufacturedItemDefinition.property:AddInfo.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Batch Formula Additional Information`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. ManufacturedItemDefinition.property:AddInfo.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 10..1
Type | markdown, date, boolean, Reference(Binary), Quantity, Attachment, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. ManufacturedItemDefinition.component
Definition | 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.
Short | 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
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. ManufacturedItemDefinition.component.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
66. ManufacturedItemDefinition.component.type
Definition | Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined] Example: Layer, Bead, Minitablet, Capsule Shell, Coating Defining type of the component e.g. shell, layer, ink.
Short | Product Part TypeDefining type of the component e.g. shell, layer, ink
Control | 1..1
Binding | The codes SHALL be taken from For codes, see Product Part Type Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. ManufacturedItemDefinition.component.amount
Definition | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
Short | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Control | 20..2*
Type | Quantity
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.amount`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ code
70. ManufacturedItemDefinition.component.amount:perBatch
Slice Name | perBatch
Definition | Specifies the amount of the component per batch size of the drug product. [Source: SME Defined] The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
Short | Component Quantity Per BatchThe measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Control | 10..1*
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. ManufacturedItemDefinition.component.amount:perBatch.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. ManufacturedItemDefinition.component.amount:perBatch.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. ManufacturedItemDefinition.component.amount:perBatch.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. ManufacturedItemDefinition.component.amount:perBatch.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 10..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from For codes, see Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. ManufacturedItemDefinition.component.amount:percent
Slice Name | percent
Definition | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
Short | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Control | 10..1*
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. ManufacturedItemDefinition.component.amount:percent.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. ManufacturedItemDefinition.component.amount:percent.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. ManufacturedItemDefinition.component.amount:percent.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. ManufacturedItemDefinition.component.amount:percent.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 10..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from For codes, see Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. ManufacturedItemDefinition.component.constituent
Definition | 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).
Short | 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)
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. ManufacturedItemDefinition.component.constituent.extension
Definition | An Extension 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.
Short | ExtensionAdditional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
94. ManufacturedItemDefinition.component.constituent.extension:additional-info
Slice Name | additional-info
Definition | A placeholder for providing any comments relevant to the constituent [Source: SME Defined] Examples: Water for wet granulation - removed during process; adjusted for loss on drying, etc.* property[
Short | Drug Product Constituent Additional Information
Control | 0..1
Type | Extension(Additional Information) (Extension Type: markdown)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
96. ManufacturedItemDefinition.component.constituent.extension:ingredientOverage
Slice Name | ingredientOverage
Definition | Extension for measurements related to excess for ingredients in the batch formula.
Short | Overage Extension
Control | 0..1
Type | Extension(Overage Extension) (Complex Extension)
Is Modifier | false
Must Support | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`) cmc-overage-percent-limit: Overage percent must be less than 1.0 (`extension.where(url='proportionDecimal').single().value < 1`)
98. ManufacturedItemDefinition.component.constituent.extension:StrengthTextual
Slice Name | StrengthTextual
Definition | Extension for strength as a string for ingredients in the batch formula.
Short | Product Batch Strength Textual Extension
Control | 0..1
Type | Extension(Product Batch Strength Textual Extension) (Extension Type: string)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
100. ManufacturedItemDefinition.component.constituent.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
102. ManufacturedItemDefinition.component.constituent.amount
Definition | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
Short | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Control | 20..2*
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.amount`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ code
104. ManufacturedItemDefinition.component.constituent.amount:perBatch
Slice Name | perBatch
Definition | Specifies the amount of the component per batch size of the drug product. [Source: SME Defined] The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
Short | Component Quantity Per BatchThe measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Control | 10..1*
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. ManufacturedItemDefinition.component.constituent.amount:perBatch.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. ManufacturedItemDefinition.component.constituent.amount:perBatch.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. ManufacturedItemDefinition.component.constituent.amount:perBatch.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 10..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from For codes, see Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. ManufacturedItemDefinition.component.constituent.amount:percent
Slice Name | percent
Definition | Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined] Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709] The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
Short | Quantity PercentThe measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Control | 10..1*
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. ManufacturedItemDefinition.component.constituent.amount:percent.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 10..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
118. ManufacturedItemDefinition.component.constituent.amount:percent.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. ManufacturedItemDefinition.component.constituent.amount:percent.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. ManufacturedItemDefinition.component.constituent.amount:percent.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 10..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from For codes, see Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. ManufacturedItemDefinition.component.constituent.location
Definition | Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend 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.
Short | Product Part Ingredient Physical LocationThe physical location of the constituent/ingredient within the component
Control | 0..*
Binding | The codes SHALL be taken from For codes, see Ingredient Location Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
126. ManufacturedItemDefinition.component.constituent.hasIngredient
Definition | The ingredient that is the constituent of the given component.
Short | The ingredient that is the constituent of the given component
Control | 10..1*
Type | CodeableReference(Literal Coded Reference)(Drug Product Batch Formula Ingredient, Ingredient)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. ManufacturedItemDefinition.component.property
Definition | General characteristics of this component.
Short | General characteristics of this component
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.property`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type.text
130. ManufacturedItemDefinition.component.property.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
132. ManufacturedItemDefinition.component.property.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. ManufacturedItemDefinition.component.property.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
136. ManufacturedItemDefinition.component.property:PPiD
Slice Name | PPiD
Definition | A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet General characteristics of this component.
Short | Product Part IdentifierGeneral characteristics of this component
Control | 10..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
138. ManufacturedItemDefinition.component.property:PPiD.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
140. ManufacturedItemDefinition.component.property:PPiD.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
142. ManufacturedItemDefinition.component.property:PPiD.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Product Part Identifier`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. ManufacturedItemDefinition.component.property:PPiD.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 10..1
Type | CodeableConcept(Text Only Codeable Concept), date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. ManufacturedItemDefinition.component.property:PPiDref
Slice Name | PPiDref
Definition | Identifies the parent or outer-level product part. [Source: SME Defined] Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead. General characteristics of this component.
Short | Product Part Identifier ReferenceGeneral characteristics of this component
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
148. ManufacturedItemDefinition.component.property:PPiDref.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
150. ManufacturedItemDefinition.component.property:PPiDref.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. ManufacturedItemDefinition.component.property:PPiDref.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Product Part Identifier Reference`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
154. ManufacturedItemDefinition.component.property:PPiDref.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 10..1
Type | CodeableConcept(Text Only Codeable Concept), date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
156. ManufacturedItemDefinition.component.property:AddInfo
Slice Name | AddInfo
Definition | A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes. General characteristics of this component.
Short | Product Part Additional InformationGeneral characteristics of this component
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
158. ManufacturedItemDefinition.component.property:AddInfo.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
160. ManufacturedItemDefinition.component.property:AddInfo.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
162. ManufacturedItemDefinition.component.property:AddInfo.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Product Part Additional Information`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
164. ManufacturedItemDefinition.component.property:AddInfo.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 10..1
Type | markdown, date, boolean, Reference(Binary), Quantity, Attachment, CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
166. ManufacturedItemDefinition.component.component
Definition | A component that this component contains or is made from.
Short | A component that this component contains or is made from
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be foundhere

0. ManufacturedItemDefinition
2. ManufacturedItemDefinition.identifier
Short | optional user designated identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Must Support | true
4. ManufacturedItemDefinition.status
Must Support | true
6. ManufacturedItemDefinition.name
Definition | A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]
Short | Product Non-proprietary Name
Control | 1..?
Must Support | true
8. ManufacturedItemDefinition.manufacturedDoseForm
Binding | The codes SHALL be taken from Manufactured Dose Form Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` )
10. ManufacturedItemDefinition.manufacturer
Type | Reference(Literal Reference)(Basic Organization)bundled
Must Support | true
12. ManufacturedItemDefinition.property
Control | 2..?
Must Support | true
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type.text
14. ManufacturedItemDefinition.property.type
Must Support | true
16. ManufacturedItemDefinition.property.type.text
Control | 1..?
Must Support | true
18. ManufacturedItemDefinition.property:BatchSize
Slice Name | BatchSize
Definition | The amount of material in a specific batch size [Source: SME Defined] Example: 1000 kg
Short | Batch Quantity
Control | 1..1
Must Support | true
20. ManufacturedItemDefinition.property:BatchSize.type
22. ManufacturedItemDefinition.property:BatchSize.type.text
Pattern Value | `Batch Quantity`
24. ManufacturedItemDefinition.property:BatchSize.value[x]
Control | 1..?
Binding | The codes SHALL be taken from Units Of Measure (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` )
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
26. ManufacturedItemDefinition.property:BatchSize.value[x].value
Control | 1..?
Must Support | true
28. ManufacturedItemDefinition.property:BatchSize.value[x].code
Definition | A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]
Short | Quantity UOM
30. ManufacturedItemDefinition.property:BatchUtil
Slice Name | BatchUtil
Definition | A categorization of the batch that identifies its usage. [Source: SME Defined] Examples: commercial, development.
Short | Batch Utilization
Control | 1..*
Must Support | true
32. ManufacturedItemDefinition.property:BatchUtil.type
34. ManufacturedItemDefinition.property:BatchUtil.type.text
Pattern Value | `Batch Utilization`
36. ManufacturedItemDefinition.property:BatchUtil.value[x]
Control | 1..?
Binding | The codes SHALL be taken from Batch utilization Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` )
Type | CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
38. ManufacturedItemDefinition.property:AddInfo
Slice Name | AddInfo
Definition | A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.
Short | Batch Formula Additional Information
Control | 0..1
Must Support | true
40. ManufacturedItemDefinition.property:AddInfo.type
42. ManufacturedItemDefinition.property:AddInfo.type.text
Pattern Value | `Batch Formula Additional Information`
44. ManufacturedItemDefinition.property:AddInfo.value[x]
Control | 1..?
Type | markdown
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
46. ManufacturedItemDefinition.component
Control | 1..?
Must Support | true
48. ManufacturedItemDefinition.component.type
Definition | Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined] Example: Layer, Bead, Minitablet, Capsule Shell, Coating
Short | Product Part Type
Binding | The codes SHALL be taken from Product Part Type Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` )
Must Support | true
50. ManufacturedItemDefinition.component.amount
Control | 2..2
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.amount`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ code
52. ManufacturedItemDefinition.component.amount:perBatch
Slice Name | perBatch
Definition | Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
Short | Component Quantity Per Batch
Control | 1..1
Must Support | true
54. ManufacturedItemDefinition.component.amount:perBatch.value
Control | 1..?
Must Support | true
56. ManufacturedItemDefinition.component.amount:perBatch.unit
Control | 1..?
Must Support | true
58. ManufacturedItemDefinition.component.amount:perBatch.code
Control | 1..?
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Must Support | true
60. ManufacturedItemDefinition.component.amount:percent
Slice Name | percent
Control | 1..1
Must Support | true
62. ManufacturedItemDefinition.component.amount:percent.value
Control | 1..?
Must Support | true
64. ManufacturedItemDefinition.component.amount:percent.unit
Control | 1..?
Must Support | true
66. ManufacturedItemDefinition.component.amount:percent.code
Control | 1..?
Binding | The codes SHALL be taken from Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Must Support | true
68. ManufacturedItemDefinition.component.constituent
Control | 1..?
Must Support | true
70. ManufacturedItemDefinition.component.constituent.extension
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
72. ManufacturedItemDefinition.component.constituent.extension:additional-info
Slice Name | additional-info
Definition | A placeholder for providing any comments relevant to the constituent [Source: SME Defined] Examples: Water for wet granulation - removed during process; adjusted for loss on drying, etc.* property[
Short | Drug Product Constituent Additional Information
Control | 0..1
Type | Extension(Additional Information) (Extension Type: markdown)
Must Support | true
74. ManufacturedItemDefinition.component.constituent.extension:ingredientOverage
Slice Name | ingredientOverage
Control | 0..1
Type | Extension(Overage Extension) (Complex Extension)
Must Support | true
76. ManufacturedItemDefinition.component.constituent.extension:StrengthTextual
Slice Name | StrengthTextual
Control | 0..1
Type | Extension(Product Batch Strength Textual Extension) (Extension Type: string)
Must Support | true
78. ManufacturedItemDefinition.component.constituent.amount
Control | 2..2
Must Support | true
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.amount`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ code
80. ManufacturedItemDefinition.component.constituent.amount:perBatch
Slice Name | perBatch
Definition | Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
Short | Component Quantity Per Batch
Control | 1..1
Must Support | true
82. ManufacturedItemDefinition.component.constituent.amount:perBatch.value
Control | 1..?
Must Support | true
84. ManufacturedItemDefinition.component.constituent.amount:perBatch.unit
Control | 1..?
Must Support | true
86. ManufacturedItemDefinition.component.constituent.amount:perBatch.code
Control | 1..?
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Must Support | true
88. ManufacturedItemDefinition.component.constituent.amount:percent
Slice Name | percent
Definition | Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined] Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]
Short | Quantity Percent
Control | 1..1
Must Support | true
90. ManufacturedItemDefinition.component.constituent.amount:percent.value
Control | 1..?
Must Support | true
92. ManufacturedItemDefinition.component.constituent.amount:percent.unit
Control | 1..?
Must Support | true
94. ManufacturedItemDefinition.component.constituent.amount:percent.code
Control | 1..?
Binding | The codes SHALL be taken from Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Must Support | true
96. ManufacturedItemDefinition.component.constituent.location
Definition | Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend
Short | Product Part Ingredient Physical Location
Binding | The codes SHALL be taken from Ingredient Location Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` )
Must Support | true
98. ManufacturedItemDefinition.component.constituent.hasIngredient
Control | 1..1
Type | CodeableReference(Literal Coded Reference)(Drug Product Batch Formula Ingredient)bundled
Must Support | true
100. ManufacturedItemDefinition.component.property
Control | 1..?
Type | BackboneElement
Must Support | true
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.property`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type.text
102. ManufacturedItemDefinition.component.property.type
Must Support | true
104. ManufacturedItemDefinition.component.property.type.text
Control | 1..?
Must Support | true
106. ManufacturedItemDefinition.component.property:PPiD
Slice Name | PPiD
Definition | A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet
Short | Product Part Identifier
Control | 1..1
Must Support | true
108. ManufacturedItemDefinition.component.property:PPiD.type
110. ManufacturedItemDefinition.component.property:PPiD.type.text
Pattern Value | `Product Part Identifier`
112. ManufacturedItemDefinition.component.property:PPiD.value[x]
Control | 1..?
Type | CodeableConcept(Text Only Codeable Concept)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
114. ManufacturedItemDefinition.component.property:PPiDref
Slice Name | PPiDref
Definition | Identifies the parent or outer-level product part. [Source: SME Defined] Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.
Short | Product Part Identifier Reference
Control | 0..1
Must Support | true
116. ManufacturedItemDefinition.component.property:PPiDref.type
118. ManufacturedItemDefinition.component.property:PPiDref.type.text
Pattern Value | `Product Part Identifier Reference`
120. ManufacturedItemDefinition.component.property:PPiDref.value[x]
Control | 1..?
Type | CodeableConcept(Text Only Codeable Concept)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Must Support | true
122. ManufacturedItemDefinition.component.property:AddInfo
Slice Name | AddInfo
Definition | A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.
Short | Product Part Additional Information
Control | 0..1
Must Support | true
124. ManufacturedItemDefinition.component.property:AddInfo.type
126. ManufacturedItemDefinition.component.property:AddInfo.type.text
Pattern Value | `Product Part Additional Information`
128. ManufacturedItemDefinition.component.property:AddInfo.value[x]
Control | 1..?
Type | markdown
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
130. ManufacturedItemDefinition.component.component
Must Support | true

Guidance on how to interpret the contents of this table can be foundhere

0. ManufacturedItemDefinition
Definition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.
Short | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-3: 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()`) dom-4: 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()`) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) dom-6: A resource should have narrative for robust management (`text.`div`.exists()`)
2. ManufacturedItemDefinition.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical id of this artifact
Comments | 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.
Control | 0..1
Type | id
Is Modifier | false
Must Support | false
Summary | true
4. ManufacturedItemDefinition.meta
Definition | 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.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. ManufacturedItemDefinition.implicitRules
Definition | 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.
Short | A set of rules under which this content was created
Comments | 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.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. ManufacturedItemDefinition.language
Definition | The base language in which the resource is written.
Short | Language of the resource content
Comments | 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).
Control | 0..1
Binding | The codes SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` ) IETF language tag for a human language
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. ManufacturedItemDefinition.text
Definition | 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.
Short | Text summary of the resource, for human interpretation
Comments | 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.
Control | 0..1 This element is affected by the following invariants: dom-6
Type | Narrative
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
12. ManufacturedItemDefinition.contained
Definition | 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.
Short | Contained, inline Resources
Comments | 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.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. ManufacturedItemDefinition.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
16. ManufacturedItemDefinition.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
Requirements | 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.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. ManufacturedItemDefinition.identifier
Definition | Unique identifier.
Short | optional user designated identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. ManufacturedItemDefinition.status
Definition | The status of this item. Enables tracking the life-cycle of the content.
Short | draft | active | retired | unknown
Comments | Allows filtering of manufactured items that are appropriate for use versus not.
Control | 1..1
Binding | The codes SHALL be taken from PublicationStatus (required to `http://hl7.org/fhir/ValueSet/publication-status|5.0.0` ) The lifecycle status of an artifact.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. ManufacturedItemDefinition.name
Definition | A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]
Short | Product Non-proprietary Name
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. ManufacturedItemDefinition.manufacturedDoseForm
Definition | Dose form as manufactured and before any transformation into the pharmaceutical product.
Short | Dose form as manufactured (before any necessary transformation)
Control | 1..1
Binding | The codes SHALL be taken from Manufactured Dose Form Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
26. ManufacturedItemDefinition.unitOfPresentation
Definition | The “real-world” units in which the quantity of the manufactured item is described.
Short | The “real-world” units in which the quantity of the item is described
Control | 0..1
Binding | For example codes, see UnitOfPresentation (example to `http://hl7.org/fhir/ValueSet/unit-of-presentation` ) The presentation type in which an administrable medicinal product is given to a patient.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. ManufacturedItemDefinition.manufacturer
Definition | Manufacturer of the item, one of several possible.
Short | Manufacturer of the item, one of several possible
Control | 0..*
Type | Reference(Literal Reference)(Basic Organization)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. ManufacturedItemDefinition.marketingStatus
Definition | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.
Short | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Control | 0..*
Type | MarketingStatus
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. ManufacturedItemDefinition.ingredient
Definition | The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.
Short | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
Control | 0..*
Binding | For example codes, see SNOMEDCTSubstanceCodes (example to `http://hl7.org/fhir/ValueSet/substance-codes` ) This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. ManufacturedItemDefinition.property
Definition | General characteristics of this item.
Short | General characteristics of this item
Control | 2..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type.text
36. ManufacturedItemDefinition.property.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
38. ManufacturedItemDefinition.property.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
40. ManufacturedItemDefinition.property.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
42. ManufacturedItemDefinition.property.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. ManufacturedItemDefinition.property.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
46. ManufacturedItemDefinition.property.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
48. ManufacturedItemDefinition.property.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
50. ManufacturedItemDefinition.property.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
52. ManufacturedItemDefinition.property.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 0..1
Type | Choice of: CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. ManufacturedItemDefinition.property:BatchSize
Slice Name | BatchSize
Definition | The amount of material in a specific batch size [Source: SME Defined] Example: 1000 kg
Short | Batch Quantity
Control | 1..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. ManufacturedItemDefinition.property:BatchSize.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
58. ManufacturedItemDefinition.property:BatchSize.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
60. ManufacturedItemDefinition.property:BatchSize.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
62. ManufacturedItemDefinition.property:BatchSize.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
64. ManufacturedItemDefinition.property:BatchSize.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
66. ManufacturedItemDefinition.property:BatchSize.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
68. ManufacturedItemDefinition.property:BatchSize.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
70. ManufacturedItemDefinition.property:BatchSize.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Batch Quantity`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
72. ManufacturedItemDefinition.property:BatchSize.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 1..1
Binding | The codes SHALL be taken from Units Of Measure (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure` )
Type | Quantity
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. ManufacturedItemDefinition.property:BatchSize.value[x].id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
76. ManufacturedItemDefinition.property:BatchSize.value[x].extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property.value[x].extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
78. ManufacturedItemDefinition.property:BatchSize.value[x].value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
80. ManufacturedItemDefinition.property:BatchSize.value[x].comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
82. ManufacturedItemDefinition.property:BatchSize.value[x].unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
84. ManufacturedItemDefinition.property:BatchSize.value[x].system
Definition | The identification of the system that provides the coded form of the unit.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
86. ManufacturedItemDefinition.property:BatchSize.value[x].code
Definition | A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]
Short | Quantity UOM
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 0..1 This element is affected by the following invariants: qty-3
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
88. ManufacturedItemDefinition.property:BatchUtil
Slice Name | BatchUtil
Definition | A categorization of the batch that identifies its usage. [Source: SME Defined] Examples: commercial, development.
Short | Batch Utilization
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
90. ManufacturedItemDefinition.property:BatchUtil.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
92. ManufacturedItemDefinition.property:BatchUtil.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
94. ManufacturedItemDefinition.property:BatchUtil.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
96. ManufacturedItemDefinition.property:BatchUtil.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. ManufacturedItemDefinition.property:BatchUtil.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
100. ManufacturedItemDefinition.property:BatchUtil.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
102. ManufacturedItemDefinition.property:BatchUtil.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
104. ManufacturedItemDefinition.property:BatchUtil.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Batch Utilization`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
106. ManufacturedItemDefinition.property:BatchUtil.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 1..1
Binding | The codes SHALL be taken from Batch utilization Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology` )
Type | CodeableConcept
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
108. ManufacturedItemDefinition.property:AddInfo
Slice Name | AddInfo
Definition | A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.
Short | Batch Formula Additional Information
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
110. ManufacturedItemDefinition.property:AddInfo.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
112. ManufacturedItemDefinition.property:AddInfo.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
114. ManufacturedItemDefinition.property:AddInfo.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
116. ManufacturedItemDefinition.property:AddInfo.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. ManufacturedItemDefinition.property:AddInfo.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
120. ManufacturedItemDefinition.property:AddInfo.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
122. ManufacturedItemDefinition.property:AddInfo.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
124. ManufacturedItemDefinition.property:AddInfo.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Batch Formula Additional Information`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
126. ManufacturedItemDefinition.property:AddInfo.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 1..1
Type | markdown
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
128. ManufacturedItemDefinition.component
Definition | 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.
Short | 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
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
130. ManufacturedItemDefinition.component.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
132. ManufacturedItemDefinition.component.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
134. ManufacturedItemDefinition.component.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
136. ManufacturedItemDefinition.component.type
Definition | Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined] Example: Layer, Bead, Minitablet, Capsule Shell, Coating
Short | Product Part Type
Control | 1..1
Binding | The codes SHALL be taken from Product Part Type Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
138. ManufacturedItemDefinition.component.function
Definition | The function of this component within the item e.g. delivers active ingredient, masks taste.
Short | The function of this component within the item e.g. delivers active ingredient, masks taste
Control | 0..*
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
140. ManufacturedItemDefinition.component.amount
Definition | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
Short | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Control | 2..2
Type | Quantity
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.amount`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ code
142. ManufacturedItemDefinition.component.amount:perBatch
Slice Name | perBatch
Definition | Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
Short | Component Quantity Per Batch
Control | 1..1
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
144. ManufacturedItemDefinition.component.amount:perBatch.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
146. ManufacturedItemDefinition.component.amount:perBatch.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.amount.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
148. ManufacturedItemDefinition.component.amount:perBatch.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
150. ManufacturedItemDefinition.component.amount:perBatch.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
152. ManufacturedItemDefinition.component.amount:perBatch.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
154. ManufacturedItemDefinition.component.amount:perBatch.system
Definition | The identification of the system that provides the coded form of the unit.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
156. ManufacturedItemDefinition.component.amount:perBatch.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 1..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
158. ManufacturedItemDefinition.component.amount:percent
Slice Name | percent
Definition | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
Short | The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Control | 1..1
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
160. ManufacturedItemDefinition.component.amount:percent.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
162. ManufacturedItemDefinition.component.amount:percent.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.amount.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
164. ManufacturedItemDefinition.component.amount:percent.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
166. ManufacturedItemDefinition.component.amount:percent.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
168. ManufacturedItemDefinition.component.amount:percent.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
170. ManufacturedItemDefinition.component.amount:percent.system
Definition | The identification of the system that provides the coded form of the unit.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
172. ManufacturedItemDefinition.component.amount:percent.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 1..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
174. ManufacturedItemDefinition.component.constituent
Definition | 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).
Short | 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)
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
176. ManufacturedItemDefinition.component.constituent.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
178. ManufacturedItemDefinition.component.constituent.extension
Definition | An Extension
Short | Extension
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
180. ManufacturedItemDefinition.component.constituent.extension:additional-info
Slice Name | additional-info
Definition | A placeholder for providing any comments relevant to the constituent [Source: SME Defined] Examples: Water for wet granulation - removed during process; adjusted for loss on drying, etc.* property[
Short | Drug Product Constituent Additional Information
Control | 0..1
Type | Extension(Additional Information) (Extension Type: markdown)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
182. ManufacturedItemDefinition.component.constituent.extension:ingredientOverage
Slice Name | ingredientOverage
Definition | Extension for measurements related to excess for ingredients in the batch formula.
Short | Overage Extension
Control | 0..1
Type | Extension(Overage Extension) (Complex Extension)
Is Modifier | false
Must Support | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`) cmc-overage-percent-limit: Overage percent must be less than 1.0 (`extension.where(url='proportionDecimal').single().value < 1`)
184. ManufacturedItemDefinition.component.constituent.extension:StrengthTextual
Slice Name | StrengthTextual
Definition | Extension for strength as a string for ingredients in the batch formula.
Short | Product Batch Strength Textual Extension
Control | 0..1
Type | Extension(Product Batch Strength Textual Extension) (Extension Type: string)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
186. ManufacturedItemDefinition.component.constituent.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
188. ManufacturedItemDefinition.component.constituent.amount
Definition | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
Short | The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Control | 2..2
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.amount`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ code
190. ManufacturedItemDefinition.component.constituent.amount:perBatch
Slice Name | perBatch
Definition | Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
Short | Component Quantity Per Batch
Control | 1..1
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
192. ManufacturedItemDefinition.component.constituent.amount:perBatch.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
194. ManufacturedItemDefinition.component.constituent.amount:perBatch.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.amount.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
196. ManufacturedItemDefinition.component.constituent.amount:perBatch.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
198. ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
200. ManufacturedItemDefinition.component.constituent.amount:perBatch.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
202. ManufacturedItemDefinition.component.constituent.amount:perBatch.system
Definition | The identification of the system that provides the coded form of the unit.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
204. ManufacturedItemDefinition.component.constituent.amount:perBatch.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 1..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from Non-Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
206. ManufacturedItemDefinition.component.constituent.amount:percent
Slice Name | percent
Definition | Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined] Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]
Short | Quantity Percent
Control | 1..1
Type | Quantity
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
208. ManufacturedItemDefinition.component.constituent.amount:percent.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
210. ManufacturedItemDefinition.component.constituent.amount:percent.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.constituent.amount.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
212. ManufacturedItemDefinition.component.constituent.amount:percent.value
Definition | The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Short | Numerical value (with implicit precision)
Comments | The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Control | 1..1
Type | decimal
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Precision is handled implicitly in almost all cases of measurement.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
214. ManufacturedItemDefinition.component.constituent.amount:percent.comparator
Definition | How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Short | < | <= | >= | > | ad - how to understand the value
Control | 0..1
Binding | The codes SHALL be taken from QuantityComparator (required to `http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0` ) How the Quantity should be understood and represented.
Type | code
Is Modifier | true because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Meaning if Missing | If there is no comparator, then there is no modification of the value
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
216. ManufacturedItemDefinition.component.constituent.amount:percent.unit
Definition | A human-readable form of the unit.
Short | Unit representation
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
218. ManufacturedItemDefinition.component.constituent.amount:percent.system
Definition | The identification of the system that provides the coded form of the unit.
Short | System that defines coded unit form
Control | 0..1 This element is affected by the following invariants: qty-3
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to know the system that defines the coded form of the unit.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
220. ManufacturedItemDefinition.component.constituent.amount:percent.code
Definition | A computer processable form of the unit in some unit representation system.
Short | Coded form of the unit
Comments | The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Control | 1..1 This element is affected by the following invariants: qty-3
Binding | The codes SHALL be taken from Percentage Units (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units` )
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
222. ManufacturedItemDefinition.component.constituent.location
Definition | Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend
Short | Product Part Ingredient Physical Location
Control | 0..*
Binding | The codes SHALL be taken from Ingredient Location Terminology (required to `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
224. ManufacturedItemDefinition.component.constituent.function
Definition | The function of this constituent within the component e.g. binder.
Short | The function of this constituent within the component e.g. binder
Control | 0..*
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
226. ManufacturedItemDefinition.component.constituent.hasIngredient
Definition | The ingredient that is the constituent of the given component.
Short | The ingredient that is the constituent of the given component
Control | 1..1
Type | CodeableReference(Literal Coded Reference)(Drug Product Batch Formula Ingredient)bundled
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
228. ManufacturedItemDefinition.component.property
Definition | General characteristics of this component.
Short | General characteristics of this component
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.property`. The slices areUnordered and Closed, and can be differentiated using the following discriminators: value @ type.text
230. ManufacturedItemDefinition.component.property.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
232. ManufacturedItemDefinition.component.property.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
234. ManufacturedItemDefinition.component.property.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
236. ManufacturedItemDefinition.component.property.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
238. ManufacturedItemDefinition.component.property.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
240. ManufacturedItemDefinition.component.property.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
242. ManufacturedItemDefinition.component.property.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
244. ManufacturedItemDefinition.component.property.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
246. ManufacturedItemDefinition.component.property.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 0..1
Type | Choice of: CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
248. ManufacturedItemDefinition.component.property:PPiD
Slice Name | PPiD
Definition | A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet
Short | Product Part Identifier
Control | 1..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
250. ManufacturedItemDefinition.component.property:PPiD.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
252. ManufacturedItemDefinition.component.property:PPiD.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
254. ManufacturedItemDefinition.component.property:PPiD.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
256. ManufacturedItemDefinition.component.property:PPiD.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
258. ManufacturedItemDefinition.component.property:PPiD.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
260. ManufacturedItemDefinition.component.property:PPiD.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
262. ManufacturedItemDefinition.component.property:PPiD.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
264. ManufacturedItemDefinition.component.property:PPiD.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Product Part Identifier`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
266. ManufacturedItemDefinition.component.property:PPiD.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 1..1
Type | CodeableConcept(Text Only Codeable Concept)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
268. ManufacturedItemDefinition.component.property:PPiDref
Slice Name | PPiDref
Definition | Identifies the parent or outer-level product part. [Source: SME Defined] Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.
Short | Product Part Identifier Reference
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
270. ManufacturedItemDefinition.component.property:PPiDref.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
272. ManufacturedItemDefinition.component.property:PPiDref.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
274. ManufacturedItemDefinition.component.property:PPiDref.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
276. ManufacturedItemDefinition.component.property:PPiDref.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
278. ManufacturedItemDefinition.component.property:PPiDref.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
280. ManufacturedItemDefinition.component.property:PPiDref.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
282. ManufacturedItemDefinition.component.property:PPiDref.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
284. ManufacturedItemDefinition.component.property:PPiDref.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Product Part Identifier Reference`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
286. ManufacturedItemDefinition.component.property:PPiDref.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 1..1
Type | CodeableConcept(Text Only Codeable Concept)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
288. ManufacturedItemDefinition.component.property:AddInfo
Slice Name | AddInfo
Definition | A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.
Short | Product Part Additional Information
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
290. ManufacturedItemDefinition.component.property:AddInfo.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
292. ManufacturedItemDefinition.component.property:AddInfo.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
294. ManufacturedItemDefinition.component.property:AddInfo.modifierExtension
Definition | 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).
Short | Extensions that cannot be ignored even if unrecognized
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | 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.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
296. ManufacturedItemDefinition.component.property:AddInfo.type
Definition | A code expressing the type of characteristic.
Short | A code expressing the type of characteristic
Control | 1..1
Binding | For example codes, see ProductCharacteristic (example to `http://hl7.org/fhir/ValueSet/product-characteristic-codes` ) This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
298. ManufacturedItemDefinition.component.property:AddInfo.type.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | id
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
300. ManufacturedItemDefinition.component.property:AddInfo.type.extension
Definition | 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.
Short | Additional content defined by implementations
Comments | 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `ManufacturedItemDefinition.component.property.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
302. ManufacturedItemDefinition.component.property:AddInfo.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | 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.
Control | 0..*
Type | Coding
Is Modifier | false
Summary | true
Requirements | Allows for alternative encodings within a code system, and translations to other code systems.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
304. ManufacturedItemDefinition.component.property:AddInfo.type.text
Definition | 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.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Requirements | 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.
Pattern Value | `Product Part Additional Information`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
306. ManufacturedItemDefinition.component.property:AddInfo.value[x]
Definition | A value for the characteristic.
Short | A value for the characteristic
Control | 1..1
Type | markdown
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
308. ManufacturedItemDefinition.component.component
Definition | A component that this component contains or is made from.
Short | A component that this component contains or is made from
Control | 0..*
Type | Seettp://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)