Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions

Resource Profile: FinishedProduct - Detailed Descriptions

Draft as of 2024-03-04

Definitions for the pqcmc-product-part resource profile.

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

0. ManufacturedItemDefinition
Invariantscmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' (manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists())
cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual (property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists())
cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule (manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists())
cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists())
cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists())
cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists())
2. ManufacturedItemDefinition.meta
4. ManufacturedItemDefinition.meta.profile
Control1..1
Must Supporttrue
6. ManufacturedItemDefinition.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
8. ManufacturedItemDefinition.status
Must Supporttrue
10. ManufacturedItemDefinition.name
Definition

Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. Example: Tylenol

Product Non-proprietary Name: 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]

ShortProduct Proprietary Name | Product Non-proprietary Name
Must Supporttrue
12. ManufacturedItemDefinition.manufacturedDoseForm
14. ManufacturedItemDefinition.manufacturedDoseForm.coding
BindingThe 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
16. ManufacturedItemDefinition.property
Control5..?
Must Supporttrue
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
18. ManufacturedItemDefinition.property:OvrRelsProf
Slice NameOvrRelsProf
Control1..1
Must Supporttrue
20. ManufacturedItemDefinition.property:OvrRelsProf.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "OvrRelsProf",
    "display" : "Product Overall Release Profile"
  }]
}
22. ManufacturedItemDefinition.property:OvrRelsProf.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
24. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids). For example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the "product overall release profile" is "ER". [Source: SME Defined]

ShortProduct Overall Release Profile
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
26. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding
BindingThe codes SHALL be taken from Release Profile Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile
28. ManufacturedItemDefinition.property:OvrRelsMech
Slice NameOvrRelsMech
Control0..1
Must Supporttrue
30. ManufacturedItemDefinition.property:OvrRelsMech.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "OvrRelsMech",
    "display" : "Product Overall Release Mechanism"
  }]
}
32. ManufacturedItemDefinition.property:OvrRelsMech.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
34. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

TThe dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]

ShortProduct Overall Release Mechanism
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
36. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding
BindingThe codes SHALL be taken from Release Mechanism Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism
38. ManufacturedItemDefinition.property:CoatInd
Slice NameCoatInd
Control0..1
Must Supporttrue
40. ManufacturedItemDefinition.property:CoatInd.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CoatInd",
    "display" : "Coating Indicator"
  }]
}
42. ManufacturedItemDefinition.property:CoatInd.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
44. ManufacturedItemDefinition.property:CoatInd.value[x]:valueBoolean
Slice NamevalueBoolean
Definition

A property that identifies whether the drug product contains any coatings. [Source: SME Defined]

ShortProduct Coating Indicator
Control1..1
Typeboolean
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
46. ManufacturedItemDefinition.property:LayCnt
Slice NameLayCnt
Control0..1
Must Supporttrue
48. ManufacturedItemDefinition.property:LayCnt.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TabLayCnt",
    "display" : "Tablet Layer Count"
  }]
}
50. ManufacturedItemDefinition.property:LayCnt.value[x]
Control1..?
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
52. ManufacturedItemDefinition.property:LayCnt.value[x].value
Definition

The total number of layers in the tablet. [Source: SME Defined] Note: Non-layered tablets will be considered as one layer tablets.

ShortProduct Tablet Layer Count
54. ManufacturedItemDefinition.property:LayCnt.value[x].code
Pattern ValueC66832
56. ManufacturedItemDefinition.property:BeaTypCnt
Slice NameBeaTypCnt
Control0..1
Must Supporttrue
58. ManufacturedItemDefinition.property:BeaTypCnt.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "BeaTypCnt",
    "display" : "Tablet Bead Type Count"
  }]
}
60. ManufacturedItemDefinition.property:BeaTypCnt.value[x]
Control1..?
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
62. ManufacturedItemDefinition.property:BeaTypCnt.value[x].value
Definition

TThe total number of type of beads present in a tablet [Source: SME Defined] Example: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.

ShortTablet Bead Type Count
64. ManufacturedItemDefinition.property:BeaTypCnt.value[x].code
Pattern ValueC66832
66. ManufacturedItemDefinition.property:CapClass
Slice NameCapClass
Control0..1
Must Supporttrue
68. ManufacturedItemDefinition.property:CapClass.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CapClass",
    "display" : "Capsule Classification Category"
  }]
}
70. ManufacturedItemDefinition.property:CapClass.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
72. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]

ShortCapsule Shell Part Classification Category
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
74. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding
BindingThe codes SHALL be taken from PQ/CMC Capsule Shell Classification Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category
76. ManufacturedItemDefinition.property:CapConCnt
Slice NameCapConCnt
Control0..1
Must Supporttrue
78. ManufacturedItemDefinition.property:CapConCnt.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CapConCnt",
    "display" : "Capsule Constituent Count"
  }]
}
80. ManufacturedItemDefinition.property:CapConCnt.value[x]
Control1..?
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
82. ManufacturedItemDefinition.property:CapConCnt.value[x].value
Definition

The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined] Example: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.

ShortProduct Capsule Constituent Count
84. ManufacturedItemDefinition.property:CapConCnt.value[x].code
Pattern ValueC66832
86. ManufacturedItemDefinition.property:Schematic
Slice NameSchematic
Control1..*
Must Supporttrue
88. ManufacturedItemDefinition.property:Schematic.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "Schematic",
    "display" : "Product Schematic"
  }]
}
90. ManufacturedItemDefinition.property:Schematic.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
92. ManufacturedItemDefinition.property:Schematic.value[x]:valueAttachment
Slice NamevalueAttachment
Definition

The pictorial representation of the drug product. [Source: SME Defined]

ShortProduct Schematic
Control1..1
TypeAttachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
94. ManufacturedItemDefinition.property:WgtTyp
Slice NameWgtTyp
Control1..1
Must Supporttrue
96. ManufacturedItemDefinition.property:WgtTyp.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "WgtTyp",
    "display" : "Product Weight Type"
  }]
}
98. ManufacturedItemDefinition.property:WgtTyp.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
100. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined] Example: Mass, Activity

ShortProduct Weight Type
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
102. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding
BindingThe codes SHALL be taken from Strength Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology
104. ManufacturedItemDefinition.property:TotWgtNum
Slice NameTotWgtNum
Control1..1
Must Supporttrue
106. ManufacturedItemDefinition.property:TotWgtNum.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtNum",
    "display" : "Product Total Weight Numeric Numerator"
  }]
}
108. ManufacturedItemDefinition.property:TotWgtNum.value[x]
Control1..?
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
110. ManufacturedItemDefinition.property:TotWgtNum.value[x].value
Definition

Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a tablet or a capsule

ShortProduct Total Weight Numeric Numerator
112. ManufacturedItemDefinition.property:TotWgtNum.value[x].code
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
114. ManufacturedItemDefinition.property:TotWgtDen
Slice NameTotWgtDen
Control0..1
Must Supporttrue
116. ManufacturedItemDefinition.property:TotWgtDen.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtDen",
    "display" : "Product Total Weight Numeric Denominator"
  }]
}
118. ManufacturedItemDefinition.property:TotWgtDen.value[x]
Control1..?
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
120. ManufacturedItemDefinition.property:TotWgtDen.value[x].value
Definition

Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined] Note: For solid oral dose forms, by definition this is 1

ShortProduct Total Weight Numeric Denominator
122. ManufacturedItemDefinition.property:TotWgtDen.value[x].code
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
124. ManufacturedItemDefinition.property:TotWgtTxt
Slice NameTotWgtTxt
Control0..1
Must Supporttrue
126. ManufacturedItemDefinition.property:TotWgtTxt.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtTxt",
    "display" : "Total Weight Textual"
  }]
}
128. ManufacturedItemDefinition.property:TotWgtTxt.value[x]
Control1..?
Typemarkdown
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
130. ManufacturedItemDefinition.property:TotWgtTxt.value[x].value
Definition

A written description of the weight of the drug product. [Source: SME Defined] Note: This is typically applicable to biologics Example: International Units for Enzymes

ShortProduct Total Weight Textual
132. ManufacturedItemDefinition.property:TotWgtOper
Slice NameTotWgtOper
Control0..1
Must Supporttrue
134. ManufacturedItemDefinition.property:TotWgtOper.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtOper",
    "display" : "Total Weight Operator"
  }]
}
136. ManufacturedItemDefinition.property:TotWgtOper.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
138. ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.

ShortProduct Total Weight Operator
Control1..1
BindingThe codes SHALL be taken from Strength Operator Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
140. ManufacturedItemDefinition.property:QualStd
Slice NameQualStd
Control1..*
Must Supporttrue
142. ManufacturedItemDefinition.property:QualStd.type
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "QualStd",
    "display" : "Quality Standard"
  }]
}
144. ManufacturedItemDefinition.property:QualStd.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • type @ $this
146. ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard

ShortProduct Quality Standard
Control1..1
BindingThe codes SHALL be taken from Quality Standard Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
148. ManufacturedItemDefinition.component
Control1..?
Must Supporttrue
Invariantscmc-ppidref-required: A PPiDref is required when the PPiD is designated a child. (property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists())
cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category onstituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. (constituent.function.coding.where(code = 'C42637' and version = 'function' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies constituent.function.coding.code.count() = 2)
150. 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

ShortProduct Part Type
Must Supporttrue
152. ManufacturedItemDefinition.component.type.coding
BindingThe codes SHALL be taken from Product Part Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
154. ManufacturedItemDefinition.component.function
156. ManufacturedItemDefinition.component.function.text
Definition

The main purpose for the part in the dosage form. [Source: SME Defined] Example: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2

ShortProduct Part Function Description
Must Supporttrue
158. ManufacturedItemDefinition.component.amount
160. ManufacturedItemDefinition.component.amount.extension:WghtlDenom
Slice NameWghtlDenom
Control0..1
TypeExtension(Optional Denominator) (Extension Type: Quantity)
Must Supporttrue
162. ManufacturedItemDefinition.component.amount.value
Definition

Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule

ShortProduct Part Total Weight Numeric Numerator
Control1..?
Must Supporttrue
164. ManufacturedItemDefinition.component.amount.unit
Definition

The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055] Example: mg

ShortProduct Part Total Weight Numeric Numerator UOM
Control1..?
Must Supporttrue
166. ManufacturedItemDefinition.component.amount.code
Control1..?
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Must Supporttrue
168. ManufacturedItemDefinition.component.constituent
Control1..?
Must Supporttrue
170. ManufacturedItemDefinition.component.constituent.extension
Control1..?
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
172. ManufacturedItemDefinition.component.constituent.extension:ConstituentPercent
Slice NameConstituentPercent
Control1..1
TypeExtension(Content Percent) (Extension Type: decimal)
Must Supporttrue
174. ManufacturedItemDefinition.component.constituent.amount
Control1..1
Must Supporttrue
176. ManufacturedItemDefinition.component.constituent.amount.extension:OptionalDenom
Slice NameOptionalDenom
Control0..1
TypeExtension(Optional Denominator) (Extension Type: Quantity)
Must Supporttrue
178. ManufacturedItemDefinition.component.constituent.amount.value
Definition

Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined] Note: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule Note: Amount can also be referred to as potency in biologics and other products.

ShortProduct Part Ingredient Amount Numeric Numerator
Control1..?
Must Supporttrue
180. ManufacturedItemDefinition.component.constituent.amount.unit
Definition

The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]

ShortProduct Part Ingredient Amount Numeric Numerator UOM
Control1..?
Must Supporttrue
182. ManufacturedItemDefinition.component.constituent.amount.code
Control1..?
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Must Supporttrue
184. ManufacturedItemDefinition.component.constituent.location
Definition

Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend

ShortProduct Part Ingredient Physical Location
Must Supporttrue
186. ManufacturedItemDefinition.component.constituent.location.coding
Control1..1
BindingThe codes SHALL be taken from Product Part Ingredient Physical Location Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
Must Supporttrue
188. ManufacturedItemDefinition.component.constituent.location.text
Must Supporttrue
190. ManufacturedItemDefinition.component.constituent.function
Control1..2
Must Supporttrue
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.function. The slices are ordered and Closed, and can be differentiated using the following discriminators:
  • value @ coding
192. ManufacturedItemDefinition.component.constituent.function.coding
Control1..1
Must Supporttrue
194. ManufacturedItemDefinition.component.constituent.function:Category
Slice NameCategory
Definition

A classification that identifies the higher level purpose of that material. [Source: SME Defined] Example: Active Ingredient, Inactive Ingredient, Adjuvant.

ShortProduct Part Ingredient Component Function Category
Control1..1
Must Supporttrue
196. ManufacturedItemDefinition.component.constituent.function:Category.coding
BindingThe codes SHALL be taken from Drug Product Component Function Category Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
198. ManufacturedItemDefinition.component.constituent.function:Function
Slice NameFunction
Definition

A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined] Examples: Filler, Surfactant

ShortProduct Part Ingredient Function
Control0..1
Must Supporttrue
200. ManufacturedItemDefinition.component.constituent.function:Function.coding
BindingThe codes SHALL be taken from Excipient Function Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology
202. ManufacturedItemDefinition.component.constituent.hasIngredient
Control1..1
TypeCodeableReference(Drug Product Component)
Must Supporttrue
204. ManufacturedItemDefinition.component.property
Control3..?
Must Supporttrue
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
206. ManufacturedItemDefinition.component.property:PPiD
Slice NamePPiD
Control1..1
TypeBackboneElement
Must Supporttrue
208. ManufacturedItemDefinition.component.property:PPiD.type
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "PPiD",
    "display" : "Product Part Identifier"
  }]
}
210. ManufacturedItemDefinition.component.property:PPiD.value[x]
Control1..?
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
212. ManufacturedItemDefinition.component.property:PPiD.value[x].coding
Definition

If the Product does not have parts the Product Part Role is 'Primary'. If the Product does have parts and the Product Part does not have a Product Part Identifier Reference then the component is a 'Parent'.
If the Product does have parts and there is a Product Part Identifier Reference the component is a 'Child'.

ShortProduct Part Role
BindingThe codes SHALL be taken from Relationship Types Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs
214. ManufacturedItemDefinition.component.property:PPiD.value[x].text
Definition

A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet

ShortProduct Part Identifier
Control1..?
Must Supporttrue
216. ManufacturedItemDefinition.component.property:PPiDref
Slice NamePPiDref
Control0..1
TypeBackboneElement
Must Supporttrue
218. ManufacturedItemDefinition.component.property:PPiDref.type
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "PPiDref",
    "display" : "Product Part Identifier Reference"
  }]
}
220. ManufacturedItemDefinition.component.property:PPiDref.value[x]
Control1..?
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
222. ManufacturedItemDefinition.component.property:PPiDref.value[x].text
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.

ShortProduct Part Identifier Reference
Control1..?
Must Supporttrue
224. ManufacturedItemDefinition.component.property:RelsProf
Slice NameRelsProf
Control1..1
TypeBackboneElement
Must Supporttrue
226. ManufacturedItemDefinition.component.property:RelsProf.type
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "RelsProf",
    "display" : "Product Part Release Profile"
  }]
}
228. ManufacturedItemDefinition.component.property:RelsProf.value[x]
Definition

The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]

ShortProduct Part Release Profile
Control1..?
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
230. ManufacturedItemDefinition.component.property:RelsProf.value[x].coding
BindingThe codes SHALL be taken from Release Profile Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile
232. ManufacturedItemDefinition.component.property:RelsMech
Slice NameRelsMech
Control0..1
TypeBackboneElement
Must Supporttrue
234. ManufacturedItemDefinition.component.property:RelsMech.type
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "RelsMech",
    "display" : "Product Part Release Mechanism"
  }]
}
236. ManufacturedItemDefinition.component.property:RelsMech.value[x]
Definition

The method employed to realize the specified part release profile. [Source: SME Defined] Example: matrix or reservoir

ShortProduct Part Release Mechanism
Control1..?
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
238. ManufacturedItemDefinition.component.property:RelsMech.value[x].coding
BindingThe codes SHALL be taken from Release Mechanism Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism
240. ManufacturedItemDefinition.component.property:CoatPurpose
Slice NameCoatPurpose
Control0..*
TypeBackboneElement
Must Supporttrue
242. ManufacturedItemDefinition.component.property:CoatPurpose.type
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CoatPurpose",
    "display" : "Coating Product Part Purpose"
  }]
}
244. ManufacturedItemDefinition.component.property:CoatPurpose.value[x]
Definition

The reason the coating or covering was added. [Source: SME Defined] Examples: rate-controlling, color, release type, protective, taste masking.

ShortCoating Product Part Purpose
Control1..?
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
246. ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding
BindingThe codes SHALL be taken from Coating Purpose Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose
248. ManufacturedItemDefinition.component.property:Color
Slice NameColor
Control0..1
TypeBackboneElement
Must Supporttrue
250. ManufacturedItemDefinition.component.property:Color.type
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "Color",
    "display" : "Product Part Color Description"
  }]
}
252. ManufacturedItemDefinition.component.property:Color.value[x]
Control1..?
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
254. ManufacturedItemDefinition.component.property:Color.value[x].text
Definition

The hue or the tint of the drug product part. [Source: SME Defined] Examples: yellow, pink, blue, pale yellow.

ShortProduct Part Color Description
Control1..?
Must Supporttrue
256. ManufacturedItemDefinition.component.property:ContPercent
Slice NameContPercent
Control1..1
TypeBackboneElement
Must Supporttrue
258. ManufacturedItemDefinition.component.property:ContPercent.type
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "ContPercent",
    "display" : "Product Part Content Percent"
  }]
}
260. ManufacturedItemDefinition.component.property:ContPercent.value[x]
Definition

The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined] Example: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5

ShortProduct Part Content Percent
Control1..?
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
262. ManufacturedItemDefinition.component.property:AddInfo
Slice NameAddInfo
Control0..1
TypeBackboneElement
Must Supporttrue
264. ManufacturedItemDefinition.component.property:AddInfo.type
Must Supporttrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "AddInfo",
    "display" : "Product Part Additional Information"
  }]
}
266. ManufacturedItemDefinition.component.property:AddInfo.value[x]
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.

ShortProduct Part Additional Information
Typemarkdown
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
268. ManufacturedItemDefinition.component.component
Must Supporttrue

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

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.

ShortThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-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())
cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' (manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists())
cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual (property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists())
cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule (manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists())
cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists())
cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists())
cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists())
2. 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.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ManufacturedItemDefinition.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control10..1*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-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.

ShortA 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.

Control0..1
Typeuri
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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.

ShortContained, 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.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
10. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
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 Namesextensions, user content
Invariantsele-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())
12. ManufacturedItemDefinition.identifier
Definition

Unique identifier.

ShortUnique identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. ManufacturedItemDefinition.status
Definition

The status of this item. Enables tracking the life-cycle of the content.

Shortdraft | active | retired | unknown
Comments

Allows filtering of manufactured items that are appropriate for use versus not.

Control1..1
BindingThe codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0
(required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. ManufacturedItemDefinition.name
Definition

Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. Example: Tylenol

Product Non-proprietary Name: 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.

ShortProduct Proprietary Name | Product Non-proprietary NameA descriptive name applied to this item
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. ManufacturedItemDefinition.manufacturedDoseForm
Definition

Dose form as manufactured and before any transformation into the pharmaceutical product.

ShortDose form as manufactured (before any necessary transformation)
Control1..1
BindingFor example codes, see ManufacturedDoseFormhttp://hl7.org/fhir/ValueSet/manufactured-dose-form
(example to http://hl7.org/fhir/ValueSet/manufactured-dose-form
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. ManufacturedItemDefinition.manufacturedDoseForm.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Manufactured Dose Form Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. ManufacturedItemDefinition.property
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control50..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
24. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
26. ManufacturedItemDefinition.property.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. ManufacturedItemDefinition.property:OvrRelsProf
Slice NameOvrRelsProf
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. ManufacturedItemDefinition.property:OvrRelsProf.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
32. ManufacturedItemDefinition.property:OvrRelsProf.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "OvrRelsProf",
    "display" : "Product Overall Release Profile"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. ManufacturedItemDefinition.property:OvrRelsProf.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
36. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids). For example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the "product overall release profile" is "ER". [Source: SME Defined]


A value for the characteristic.

ShortProduct Overall Release ProfileA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Release Profile Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. ManufacturedItemDefinition.property:OvrRelsMech
Slice NameOvrRelsMech
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. ManufacturedItemDefinition.property:OvrRelsMech.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
44. ManufacturedItemDefinition.property:OvrRelsMech.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "OvrRelsMech",
    "display" : "Product Overall Release Mechanism"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. ManufacturedItemDefinition.property:OvrRelsMech.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
48. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

TThe dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]


A value for the characteristic.

ShortProduct Overall Release MechanismA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Release Mechanism Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. ManufacturedItemDefinition.property:CoatInd
Slice NameCoatInd
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. ManufacturedItemDefinition.property:CoatInd.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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:CoatInd.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CoatInd",
    "display" : "Coating Indicator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ManufacturedItemDefinition.property:CoatInd.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
Typeboolean, date, Reference(Binary), markdown, Quantity, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
60. ManufacturedItemDefinition.property:CoatInd.value[x]:valueBoolean
Slice NamevalueBoolean
Definition

A property that identifies whether the drug product contains any coatings. [Source: SME Defined]


A value for the characteristic.

ShortProduct Coating IndicatorA value for the characteristic
Control10..1
Typeboolean, date, Reference(Binary), markdown, Quantity, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. ManufacturedItemDefinition.property:LayCnt
Slice NameLayCnt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. ManufacturedItemDefinition.property:LayCnt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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.property:LayCnt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TabLayCnt",
    "display" : "Tablet Layer Count"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. ManufacturedItemDefinition.property:LayCnt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. ManufacturedItemDefinition.property:LayCnt.value[x].value
Definition

The total number of layers in the tablet. [Source: SME Defined] Note: Non-layered tablets will be considered as one layer tablets.


The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortProduct Tablet Layer CountNumerical 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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. ManufacturedItemDefinition.property:LayCnt.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. ManufacturedItemDefinition.property:LayCnt.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Pattern ValueC66832
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. ManufacturedItemDefinition.property:BeaTypCnt
Slice NameBeaTypCnt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. ManufacturedItemDefinition.property:BeaTypCnt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
80. ManufacturedItemDefinition.property:BeaTypCnt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "BeaTypCnt",
    "display" : "Tablet Bead Type Count"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. ManufacturedItemDefinition.property:BeaTypCnt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. ManufacturedItemDefinition.property:BeaTypCnt.value[x].value
Definition

TThe total number of type of beads present in a tablet [Source: SME Defined] Example: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.


The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortTablet Bead Type CountNumerical 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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. ManufacturedItemDefinition.property:BeaTypCnt.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. ManufacturedItemDefinition.property:BeaTypCnt.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Pattern ValueC66832
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. ManufacturedItemDefinition.property:CapClass
Slice NameCapClass
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. ManufacturedItemDefinition.property:CapClass.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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:CapClass.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CapClass",
    "display" : "Capsule Classification Category"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. ManufacturedItemDefinition.property:CapClass.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
98. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]


A value for the characteristic.

ShortCapsule Shell Part Classification CategoryA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see PQ/CMC Capsule Shell Classification Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. ManufacturedItemDefinition.property:CapConCnt
Slice NameCapConCnt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. ManufacturedItemDefinition.property:CapConCnt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
106. ManufacturedItemDefinition.property:CapConCnt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CapConCnt",
    "display" : "Capsule Constituent Count"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. ManufacturedItemDefinition.property:CapConCnt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. ManufacturedItemDefinition.property:CapConCnt.value[x].value
Definition

The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined] Example: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.


The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortProduct Capsule Constituent CountNumerical 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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. ManufacturedItemDefinition.property:CapConCnt.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. ManufacturedItemDefinition.property:CapConCnt.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Pattern ValueC66832
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. ManufacturedItemDefinition.property:Schematic
Slice NameSchematic
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control10..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
118. ManufacturedItemDefinition.property:Schematic.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
120. ManufacturedItemDefinition.property:Schematic.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "Schematic",
    "display" : "Product Schematic"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. ManufacturedItemDefinition.property:Schematic.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeAttachment, date, boolean, Reference(Binary), markdown, Quantity, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
124. ManufacturedItemDefinition.property:Schematic.value[x]:valueAttachment
Slice NamevalueAttachment
Definition

The pictorial representation of the drug product. [Source: SME Defined]


A value for the characteristic.

ShortProduct SchematicA value for the characteristic
Control10..1
TypeAttachment, date, boolean, Reference(Binary), markdown, Quantity, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
126. ManufacturedItemDefinition.property:WgtTyp
Slice NameWgtTyp
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. ManufacturedItemDefinition.property:WgtTyp.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
130. ManufacturedItemDefinition.property:WgtTyp.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "WgtTyp",
    "display" : "Product Weight Type"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. ManufacturedItemDefinition.property:WgtTyp.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
134. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined] Example: Mass, Activity


A value for the characteristic.

ShortProduct Weight TypeA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
136. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Strength Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
138. ManufacturedItemDefinition.property:TotWgtNum
Slice NameTotWgtNum
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. ManufacturedItemDefinition.property:TotWgtNum.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
142. ManufacturedItemDefinition.property:TotWgtNum.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtNum",
    "display" : "Product Total Weight Numeric Numerator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. ManufacturedItemDefinition.property:TotWgtNum.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. ManufacturedItemDefinition.property:TotWgtNum.value[x].value
Definition

Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a tablet or a capsule


The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortProduct Total Weight Numeric NumeratorNumerical 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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
148. ManufacturedItemDefinition.property:TotWgtNum.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
150. ManufacturedItemDefinition.property:TotWgtNum.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. ManufacturedItemDefinition.property:TotWgtDen
Slice NameTotWgtDen
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
154. ManufacturedItemDefinition.property:TotWgtDen.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
156. ManufacturedItemDefinition.property:TotWgtDen.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtDen",
    "display" : "Product Total Weight Numeric Denominator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
158. ManufacturedItemDefinition.property:TotWgtDen.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
160. ManufacturedItemDefinition.property:TotWgtDen.value[x].value
Definition

Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined] Note: For solid oral dose forms, by definition this is 1


The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortProduct Total Weight Numeric DenominatorNumerical 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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
162. ManufacturedItemDefinition.property:TotWgtDen.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
164. ManufacturedItemDefinition.property:TotWgtDen.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
166. ManufacturedItemDefinition.property:TotWgtTxt
Slice NameTotWgtTxt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
168. ManufacturedItemDefinition.property:TotWgtTxt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
170. ManufacturedItemDefinition.property:TotWgtTxt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtTxt",
    "display" : "Total Weight Textual"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
172. ManufacturedItemDefinition.property:TotWgtTxt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
Typemarkdown, date, boolean, Reference(Binary), Quantity, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
174. ManufacturedItemDefinition.property:TotWgtTxt.value[x].value
Definition

A written description of the weight of the drug product. [Source: SME Defined] Note: This is typically applicable to biologics Example: International Units for Enzymes


The actual value

ShortProduct Total Weight TextualPrimitive value for string
Control0..1
Typemarkdownstring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
Max Length1048576
176. ManufacturedItemDefinition.property:TotWgtOper
Slice NameTotWgtOper
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
178. ManufacturedItemDefinition.property:TotWgtOper.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
180. ManufacturedItemDefinition.property:TotWgtOper.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtOper",
    "display" : "Total Weight Operator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
182. ManufacturedItemDefinition.property:TotWgtOper.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
184. ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.


A value for the characteristic.

ShortProduct Total Weight OperatorA value for the characteristic
Control10..1
BindingThe codes SHALL be taken from For codes, see Strength Operator Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
186. ManufacturedItemDefinition.property:QualStd
Slice NameQualStd
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control10..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
188. ManufacturedItemDefinition.property:QualStd.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
190. ManufacturedItemDefinition.property:QualStd.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from For example codes, see Code System PQCMC Product Characteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "QualStd",
    "display" : "Quality Standard"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
192. ManufacturedItemDefinition.property:QualStd.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
194. ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard


A value for the characteristic.

ShortProduct Quality StandardA value for the characteristic
Control10..1
BindingThe codes SHALL be taken from For codes, see Quality Standard Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
196. 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.

ShortPhysical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
Control10..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child. (property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists())
cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category onstituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. (constituent.function.coding.where(code = 'C42637' and version = 'function' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies constituent.function.coding.code.count() = 2)
198. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
200. 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.

ShortProduct Part TypeDefining type of the component e.g. shell, layer, ink
Control1..1
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
202. ManufacturedItemDefinition.component.type.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe 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
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
204. ManufacturedItemDefinition.component.function
Definition

The function of this component within the item e.g. delivers active ingredient, masks taste.

ShortThe function of this component within the item e.g. delivers active ingredient, masks taste
Control0..*
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
206. ManufacturedItemDefinition.component.function.text
Definition

The main purpose for the part in the dosage form. [Source: SME Defined] Example: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2


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.

ShortProduct Part Function DescriptionPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
208. 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).

ShortThe measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Control0..*
TypeQuantity
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
210. ManufacturedItemDefinition.component.amount.extension:WghtlDenom
Slice NameWghtlDenom
Definition

Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1

ShortProduct Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
Control0..1
TypeExtension(Optional Denominator) (Extension Type: Quantity)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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())
212. ManufacturedItemDefinition.component.amount.value
Definition

Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule


The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortProduct Part Total Weight Numeric NumeratorNumerical 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).

Control10..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
214. ManufacturedItemDefinition.component.amount.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
216. ManufacturedItemDefinition.component.amount.unit
Definition

The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055] Example: mg


A human-readable form of the unit.

ShortProduct Part Total Weight Numeric Numerator UOMUnit representation
Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
218. ManufacturedItemDefinition.component.amount.code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control10..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
220. 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).

ShortA 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)
Control10..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
222. 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.

ShortExtensionAdditional 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.

Control10..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
224. ManufacturedItemDefinition.component.constituent.extension:ConstituentPercent
Slice NameConstituentPercent
Definition

The percentage of the constituent in the component. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08

ShortConstituent Content Percent
Control1..1
TypeExtension(Content Percent) (Extension Type: decimal)
Is Modifierfalse
Must Supporttrue
Invariantsele-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())
226. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
228. ManufacturedItemDefinition.component.constituent.amount
Definition

The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).

ShortThe measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Control10..1*
TypeQuantity
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
230. ManufacturedItemDefinition.component.constituent.amount.extension:OptionalDenom
Slice NameOptionalDenom
Definition

Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1

ShortProduct Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
Control0..1
TypeExtension(Optional Denominator) (Extension Type: Quantity)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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())
232. ManufacturedItemDefinition.component.constituent.amount.value
Definition

Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined] Note: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule Note: Amount can also be referred to as potency in biologics and other products.


The value of the measured amount. The value includes an implicit precision in the presentation of the value.

ShortProduct Part Ingredient Amount Numeric NumeratorNumerical 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).

Control10..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
234. ManufacturedItemDefinition.component.constituent.amount.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
236. ManufacturedItemDefinition.component.constituent.amount.unit
Definition

The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]


A human-readable form of the unit.

ShortProduct Part Ingredient Amount Numeric Numerator UOMUnit representation
Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
238. ManufacturedItemDefinition.component.constituent.amount.code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control10..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from For codes, see Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
240. 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.

ShortProduct Part Ingredient Physical LocationThe physical location of the constituent/ingredient within the component
Control0..*
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
242. ManufacturedItemDefinition.component.constituent.location.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control10..1*
BindingThe codes SHALL be taken from For codes, see Product Part Ingredient Physical Location Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
TypeCoding
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
244. ManufacturedItemDefinition.component.constituent.location.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
246. ManufacturedItemDefinition.component.constituent.function
Definition

The function of this constituent within the component e.g. binder.

ShortThe function of this constituent within the component e.g. binder
Control10..2*
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.function. The slices are ordered and Closed, and can be differentiated using the following discriminators:
  • value @ coding
248. ManufacturedItemDefinition.component.constituent.function.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control10..1*
TypeCoding
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
250. ManufacturedItemDefinition.component.constituent.function:Category
Slice NameCategory
Definition

A classification that identifies the higher level purpose of that material. [Source: SME Defined] Example: Active Ingredient, Inactive Ingredient, Adjuvant.


The function of this constituent within the component e.g. binder.

ShortProduct Part Ingredient Component Function CategoryThe function of this constituent within the component e.g. binder
Control10..1*
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
252. ManufacturedItemDefinition.component.constituent.function:Category.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Drug Product Component Function Category Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
254. ManufacturedItemDefinition.component.constituent.function:Function
Slice NameFunction
Definition

A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined] Examples: Filler, Surfactant


The function of this constituent within the component e.g. binder.

ShortProduct Part Ingredient FunctionThe function of this constituent within the component e.g. binder
Control0..1*
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
256. ManufacturedItemDefinition.component.constituent.function:Function.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Excipient Function Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
258. ManufacturedItemDefinition.component.constituent.hasIngredient
Definition

The ingredient that is the constituent of the given component.

ShortThe ingredient that is the constituent of the given component
Control10..1*
TypeCodeableReference(Drug Product Component, Ingredient)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
260. ManufacturedItemDefinition.component.property
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control30..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.property
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
262. ManufacturedItemDefinition.component.property:PPiD
Slice NamePPiD
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
264. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
266. ManufacturedItemDefinition.component.property:PPiD.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "PPiD",
    "display" : "Product Part Identifier"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
268. ManufacturedItemDefinition.component.property:PPiD.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
270. ManufacturedItemDefinition.component.property:PPiD.value[x].coding
Definition

If the Product does not have parts the Product Part Role is 'Primary'. If the Product does have parts and the Product Part does not have a Product Part Identifier Reference then the component is a 'Parent'.
If the Product does have parts and there is a Product Part Identifier Reference the component is a 'Child'.


A reference to a code defined by a terminology system.

ShortProduct Part RoleCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Relationship Types Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
272. ManufacturedItemDefinition.component.property:PPiD.value[x].text
Definition

A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet


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.

ShortProduct Part IdentifierPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
274. ManufacturedItemDefinition.component.property:PPiDref
Slice NamePPiDref
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
276. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
278. ManufacturedItemDefinition.component.property:PPiDref.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "PPiDref",
    "display" : "Product Part Identifier Reference"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
280. ManufacturedItemDefinition.component.property:PPiDref.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
282. ManufacturedItemDefinition.component.property:PPiDref.value[x].text
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.


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.

ShortProduct Part Identifier ReferencePlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
284. ManufacturedItemDefinition.component.property:RelsProf
Slice NameRelsProf
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
286. ManufacturedItemDefinition.component.property:RelsProf.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
288. ManufacturedItemDefinition.component.property:RelsProf.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "RelsProf",
    "display" : "Product Part Release Profile"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
290. ManufacturedItemDefinition.component.property:RelsProf.value[x]
Definition

The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]


A value for the characteristic.

ShortProduct Part Release ProfileA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
292. ManufacturedItemDefinition.component.property:RelsProf.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Release Profile Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
294. ManufacturedItemDefinition.component.property:RelsMech
Slice NameRelsMech
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
296. ManufacturedItemDefinition.component.property:RelsMech.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
298. ManufacturedItemDefinition.component.property:RelsMech.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "RelsMech",
    "display" : "Product Part Release Mechanism"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
300. ManufacturedItemDefinition.component.property:RelsMech.value[x]
Definition

The method employed to realize the specified part release profile. [Source: SME Defined] Example: matrix or reservoir


A value for the characteristic.

ShortProduct Part Release MechanismA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
302. ManufacturedItemDefinition.component.property:RelsMech.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Release Mechanism Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
304. ManufacturedItemDefinition.component.property:CoatPurpose
Slice NameCoatPurpose
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
306. ManufacturedItemDefinition.component.property:CoatPurpose.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
308. ManufacturedItemDefinition.component.property:CoatPurpose.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CoatPurpose",
    "display" : "Coating Product Part Purpose"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
310. ManufacturedItemDefinition.component.property:CoatPurpose.value[x]
Definition

The reason the coating or covering was added. [Source: SME Defined] Examples: rate-controlling, color, release type, protective, taste masking.


A value for the characteristic.

ShortCoating Product Part PurposeA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
312. ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from For codes, see Coating Purpose Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
314. ManufacturedItemDefinition.component.property:Color
Slice NameColor
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
316. ManufacturedItemDefinition.component.property:Color.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
318. ManufacturedItemDefinition.component.property:Color.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "Color",
    "display" : "Product Part Color Description"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
320. ManufacturedItemDefinition.component.property:Color.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control10..1
TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
322. ManufacturedItemDefinition.component.property:Color.value[x].text
Definition

The hue or the tint of the drug product part. [Source: SME Defined] Examples: yellow, pink, blue, pale yellow.


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.

ShortProduct Part Color DescriptionPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
324. ManufacturedItemDefinition.component.property:ContPercent
Slice NameContPercent
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
326. ManufacturedItemDefinition.component.property:ContPercent.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
328. ManufacturedItemDefinition.component.property:ContPercent.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "ContPercent",
    "display" : "Product Part Content Percent"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
330. ManufacturedItemDefinition.component.property:ContPercent.value[x]
Definition

The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined] Example: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5


A value for the characteristic.

ShortProduct Part Content PercentA value for the characteristic
Control10..1
TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
332. ManufacturedItemDefinition.component.property:AddInfo
Slice NameAddInfo
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
334. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
336. ManufacturedItemDefinition.component.property:AddInfo.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "AddInfo",
    "display" : "Product Part Additional Information"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
338. ManufacturedItemDefinition.component.property:AddInfo.value[x]
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.


A value for the characteristic.

ShortProduct Part Additional InformationA value for the characteristic
Control0..1
Typemarkdown, date, boolean, Reference(Binary), Quantity, Attachment, CodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
340. ManufacturedItemDefinition.component.component
Definition

A component that this component contains or is made from.

ShortA component that this component contains or is made from
Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-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 found here

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.

ShortThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-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())
cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' (manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists())
cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual (property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists())
cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule (manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists())
cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists())
cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists())
cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory (manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).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.

ShortLogical 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.

Control0..1
Typeid
Is Modifierfalse
Must Supportfalse
Summarytrue
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.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. ManufacturedItemDefinition.meta.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
8. ManufacturedItemDefinition.meta.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
10. ManufacturedItemDefinition.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

ShortVersion specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Control0..1
Typeid
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. ManufacturedItemDefinition.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

ShortWhen the resource version last changed
Comments

This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. ManufacturedItemDefinition.meta.source
Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

ShortIdentifies where the resource comes from
Comments

The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. ManufacturedItemDefinition.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control1..1
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. ManufacturedItemDefinition.meta.security
Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

ShortSecurity Labels applied to this resource
Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
(extensible to http://hl7.org/fhir/ValueSet/security-labels
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. ManufacturedItemDefinition.meta.tag
Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

ShortTags applied to this resource
Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Control0..*
BindingFor example codes, see CommonTags
(example to http://hl7.org/fhir/ValueSet/common-tags
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. 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.

ShortA 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.

Control0..1
Typeuri
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. ManufacturedItemDefinition.language
Definition

The base language in which the resource is written.

ShortLanguage 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).

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. 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.

ShortText 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.

Control0..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. 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.

ShortContained, 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.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
30. 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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
32. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
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 Namesextensions, user content
Invariantsele-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())
34. ManufacturedItemDefinition.identifier
Definition

Unique identifier.

ShortUnique identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. ManufacturedItemDefinition.status
Definition

The status of this item. Enables tracking the life-cycle of the content.

Shortdraft | active | retired | unknown
Comments

Allows filtering of manufactured items that are appropriate for use versus not.

Control1..1
BindingThe codes SHALL be taken from PublicationStatus
(required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. ManufacturedItemDefinition.name
Definition

Product Proprietary Name: The exclusive name of a drug product owned by a company under trademark law regardless of registration status with the Patent and Trademark Office (PTO). [Source: SME Defined] Note: Excludes dosage form, route of administration and strength. Example: Tylenol

Product Non-proprietary Name: 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]

ShortProduct Proprietary Name | Product Non-proprietary Name
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. ManufacturedItemDefinition.manufacturedDoseForm
Definition

Dose form as manufactured and before any transformation into the pharmaceutical product.

ShortDose form as manufactured (before any necessary transformation)
Control1..1
BindingFor example codes, see ManufacturedDoseForm
(example to http://hl7.org/fhir/ValueSet/manufactured-dose-form
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. ManufacturedItemDefinition.manufacturedDoseForm.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
44. ManufacturedItemDefinition.manufacturedDoseForm.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.manufacturedDoseForm.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
46. ManufacturedItemDefinition.manufacturedDoseForm.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe 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
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. ManufacturedItemDefinition.manufacturedDoseForm.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. ManufacturedItemDefinition.unitOfPresentation
Definition

The “real-world” units in which the quantity of the manufactured item is described.

ShortThe “real-world” units in which the quantity of the item is described
Control0..1
BindingFor example codes, see UnitOfPresentation
(example to http://hl7.org/fhir/ValueSet/unit-of-presentation
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. ManufacturedItemDefinition.manufacturer
Definition

Manufacturer of the item, one of several possible.

ShortManufacturer of the item, one of several possible
Control0..*
TypeReference(Organization)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. 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.

ShortAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Control0..*
TypeMarketingStatus
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. 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.

ShortThe ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
Control0..*
BindingFor example codes, see SNOMEDCTSubstanceCodes
(example to http://hl7.org/fhir/ValueSet/substance-codes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ManufacturedItemDefinition.property
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control5..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
60. 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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
62. 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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
64. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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.property.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. ManufacturedItemDefinition.property.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control0..1
TypeChoice of: CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. ManufacturedItemDefinition.property:OvrRelsProf
Slice NameOvrRelsProf
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. ManufacturedItemDefinition.property:OvrRelsProf.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
74. ManufacturedItemDefinition.property:OvrRelsProf.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
76. ManufacturedItemDefinition.property:OvrRelsProf.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
78. ManufacturedItemDefinition.property:OvrRelsProf.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "OvrRelsProf",
    "display" : "Product Overall Release Profile"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. ManufacturedItemDefinition.property:OvrRelsProf.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
82. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

The overall release profile is the drug release profile (e.g., IR, DR, or ER-USP nomenclature) that is achieved by the drug delivery system used in the dosage form design as evident from the pharmacokinetic plasma drug concentration versus time curve (this is currently focused on solids). For example, a capsule filled with IR and DR beads will exhibit an ER release profile as evident from the pharmacokinetic curve. In this example, the "product overall release profile" is "ER". [Source: SME Defined]

ShortProduct Overall Release Profile
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
86. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
88. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Release Profile Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. ManufacturedItemDefinition.property:OvrRelsMech
Slice NameOvrRelsMech
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. ManufacturedItemDefinition.property:OvrRelsMech.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
96. ManufacturedItemDefinition.property:OvrRelsMech.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
98. ManufacturedItemDefinition.property:OvrRelsMech.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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.property:OvrRelsMech.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "OvrRelsMech",
    "display" : "Product Overall Release Mechanism"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. ManufacturedItemDefinition.property:OvrRelsMech.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
104. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

TThe dosage form design used to achieve an ER release profile. Examples of overall release mechanisms include osmotic pump, reservoir, and matrix. [Source: SME Defined]

ShortProduct Overall Release Mechanism
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
108. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
110. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Release Mechanism Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. ManufacturedItemDefinition.property:CoatInd
Slice NameCoatInd
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. ManufacturedItemDefinition.property:CoatInd.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
118. ManufacturedItemDefinition.property:CoatInd.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
120. ManufacturedItemDefinition.property:CoatInd.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
122. ManufacturedItemDefinition.property:CoatInd.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CoatInd",
    "display" : "Coating Indicator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. ManufacturedItemDefinition.property:CoatInd.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
Typeboolean
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
126. ManufacturedItemDefinition.property:CoatInd.value[x]:valueBoolean
Slice NamevalueBoolean
Definition

A property that identifies whether the drug product contains any coatings. [Source: SME Defined]

ShortProduct Coating Indicator
Control1..1
Typeboolean
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. ManufacturedItemDefinition.property:LayCnt
Slice NameLayCnt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. ManufacturedItemDefinition.property:LayCnt.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
132. ManufacturedItemDefinition.property:LayCnt.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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.property:LayCnt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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.property:LayCnt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TabLayCnt",
    "display" : "Tablet Layer Count"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
138. ManufacturedItemDefinition.property:LayCnt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. ManufacturedItemDefinition.property:LayCnt.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
142. ManufacturedItemDefinition.property:LayCnt.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
144. ManufacturedItemDefinition.property:LayCnt.value[x].value
Definition

The total number of layers in the tablet. [Source: SME Defined] Note: Non-layered tablets will be considered as one layer tablets.

ShortProduct Tablet Layer Count
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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. ManufacturedItemDefinition.property:LayCnt.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
148. ManufacturedItemDefinition.property:LayCnt.value[x].unit
Definition

A human-readable form of the unit.

ShortUnit representation
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
150. ManufacturedItemDefinition.property:LayCnt.value[x].system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control0..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. ManufacturedItemDefinition.property:LayCnt.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Pattern ValueC66832
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
154. ManufacturedItemDefinition.property:BeaTypCnt
Slice NameBeaTypCnt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
156. ManufacturedItemDefinition.property:BeaTypCnt.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
158. ManufacturedItemDefinition.property:BeaTypCnt.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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.property:BeaTypCnt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
162. ManufacturedItemDefinition.property:BeaTypCnt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "BeaTypCnt",
    "display" : "Tablet Bead Type Count"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
164. ManufacturedItemDefinition.property:BeaTypCnt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
166. ManufacturedItemDefinition.property:BeaTypCnt.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
168. ManufacturedItemDefinition.property:BeaTypCnt.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
170. ManufacturedItemDefinition.property:BeaTypCnt.value[x].value
Definition

TThe total number of type of beads present in a tablet [Source: SME Defined] Example: For the case of a 1- layer tablet containing 2 types of beads, Tablet Bead Type Count = 2.

ShortTablet Bead Type Count
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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
172. ManufacturedItemDefinition.property:BeaTypCnt.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
174. ManufacturedItemDefinition.property:BeaTypCnt.value[x].unit
Definition

A human-readable form of the unit.

ShortUnit representation
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
176. ManufacturedItemDefinition.property:BeaTypCnt.value[x].system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control0..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
178. ManufacturedItemDefinition.property:BeaTypCnt.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Pattern ValueC66832
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
180. ManufacturedItemDefinition.property:CapClass
Slice NameCapClass
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
182. ManufacturedItemDefinition.property:CapClass.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
184. ManufacturedItemDefinition.property:CapClass.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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.property:CapClass.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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.property:CapClass.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CapClass",
    "display" : "Capsule Classification Category"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
190. ManufacturedItemDefinition.property:CapClass.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
192. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

Categorization of the capsule shell based on factors such as the shell’s barrier to water and oxygen, reactivity, and the material it is made of. [Source: SME Defined]

ShortCapsule Shell Part Classification Category
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
194. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
196. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
198. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from PQ/CMC Capsule Shell Classification Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
200. ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
202. ManufacturedItemDefinition.property:CapConCnt
Slice NameCapConCnt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
204. ManufacturedItemDefinition.property:CapConCnt.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
206. ManufacturedItemDefinition.property:CapConCnt.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
208. ManufacturedItemDefinition.property:CapConCnt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
210. ManufacturedItemDefinition.property:CapConCnt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CapConCnt",
    "display" : "Capsule Constituent Count"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
212. ManufacturedItemDefinition.property:CapConCnt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
214. ManufacturedItemDefinition.property:CapConCnt.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
216. ManufacturedItemDefinition.property:CapConCnt.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
218. ManufacturedItemDefinition.property:CapConCnt.value[x].value
Definition

The number of distinct constituents contained in the capsule shell of the drug product. [Source: SME Defined] Example: For the case of a capsule shell filled with one type of bead and a minitablet, Constituent Type Count = 2.

ShortProduct Capsule Constituent Count
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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
220. ManufacturedItemDefinition.property:CapConCnt.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
222. ManufacturedItemDefinition.property:CapConCnt.value[x].unit
Definition

A human-readable form of the unit.

ShortUnit representation
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
224. ManufacturedItemDefinition.property:CapConCnt.value[x].system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control0..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
226. ManufacturedItemDefinition.property:CapConCnt.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Pattern ValueC66832
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
228. ManufacturedItemDefinition.property:Schematic
Slice NameSchematic
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
230. ManufacturedItemDefinition.property:Schematic.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
232. ManufacturedItemDefinition.property:Schematic.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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.property:Schematic.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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.property:Schematic.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "Schematic",
    "display" : "Product Schematic"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
238. ManufacturedItemDefinition.property:Schematic.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeAttachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
240. ManufacturedItemDefinition.property:Schematic.value[x]:valueAttachment
Slice NamevalueAttachment
Definition

The pictorial representation of the drug product. [Source: SME Defined]

ShortProduct Schematic
Control1..1
TypeAttachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
242. ManufacturedItemDefinition.property:WgtTyp
Slice NameWgtTyp
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
244. ManufacturedItemDefinition.property:WgtTyp.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
246. ManufacturedItemDefinition.property:WgtTyp.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
248. ManufacturedItemDefinition.property:WgtTyp.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
250. ManufacturedItemDefinition.property:WgtTyp.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "WgtTyp",
    "display" : "Product Weight Type"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
252. ManufacturedItemDefinition.property:WgtTyp.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
254. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A physical (content) or activity measurement of the weight of the drug product unit. [Source: SME Defined] Example: Mass, Activity

ShortProduct Weight Type
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
256. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
258. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
260. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Strength Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
262. ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
264. ManufacturedItemDefinition.property:TotWgtNum
Slice NameTotWgtNum
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
266. ManufacturedItemDefinition.property:TotWgtNum.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
268. ManufacturedItemDefinition.property:TotWgtNum.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
270. ManufacturedItemDefinition.property:TotWgtNum.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
272. ManufacturedItemDefinition.property:TotWgtNum.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtNum",
    "display" : "Product Total Weight Numeric Numerator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
274. ManufacturedItemDefinition.property:TotWgtNum.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
276. ManufacturedItemDefinition.property:TotWgtNum.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
278. ManufacturedItemDefinition.property:TotWgtNum.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
280. ManufacturedItemDefinition.property:TotWgtNum.value[x].value
Definition

Specifies the total quantity of all ingredients in a single unit of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a tablet or a capsule

ShortProduct Total Weight Numeric Numerator
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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
282. ManufacturedItemDefinition.property:TotWgtNum.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
284. ManufacturedItemDefinition.property:TotWgtNum.value[x].unit
Definition

A human-readable form of the unit.

ShortUnit representation
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
286. ManufacturedItemDefinition.property:TotWgtNum.value[x].system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control0..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
288. ManufacturedItemDefinition.property:TotWgtNum.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
290. ManufacturedItemDefinition.property:TotWgtDen
Slice NameTotWgtDen
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
292. ManufacturedItemDefinition.property:TotWgtDen.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
294. ManufacturedItemDefinition.property:TotWgtDen.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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.property:TotWgtDen.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
298. ManufacturedItemDefinition.property:TotWgtDen.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtDen",
    "display" : "Product Total Weight Numeric Denominator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
300. ManufacturedItemDefinition.property:TotWgtDen.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
302. ManufacturedItemDefinition.property:TotWgtDen.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
304. ManufacturedItemDefinition.property:TotWgtDen.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
306. ManufacturedItemDefinition.property:TotWgtDen.value[x].value
Definition

Specifies the quantity of the ingredient (s) consistent with a single unit dose or as expressed on the label. [Source: SME Defined] Note: For solid oral dose forms, by definition this is 1

ShortProduct Total Weight Numeric Denominator
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).

Control0..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
308. ManufacturedItemDefinition.property:TotWgtDen.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
310. ManufacturedItemDefinition.property:TotWgtDen.value[x].unit
Definition

A human-readable form of the unit.

ShortUnit representation
Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
312. ManufacturedItemDefinition.property:TotWgtDen.value[x].system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control0..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
314. ManufacturedItemDefinition.property:TotWgtDen.value[x].code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control0..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
316. ManufacturedItemDefinition.property:TotWgtTxt
Slice NameTotWgtTxt
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
318. ManufacturedItemDefinition.property:TotWgtTxt.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
320. ManufacturedItemDefinition.property:TotWgtTxt.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
322. ManufacturedItemDefinition.property:TotWgtTxt.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
324. ManufacturedItemDefinition.property:TotWgtTxt.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtTxt",
    "display" : "Total Weight Textual"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
326. ManufacturedItemDefinition.property:TotWgtTxt.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
Typemarkdown
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
328. ManufacturedItemDefinition.property:TotWgtTxt.value[x].id
Definition

unique id for the element within a resource (for internal references)

Shortxml:id (or equivalent in JSON)
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
330. ManufacturedItemDefinition.property:TotWgtTxt.value[x].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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
332. ManufacturedItemDefinition.property:TotWgtTxt.value[x].value
Definition

A written description of the weight of the drug product. [Source: SME Defined] Note: This is typically applicable to biologics Example: International Units for Enzymes

ShortProduct Total Weight Textual
Control0..1
Typemarkdown
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
334. ManufacturedItemDefinition.property:TotWgtOper
Slice NameTotWgtOper
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
336. ManufacturedItemDefinition.property:TotWgtOper.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
338. ManufacturedItemDefinition.property:TotWgtOper.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
340. ManufacturedItemDefinition.property:TotWgtOper.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
342. ManufacturedItemDefinition.property:TotWgtOper.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "TotWgtOper",
    "display" : "Total Weight Operator"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
344. ManufacturedItemDefinition.property:TotWgtOper.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
346. ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

A mathematical symbol that denotes equality or inequality between two values. [Source: SME Defined] Examples: LT, EQ, NMT. Note: This is typically applicable to biologics.

ShortProduct Total Weight Operator
Control1..1
BindingThe codes SHALL be taken from Strength Operator Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
348. ManufacturedItemDefinition.property:QualStd
Slice NameQualStd
Definition

General characteristics of this item.

ShortGeneral characteristics of this item
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
350. ManufacturedItemDefinition.property:QualStd.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
352. ManufacturedItemDefinition.property:QualStd.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
354. ManufacturedItemDefinition.property:QualStd.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
356. ManufacturedItemDefinition.property:QualStd.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingThe codes SHALL be taken from Code System PQCMC Product Characteristic
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "QualStd",
    "display" : "Quality Standard"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
358. ManufacturedItemDefinition.property:QualStd.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
360. ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept
Slice NamevalueCodeableConcept
Definition

The established benchmark to which the component complies. [Source: SME Defined] Examples: USP/NF, EP, Company Standard

ShortProduct Quality Standard
Control1..1
BindingThe codes SHALL be taken from Quality Standard Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
362. 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.

ShortPhysical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child. (property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists())
cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category onstituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. (constituent.function.coding.where(code = 'C42637' and version = 'function' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies constituent.function.coding.code.count() = 2)
364. 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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
366. 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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
368. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
370. 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

ShortProduct Part Type
Control1..1
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
372. ManufacturedItemDefinition.component.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
374. ManufacturedItemDefinition.component.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
376. ManufacturedItemDefinition.component.type.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Product Part Type Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
378. ManufacturedItemDefinition.component.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
380. ManufacturedItemDefinition.component.function
Definition

The function of this component within the item e.g. delivers active ingredient, masks taste.

ShortThe function of this component within the item e.g. delivers active ingredient, masks taste
Control0..*
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
382. ManufacturedItemDefinition.component.function.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
384. ManufacturedItemDefinition.component.function.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.function.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
386. ManufacturedItemDefinition.component.function.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
388. ManufacturedItemDefinition.component.function.text
Definition

The main purpose for the part in the dosage form. [Source: SME Defined] Example: In a two layer tablet with two APIs: Product Part Function Description for Layer 1 = Deliver API 1 and Product Part Function Description for Layer 2 = Deliver API 2

ShortProduct Part Function Description
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
390. 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).

ShortThe measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
Control0..*
TypeQuantity
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
392. ManufacturedItemDefinition.component.amount.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
394. ManufacturedItemDefinition.component.amount.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.amount.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
396. ManufacturedItemDefinition.component.amount.extension:WghtlDenom
Slice NameWghtlDenom
Definition

Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1

ShortProduct Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
Control0..1
TypeExtension(Optional Denominator) (Extension Type: Quantity)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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())
398. ManufacturedItemDefinition.component.amount.value
Definition

Specifies the total quantity of all ingredients in a single part of the drug product. [Source: SME Defined] Note: a single unit of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule

ShortProduct Part Total Weight Numeric Numerator
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).

Control1..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
400. ManufacturedItemDefinition.component.amount.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
402. ManufacturedItemDefinition.component.amount.unit
Definition

The labeled unit of measure for the content of the drug product, expressed quantitatively per dosage unit. [Source: Adapted for NCI E C117055] Example: mg

ShortProduct Part Total Weight Numeric Numerator UOM
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
404. ManufacturedItemDefinition.component.amount.system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control0..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
406. ManufacturedItemDefinition.component.amount.code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control1..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
408. 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).

ShortA 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)
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
410. 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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
412. ManufacturedItemDefinition.component.constituent.extension
Definition

An Extension

ShortExtension
Control1..*
TypeExtension
Is Modifierfalse
Summaryfalse
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
414. ManufacturedItemDefinition.component.constituent.extension:ConstituentPercent
Slice NameConstituentPercent
Definition

The percentage of the constituent in the component. [Source: SME Defined] Example: Product Total Weight = 1200 mg and Product Ingredient Amount = 325 mg, so Product Ingredient Content Percent = 27.08

ShortConstituent Content Percent
Control1..1
TypeExtension(Content Percent) (Extension Type: decimal)
Is Modifierfalse
Must Supporttrue
Invariantsele-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())
416. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
418. ManufacturedItemDefinition.component.constituent.amount
Definition

The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).

ShortThe measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
Control1..1
TypeQuantity
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
420. ManufacturedItemDefinition.component.constituent.amount.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
422. ManufacturedItemDefinition.component.constituent.amount.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.amount.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
424. ManufacturedItemDefinition.component.constituent.amount.extension:OptionalDenom
Slice NameOptionalDenom
Definition

Specifies the quantity of the ingredient(s) consistent with this single dose unit (e.g., one tablet, capsule) of drug product. [Source: SME Defined] Example: if the tablet contains 325 mg of the ingredient in each unit dose, then Product Ingredient Numeric Denominator = 1

ShortProduct Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator
Control0..1
TypeExtension(Optional Denominator) (Extension Type: Quantity)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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())
426. ManufacturedItemDefinition.component.constituent.amount.value
Definition

Specifies the quantity of an ingredient in a single part of the drug product. [Source: SME Defined] Note: a single part of a solid oral dose form could be a layer of a tablet or a minitablet in a capsule Note: Amount can also be referred to as potency in biologics and other products.

ShortProduct Part Ingredient Amount Numeric Numerator
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).

Control1..1
Typedecimal
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

Precision is handled implicitly in almost all cases of measurement.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
428. ManufacturedItemDefinition.component.constituent.amount.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
Control0..1
BindingThe codes SHALL be taken from QuantityComparator
(required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 MissingIf there is no comparator, then there is no modification of the value
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
430. ManufacturedItemDefinition.component.constituent.amount.unit
Definition

The labeled unit of measure for the content of an ingredient, expressed quantitatively per product part. [Source: Adapted for NCI EVS C117055]

ShortProduct Part Ingredient Amount Numeric Numerator UOM
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
432. ManufacturedItemDefinition.component.constituent.amount.system
Definition

The identification of the system that provides the coded form of the unit.

ShortSystem that defines coded unit form
Control0..1
This element is affected by the following invariants: qty-3
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to know the system that defines the coded form of the unit.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
434. ManufacturedItemDefinition.component.constituent.amount.code
Definition

A computer processable form of the unit in some unit representation system.

ShortCoded 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.

Control1..1
This element is affected by the following invariants: qty-3
BindingThe codes SHALL be taken from Units Of Measure Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
436. ManufacturedItemDefinition.component.constituent.location
Definition

Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend

ShortProduct Part Ingredient Physical Location
Control0..*
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
438. ManufacturedItemDefinition.component.constituent.location.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
440. ManufacturedItemDefinition.component.constituent.location.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.location.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
442. ManufacturedItemDefinition.component.constituent.location.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control1..1
BindingThe codes SHALL be taken from Product Part Ingredient Physical Location Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
TypeCoding
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
444. ManufacturedItemDefinition.component.constituent.location.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
446. ManufacturedItemDefinition.component.constituent.function
Definition

The function of this constituent within the component e.g. binder.

ShortThe function of this constituent within the component e.g. binder
Control1..2
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.function. The slices are ordered and Closed, and can be differentiated using the following discriminators:
  • value @ coding
448. ManufacturedItemDefinition.component.constituent.function.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
450. ManufacturedItemDefinition.component.constituent.function.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.function.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
452. ManufacturedItemDefinition.component.constituent.function.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control1..1
TypeCoding
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
454. ManufacturedItemDefinition.component.constituent.function.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
456. ManufacturedItemDefinition.component.constituent.function:Category
Slice NameCategory
Definition

A classification that identifies the higher level purpose of that material. [Source: SME Defined] Example: Active Ingredient, Inactive Ingredient, Adjuvant.

ShortProduct Part Ingredient Component Function Category
Control1..1
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
458. ManufacturedItemDefinition.component.constituent.function:Category.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
460. ManufacturedItemDefinition.component.constituent.function:Category.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.function.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
462. ManufacturedItemDefinition.component.constituent.function:Category.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Drug Product Component Function Category Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
464. ManufacturedItemDefinition.component.constituent.function:Category.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
466. ManufacturedItemDefinition.component.constituent.function:Function
Slice NameFunction
Definition

A sub-classification of part ingredients identifying its purpose/role in the drug product part (e.g., in the layer, bead, minitablet). [Source: SME Defined] Examples: Filler, Surfactant

ShortProduct Part Ingredient Function
Control0..1
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
468. ManufacturedItemDefinition.component.constituent.function:Function.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
470. ManufacturedItemDefinition.component.constituent.function:Function.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.constituent.function.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
472. ManufacturedItemDefinition.component.constituent.function:Function.coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Excipient Function Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
474. ManufacturedItemDefinition.component.constituent.function:Function.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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
476. ManufacturedItemDefinition.component.constituent.hasIngredient
Definition

The ingredient that is the constituent of the given component.

ShortThe ingredient that is the constituent of the given component
Control1..1
TypeCodeableReference(Drug Product Component)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
478. ManufacturedItemDefinition.component.property
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control3..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.property
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
480. ManufacturedItemDefinition.component.property:PPiD
Slice NamePPiD
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
482. 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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
484. 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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
486. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
488. ManufacturedItemDefinition.component.property:PPiD.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "PPiD",
    "display" : "Product Part Identifier"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
490. ManufacturedItemDefinition.component.property:PPiD.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
492. ManufacturedItemDefinition.component.property:PPiD.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
494. ManufacturedItemDefinition.component.property:PPiD.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
496. ManufacturedItemDefinition.component.property:PPiD.value[x].coding
Definition

If the Product does not have parts the Product Part Role is 'Primary'. If the Product does have parts and the Product Part does not have a Product Part Identifier Reference then the component is a 'Parent'.
If the Product does have parts and there is a Product Part Identifier Reference the component is a 'Child'.

ShortProduct Part Role
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.

Control0..*
BindingThe codes SHALL be taken from Relationship Types Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
498. ManufacturedItemDefinition.component.property:PPiD.value[x].text
Definition

A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet

ShortProduct Part Identifier
Comments

Very often the text is the same as a displayName of one of the codings.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
500. ManufacturedItemDefinition.component.property:PPiDref
Slice NamePPiDref
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
502. 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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
504. 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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
506. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
508. ManufacturedItemDefinition.component.property:PPiDref.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "PPiDref",
    "display" : "Product Part Identifier Reference"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
510. ManufacturedItemDefinition.component.property:PPiDref.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
512. ManufacturedItemDefinition.component.property:PPiDref.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
514. ManufacturedItemDefinition.component.property:PPiDref.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
516. ManufacturedItemDefinition.component.property:PPiDref.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
518. ManufacturedItemDefinition.component.property:PPiDref.value[x].text
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.

ShortProduct Part Identifier Reference
Comments

Very often the text is the same as a displayName of one of the codings.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
520. ManufacturedItemDefinition.component.property:RelsProf
Slice NameRelsProf
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
522. ManufacturedItemDefinition.component.property:RelsProf.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
524. ManufacturedItemDefinition.component.property:RelsProf.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
526. ManufacturedItemDefinition.component.property:RelsProf.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
528. ManufacturedItemDefinition.component.property:RelsProf.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "RelsProf",
    "display" : "Product Part Release Profile"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
530. ManufacturedItemDefinition.component.property:RelsProf.value[x]
Definition

The behavior in which drug substance migrates from the drug product part to the surrounding environment (e.g., biological fluids, dissolution media, etc.) [Source: SME Defined]

ShortProduct Part Release Profile
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
532. ManufacturedItemDefinition.component.property:RelsProf.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
534. ManufacturedItemDefinition.component.property:RelsProf.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
536. ManufacturedItemDefinition.component.property:RelsProf.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Release Profile Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
538. ManufacturedItemDefinition.component.property:RelsProf.value[x].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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
540. ManufacturedItemDefinition.component.property:RelsMech
Slice NameRelsMech
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
542. ManufacturedItemDefinition.component.property:RelsMech.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
544. ManufacturedItemDefinition.component.property:RelsMech.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
546. ManufacturedItemDefinition.component.property:RelsMech.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
548. ManufacturedItemDefinition.component.property:RelsMech.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "RelsMech",
    "display" : "Product Part Release Mechanism"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
550. ManufacturedItemDefinition.component.property:RelsMech.value[x]
Definition

The method employed to realize the specified part release profile. [Source: SME Defined] Example: matrix or reservoir

ShortProduct Part Release Mechanism
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
552. ManufacturedItemDefinition.component.property:RelsMech.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
554. ManufacturedItemDefinition.component.property:RelsMech.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
556. ManufacturedItemDefinition.component.property:RelsMech.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Release Mechanism Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
558. ManufacturedItemDefinition.component.property:RelsMech.value[x].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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
560. ManufacturedItemDefinition.component.property:CoatPurpose
Slice NameCoatPurpose
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
562. ManufacturedItemDefinition.component.property:CoatPurpose.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
564. ManufacturedItemDefinition.component.property:CoatPurpose.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
566. ManufacturedItemDefinition.component.property:CoatPurpose.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
568. ManufacturedItemDefinition.component.property:CoatPurpose.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "CoatPurpose",
    "display" : "Coating Product Part Purpose"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
570. ManufacturedItemDefinition.component.property:CoatPurpose.value[x]
Definition

The reason the coating or covering was added. [Source: SME Defined] Examples: rate-controlling, color, release type, protective, taste masking.

ShortCoating Product Part Purpose
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
572. ManufacturedItemDefinition.component.property:CoatPurpose.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
574. ManufacturedItemDefinition.component.property:CoatPurpose.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
576. ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
BindingThe codes SHALL be taken from Coating Purpose Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
578. ManufacturedItemDefinition.component.property:CoatPurpose.value[x].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.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
580. ManufacturedItemDefinition.component.property:Color
Slice NameColor
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
582. ManufacturedItemDefinition.component.property:Color.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
584. ManufacturedItemDefinition.component.property:Color.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
586. ManufacturedItemDefinition.component.property:Color.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
588. ManufacturedItemDefinition.component.property:Color.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "Color",
    "display" : "Product Part Color Description"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
590. ManufacturedItemDefinition.component.property:Color.value[x]
Definition

A value for the characteristic.

ShortA value for the characteristic
Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
592. ManufacturedItemDefinition.component.property:Color.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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
594. ManufacturedItemDefinition.component.property:Color.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ManufacturedItemDefinition.component.property.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
596. ManufacturedItemDefinition.component.property:Color.value[x].coding
Definition

A reference to a code defined by a terminology system.

ShortCode 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.

Control0..*
TypeCoding
Is Modifierfalse
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
598. ManufacturedItemDefinition.component.property:Color.value[x].text
Definition

The hue or the tint of the drug product part. [Source: SME Defined] Examples: yellow, pink, blue, pale yellow.

ShortProduct Part Color Description
Comments

Very often the text is the same as a displayName of one of the codings.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
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.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
600. ManufacturedItemDefinition.component.property:ContPercent
Slice NameContPercent
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
602. ManufacturedItemDefinition.component.property:ContPercent.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
604. ManufacturedItemDefinition.component.property:ContPercent.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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
606. ManufacturedItemDefinition.component.property:ContPercent.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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
608. ManufacturedItemDefinition.component.property:ContPercent.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "ContPercent",
    "display" : "Product Part Content Percent"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
610. ManufacturedItemDefinition.component.property:ContPercent.value[x]
Definition

The percentage of the drug product as a whole, that is represented by this part. [Source: SME Defined] Example: total tablet weight = 400 mg, total weight of layer = 250 mg, then Content Percent for the layer = 62.5

ShortProduct Part Content Percent
Control1..1
TypeQuantity
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
612. ManufacturedItemDefinition.component.property:AddInfo
Slice NameAddInfo
Definition

General characteristics of this component.

ShortGeneral characteristics of this component
Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
614. 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.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
616. 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.

ShortAdditional 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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
618. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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())
620. ManufacturedItemDefinition.component.property:AddInfo.type
Definition

A code expressing the type of characteristic.

ShortA code expressing the type of characteristic
Control1..1
BindingFor example codes, see ProductCharacteristic
(example to http://hl7.org/fhir/ValueSet/product-characteristic-codes
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
    "code" : "AddInfo",
    "display" : "Product Part Additional Information"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
622. ManufacturedItemDefinition.component.property:AddInfo.value[x]
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.

ShortProduct Part Additional Information
Control0..1
Typemarkdown
[x] NoteSee Choice of Data Types for further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
624. ManufacturedItemDefinition.component.component
Definition

A component that this component contains or is made from.

ShortA component that this component contains or is made from
Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))