| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
Composition
|
Composition | |||
meta
|
||||
profile
|
S | ..1 | ||
|
identifier
|
S | ..1 | ||
|
status
|
Required Pattern: final | |||
|
type
|
Required Pattern: At least the following | |||
coding
|
1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
system
|
1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types |
|
|
code
|
1..1 | code |
Symbol in syntax defined by the system Fixed Value: 32P10 |
|
|
display
|
1..1 | string |
Representation defined by the system Fixed Value: Product Description and Composition of the Drug Product |
|
author
|
S | ..1 | Reference (Sponsor Organization) | |
|
title
|
S | |||
Slices for section
|
S | 3 .. 3 | Slice: Unordered, Open by value:code | |
section:All Slices
|
Content/Rules for all slices | |||
title
|
S | 1.. | ||
code
|
S | 1.. | Binding: eCTD sections Value Set ( required ) | |
section:ProductDescription
|
S | 1..1 | ||
code
|
Required Pattern: At least the following | |||
coding
|
1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
|
system
|
1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types |
|
|
code
|
1..1 | code |
Symbol in syntax defined by the system Fixed Value: 32P11 |
|
|
display
|
1..1 | string |
Representation defined by the system Fixed Value: Product Description |
|
entry
|
S | 1..1 | Reference (Drug Product Description) | |
|
section:ContainerClosure
|
S | 1..1 | ||
|
code
|
Required Pattern: At least the following | |||
|
coding
|
1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
|
system
|
1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types |
|
|
code
|
1..1 | code |
Symbol in syntax defined by the system Fixed Value: 32P13 |
|
|
display
|
1..1 | string |
Representation defined by the system Fixed Value: Product Container Closure Description |
|
|
entry
|
S | 1..1 | Reference (Drug Product Container Closure) | |
|
section:ProductComposition
|
S | 1..1 | ||
|
code
|
Required Pattern: At least the following | |||
|
coding
|
1..* | Coding |
Code defined by a terminology system Fixed Value: (complex) |
|
|
system
|
1..1 | uri |
Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-comp-section-types |
|
|
code
|
1..1 | code |
Symbol in syntax defined by the system Fixed Value: 32P12 |
|
|
display
|
1..1 | string |
Representation defined by the system Fixed Value: Product Composition |
|
|
entry
|
S | 1.. | Reference (Manufactured Drug Product) | |
|
Documentation for this format
|
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