| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
RegulatedAuthorization
|
RegulatedAuthorization | |||
identifier
|
1.. | Identifier assigned by the health authority to a single medicinal product | ||
system
|
1.. | Binding: Type of Regulated Authorization ( extensible ) | ||
value
|
1.. | |||
subject
|
1.. | Reference (MedicinalProductDefinition (ePI)) | ||
|
type
|
Binding: Regulated Authorization Type identifier systems ( extensible ) | |||
|
description
|
Brief description of the authorization | |||
|
region
|
The jusrisdiction in which the authorization has been granted Binding: ISO Country two letter code ( preferred ) |
|||
|
status
|
The current status of this authorization Binding: Authorization Status ( preferred ) |
|||
|
indication
|
CodeableReference (ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition | ||
|
reference
|
1.. | |||
|
holder
|
1.. | Reference (Organization (ePI)) | ||
|
regulator
|
Reference (Organization (ePI)) | |||
|
case
|
The regulatory procedure for granting or amending a regulated authorization. | |||
identifier
|
||||
|
system
|
Binding: Case System Identifiers ( preferred ) | |||
|
type
|
Binding: Regulatory Activity Type ( preferred ) | |||
|
status
|
Binding: General Status used across ePI resources ( preferred ) | |||
|
Documentation for this format
|
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