| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
RegulatedAuthorization
|
RegulatedAuthorization | |||
identifier
|
1.. | Marketing authorisation number | ||
system
|
Required Pattern: http://ema.europa.eu/fhir/marketingAuthorizationNumber | |||
subject
|
1..1 | Reference (PPL Medicinal Product profile | PPL Packaged Product profile) | Reference to the medicinal product or a single package, depending on how the MA has been issued | |
|
type
|
1.. | 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: https://spor.ema.europa.eu/v1/lists/220000000060 |
|
|
code
|
1..1 | code |
Symbol in syntax defined by the system Fixed Value: 220000000061 |
|
|
display
|
1..1 | string |
Representation defined by the system Fixed Value: Marketing Authorisation |
|
|
region
|
1..1 | |||
|
coding
|
Binding: EMA SPOR Country ( required ) | |||
|
status
|
1.. |
Marketing authorisation status Binding: EMA SPOR Regulatory Entitlement Status ( required ) |
||
|
statusDate
|
Issue/changing date of the marketing authorisation | |||
|
holder
|
1.. | Reference (PPL Organization) | ||
|
Documentation for this format
|
||||