This code system
http://hl7.org/fhir/regulated-authorization-case-type defines the following codes:
|
Code
|
Display
|
| InitialMAA
|
Initial Marketing Authorization Application |
| Variation
|
Variation |
| LineExtension
|
Line Extension |
| PSUR
|
Periodic Safety Update Report |
| Renewal
|
Renewal |
| Follow-up
|
Follow-up Measure |
| 100000155699
|
Specific Obligation |
| AnnualReassessment
|
Annual Reassessment |
| UrgentSafetyRestriction
|
Urgent Safety Restriction |
| PaediatricSubmission
|
Paediatric Submission |
| TransferMA
|
Transfer of a marketing authorization |
| LiftingSuspension
|
Lifting of a Suspension |
| Withdrawal
|
Withdrawal |
| Reformatting
|
Reformatting |
| RMP
|
Risk Management Plan |
| ReviewSuspension
|
Review of a Suspension of MA |
| SupplementalInformation
|
Supplemental Information |
| RepeatUse
|
Repeat Use Procedure |
| SignalDetection
|
Signal detection |
| FLU
|
FLU STRAIN UPDATE |
| PANDEMIC
|
PANDEMIC UPDATE |
| Orphan
|
Orphan Designation Application |