MHRA-2022-0028
This application view consolidates identifiers, linked product and market authorization context, dossier structure, sequence history, and active authority obligations in one place. Regulatory teams use it to understand readiness and risk before publishing new sequences or responding to open questions. Cross-links to labeling and variations maintain lifecycle traceability for post-approval changes. Inspection readiness risk is calculated from overdue commitments, failed sequences, and unresolved high-risk correspondence for immediate action.
Application ID
APP-028
Application Number
MHRA-2022-0028
Procedure Type
sMAA
Status
Failed
Linked Product
Market Authorization
Austria · MHRA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-028 | CTD | 5.8.9 | 5 | M1 (15), M2 (5), M3 (9), M4 (9), M5 (15) | Active |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for post-marketing commitment progress update | 2025-01-09 | medium | Open |
| Request for additional clinical data on primary endpoint | 2025-02-03 | low | Open |
| Request for additional clinical data on primary endpoint | 2025-03-07 | low | Draft |
| Information request: extractables and leachables data | 2024-11-29 | medium | Draft |
| Query regarding bioequivalence study design | 2025-02-16 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-12-03 | medium | Blocked |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2024-10-25 | low | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2025-09-15 | low | Blocked |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-08-26 | medium | Blocked |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MHRA-2022-0028-V028 | Minor | Submitted | 2024-05-28 |
| MHRA-2022-0028-V128 | Type II | Active | 2023-08-03 |
| MHRA-2022-0028-V228 | Type IA | In Progress | pending |
| MHRA-2022-0028-V328 | Minor | Draft | pending |
| MHRA-2022-0028-V428 | Type IB | Active | pending |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.