MHRA-2022-0048
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-048
Application Number
MHRA-2022-0048
Procedure Type
Type IB Variation
Status
In Progress
Linked Product
Market Authorization
India · MHRA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-048 | eCTD | 1.7.4 | 5 | M1 (13), M2 (5), M3 (7), M4 (15), M5 (9) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2025-01-11 | medium | Overdue |
| Information request: manufacturing process change justification | 2024-12-10 | medium | Draft |
| Query regarding bioequivalence study design | 2025-03-21 | medium | Open |
| Request for benefit-risk assessment addendum | 2025-02-17 | low | Open |
| Query regarding bioequivalence study design | 2024-12-17 | high | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-10-30 | high | Blocked |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-01-25 | medium | Overdue |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MHRA-2022-0048-V048 | Minor | Blocked | 2022-11-27 |
| MHRA-2022-0048-V148 | Type II | Approved | 2024-04-28 |
| MHRA-2022-0048-V248 | Minor | Pending | pending |
| MHRA-2022-0048-V348 | Type IB | Draft | pending |
| MHRA-2022-0048-V448 | Type II | Failed | pending |
Inspection Readiness Risk Panel
Risk Score: 5 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.