EMA-2023-0022
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-022
Application Number
EMA-2023-0022
Procedure Type
MAA
Status
Blocked
Linked Product
Market Authorization
Saudi Arabia · EMA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-022 | NeeS | 1.4.5 | 5 | M1 (6), M2 (5), M3 (8), M4 (15), M5 (5) | Active |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-03-14 | low | Open |
| GMP inspection findings clarification | 2025-01-29 | medium | In Progress |
| Deficiency letter: missing stability data for 40°C condition | 2025-04-11 | high | Open |
| Request for benefit-risk assessment addendum | 2025-02-21 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-01-02 | high | Overdue |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-04-03 | high | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-06-16 | low | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-08-04 | low | Overdue |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| EMA-2023-0022-V022 | Type II | Submitted | 2023-12-08 |
| EMA-2023-0022-V122 | Type IB | Failed | 2023-01-30 |
| EMA-2023-0022-V222 | Major | Overdue | 2023-11-24 |
| EMA-2023-0022-V322 | Minor | In Progress | 2023-11-24 |
| EMA-2023-0022-V422 | Major | Pending | 2023-09-11 |
Inspection Readiness Risk Panel
Risk Score: 9 · Overdue commitments: 4, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.