EMA-2023-0002
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-002
Application Number
EMA-2023-0002
Procedure Type
Type IA Variation
Status
Approved
Linked Product
Market Authorization
European Union · EMA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-002 | NeeS | 6.8.9 | 5 | M1 (14), M2 (4), M3 (13), M4 (4), M5 (7) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for updated SmPC section 4.1 | 2025-04-07 | medium | Draft |
| Request for benefit-risk assessment addendum | 2025-02-19 | medium | Overdue |
| Deficiency letter: missing stability data for 40°C condition | 2025-02-19 | high | In Progress |
| Question on comparative dissolution data | 2025-02-15 | low | Open |
| Query regarding bioequivalence study design | 2024-12-28 | high | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2024-12-18 | high | Overdue |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-07-26 | high | In Progress |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-10-25 | low | Open |
| Submit harmonised global label per ICH Q12 PLCR | 2025-10-12 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-004 | Labeling | 19.9 | Pending |
| LBL-005 | Labeling | 1.2 | In Progress |
| LBL-006 | IFU | 12.4 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| EMA-2023-0002-V002 | Major | Failed | 2024-02-05 |
| EMA-2023-0002-V102 | Type IB | Approved | 2023-08-10 |
| EMA-2023-0002-V202 | Type II | Pending | pending |
| EMA-2023-0002-V302 | Minor | Pending | pending |
| EMA-2023-0002-V402 | Type IB | Submitted | 2023-10-31 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.