MFDS-2020-0070
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-070
Application Number
MFDS-2020-0070
Procedure Type
Label Update
Status
Submitted
Linked Product
Market Authorization
Germany · MFDS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-070 | eCTD | 1.8.3 | 5 | M1 (3), M2 (7), M3 (5), M4 (15), M5 (13) | Active |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency: inadequate paediatric data justification | 2024-12-17 | high | In Progress |
| Deficiency letter: missing stability data for 40°C condition | 2025-01-30 | low | Open |
| Query: container closure integrity study methodology | 2024-12-22 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-09-11 | low | In Progress |
| Provide carcinogenicity study report for 2-year rat study | 2025-01-19 | high | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-01-22 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-208 | SmPC | 15.5 | Pending |
| LBL-209 | PIL | 7.4 | Pending |
| LBL-210 | Labeling | 12.6 | Active |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MFDS-2020-0070-V070 | Type IA | Failed | 2022-11-01 |
| MFDS-2020-0070-V170 | Type IB | Overdue | 2023-12-14 |
| MFDS-2020-0070-V270 | Type IB | Failed | 2023-01-01 |
| MFDS-2020-0070-V370 | Major | Failed | 2023-10-25 |
| MFDS-2020-0070-V470 | Type IA | Approved | 2023-12-01 |
Inspection Readiness Risk Panel
Risk Score: 11 · Overdue commitments: 2, failed/blocked sequences: 3, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.