MFDS-2020-0050
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-050
Application Number
MFDS-2020-0050
Procedure Type
sMAA
Status
Overdue
Linked Product
Market Authorization
Argentina · MFDS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-050 | NeeS | 5.3.4 | 5 | M1 (11), M2 (13), M3 (14), M4 (7), M5 (12) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| GMP inspection findings clarification | 2025-05-01 | low | Open |
| Question on comparative dissolution data | 2025-02-05 | medium | Open |
| Request for updated SmPC section 4.1 | 2025-02-15 | low | Open |
| Information request: manufacturing process change justification | 2025-01-29 | low | Open |
| Query regarding bioequivalence study design | 2025-03-05 | medium | In Progress |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2025-09-23 | low | Overdue |
| Submit harmonised global label per ICH Q12 PLCR | 2025-09-30 | medium | Blocked |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-06-05 | medium | In Progress |
| Complete Phase IV post-marketing observational study (n=500) | 2025-08-03 | high | Overdue |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MFDS-2020-0050-V050 | Type IA | Approved | 2023-01-27 |
| MFDS-2020-0050-V150 | Type IA | Draft | 2022-08-28 |
| MFDS-2020-0050-V250 | Type IB | Approved | 2024-04-04 |
| MFDS-2020-0050-V350 | Type IB | Completed | 2022-08-23 |
| MFDS-2020-0050-V450 | Type IB | Pending | 2023-12-03 |
Inspection Readiness Risk Panel
Risk Score: 8 · Overdue commitments: 2, failed/blocked sequences: 2, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.