MFDS-2020-0030
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-030
Application Number
MFDS-2020-0030
Procedure Type
sMAA
Status
Submitted
Linked Product
Market Authorization
Denmark · MFDS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-030 | eCTD | 7.5.3 | 5 | M1 (12), M2 (4), M3 (6), M4 (15), M5 (9) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query regarding bioequivalence study design | 2025-01-11 | medium | Open |
| Information request: manufacturing process change justification | 2025-03-06 | low | Open |
| Information request: manufacturing process change justification | 2025-02-12 | medium | In Progress |
| Request for benefit-risk assessment addendum | 2025-04-30 | high | Overdue |
| Request for updated SmPC section 4.1 | 2025-04-05 | high | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Validate analytical method for dissolution test per USP <711> | 2025-10-31 | low | Open |
| Validate analytical method for dissolution test per USP <711> | 2025-10-05 | medium | Blocked |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-06-03 | medium | Blocked |
| Validate analytical method for dissolution test per USP <711> | 2024-11-09 | medium | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-088 | IFU | 17.6 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MFDS-2020-0030-V030 | Type II | Completed | 2023-04-04 |
| MFDS-2020-0030-V130 | Minor | Active | pending |
| MFDS-2020-0030-V230 | Minor | Pending | 2022-08-13 |
| MFDS-2020-0030-V330 | Type IA | Completed | 2024-04-14 |
| MFDS-2020-0030-V430 | Minor | Submitted | pending |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.