SwissMedic-2021-0049
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-049
Application Number
SwissMedic-2021-0049
Procedure Type
Type II Variation
Status
In Progress
Linked Product
Market Authorization
Mexico · SwissMedic
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-049 | eCTD | 1.0.9 | 5 | M1 (14), M2 (15), M3 (13), M4 (3), M5 (15) | Completed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-03-10 | medium | Open |
| Information request: manufacturing process change justification | 2025-01-08 | low | Overdue |
| Deficiency: inadequate paediatric data justification | 2025-01-24 | medium | Draft |
| Query: container closure integrity study methodology | 2025-01-16 | low | In Progress |
| Query: container closure integrity study methodology | 2025-01-13 | low | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2024-11-17 | low | Open |
| Submit final study report for paediatric use study KCL-PED-001 | 2024-11-21 | medium | Overdue |
| Complete Phase IV post-marketing observational study (n=500) | 2025-07-10 | medium | Open |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2024-10-28 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-145 | PIL | 17.5 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SwissMedic-2021-0049-V049 | Major | Failed | 2023-03-17 |
| SwissMedic-2021-0049-V149 | Type IB | Submitted | pending |
| SwissMedic-2021-0049-V249 | Type II | Active | pending |
| SwissMedic-2021-0049-V349 | Type IB | Completed | 2022-08-06 |
| SwissMedic-2021-0049-V449 | Type IB | Overdue | 2023-05-08 |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 2, failed/blocked sequences: 1, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.