SwissMedic-2021-0029
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-029
Application Number
SwissMedic-2021-0029
Procedure Type
NDS
Status
Active
Linked Product
Market Authorization
Portugal · SwissMedic
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-029 | eCTD | 1.7.1 | 5 | M1 (3), M2 (3), M3 (5), M4 (9), M5 (10) | In Progress |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-01-21 | medium | In Progress |
| Query regarding bioequivalence study design | 2025-04-12 | medium | In Progress |
| Question on comparative dissolution data | 2025-04-26 | low | Draft |
| Request for benefit-risk assessment addendum | 2025-03-29 | high | In Progress |
| Query regarding bioequivalence study design | 2024-12-12 | low | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-04-21 | medium | Blocked |
| Provide carcinogenicity study report for 2-year rat study | 2025-07-28 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-085 | PIL | 11.5 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SwissMedic-2021-0029-V029 | Type II | Failed | 2022-08-18 |
| SwissMedic-2021-0029-V129 | Major | Approved | pending |
| SwissMedic-2021-0029-V229 | Type IA | Draft | pending |
| SwissMedic-2021-0029-V329 | Type II | Overdue | pending |
| SwissMedic-2021-0029-V429 | Type IB | Blocked | 2022-07-29 |
Inspection Readiness Risk Panel
Risk Score: 1 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.