HC-2024-0026
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-026
Application Number
HC-2024-0026
Procedure Type
sNDA
Status
Pending
Linked Product
Market Authorization
Sweden · HC
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-026 | NeeS | 5.1.6 | 5 | M1 (11), M2 (10), M3 (11), M4 (10), M5 (7) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Request for post-marketing commitment progress update | 2025-02-18 | high | In Progress |
| Query: container closure integrity study methodology | 2025-04-16 | medium | In Progress |
| Question on comparative dissolution data | 2025-03-27 | high | Draft |
| Query regarding bioequivalence study design | 2025-05-01 | medium | In Progress |
| Request for benefit-risk assessment addendum | 2025-04-05 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-09-08 | low | Blocked |
| Complete Phase IV post-marketing observational study (n=500) | 2025-10-15 | low | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-076 | SmPC | 18.1 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| HC-2024-0026-V026 | Type IA | Blocked | 2024-02-05 |
| HC-2024-0026-V126 | Type II | Blocked | 2023-05-02 |
| HC-2024-0026-V226 | Type IA | Completed | 2023-10-21 |
| HC-2024-0026-V326 | Major | Overdue | 2024-05-28 |
| HC-2024-0026-V426 | Type II | In Progress | pending |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 0, failed/blocked sequences: 2, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.