SAHPRA-2022-0098
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-098
Application Number
SAHPRA-2022-0098
Procedure Type
sMAA
Status
Pending
Linked Product
Market Authorization
United Kingdom · SAHPRA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-098 | eCTD | 3.4.1 | 5 | M1 (6), M2 (5), M3 (6), M4 (4), M5 (6) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-04-04 | medium | Open |
| Query regarding bioequivalence study design | 2025-03-30 | medium | In Progress |
| Question on comparative dissolution data | 2024-12-28 | medium | Overdue |
| Information request: extractables and leachables data | 2025-01-31 | low | Open |
| Request for updated SmPC section 4.1 | 2024-12-10 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Provide carcinogenicity study report for 2-year rat study | 2025-05-01 | medium | Open |
| Provide 36-month accelerated stability data for 25°C/60% RH condition | 2025-03-17 | high | Overdue |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-01-02 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-292 | SmPC | 6.2 | Approved |
| LBL-293 | SmPC | 15.0 | In Progress |
| LBL-294 | Labeling | 5.6 | Pending |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SAHPRA-2022-0098-V098 | Type II | Overdue | 2023-03-23 |
| SAHPRA-2022-0098-V198 | Type IB | Completed | 2024-06-13 |
| SAHPRA-2022-0098-V298 | Major | Approved | 2023-03-21 |
| SAHPRA-2022-0098-V398 | Major | Approved | 2024-05-24 |
| SAHPRA-2022-0098-V498 | Major | Pending | pending |
Inspection Readiness Risk Panel
Risk Score: 2 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.