SAHPRA-2022-0018
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-018
Application Number
SAHPRA-2022-0018
Procedure Type
Lifecycle Extension
Status
Submitted
Linked Product
Market Authorization
India · SAHPRA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-018 | NeeS | 8.7.2 | 5 | M1 (6), M2 (7), M3 (3), M4 (6), M5 (5) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Query: container closure integrity study methodology | 2025-01-05 | medium | Draft |
| Request for benefit-risk assessment addendum | 2024-12-17 | medium | Draft |
| Deficiency letter: missing stability data for 40°C condition | 2024-12-26 | medium | In Progress |
| Information request: extractables and leachables data | 2025-04-25 | medium | Overdue |
| Information request: manufacturing process change justification | 2025-02-10 | low | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-11-07 | high | In Progress |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-052 | IFU | 8.8 | Pending |
| LBL-053 | Labeling | 20.2 | Active |
| LBL-054 | SmPC | 7.4 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| SAHPRA-2022-0018-V018 | Minor | Approved | 2024-02-23 |
| SAHPRA-2022-0018-V118 | Minor | Failed | pending |
| SAHPRA-2022-0018-V218 | Type II | In Progress | 2024-01-19 |
| SAHPRA-2022-0018-V318 | Minor | Submitted | pending |
| SAHPRA-2022-0018-V418 | Minor | Approved | 2023-07-15 |
Inspection Readiness Risk Panel
Risk Score: 0 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.