MOH-IL-2020-0080
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-080
Application Number
MOH-IL-2020-0080
Procedure Type
sMAA
Status
Overdue
Linked Product
Market Authorization
Argentina · MOH-IL
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-080 | eCTD | 1.5.6 | 5 | M1 (6), M2 (4), M3 (7), M4 (7), M5 (4) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2025-01-14 | low | Overdue |
| GMP inspection findings clarification | 2025-01-04 | low | Draft |
| Deficiency letter: missing stability data for 40°C condition | 2025-03-24 | medium | Overdue |
| Deficiency: inadequate paediatric data justification | 2025-02-18 | high | Open |
| Question on comparative dissolution data | 2025-01-22 | medium | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Update SmPC section 4.4 with hepatic impairment data | 2025-06-05 | high | Overdue |
| Provide confirmatory bioequivalence study for 200 mg strength | 2025-07-29 | medium | Blocked |
| Submit harmonised global label per ICH Q12 PLCR | 2024-12-31 | medium | Blocked |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-07-25 | medium | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-238 | PIL | 11.0 | Submitted |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MOH-IL-2020-0080-V080 | Minor | In Progress | pending |
| MOH-IL-2020-0080-V180 | Major | In Progress | 2022-08-12 |
| MOH-IL-2020-0080-V280 | Type IB | In Progress | pending |
| MOH-IL-2020-0080-V380 | Type II | Draft | 2023-02-20 |
| MOH-IL-2020-0080-V480 | Type IA | Blocked | 2023-01-24 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 1, failed/blocked sequences: 0, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.