MOH-IL-2020-0020
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-020
Application Number
MOH-IL-2020-0020
Procedure Type
NDA
Status
Blocked
Linked Product
Market Authorization
Argentina · MOH-IL
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-020 | eCTD | 8.4.4 | 5 | M1 (14), M2 (8), M3 (6), M4 (4), M5 (9) | Approved |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Question on comparative dissolution data | 2025-04-30 | high | In Progress |
| Query regarding bioequivalence study design | 2025-04-26 | low | Open |
| Deficiency: inadequate paediatric data justification | 2024-12-30 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Validate analytical method for dissolution test per USP <711> | 2025-03-01 | low | In Progress |
| Provide confirmatory bioequivalence study for 200 mg strength | 2026-01-09 | high | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-12-11 | medium | Overdue |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-058 | Labeling | 9.2 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| MOH-IL-2020-0020-V020 | Type II | Blocked | 2023-07-22 |
| MOH-IL-2020-0020-V120 | Type IB | Blocked | pending |
| MOH-IL-2020-0020-V220 | Major | Approved | 2023-06-28 |
| MOH-IL-2020-0020-V320 | Minor | Approved | 2023-04-27 |
| MOH-IL-2020-0020-V420 | Minor | Failed | pending |
Inspection Readiness Risk Panel
Risk Score: 7 · Overdue commitments: 2, failed/blocked sequences: 1, high-risk questions: 1.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.