ANMAT-2020-0035
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-035
Application Number
ANMAT-2020-0035
Procedure Type
MAA
Status
Active
Linked Product
Market Authorization
Brazil · ANMAT
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-035 | eCTD | 8.6.9 | 5 | M1 (8), M2 (13), M3 (15), M4 (4), M5 (9) | Submitted |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: extractables and leachables data | 2024-12-31 | medium | Open |
| Request for benefit-risk assessment addendum | 2025-01-17 | high | Draft |
| Request for additional clinical data on primary endpoint | 2025-01-27 | high | Draft |
| Query regarding bioequivalence study design | 2025-01-26 | high | Overdue |
| Request for additional clinical data on primary endpoint | 2024-12-11 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit harmonised global label per ICH Q12 PLCR | 2025-01-29 | medium | Blocked |
| Submit final study report for paediatric use study KCL-PED-001 | 2024-11-19 | high | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-103 | IFU | 7.7 | In Progress |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANMAT-2020-0035-V035 | Minor | Approved | 2023-11-20 |
| ANMAT-2020-0035-V135 | Type IB | Pending | 2023-12-30 |
| ANMAT-2020-0035-V235 | Type II | Completed | pending |
| ANMAT-2020-0035-V335 | Type IA | In Progress | 2023-05-28 |
| ANMAT-2020-0035-V435 | Type IA | Draft | 2022-10-19 |
Inspection Readiness Risk Panel
Risk Score: 3 · Overdue commitments: 0, failed/blocked sequences: 0, high-risk questions: 3.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.