ANVISA-2020-0005
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-005
Application Number
ANVISA-2020-0005
Procedure Type
Type IB Variation
Status
Active
Linked Product
Market Authorization
Brazil · ANVISA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-005 | NeeS | 5.3.5 | 5 | M1 (12), M2 (13), M3 (12), M4 (15), M5 (14) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2025-03-31 | high | Draft |
| Deficiency: inadequate paediatric data justification | 2025-04-26 | medium | In Progress |
| Deficiency: inadequate paediatric data justification | 2025-03-22 | low | Overdue |
| Request for post-marketing commitment progress update | 2025-04-17 | medium | Overdue |
| Query: container closure integrity study methodology | 2025-02-16 | high | Open |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Complete Phase IV post-marketing observational study (n=500) | 2025-06-12 | medium | Overdue |
| Implement Risk Minimisation Measures (RMM) per REMS requirements | 2025-12-06 | medium | Open |
| Provide carcinogenicity study report for 2-year rat study | 2024-12-31 | high | Blocked |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| ANVISA-2020-0005-V005 | Type IA | Submitted | 2023-03-10 |
| ANVISA-2020-0005-V105 | Major | Draft | 2022-08-12 |
| ANVISA-2020-0005-V205 | Type II | Approved | 2023-01-13 |
| ANVISA-2020-0005-V305 | Type II | Overdue | 2022-11-23 |
| ANVISA-2020-0005-V405 | Type II | Blocked | 2023-02-25 |
Inspection Readiness Risk Panel
Risk Score: 6 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.