COFEPRIS-2021-0014
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-014
Application Number
COFEPRIS-2021-0014
Procedure Type
MAA
Status
Pending
Linked Product
Market Authorization
Netherlands · COFEPRIS
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-014 | eCTD | 6.0.9 | 5 | M1 (12), M2 (5), M3 (4), M4 (6), M5 (11) | Blocked |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Deficiency letter: missing stability data for 40°C condition | 2025-04-22 | medium | Draft |
| Request for post-marketing commitment progress update | 2025-02-06 | high | Overdue |
| Request for additional clinical data on primary endpoint | 2025-02-23 | high | Draft |
| Query: container closure integrity study methodology | 2024-12-29 | medium | Draft |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2025-11-20 | low | Open |
| Submit harmonised global label per ICH Q12 PLCR | 2025-07-01 | medium | In Progress |
Linked Labeling and Variations
| Variation | Type | Status | Submitted |
|---|---|---|---|
| COFEPRIS-2021-0014-V014 | Type IB | Completed | 2023-11-24 |
| COFEPRIS-2021-0014-V114 | Type II | Overdue | 2023-01-31 |
| COFEPRIS-2021-0014-V214 | Major | Approved | 2023-09-24 |
| COFEPRIS-2021-0014-V314 | Type IA | In Progress | 2023-05-18 |
| COFEPRIS-2021-0014-V414 | Minor | Failed | 2023-02-22 |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 0, failed/blocked sequences: 1, high-risk questions: 2.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.