GMP inspection findings clarification
Correspondence from European Medicines Agency regarding EMA-2023-0062. Type: information-request. Risk: high. Category: Labeling.
Correspondence ID
COR-162
Type
information-request
Application
Authority
European Medicines Agency
Category
Labeling
Risk
High
Due Date
2025-03-02
Status
Overdue
Owner
Priya Sharma
Created
2023-05-18
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0062, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-02 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.