Request for updated SmPC section 4.1
Correspondence from Turkish Medicines and Medical Devices Agency regarding TITCK-2024-0016. Type: commitment-request. Risk: high. Category: Administrative.
Correspondence ID
COR-016
Type
commitment-request
Application
Authority
Turkish Medicines and Medical Devices Agency
Category
Administrative
Risk
High
Due Date
2025-03-28
Status
Overdue
Owner
James O'Brien
Created
2023-02-05
Correspondence Body
Dear TITCK Review Team,
With reference to application TITCK-2024-0016, we wish to address the following:
[Detailed response body regarding information request: extractables and leachables data]
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: 2025-03-28 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.