Request for updated SmPC section 4.1
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0030. Type: information-request. Risk: high. Category: Quality.
Correspondence ID
COR-430
Type
information-request
Application
Authority
Ministry of Food and Drug Safety
Category
Quality
Risk
High
Due Date
2025-04-05
Status
Draft
Owner
Carlos Mendez
Created
2022-07-01
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0030, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
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: 2025-04-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.