Request for updated SmPC section 4.1
Correspondence from Health Canada regarding HC-2024-0086. Type: commitment-request. Risk: low. Category: Administrative.
Correspondence ID
COR-586
Type
commitment-request
Application
Authority
Health Canada
Category
Administrative
Risk
Low
Due Date
2025-04-02
Status
In Progress
Owner
Sarah Chen
Created
2022-05-25
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0086, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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: 2025-04-02 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.