Request for post-marketing commitment progress update

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0038. Type: information-request. Risk: medium. Category: Labeling.

Correspondence ID
COR-538
Type
information-request
Application
SAHPRA-2022-0038
Authority
South African Health Products Regulatory Authority
Category
Labeling
Risk
Medium
Due Date
2025-01-28
Status
Draft
Owner
Tomoko Ikeda
Created
2022-12-03
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0038, we wish to address the following: [Detailed response body regarding information request: manufacturing process change justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
data_table_538.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-28 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.