Deficiency letter: missing stability data for 40°C condition
Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0098. Type: information-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-098
Type
information-request
Application
Authority
South African Health Products Regulatory Authority
Category
Administrative
Risk
Medium
Due Date
2025-04-04
Status
Open
Owner
Nadia Petrova
Created
2023-05-24
Correspondence Body
Dear SAHPRA Review Team,
With reference to application SAHPRA-2022-0098, 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: 2025-04-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.