Request for updated SmPC section 4.1

Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0057. Type: deficiency. Risk: low. Category: Administrative.

Correspondence ID
COR-257
Type
deficiency
Application
SFDA-2023-0057
Authority
Saudi Food and Drug Authority
Category
Administrative
Risk
Low
Due Date
2024-12-27
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-07-01
Correspondence Body
Dear SFDA Review Team, With reference to application SFDA-2023-0057, 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
Attachments
study_report_257.pdfattachment_257_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.