Query: container closure integrity study methodology

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0018. Type: query. Risk: medium. Category: Administrative.

Correspondence ID
COR-018
Type
query
Application
SAHPRA-2022-0018
Authority
South African Health Products Regulatory Authority
Category
Administrative
Risk
Medium
Due Date
2025-01-05
Status
Draft
Owner
Dmitri Volkov
Created
2023-12-29
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0018, we wish to address the following: [Detailed response body regarding request for benefit-risk assessment addendum] 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_18.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.