Request for benefit-risk assessment addendum

Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0048. Type: deficiency. Risk: low. Category: Labeling.

Correspondence ID
COR-448
Type
deficiency
Application
MHRA-2022-0048
Authority
Medicines and Healthcare products Regulatory Agency
Category
Labeling
Risk
Low
Due Date
2025-02-17
Status
Open
Owner
James O'Brien
Created
2024-02-29
Correspondence Body
Dear MHRA Review Team, With reference to application MHRA-2022-0048, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] 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_448.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-17 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.