Query: container closure integrity study methodology

Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0088. Type: question. Risk: medium. Category: Labeling.

Correspondence ID
COR-588
Type
question
Application
MHRA-2022-0088
Authority
Medicines and Healthcare products Regulatory Agency
Category
Labeling
Risk
Medium
Due Date
2025-01-18
Status
Overdue
Owner
James O'Brien
Created
2022-05-07
Correspondence Body
Dear MHRA Review Team, With reference to application MHRA-2022-0088, 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
attachment_588_1.pdfdata_table_588.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-18 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.