Query: container closure integrity study methodology

Correspondence from European Medicines Agency regarding EMA-2023-0062. Type: query. Risk: medium. Category: Administrative.

Correspondence ID
COR-262
Type
query
Application
EMA-2023-0062
Authority
European Medicines Agency
Category
Administrative
Risk
Medium
Due Date
2025-02-12
Status
Open
Owner
Dmitri Volkov
Created
2022-06-16
Correspondence Body
Dear EMA Review Team, With reference to application EMA-2023-0062, we wish to address the following: [Detailed response body regarding information request: extractables and leachables data] 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: 2025-02-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.