Query: container closure integrity study methodology
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0060. Type: deficiency. Risk: medium. Category: Nonclinical.
Correspondence ID
COR-160
Type
deficiency
Application
Authority
Israel Ministry of Health
Category
Nonclinical
Risk
Medium
Due Date
2025-02-06
Status
Overdue
Owner
James O'Brien
Created
2022-07-28
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0060, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
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_160.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.