Information request: manufacturing process change justificat
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0040. Type: question. Risk: low. Category: Administrative.
Correspondence ID
COR-240
Type
question
Application
Authority
Israel Ministry of Health
Category
Administrative
Risk
Low
Due Date
2025-03-01
Status
Overdue
Owner
Lieselotte van der Berg
Created
2022-10-17
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0040, we wish to address the following:
[Detailed response body regarding request for post-marketing commitment progress update]
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: 2025-03-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.