GMP inspection findings clarification
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0100. Type: question. Risk: low. Category: Labeling.
Correspondence ID
COR-600
Type
question
Application
Authority
Israel Ministry of Health
Category
Labeling
Risk
Low
Due Date
2025-03-27
Status
Overdue
Owner
Lieselotte van der Berg
Created
2023-10-22
Correspondence Body
Dear MOH-IL Review Team,
With reference to application MOH-IL-2020-0100, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_600_1.pdfdata_table_600.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-27 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.