Information request: extractables and leachables data
Correspondence from Israel Ministry of Health regarding MOH-IL-2020-0100. Type: commitment-request. Risk: low. Category: Clinical.
Correspondence ID
COR-500
Type
commitment-request
Application
Authority
Israel Ministry of Health
Category
Clinical
Risk
Low
Due Date
2024-12-19
Status
Open
Owner
Nadia Petrova
Created
2023-08-02
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 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_500.pdfdata_table_500.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-19 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.