Information request: manufacturing process change justificat
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0019. Type: commitment-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-519
Type
commitment-request
Application
Authority
Ministry of Health of Russia
Category
Labeling
Risk
Medium
Due Date
2025-04-15
Status
Open
Owner
Carlos Mendez
Created
2022-12-28
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0019, we wish to address the following:
[Detailed response body regarding request for benefit-risk assessment addendum]
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_519.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-15 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.