Request for post-marketing commitment progress update
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0039. Type: information-request. Risk: low. Category: Clinical.
Correspondence ID
COR-139
Type
information-request
Application
Authority
Ministry of Health of Russia
Category
Clinical
Risk
Low
Due Date
2024-12-08
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-07-18
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0039, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_139_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.