Information request: manufacturing process change justificat
Correspondence from Ministry of Health of Russia regarding Roszdravnadzor-2021-0039. Type: information-request. Risk: low. Category: Nonclinical.
Correspondence ID
COR-039
Type
information-request
Application
Authority
Ministry of Health of Russia
Category
Nonclinical
Risk
Low
Due Date
2025-04-27
Status
Completed
Owner
Dmitri Volkov
Created
2022-04-18
Correspondence Body
Dear Roszdravnadzor Review Team,
With reference to application Roszdravnadzor-2021-0039, 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
attachment_39_1.pdf
Response Package
Response package assembled: RP-039