Request for post-marketing commitment progress update
Correspondence from COFEPRIS regarding COFEPRIS-2021-0014. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-114
Type
question
Application
Authority
COFEPRIS
Category
Administrative
Risk
Medium
Due Date
2025-02-08
Status
Completed
Owner
Priya Sharma
Created
2022-10-12
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0014, 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
Response Package
Response package assembled: RP-114