GMP inspection findings clarification
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0003. Type: question. Risk: high. Category: Labeling.
Correspondence ID
COR-003
Type
question
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Labeling
Risk
High
Due Date
2025-01-21
Status
Completed
Owner
Nadia Petrova
Created
2024-01-22
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0003, 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_3_1.pdfdata_table_3.xlsx
Response Package
Response package assembled: RP-003