Request for benefit-risk assessment addendum
Correspondence from European Medicines Agency regarding EMA-2023-0082. Type: information-request. Risk: high. Category: Quality.
Correspondence ID
COR-082
Type
information-request
Application
Authority
European Medicines Agency
Category
Quality
Risk
High
Due Date
2025-04-07
Status
Open
Owner
Lieselotte van der Berg
Created
2022-06-11
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0082, 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
study_report_82.pdfattachment_82_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.