RFIs are handled by MHRA... not CHM... Major objections get referred to CHM after all the RFIs were reviewed by MHRA
The CHM (Commission on Human Medicines) is an expert advisory committee that provides independent advice to the MHRA on matters like safety, quality, and efficacy. It does not issue or handle RFIs itself. Instead:The MHRA may consult the CHM during assessment.
If major objections remain unresolved (or if responses to final RFIs are inadequate/no response is received), the MHRA refers the application to the CHM for advice on potential refusal.
In such cases, the applicant receives a letter from the CHM (not an RFI), outlining the provisional opinion and next steps.
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