So there’s no timeframe or number of time to revise the documents? Is it just really up to mhra to tell them that all docs looks here and we acceptable?
The MGRA and FDA both state the overall process.
When sections of the application have been provided the agency will evaluate and provide feedback.
When the final section(s) is submitted, the application is complete and the formal review starts.
But why believe what the MHRA and FDA both say vs an unknown friend of some poster.