looks like this is big: see the below from chatGPT -
Under UK medicines law, before MHRA can issue a Marketing Authorisation (MA) for a medicinal product, it must confirm that: The commercial manufacturing site Is licensed (MIA in place)
For the exact scope of activities described in the application (manufacture, QC, release)
If the licence is missing: MHRA may continue reviewing the application
But it cannot issue a positive approval decision
So without today’s UK MIA 54923:
Approval could not be granted, even if the clinical data were acceptable.
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