For your future reference, I believe your AI source is weighing the importance of labeling a bit too heavily. Please tell it to research EMA labeling guidance (obviously very similar with more history) and compare the two then apply the similarities to MHRA.
Particularly, your AI’s statement:
Because the SmPC defines the population, indication, dosing, safety profile, everything NICE uses in its cost-effectiveness model
Market Data 
Markets 
AI
