I reviewed the NICE Submission Manual (PMG24, December 2024) directly. The guidance makes it clear that companies are permitted, and expected, to submit draft versions of the SmPC and the UK public assessment report. This is a standard part of the procedure.
It’s designed specifically to allow NICE to begin its review in parallel with the MHRA, not after. That parallel structure is intentional and enables progress during the window when MHRA is finalizing the product label.
That’s exactly where we are right now: in the labeling phase. The final SmPC is still being negotiated, but that does not prevent NICE from reviewing the draft documents already submitted. There is no requirement to wait for MHRA to publish a final label before submission proceeds. That claim is inconsistent with the current NICE process.
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