Ask your precious AI when the draft SmPC is completed. Bet you won't post that response.
That'll be the 4th time you've been proven wrong on major points in the past week. You have an outstanding track record of unmitigated failure.
You know what, here, I asked it for you:
During the process of submitting a Marketing Authorization Application (MAA) to the MHRA (Medicines and Healthcare products Regulatory Agency), the draft Summary of Product Characteristics (SmPC) is submitted as part of the initial dossier submitted by the pharmaceutical company....Company Proposal: The pharmaceutical company proposing the new medicine drafts the SmPC text and includes it in Module 1 of the Common Technical Document (CTD) dossier, which is submitted to the MHRA.