Q: Could you explain me more on potential impact on the national licences that are currently UK-wide ones. Also for CAPs which are currently pending and we will submit baseline submission to NI and there is no need for GB, what would be submitted with sequence 0000? (e.g. module 1 only). There will also be a chance for discrepancy as we might not submit all submissions to the GB which we will submit for NI.
Presenter Answer: UK national MAs may not be impacted if they meet EU requirements for NI e.g. have EU MAH & QP release site
CAP – NI is automatically included in centralised procedure. GB will approve base din EMA assessment:
On receipt of the positive CHMP opinion, or as soon as possible after this date, the ECDRP MAA should be submitted to the MHRA as one electronic Common Technical Document sequence through MHRA Submissions.
The submission should include the entire dossier as reviewed by the CHMP (and approved by the EC if the EC decision has already been received), including the full responses to CHMP questions. If the entire dossier has already been submitted to the MHRA as Northern Ireland, and no changes are required for the ECDRP MAA dossier, the dossier need not be submitted for the ECDRP MAA.
The Working Documents Folder should include:
all iterations of the CHMP assessment reports and the CHMP opinion for the initial MAA and any subsequent variations,
the proposed product information in Microsoft Word format.