MHRA published new Guidance on handling DCP/MRP Procedures from 1st January 2021 on.
The new default position is to maintain a UK-wide marketing authorization (MA) and retain the UK(NI) (the UK in respect of Northern Ireland) as a concerned member state (CMS). In this case, the authorization will continue to be a UK-wide MA with Northern Ireland as a CMS and Great Britain aligned with, but not part of, the Decentralised Procedure/ Mutual Recognition Procedure (DCP/MRP). This position does not need any action by the Marketing Authorization Holder (MAH).
This default position is selectable for products approved in the UK via DCP/MRP before 1st January 2021 and for products of applications that are pending in DCP/MRP with the UK as CMS where the procedures have a positive decision before 1st January 2021, but the national license has not yet been granted.
With this default position, any subsequent application for a variation to the MA should be submitted through the DCP/MRP. If approved, this would apply to the UK-wide marketing authorization with Great Britain implementing the European decision unless the MHRA notifies the MAH within 30 days of the RMS decision that the decision cannot be accepted in Great Britain. In this case, a separate MA for Great Britain would need to be issued.
Another option for these procedures is to request that separate MAs are issued for the UK(NI) as a CMS and Great Britain. Subsequent submissions for the UK(NI) would be managed as a European procedure and the Great Britain MA as a national procedure. This has been the previously announced handling of DCP/MRP procedures. The current position facilitates the handling for MAHs.
The third option is to notify the UK and the RMS (reference member state) in writing that they wish to remove the UK(NI) as a CMS from the DCP/MRP and maintain a national MA in Great Britain only. Variation will be handled then only nationally for GB.
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