Today we’re looking at Renewals submitted for Marketing Authorisations (MAs) granted through Mutual Recognition Procedure/ Decentralised Procedure ( MRP/ DCP) (MHRA guidance can be found here.)
What is the default position for MRP/ DCP MAs?
The default position for MRP/ DCP licences is to maintain a UK-wide MA and retain UK in respect of Northern Ireland (UK(NI)) as a Concerned Member State (CMS). In this case, the authorisation will continue to be a UK-wide MA with Northern Ireland as a CMS and Great Britain aligned with, but not part of, the MRP/ DCP.
What about pending renewal applications?
Where this situation with the licences applies, any pending applications will be processed to conclusion after 1 January 2021 as MR/DC renewals using the relevant MRPs/ DCPs led by the Reference Member State (RMS).
What about new renewal applications?
New renewal applications should be submitted via the DCP/MRP and if approved would apply to the UK wide authorisation 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).
What happens if MHRA disagree with RMS decision to approve the renewal?
If this happens then a separate MA for Great Britain would need to be issued.
Are there any other scenarios we need to know about?
You may have separate MAs for UK(NI) as CMS, and Great Britain. Where this is the case, renewal applications for Great Britain MAs will be processed via the purely national route.
What about renewals submitted prior to 1 January 2021?
If you have submitted renewals for MAs granted through DCP/MRP and do not get a decision before 1 January 2021, you will not need to resubmit them.
If a final decision has been made on your renewal but it has not been processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome.
Are there any general tips for submitting renewals after 1 January 2021?
You should continue to submit your renewal applications 9 months before they expire.
The requirements for renewal submissions will remain the same for products authorised in the UK and should include the same documents currently required in the EU as detailed in the following guidance:
– CAP renewals and annual reassessments
– Renewals for products authorised through MRP or DCP procedures
What about renewals for MAs granted via unfettered access?
Where you have a Great Britain-only MA granted via the Unfettered Access route, an application to renew the MA should be submitted in line with the above guidance. Where the MA has remained in line with the EU or Northern Ireland MA, the good news is that MHRA will accept the same renewal application as submitted to the EU and a reduced fee will be applied.
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