Medicines Marketing Authorisations UK Post-Deal Guidance


Renewing Marketing Authorisations for medicines

How to renew marketing authorisations for products granted through different routes and at different times.

The MHRA acts as the regulator for products placed on the market in Northern Ireland. There are some different requirements for products placed on the market in the UK with respect to Great Britain (England, Scotland, Wales) and Northern Ireland.

Renewals for converted Centrally Authorised Products (CAPS)

CAPS converted from EU to UK MAs will be treated as if they were granted on the date the corresponding EU MA was granted. The renewal date will stay the same.

Please refer to Guidance on Converting Centrally Authorised Product (CAPS) to UK MAs.

Your MAs remain in force until a decision has been made on your renewal applications.

Renewals submitted for MAs granted through mutual recognition (MR) or decentralised (DC) procedures

All holders of existing marketing authorisations (MAs), or applicants for MAs with applications submitted by 1 January 2021 and under review within a decentralised or mutual recognition procedure with UK as a CMS will have a choice on how to manage their marketing authorisations/applications.

Refer to the guidance on handling of decentralised and mutual recognition procedures.

The default position is to maintain a UK wide marketing authorisation and retain UK in respect of Northern Ireland (UK(NI) (UK in respect of Northern Ireland) as a 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 DCP/MRP.

Where this applies any pending applications will be processed to conclusion after 1 January 2021 as MR/DC renewals using the relevant MR/DC procedures led by the RMS.

New applications for a renewal of the MA 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.

In this case, a separate MA for Great Britain would need to be issued. Other options include having separates MAs for UK(NI) as CMS, and Great Britain. Renewal applications for Great Britain MAs will be processed via the purely national route.

If you’ve submitted renewals for MAs granted through the the 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 hasn’t been processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome.

Where a final decision has not been made, the MHRA will ensure that the renewal process is concluded and processed by the appropriate route.

Renewals submitted from 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:

The MHRA will continue to follow the shortened renewal procedure accept the reduced submission requirements for renewals of MAs for products authorised under Article 10.1, 10c and 10.a as set out in the CMDh Best Practice Guide on processing renewals in the MRP/DCP.

Conditional Marketing Authorisations

You should continue to submit your renewal applications for conditional MAs 6 months before they expire.

For Great Britain MAs the application should be submitted to the MHRA, who will consider the application in accordance with new regulation 66B of the Human Medicines Regulations 2012.

The same applies to converted EU MAs that were granted as conditional MAs.

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 we will accept the same renewal application as submitted to the EU and a reduced fee will be applied.

Changes to fees

The new fees will be:

  • £9,682 for the first renewal of a product containing a new active ingredient at the time of authorisation
  • £747 for related applications made at the same time as the first renewal

There will be no fees for:

  • subsequent MA renewal applications
  • renewing conditional MAs


For further information, please email our Customer Services Centre at or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Published 31 December 2020