This guidance describes the approach the MHRA intends to take from 1 January 2021 for products already approved or that are included in ongoing decentralised procedures (DCP) or mutual recognition procedures (MRP) with UK as a Concerned Member State (CMS) and that will not be completed by 31 December 2020.

On 1 January 2021 all holders of existing marketing authorisations (MAs), or applicants for MAs with applications submitted by that date 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.

For new applications submitted from 1 January 2021, Northern Ireland may continue to be included in decentralised and mutual recognition procedures as a CMS. Any marketing authorisation applications submitted from 1 January 2021 following these procedures will be effective in Northern Ireland only. A separate marketing authorisation application will be needed for Great Britain (England, Wales and Scotland).

Products approved in the UK via DCP/MRP before 1 January 2021

Products approved via the DCP or MRP before 1 January 2021 were issued with national UK MAs. On 1 January 2021, the Marketing Authorisation Holder (MAH) has the option to do one of the following:

a. Maintain a UK wide marketing authorisation and retain UK(NI) (the 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. This will be the default position and no action will need to be taken by the MAH.

b. Request that separate MAs are issued for UK(NI) as a CMS, and Great Britain

c. Notify the UK and the RMS (reference member state) in writing that they wish to remove UK(NI) as a CMS from the DCP/MRP and maintain a national MA in Great Britain only.

With option (a), 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 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.

With option (b), the UK(NI) MA would be managed post approval as a European procedure and the Great Britain MA as a national procedure.

With option (c), a national (Great Britain) variation should be submitted see guidance on variations.

Applications pending in DCP/MRP with the UK as CMS where the procedure has ended with a positive decision before 1 January 2021 but the national licence has not yet been granted.

All ongoing DCP/MRPs that are positively concluded before 1 January 2021 but are in the national phase of the procedure, will continue to be processed in conformity with the approved assessment report, the summary of product characteristics and the labelling and package leaflet.

The MAH has the option to do one of the following:

a. Maintain a UK wide marketing authorisation by retaining UK(NI) 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. This will be the default position and no action will need to be taken by the MAH.

b. Request that separate MAs are issued for UK(NI) as a CMS, and Great Britain

c. Notify the UK and the RMS in writing that they wish to remove UK(NI) as a CMS from the DCP/MRP and maintain a national MA in Great Britain only.

Applications pending in DCP/MRP with the UK as a CMS where the procedure has ended with a negative decision before 1 January 2021

All ongoing DCP/MRPs that are negatively concluded before 1 January 2021 will be refused, and no MA will be issued.

Applications pending in DCP/MRP with the UK as CMS where the procedure has started but not been finalised before 1 January 2021

For procedures ongoing in DCP/MRP and not completed by 31 December 2020, the applicant has the following two options:

a. Retain Northern Ireland as a CMS, and then, at conclusion of a positive procedure with which the UK agrees, either:

(i) have a UK wide MA issued with Northern Ireland as a CMS and Great Britain aligned with the decisions taken by the RMS but not part of the DCP/MRP. This will be the default position and no action need to be taken by the applicant. The MHRA will advise the applicant within 30 days if it is unable to accept the procedure outcome for Great Britain. In this case, separate MAs for UK(NI) and Great Britain would need to be issued, if Great Britain reaches a positive outcome that is different to the outcome in the DCP/MRP.

(ii) at the end of procedure, request that separate MAs are issued for Northern Ireland as a CMS (to be managed post approval as a European procedure) and Great Britain (to be managed post approval as a GB national procedure)

b. Notify the UK and RMS in writing that they wish to remove UK(NI) as a CMS and continue the application in Great Britain only.

With Option b, the MHRA will complete the assessment as a national (GB) procedure. The MHRA will take into account any assessment that has already been reported by the RMS including any points raised by the RMS and other CMSs.

The MHRA will determine the application as soon as reasonably practicable and will take all reasonable steps to ensure that it makes a decision to grant or refuse a Great Britain MA in the time period that would have applied to that application on the date on which the application was submitted in DCP/MRP.

No additional or different fee will be charged for an application already submitted and ongoing in DCP/MRP that is completed as a national (GB) procedure.

Action to take if the applicant wishes to withdraw the application from Northern Ireland and Great Britain

The applicant should notify the licensing authority in writing that they no longer want the application to proceed. A partial fee refund may be applicable in line with the current MHRA fees regulations.

Applications submitted in DCP/MRP with the UK as CMS where the procedure has not started on 1 January 2021

For DCP/MRPs that have been submitted to the UK but not started by the RMS before 1 January 2021, any resulting marketing authorisation will be valid in Northern Ireland only. Please contact MHRA if you require further information.

Action to take if the applicant wishes to withdraw the application from the DCP/MRP

The applicant should notify the licensing authority in writing that they no longer want the application to proceed. A partial fee refund may be applicable in line with the current MHRA fees regulations.

Contact

For specific queries please contact RIS.NA@mhra.gov.uk.

This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.