Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
National applications for UK-wide marketing authorisations are permitted irrespective of whether an application for the same product is approved or has been submitted through the EU decentralised procedures (DCP) or mutual recognition procedures (MRP).
This guidance describes the approach the MHRA intends to take for products already approved or that are included in ongoing DCPs or MRPs with UK in respect of NI (UK(NI)) as a Concerned Member State (CMS).
All holders of existing marketing authorisations (MAs), or applicants for MAs with applications under review within a decentralised or mutual recognition procedure with UK(NI) as a CMS, have a choice on how to manage their marketing authorisations/applications.
For new applications, UK(NI) may continue to be included in decentralised and mutual recognition procedures as a CMS. Any marketing authorisations issued 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-wide MAs. The Marketing Authorisation Holder (MAH) has the option to do one of the following:
a. Maintain a UK-wide marketing authorisation and retain the UK in respect of Northern Ireland (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. 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 UK wide national MA.
c. Request that separate MAs are issued for UK(NI) as a CMS, and Great Britain (England, Wales and Scotland)
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), any subsequent application for a variation to the MA should be submitted as a national (UK) variation.
With option (c), the UK(NI) MA would be managed post approval as a European procedure and the Great Britain MA as a national procedure.
See also guidance on variations.
Products authorised for the UK(NI) via DCP/MRP from 1 January 2021
Where products have been approved via the DCP or MRP and have been issued with a national UK(NI) MA valid only in Northern Ireland from 1 January 2021, the MAH has the option to do one of the following:
a. Retain UK(NI) as a CMS. In this case, the authorisation will continue as a UK(NI) MA. This will be the default position and no action will need to be taken by the MAH. If the MAH has a separate UK(GB) MA this will also continue in force.
b. Notify the UK and the RMS in writing that they wish to remove UK(NI) as a CMS from the DCP/MRP and request a UK wide national MA from MHRA.
With option (a), any subsequent application for a variation to the MA should be submitted through the DCP/MRP.
With option (b), the MHRA will agree with the MAH how to manage changes to the route of authorisation and the territorial validity of each MA. Any subsequent application for a variation to the MA should be submitted as a national (UK) variation.
See also guidance on variations.
Applications pending in DCP/MRP with the UK(NI) as CMS where the procedure started before 1 January 2021
For procedures ongoing in DCP/MRP that were started before 1 January 2021 the applicant has the following options:
a. Retain UK(NI) 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 UK(NI) as a CMS and Great Britain aligned with the decision taken by the RMS but not part of the DCP/MRP. This will be the default position and no action will 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 UK(NI) as a CMS (to be managed post approval as a European procedure) and Great Britain (to be managed post approval as a Great Britain national procedure).
b. Notify the UK and RMS in writing that they wish to remove UK(NI) as a CMS and continue the application as a UK wide national application.
With Option b, the MHRA will complete the assessment as a national UK wide 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 the national application 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 fee will be charged for an application already submitted and ongoing in DCP/MRP that is completed as a national procedure.
c. Withdraw the application from the DCP/MRP and apply for a national UK MA on completion of the European procedure using the MRDC Reliance Procedure
Applications pending in DCP/MRP with the UK(NI) as CMS where the procedure started on or after 1 January 2021
For procedures ongoing in DCP/MRP with UK(NI) as a CMS that were started on or after 1 January 2021 the applicant has the following options:
a. Retain UK(NI) as a CMS to obtain a UK MA valid only in Northern Ireland. A separate MA is needed for Great Britain.
b. Notify the UK and RMS in writing that they wish to remove UK(NI) as a CMS and continue the application as a UK wide national application. If there is already a parallel application to Great Britain the application to NI can be withdrawn and the GB application will continue as a UK wide national application.
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 and determine the application as soon as reasonably practicable. MHRA will take all reasonable steps to ensure that it makes a decision to grant or refuse the national application 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 fee will be charged for an application already submitted and ongoing in DCP/MRP that is completed as a national procedure.
c. Withdraw the application from the DCP/MRP and apply for a national UK MA on completion of the European procedure using the MRDC Reliance Procedure
Applications submitted in DCP/MRP with the UK(NI) as CMS where the procedure has not started
For DCP/MRPs that have been submitted to the UK but have not been started by the RMS, the applicant has the following options:
a. Retain UK(NI) as a CMS. A separate marketing authorisation application is needed for Great Britain (England, Wales and Scotland).
b. Withdraw the application from UK(NI) in the EU procedure and apply as a national procedure in the UK to obtain a UK-wide marketing authorisation.
c. Withdraw the application from the DCP/MRP and apply for a national MA on completion of the European procedure using the MRDC Reliance Procedure.
Guidance for The Conversion of PLGB or PLNI licences to PL
The scope of this guidance excludes products which are:
- Already the subject of an EU Community Marketing authorisation in Northern Ireland
- Fall within the mandatory scope of the EMA’s centralised procedure
Therefore, this process does not apply to any GB marketing authorisation that has been approved through the European Community Decision Recognition Procedure (ECDRP) or those that are converted EU Marketing authorisations (so-called grandfathered products).
When submitting the below submissions via MHRA Submission Portal, please ensure you select ‘Territory change’ for regulatory activity and ‘Original submission’ for regulatory sub activity. Please note, the submission requirements are applicable for both initial applications that have not yet been approved and approved marketing authorisations (further details for not yet approved and approved marketing authorisations are provided below).
Amending of Great Britain Licence (PLGB) or Northern Ireland Licence (PLNI) to a UK wide PL Licence
If both a PLGB and a PLNI licence are held for the same product, please confirm which licence will be changed to the PL licence number and confirm that the other licence should be cancelled.
Please Note: The documents below must be submitted using the next available sequence number in the original PLxx dossier. The sequence must be in eCTD format.
Documents required from applicant
- Cover Letter – to include a table with current licence numbers and the corresponding new PL licence numbers to confirm the change of prefix.
- PL number must be provided. This can be allocated by yourself using our MHRA Submissions Portal. Register for the MHRA Submission Portal.
Once registered on the home page, please select human medicines and then ‘PL Number Generation’. Please follow steps provided.
- Full Summary of Product Characteristics (SmPC) is required for each strength and pharmaceutical form in Microsoft Word format
- Patient Information Leaflet (PIL) and Label with new PL number
For Initial applications that have not yet been approved
The change of PLGB / PLNI number to a PL number should be discussed with the assessment team and at the end of procedure stage the replacement PL number supplied in the cover letter confirming the change of prefix
We will accept a text version of the PIL/Label, however the full-colour mock-up must be supplied as a National phase or end of procedure submission. Implementation of updated packaging should be within 6 months of approval of the conversion.
For approved marketing authorisations
If only QRD text is provided a subsequent PIQ application will have to be submitted under Regulation 267 of the Human Medicines Regulations 2012 (change code P1) prior to marketing the product using the PL number and a justification must be provided in the Cover Letter. The usual 6-month implementation timeline for updated packaging will apply.
The time lines for the completion of the process are 42 days for granted cases and for the conversion of pending applications at the end of procedure these will be completed within the 30 day national phase.
For further information on the process please contact MR-DCprocedures@mhra.gov.uk.
Contact
For specific queries please contact RIS.NA@mhra.gov.uk.
Last updated 24 June 2022 + show all updates
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Section added for 'Guidance for The Conversion of PLGB or PLNI licences to PL'
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Update to post-Brexit protocols
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Updated guidance to clarify that UK national MA applications can be submitted irrespective of applications for the same product in EU and clarification of options for ongoing procedures that were not completed by 31 December 2020.
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First published.