Variations to marketing authorisations (MAs)
How the MHRA processes variations to marketing authorisations.
1. Overview
The procedures detailed under Chapter IIa of Variations Regulation (EC) No 1234/2008, which specifically applied to variations to purely national Marketing Authorisations (MA), were incorporated into UK law from 11pm on 31 December 2020, and as such continue to apply to both pending and new variations to purely national UK marketing authorisations as set out in regulation 65C and Schedule 10A to the Human Medicines Regulations 2012 (HMRs).
In addition, unless specifically highlighted under section 3, the current variations classification guidelines, which explain the type of variation (Type IA, Type IAIN, Type IB, Type II or Extension) to submit and, where relevant, the conditions to be met and any required supporting documentation, continue to apply.
The variations classification guidelines will continue to apply unless and until the MHRA issues any revised guidance in the future.
Any marketing authorisation extension application should be submitted in accordance with the procedures for new marketing authorisations.
These procedures are not impacted by the new arrangements for human medicines which come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework.
Variations may be submitted as direct national applications or through the International Recognition Procedure (IRP). See guidance on IRP.
2. Variation of a UK marketing authorisation
2.1 UK-wide marketing authorisations
2.1.1 Purely national variations
Variations to purely national UK-wide MAs will be handled in line with the procedures set out above.
2.1.2 UK-wide MAs managed in line with an EU mutual recognition decentralised procedure (MRDC)
For UK-wide MAs (PL) authorised before 1 January 2021 where NI remains – NI as a CMS, and Great Britain (GB) aligned with the decisions taken by the reference member state (RMS) (but where GB is not part of the decentralised procedure/mutual recognition procedure (DCP/MRP)):
-
variations to these MAs will be managed as part of the specific MR/DC procedure
-
variations must be submitted and managed as part of the relevant MR/DC procedure under Chapter II of the Variations Regulation ((EC) No 1234/2008 as amended)
-
work sharing will also be possible
-
since the MRP variation decision applies UK wide, it can be implemented unless the MHRA notifies the marketing authorisation Holder (MAH) within 30 days of the RMS decision that it cannot be accepted
Until and including 31 December 2024
If the MHRA cannot accept the outcome of a variation submitted via MRP, then either NI will need to be withdrawn from the MRP and the authorisation managed as a purely national UK-wide MA, or separate MAs will need to be issued for Northern Ireland and Great Britain.
Where the same product is separately authorised in NI and GB, separate variation applications will need to be submitted to vary the authorisations, under domestic legislation for GB and under EU legislation for NI.
Type IA notifications will need to be submitted to MHRA for the GB part of the licence.
However, for Type IB and Type II variations, a variation to the corresponding GB authorisation may be submitted as a direct national variation or through the International Recognition Procedure, after approval of the identical changes through the MRP citing the RMS as the reference member state as reference regulator.
From 1 January 2025
If the MHRA cannot accept the outcome of a variation submitted via MRP, then NI will need to be withdrawn from the MRP and the authorisation managed as a purely national UK-wide MA, or the MA will need to be restricted to NI only.
2.2 NI marketing authorisations
Under the provisions of the Northern Ireland Protocol, medicinal products authorised for NI only continue to follow EU rules. The requirements of unfettered access will be respected for those products where the MAH is established in NI and the UK/GB MA has been obtained as a qualifying NI good.
The definition of qualifying NI goods (EU Exit) Regulations 2020.
From 1 January 2025, NI-only applications will only be accepted through the EU MR and DC procedures with NI as a CMS. Variations to these MAs will also need to be made through these procedures. Existing NI MAs authorised as standalone MAs can continue to be varied nationally.
2.3 Great Britain marketing authorisations
Until and including 31 December 2024
Great Britain authorisations will follow the procedures outlined in sections 1 and 2 above.
From 1 January 2025
Great Britain marketing authorisations will become valid UK-wide marketing authorisations from 1 January 2025 and will follow the procedures outlined in section 2 and in relation to purely national MAs in 2.1 above.
3. European Union Authorisations
Until and including 31 December 2024
Under the Windsor Framework, medicinal products authorised via the centralised route will be directly authorised for use in NI. Any variations to these MAs will be centrally managed by the European Medicines Agency (EMA) in accordance with relevant procedures. A separate MA will not need to be issued by the MHRA for NI.
If the same product is separately authorised in GB by MHRA, a separate variation application will need to be submitted to vary that authorisation.
Type IA notifications will need to be submitted to MHRA for the GB licence.
Type IB and Type II variations can utilise the international recognition procedure. This means that when these changes have been submitted and approved by EMA, the identical changes can then be submitted for the corresponding GB authorisation. A lower fee will be charged.
From 1 January 2025
From 1 January 2025, Union authorisations will no longer be valid in NI. If the MA holder holds a GB MA for the same product this will become valid UK-wide on that date. Any pending variations and future variation submissions will therefore automatically include NI. The procedures outlined in Section 2 will apply.
4. Variations pending on 1 January 2025
Any variations that have not been determined on or before 31 December 2024 will be progressed as follows:
For UK-wide purely national marketing authorisations
These variations will be processed to conclusion using the same procedures that were in place prior to 1 January 2021 (refer to Section 2).
For UK-wide marketing authorisation where Northern Ireland remains a concerned member state in an MRP/DCP
These variations, covered under Chapter II of Regulation (EC) No 1234/2008, will be processed to conclusion as MR/DC variations using the relevant MR/DC procedures led by the RMS, with GB aligned unless MHRA cannot accept the MRP outcome (refer to Section 2.1 above).
For GB marketing authorisations
GB MAs will become UK-wide on 1 January 2025, pending variations will be processed to conclusion using the same procedures that were in place before 1 January 2025 (refer to Section 1) and will apply UK-wide.
For NI marketing authorisations
These variations, covered under Chapter II of Regulation (EC) No 1234/2008, will be processed to conclusion as MR/DC variations using the relevant MR/DC procedures led by the RMS.
For European Union authorisations
Union authorisations will cease to be valid in Northern Ireland from 1 January 2025. The outcome of any pending variations submitted to the European Medicines Agency will not apply in NI.
5. Contact
For further information, email our Customer Services Centre at [email protected].
Updates to this page
Published 31 December 2020Last updated 20 December 2024 + show all updates
-
Major update, removing outdated information with respect to Brexit. Added information related to the Windsor Framework. Revised section numbering and updated contacts section 5.
-
First published.