Variations to marketing authorisations (MAs)
Source: gov.uk (2025-10-16)

How the MHRA processes variations to marketing authorisations.

1. Overview

The procedures detailed under Chapter IIa of Variations Regulation (EC) No 1234/2008 as amended by 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 in their amended form 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 EU variations classification guidelines (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013XC0802(04)), 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 (https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk).

These procedures are not impacted by the arrangements for human medicines which came 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 (https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure#post-authorisation-irp-applications-variations-and-renewals).

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 to the UK wide authorisation, 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
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 (https://www.legislation.gov.uk/ukdsi/2020/9780348212969/contents).

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 issued prior to 1 Janaury 2025

From 1 January 2025

Great Britain marketing authorisations became 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

From 1 January 2025

From 1 January 2025, Union authorisations will no longer be valid in NI. If the MA holder held a GB MA for the same product this became 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 were not 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 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 ceased 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 xxx@xxx.xx (mailto:xxx@xxx.xx).