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1. Overview听听

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).听

In addition, unless specifically highlighted under section 3, the current EU 鈥�, 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.听

The variations classification guidelines will continue to apply unless and until the听MHRA鈥痠ssues any revised guidance in the future.听听

Any marketing authorisation extension application should be submitted in accordance with the听procedures for new marketing authorisations.听听

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.听

Variations may be submitted as direct national applications or through the International Recognition Procedure (IRP). See听guidance on听IRP.听听

2. Variation of a UK marketing authorisation听

2.1 UK-wide marketing authorisations听

2.1.1 Purely national variations听

Variations to purely national UK-wide听MAs听will be handled in line with the procedures set out above.听听听

2.1.2 UK-wide听MAs听managed in line with an听EU听mutual recognition decentralised procedure (MRDC)

For UK-wide听MAs听(PL) authorised before 1 January 2021 where NI remains 鈥� 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鈥�(DCP/MRP)):听

• variations to these听MAs听will be managed as part of the specific鈥�MR/DC听辫谤辞肠别诲耻谤别
• variations must be submitted and managed as part of the relevant鈥�MR/DC听辫谤辞肠别诲耻谤别 under Chapter II of the Variations Regulation ((EC) No 1234/2008 as amended)
• work sharing will also be possible
• since the鈥疢RP variation decision applies to the UK wide authorisation, it can be implemented unless the鈥�MHRA鈥痭otifies the鈥痬arketing authorisation Holder (MAH)鈥痺ithin 30 days of the RMS decision that it cannot be accepted

From 1 January 2025听

If the听MHRA听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.听

2.2 NI marketing authorisations听

Under the provisions of the Northern Ireland Protocol, medicinal products authorised for NI only continue to follow鈥�EU鈥痳ules. The requirements of unfettered access will be respected for those products where the听MAH听is established in NI and the UK/GB MA has been obtained as a qualifying NI good.听

.听

From 1 January 2025, NI-only applications will only be accepted through the听EU听MR听and DC procedures with NI as a CMS. Variations to these听MAs听will also need to be made through these procedures. Existing NI听MAs听authorised as standalone听MAs听can continue to be varied nationally.听

2.3 Great Britain marketing authorisations听issued prior to 1 Janaury 2025

From 1 January 2025听

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听MAs听in 2.1 above.听

3. European Union Authorisations听

From 1 January 2025听

From 1 January 2025, Union authorisations will no longer be valid in NI.听 If the MA holder held a GB MA for the same product this became valid UK-wide on that date.听 Any pending variations and future variation submissions听will therefore automatically include NI. The procedures outlined in Section 2 will apply.听听听

4. Variations pending on 1 January 2025听听

Any variations that were not determined on or before 31 December 2024 will be progressed as follows:听

For UK-wide purely national marketing authorisations听听

These variations will be processed to conclusion using the same procedures that were in place prior to 1 January 2021 (refer to Section听 2).听

For UK-wide marketing authorisation where Northern Ireland remains a concerned member state in an MRP/DCP听

These variations, covered under Chapter II of Regulation (EC) No 1234/2008, will be processed to conclusion as鈥�MR/DC听variations using the relevant鈥�MR/DC听辫谤辞肠别诲耻谤别s led by the RMS, with GB aligned unless听MHRA听cannot accept the MRP outcome (refer to Section 2.1 above).听

For NI marketing authorisations听

These variations, covered under Chapter II of Regulation (EC) No 1234/2008, will be processed to conclusion as鈥�MR/DC听variations using the relevant鈥�MR/DC听辫谤辞肠别诲耻谤别s led by the RMS.听

For European Union authorisations听

Union authorisations ceased to be valid in Northern Ireland from 1 January 2025.听The outcome of any pending variations submitted to the European Medicines Agency will not apply in NI.听

5. Contact听

For further information, email our Customer Services Centre at鈥�variationqueries@mhra.gov.uk.听