Windsor Framework medicines: what SI 2024/832 changed for licences and packs from 1 January 2025
List every pack by authorisation, market and release date, then decide which need 'UK only' wording under change control.
In Short
- In force 1 January 2025.
- 'UK only' added to Schedule 24.
- Pre-2025 packs: see reg 257AB.
Medicines arrangements for Northern Ireland changed under the Windsor Framework. This guide summarises the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (SI 2024/832) as made: commencement, the new UK-wide authorisation categories, the 'UK only' labelling particular, transitional packs and the removal of some safety features provisions. MHRA guidance, the Windsor Framework text, EU Regulation 2023/1182 and the consolidated 2012 regulations were not reviewed. It is orientation, not legal advice. Sources checked 5 Oct 2026.
What the instrument does
SI 2024/832 amends the Human Medicines Regulations 2012 and came into force on 1 January 2025. It extends to England and Wales, Scotland and Northern Ireland.
More on what the instrument does
Regulation 1(2) says the amendments made by regulations 110, 111 and 140(c) and (d) apply to medicinal products placed on the market for the first time on or after 1 January 2025. Many of its changes remove references to EU marketing authorisations and to sale or supply in Great Britain only, reflecting UK-wide licensing.
The 'UK Only' Labelling Particular
The instrument adds the words 'UK only' as a labelling particular in Schedule 24 (paragraph 18B). New regulation 257AB says this wording is not required on packaging of a product released for sale or distribution before 1 January 2025, unless it was re-packaged or relabelled after that date.
Does this pack need 'UK only'? (simplified)
- Regulation 257AB transitional rule.
- Keep release evidence.
More on the 'UK Only' Labelling Particular
Under new regulation 257AA, where the licensing authority treats a Category 2 authorisation as separate GB and NI authorisations, it may require the GB packs to carry a statement that the product is for sale or supply in Great Britain only instead.
Safety Features and Unique Identifiers
The instrument omits regulation 43A of the 2012 regulations, the requirement for wholesale dealers to decommission the unique identifier, and regulation 257A, the packaging requirement for medicinal products required to bear safety features. It also omits the definition of Commission Regulation 2016/161.
More on safety Features and Unique Identifiers
Read those changes with the consolidated regulations and MHRA guidance before altering serialisation, verification or decommissioning procedures, because this guide did not review what replaced them in practice or any other obligations that still apply.
Managing the Artwork Change
Treat the change as a controlled artwork project. List each pack by product, authorisation, market and release date; record whether it needs the new wording or falls under the transitional rule; and link each artwork version to its approval and the first batch that used it.
Worked Example: Artwork Register for Product PX-30
| Pack | Status | Approved by |
|---|---|---|
| PX-30 28-tab, rev 6 | Pre-2025 stock, not relabelled | No change |
| PX-30 28-tab, rev 7 | 'UK only' added | Regulatory and QA |
| PX-30 56-tab, rev 3 | Awaiting authorisation category check | Regulatory |
- PX-30 28-tab, rev 6
- Status
- Pre-2025 stock, not relabelled
- Approved by
- No change
- PX-30 28-tab, rev 7
- Status
- 'UK only' added
- Approved by
- Regulatory and QA
- PX-30 56-tab, rev 3
- Status
- Awaiting authorisation category check
- Approved by
- Regulatory
More on managing the Artwork Change
Re-packaging or relabelling after 1 January 2025 brings older stock into scope, so stock movements matter too. Named people in regulatory and quality approve each artwork version and its release.
Questions
When did the Windsor Framework medicines changes apply?
SI 2024/832 came into force on 1 January 2025, with certain amendments applying to products placed on the market for the first time on or after that date.
Do packs released before 2025 need relabelling?
Under regulation 257AB, the 'UK only' wording is not required on packs released before 1 January 2025 unless they were re-packaged or relabelled after that date.
Does SI 2024/832 change safety features rules?
It omits regulation 43A on wholesaler decommissioning of the unique identifier and regulation 257A on safety features packaging. Check current guidance before changing procedures.
Does V5 approve artwork or licences?
No. V5 keeps label versions, approvals and batch links together. Your regulatory and quality people approve artwork and decide release.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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