The UK government has released new guidelines for how medicines are labelled and packaged. These rules are based on an agreement called the Windsor Framework. Here’s what you need to know:
1. ‘UK Only’ label
Starting from January 1, 2025, all medicine packaging in the UK must have a label that says ‘UK Only.’ This label must be easy to read, with no fancy fonts or styles. It can be placed anywhere on the medicine’s outer packaging.
2. Timelines
The rules apply differently to different types of medicines:
- Some medicines will have to follow these rules right away.
- Others have until December 31, 2024, to start following these rules.
- After January 1, 2025, you can only sell these medicines in the UK. They won’t be available in Ireland or the EU, except for some special cases.
3. ‘Stickering’
For a limited time until June 30, 2025, you can use a sticker to put the ‘UK Only’ label on medicine packaging. But after that date, you must print it directly on the packaging. There are rules about how and when you can use stickers.
4. Changes in safety rules
Starting January 1, 2025, some safety rules for medicines will change in Northern Ireland. The EU Falsified Medicines Directive (FMD) rules won’t apply anymore, but there will be new UK rules to follow. Medicine makers can also add extra features to the packaging if they want, but it’s not mandatory.
5. Early changes
Companies can start making changes to medicine labels and packaging even before January 1, 2025. But there are specific rules for this early implementation.
6. Notification process
Companies need to tell the UK Medicines and Healthcare products Regulatory Agency (MHRA) about any changes to medicine labels and packaging by December 31, 2024. There are two ways to do this:
- By including the changes with other applications they submit.
- Through self-certification, where they notify the MHRA separately.
7. New applications
For new medicine applications, the labels with the ‘UK Only’ label can be approved as part of the process. But after January 1, 2025, all new applications must include this label from the start.
8. Parallel imports (PLPI) packs
From January 1, 2025, all parallel imports in the UK market will be authorised, and they won’t need the ‘UK Only’ label. There will be more guidance on how this works.
9. Joint EU/UK packs
From January 1, 2025, medicines in packs that include both EU and UK information won’t be allowed anymore. You can still use the existing packs until they expire.
10. PLGB licence numbers
Licenses that used to be only for Great Britain will now work for the whole UK. More details about this will come out later, and these packs will need both the PLGB number and the ‘UK Only’ label.
