The UK government has unveiled fresh guidelines for the labeling and packaging of medicines, in accordance with the Windsor Framework agreement. Here’s an overview of the key points:
- ‘UK Only’ Label:
- Commencing on January 1, 2025, all medicine packaging in the UK is required to feature a ‘UK Only’ label.
- The label must be easily readable, devoid of elaborate fonts or styles.
- It can be placed anywhere on the outer packaging of the medicine.
- Timelines:
- Different timelines apply to different categories of medicines:
- Some medicines must adhere to these rules immediately.
- Others have until December 31, 2024, to comply.
- After January 1, 2025, these medicines can only be sold in the UK, with exceptions for certain cases in Ireland or the EU.
- ‘Stickering’:
- Until June 30, 2025, a sticker may be used to affix the ‘UK Only’ label to medicine packaging.
- Following this date, the label must be directly printed on the packaging, with specific guidelines on sticker usage.
- Changes in Safety Rules:
- Effective January 1, 2025, there will be changes in safety rules for medicines in Northern Ireland.
- EU Falsified Medicines Directive (FMD) rules will no longer apply, replaced by new UK regulations.
- Optional additional features can be added to the packaging by medicine manufacturers.
- Early Changes:
- Companies can initiate changes to medicine labels and packaging before January 1, 2025, following specific early implementation rules.
- Notification Process:
- By December 31, 2024, companies must inform the UK Medicines and Healthcare products Regulatory Agency (MHRA) about any labeling and packaging changes.
- Notification can be included with other applications or separately through self-certification.
- New Applications:
- New medicine applications must include the ‘UK Only’ label starting January 1, 2025.
- Parallel Imports (PLPI) Packs:
- From January 1, 2025, all parallel imports in the UK market will be authorized and won’t require the ‘UK Only’ label. Detailed guidance will be provided.
- Joint EU/UK Packs:
- Starting January 1, 2025, medicines in packs containing both EU and UK information won’t be allowed. Existing packs can still be used until expiry.
- PLGB Licence Numbers:
- Licenses previously applicable only to Great Britain will now cover the entire UK. Further details will be released, and these packs will require both the PLGB number and the ‘UK Only’ label.
Please note that this information is provided for general informational purposes only, and it is advisable to seek professional or specialist advice before taking any action based on this content.
