Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

1. Overview

This guidance aims to outline the labelling and packaging requirements for medicinal products intended for human use, following the agreement of the Windsor Framework. It should be used alongside the existing guidance for wholesale dealers and manufacturers.

The Windsor Framework establishes long-term arrangements for the distribution of medicines in Northern Ireland. It ensures that medicines can be approved and licensed throughout the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), and it exempts certain medicines in Northern Ireland from the European Union (EU) Falsified Medicines Directive (FMD) requirements.

To prevent the distribution of these medicines to any part of the EU while maintaining consistent packaging and labelling across the UK, all medicines marketed in the UK must feature a “UK Only” label.

These new regulations will take effect on January 1, 2025. As of this date:

1. All packaging for products aimed at the UK market must display a clearly visible “UK Only” label.

2. All new medicines and those currently in Northern Ireland that are subject to the EU Central Authorization Procedure will be approved by the MHRA for the UK market. Additional guidance on the transition of licenses will be provided.

3. These products will only be available in the UK and not in Ireland or other EU countries, except as ‘specials’ under EU rules.

All packaging for products aimed at the UK market must display a clearly visible “UK Only” label.

2. Glossary of Terms

3. Timelines

4. ‘UK Only’ Label Requirements

Starting January 1, 2025, all medicinal products intended for the UK market must have a prominently displayed “UK Only” label on their packaging. This includes Prescription Only Medicines and Pharmacy and General Sales List items.

Guidelines for the “UK Only” label include:

1. The label may be positioned anywhere on the outer packaging.

2. The text must be at least 7-point font and easily readable, following Article 5 of EU Regulation 2023/1182 and current MHRA guidelines.

3. No additional font or style requirements are specified beyond these criteria.

4. To provide a single deadline for new packaging requirements, manufacturers will be allowed to distribute medicines in existing EU-compliant packaging until December 31, 2024, extending the previous deadline.

5. Stickering

The “UK Only” label may be temporarily applied with a sticker for a period of six months, expiring on June 30, 2025. After this date, the label must be printed directly onto the packaging. The guidance on stickering includes:

If a sticker is used, an updated mock-up indicating the sticker placement must be submitted to the MHRA.

1. Stickers must be applied before certification by a Qualified Person (QP).

2. Stickers must not cover any mandatory information such as batch numbers or expiration dates.

6. Disapplication of FMD Safety Features and Encoding of Pack Information

Beginning January 1, 2025, the EU Falsified Medicines Directive (FMD) will not apply to Northern Ireland. Features required for FMD compliance may be removed or covered.

Existing UK safety requirements, such as expiry dates and batch numbers, remain unchanged. MA holders may choose to include features like a 2D barcode, but this is not mandatory. If a pack includes a 2D barcode, it must comply with UK law and cannot include any elements that were intended for EU compliance.

7. Supply of Existing Stock in Current Packaging

Medicinal products already in circulation in Northern Ireland and Great Britain can continue to be supplied until their expiration date, as long as they were certified by a Qualified Person (QP) before January 1, 2025.

8. Early Market Release

Changes to labelling and packaging can begin prior to January 1, 2025, as outlined in the guidance. This applies to UK-wide Product Licences (PLs) and GB Product Licences (PLGBs):

UK-wide MAs: The “UK Only” label can be applied and released to the UK market before the deadline.

PLGBs: The same applies; however, after January 1, 2025, PLGB packs must comply with the relevant regulations.

9. Notification Procedure

Companies must notify the MHRA of any new artwork changes by December 31, 2024. There are three methods for notification:

Regulatory Opportunity: Submit artwork changes alongside another application without additional fees, waiting for approval before implementing changes.

Self-Certification: Submit a separate notification, allowing companies to implement changes immediately upon submission.

Self-Certification without eCTD: Initial submissions can be made without an updated eCTD sequence, followed by an updated submission by December 31, 2025.

10. New Marketing Authorization Applications

For Marketing Authorisation Applications (MAAs) under review, labelling including the “UK Only” statement can be included as part of the licensing process. Early implementation of labelling is allowed as per the guidance.

11. Homeopathic (NR and HR) and Traditional Herbal (THR) Pharmaceuticals

All UK Homeopathic (NR) medicinal products must include the “UK Only” label. While UK Herbal (THR) and Homeopathic (HR) products are not required to apply the label, they may choose to do so for consistency.

12. Parallel Imports (PLPI)

From January 1, 2025, all Parallel Imports (PLPIs) will be permitted in the UK. PLPIs previously restricted to “GB” will be authorized for UK-wide distribution. All PLPIs must display the “UK Only” label and will not need to comply with the EU FMD requirements.

13. Joint EU/UK Packs

Joint EU/UK packs can no longer be distributed in the UK starting January 1, 2025. Any information relevant to other markets must be removed, but packs already in circulation can continue to be supplied until they expire.

14. PLGB License Numbers

From January 1, 2025, all GB-only licenses will transition to UK-wide licenses without requiring a change in license numbers. Current PLGB numbers must remain visible on packs along with the “UK Only” label. Further information is available in the UK-wide licensing guidance.