Guidance for medicine packaging under Windsor Framework

The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance to support implementation of new requirements for medicine packaging in 2025 under the Windsor Framework.

Guidance for medicine packaging under Windsor Framework

The Windsor Framework, announced on 9 June 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA), provides a long-term solution for the supply of medicines into Northern Ireland. The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. 

In preparation for the implementation of these requirements under the Windsor Framework, new guidance for the industry was published by the MHRA on 28 July 2023.

The following new measures are set to be introduced on 1 January 2025. After this date:

  • Under the framework, medicines can have the same packaging and labelling across the UK. All medicines on the UK market must be labelled as for sale only within the UK, including in Northern Ireland.
  • New medicines for the UK market will be authorised by UK authorities. UK packaging must carry a clearly legible ‘UK only’ label to be allowed onto the UK market.
  • These products will only be able to be sold in the UK, and will not be available on the market in Ireland, or elsewhere in the EU
  • Medicines entering Northern Ireland will not display features required under the EU Falsified Medicines Directive (FMD) including 2D barcodes and serialisation numbers that are compliant with the EU FMD Directive
  • The MHRA expects anti-tamper devices to remain on all medicine packaging.

The MHRA will provide a single deadline for new packaging requirements. This will continue to allow medicine manufacturers to use legacy EU packaging until 31 December 2024. This extends the earlier 31 December 2023 deadline, which requires medicines for Great Britain (GB) to be presented in GB compliant packaging.

Implementing compliant medicine packaging and labelling

With the new measures set to come into force at the start of 2025, joint EU/UK packs can no longer enter the supply chain. Information relevant to other markets will need to be removed from these packs when the ‘UK Only’ statement is added. These changes should be made within the same submission. According to the MHRA, packs already released to market may however continue to be supplied until their expiry date.

A Centrally Authorised Products (CAPs) Bridging Mechanism will be enforced to allow companies to supply Northern Ireland with innovative medicines (those presently subject to the EU Centrally Authorised Procedure) for up to six months when the MHRA licenses a product before the European Medicines Agency (EMA).

European Affairs Committee perspective

According to a July 2023 report by the European Affairs Committee, the pharmaceutical industry strongly welcomed the Windsor Framework’s provisions on human medicines. The committee stated the agreement provides sustainable solutions to the issues related to medicine supply to Northern Ireland.

However, witnesses emphasised that further information on the operational requirements of the new arrangements is required.

The committee requested for the Government to “respond to the calls from industry representatives for clarity over labelling requirements, safety features, the supply of medical devices and concerns that Northern Ireland may get slower access to cutting-edge products than Ireland.”