Windsor Framework: supply of medicines into Northern Ireland
New medicine measures to commence 1 January 2025.
The Windsor Framework sets out a long-term solution for the supply of medicines into Northern Ireland. It will ensure that medicines can be approved and licensed on a UK-wide basis by the Medicines and Healthcare products Regulatory Agency (MHRA).
This will enable medicines to use the same packaging and labelling across the UK. As such, all medicines on the UK market will be labelled as for sale only within the UK.
These measures will commence on 1 January 2025. This means that, after this date:
- New medicines for the UK market will be authorised by UK authorities, and UK packaging must carry a clearly legible ‘UK only’ label to be allowed onto the UK market, including in Northern Ireland
- 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 will expect anti-tamper devices to remain on all medicine packaging.
It is intended that due flexibility will be provided in meeting these requirements where possible. ‘UK only’ labels may be placed anywhere on a medicine pack. This label will need to follow MHRA guidance on labelling.
To provide a single deadline for new packaging requirements, the MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024. This extends the previous 31 December 2023 deadline requiring medicines for GB to be presented in GB compliant packaging by the end of 2023 by one year.
Packs in existing packaging already on the UK market, and within the supply chain, may remain until the date of their expiry.
UK-based suppliers or distributors of medicines should prepare for different packaging for medicines to be supplied to UK and EU markets from 1 January 2025.
Comprehensive guidance on the requirements for medicines to be placed on the market in Northern Ireland will be provided in due course. This will include formal guidance covering labelling requirements and authorisations from the MHRA. In advance of these new arrangements taking effect, the Northern Ireland MHRA Authorised Route (NIMAR) will continue to function to support the supply of medicines into Northern Ireland.
As a further safeguard for medicines supplies ahead of the new arrangements taking effect in January 2025, the Government will also bring into force a bridging mechanism 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).
First published 12 June 2023