As announced in February, the EU and UK have agreed the Windsor Framework (the Framework) to revise the Northern Ireland Protocol. The changes seek to address the practical challenges of implementing the Protocol and, in particular, to simplify the process of supplying medicines from Great Britain (GB) to Northern Ireland (NI). The Framework empowers the MHRA to grant UK-wide approvals for medicines and enable the same packaging and labelling to be used across the UK, allowing for free movement of medicines between GB and NI (for more information, see our summary of the key changes here).
Following this, the MHRA recently confirmed that the medicines aspects of the Framework will apply from 1 January 2025. The announcement also provides information on the transitional arrangements and clarification on the new labelling requirements under the Framework.
What will happen prior to 1 January 2025?
The UK Government has introduced the Centrally Authorised Products (CAP) Bridging Mechanism to enable novel medicines authorised in GB but awaiting EU authorisation to be supplied to NI for a limited time. The mechanism will cover a period of delay between obtaining the authorisations, therefore allowing patients in GB and NI to access innovative medicines simultaneously, and will operate until the Framework takes effect on 1 January 2025.
A Marketing Authorisation (MA) issued by the European Commission under the centralised procedure is not valid in GB, for which a separate application is needed. Accordingly, where parallel MA applications have been made to both the EMA and the MHRA, NI patients will now be able to access medicines approved by the MHRA even if the medicines have not yet been approved by the European Commission. In this scenario, medicines authorised in GB can be supplied to NI for up to six months or until the Commission (a) grants a CAP MA or (b) refuses the application.
Additionally, the Northern Ireland MHRA Authorised Route (NIMAR), which allows certain prescription-only medicines be supplied to NI if licensed in GB, will continue to operate.
What will happen from 1 January 2025?
The Framework will come into force on 1 January 2025 when the MHRA will be solely responsible for authorising medicines for the NI market.
To align with the Framework’s commencement, MA Holders can continue to supply medicines bearing EU legacy packaging until 31 December 2024. This gives MA Holders an additional year from the previous deadline to ensure medicines are presented in GB-compliant packaging. Packs in existing packaging already placed on the UK market and in the supply chain as of 1 January 2025 can continue to be marketed until their expiry.
The MHRA press release specifically addresses labelling requirements for UK medicines.
Medicines intended for the UK market (including NI) must include a clearly visible ‘UK only’ label. The label needs to follow MHRA guidance on labelling, but can be placed anywhere on the packaging. Such products can only be sold in the UK, thereby excluding the Republic of Ireland and the rest of the EU.
Packaging for UK medicines will no longer need to display features required by the EU Falsified Medicines Directive, such as 2D barcodes and serialisation numbers, but anti-tamper devices are expected to remain.
Companies should look out for detailed guidance, including on labelling requirements and MHRA authorisations, to be published by the MHRA in due course. UK-based suppliers and distributors should prepare for use of different packaging for EU and UK medicines from 1 January 2025.