A new post-Brexit approach for the authorisation of medicines in the UK
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In this blog, we take a look at some of the key changes for the authorisation of medicines in the UK that will be introduced from next year by the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (the 2024 Regulations).
Background to the 2024 Regulations: the Windsor Framework
The post-Brexit agreement of the Windsor Framework between the UK and the EU in 2023 set out new arrangements relating to the supply of medicines from Great Britain to Northern Ireland.
The Windsor Framework provided that medicinal products that previously had to be authorised across the EU and Northern Ireland by the European Commission (on the recommendation of the European Medicines Agency) would, from 1 January 2025, instead be authorised by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
On 29 July 2024, the UK Government laid before Parliament the 2024 Regulations in order to implement these changes in the UK. The 2024 Regulations will amend the Human Medicines Regulations 2012 and come into force on 1 January 2025. The new arrangements will better reflect the fact that the vast majority of medicines on the Northern Ireland market come from Great Britain [1] and ensure that medicines can be approved by the MHRA for marketing on a UK-wide basis.
The new approach to authorisation under the 2024 Regulations
From 1 January 2025, new medicines for the UK market will be authorised by the MHRA and will be supplied with a single licence in singular packaging for the whole of the UK. These products will only be marketable in the UK (England, Wales, Scotland, and Northern Ireland), and will not be available for the market in Ireland, or elsewhere in the EU.
New UK packaging will have to carry a clear 'UK only' label to be cleared for circulation on the UK market, including Northern Ireland. To provide flexibility, the MHRA has said that the 'UK only' labels can be placed anywhere on the packaging, so long as the label follows the MHRA's general labelling guidance.
The 2024 Regulations provide two categories of UK-wide marketing authorisation (Categories 1 and 2). Whether a product is authorised under Category 1 or Category 2 will depend on whether or not it would have fallen within the previous EU centralised procedure (i.e. products that were required under EU law to be authorised across the EU and Northern Ireland on a centralised basis by the European Commission). This means that, when taken with the categories already available under the Human Medicines Regulations 2012, there will in total will be four types of authorisations available:
- UKMA(UK) (Category 1) - permits the marketing of a medicinal product across the UK;
- UKMA (Category 2) - permits the marketing of a medicinal product across the UK;
- UKMA (GB) - only permits the marketing of a medicinal product in Great Britain (England, Wales and Scotland); and
- UKMA (NI) - only permits the marketing of a medicinal product in Northern Ireland.
Manufacturers will be able to continue to supply medicines in legacy EU packaging until 31 December 2024. Medicines in legacy packaging already on the UK market and within the supply chain may remain so until the date of their expiry.
Steps that medicines suppliers should be taking
Businesses supplying medicines to the UK market should be preparing now for the requirement of new medicinal packaging from 1 January 2025. Now is a good time to consider the steps that you will need to take to ensure that your packaging will be compliant with the new arrangements.
If you would like to discuss any of the issues covered in this blog, please get in touch with regulatory specialist Taly Dvorkis.
With thanks to trainee solicitor Alexandra Basford for her assistance in preparing this blog.
The content of this blog does not constitute legal advice and is provided for general information purposes only. Specific legal advice should be sought before taking any actions based on the content of this blog.