The UK Government in tandem with the EU commission has announced the new Windsor Framework, which contains new arrangements for a wide range of changes, with the fundamental principle underpinning the arrangements being the distinction between goods for the UK internal market, and goods at risk of entering the EU’s Single Market.
This new agreement replaces the Northern Ireland Protocol (NIP), which the UK and EU both believed had failed to accommodate for the fact that the flow of medicines to Northern Ireland is largely from Great Britain. As such, the new agreement seeks to address the issues with the NIP and safeguard the supply and access of medicines from GB into Northern Ireland. Implementation of the framework will result in significant changes to medicine regulatory arrangements.
One of the more fundamental changes to the existing system in the new agreement is the replacement of the European Medicines Agency (EMA) by the Medicines and Healthcare products Regulatory Agency (MHRA) as the sole regulator and assessor of all medicinal products, including new and innovative products, destined for the UK internal market in Northern Ireland. This will result in a single UK wide marketing authorisation, and ameliorate situations in which products are not available in Northern Ireland but are in Great Britain due to earlier authorisation by the MHRA compared to the EMA. Moreover, UK medicines packs will require a “UK-only” marking, which is aimed to reduce unnecessary paperwork, checks and duties using ordinary commercial information. The new framework also includes changes such as the disapplication of the Falsified Medicines Directive in Northern Ireland, and simplifications to customers and Sanitary and Phytosanitary processes to reduce trader requirements.
Although the changes may result in companies needing to adjust supply chains, a single regulatory framework for the UK and its capacity to address issues in the NIP is believed to be welcomed. The Windsor Framework must be approved by the EU-UK Joint Committee, which is expected to happen in March 2023, and must be followed by legislation put into place by the UK government and the EU for the framework to become effective.
- Windsor Framework – Fundamental Shift for Post-Brexit Medicine Regulation in NI. Covington. https://www.cov.com/en/news-and-insights/insights/2023/03/windsor-framework-fundamental-shift-for-post-brexit-medicine-regulation-in-ni. Accessed 13th March 2023.
- The Windsor Framework – what does it mean for life sciences? Mills and Reeve. https://www.mills-reeve.com/insights/blogs/life-sciences/february-2023/the-windsor-framework-what-does-it-mean-for-life-s#:~:text=The%20Falsified%20Medicines%20Directive%20will,are%20compliant%20with%20EU%20law.. Accessed 13th March 2023.
- The Windsor Framework. GOV.UK. https://www.gov.uk/government/publications/the-windsor-framework. Accessed 13th March 2023.