On 27 February 2023 the UK and EU agreed the Windsor Framework, which looked, amongst other things, to provide a solution to the supply and access of medicines from Great Britain into Northern Ireland.
What is the current situation?
Currently, medicines authorised in Northern Ireland follow European Union (EU) legislation and can therefore have approvals under European Centralised (CAP), Decentralised (DCP) or Mutual Recognition procedures (MRP). In these cases, it is required that the packaging includes the features of the EU Falsified Medicine Directive (FMD) to ensure that medicines are safe and controlled, which means the use of a unique identifier and tamper evident device on each pack. As such, any medicine in Northern Ireland currently authorised via a European procedure does not require full authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) before marketing the product.
What changes?
The Windsor Framework will commence on the 01 January 2025 and brings about changes to the legislation, aligning Northern Ireland with the rest of the UK by giving the MHRA full control of the approval and licensing of all medicines in Northern Ireland, and allowing a medicine to be sold in the same packaging and labelling across the UK. Under the framework, all UK packaging must carry a ‘UK only’ label to be allowed to be sold in Northern Ireland, and will no longer be required to display all of the features required under the EU FMD, although a tamper evident device is still required in line with current UK packaging requirements.
Consequently, all ‘UK only’ products will be specific to the UK market and will not be available to be sold in the EU, including the Republic of Ireland. Therefore, the MHRA is advising UK-based suppliers or distributors of medicines to prepare for different packaging for medicines to be supplied to UK and EU markets from 2025. It is important to note, though, that any packs still in circulation within the supply chain in their current packaging format after January 2025 will remain valid until their date of expiry.
In terms of any products approved by CAP, MRP or DCP within Northern Ireland, it is envisaged that it will not be possible for these medicines to remain within a European procedure once the framework is in place, so the approvals for these products will need to be converted to a UK wide authorisation. The MHRA are in the process of developing guidance that will cover the labelling requirements and the handling of authorisations, therefore the exact requirements for the changes to any Northern Ireland authorisations is still to be determined.
The requirements of the Windsor Framework therefore could potentially have a big regulatory impact for Marketing Authorisation Holders.
How can S-cubed help you?
S-cubed have extensive experience in both Marketing Authorisation and Licence Maintenance activities both within the UK, and for CAP, MRP and DCP products, and have an excellent understanding of the MHRA requirements.
S-cubed can assist clients with any changes that may be required to medicines in Northern Ireland as a result of the Windsor Framework, ranging from advice and planning to preparation and submission of any variations or notifications that may be required.
Any Questions?
If you have any questions on this topic or want to reach out regarding your own programme, please don’t hesitate to get in touch! You can contact us here, via email info@s-cubed-global.com, or by telephone (S-cubed Ltd: +44 1235 77 22 60).