On January 1, 2025, new UK-wide arrangements for the supply of medicines came into effect on account of the “Windsor Framework.” The overarching aim is to secure the long-term stability of the supply of medicines to Northern Ireland (NI), ensuring that medicines will be available at the same time, and on the same basis, across the whole of the UK.

To do this, the Windsor Framework changes the regulation of medicines that were formerly within the scope of the EU centralized procedure. Beginning January 1, 2025, medicines for supply in the UK are now authorized UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA) only and therefore, companies will no longer need to apply for, or maintain, separate licenses for Great Britain (GB) and NI to market novel medicines. Other key changes include removing the requirements of the EU Falsified Medicines Directive (FMD) and a requirement that all medicines placed on the UK market be labeled “UK Only.”

While the changes seek to simplify the post-Brexit regime in the UK, in practice, companies may be faced with meeting two sets of requirements depending on the type of product. We set out an overview of the key requirements in our recent Advisory, although the changes impact a range of regulatory obligations, and we anticipate further complications in the future when the EU Pharma Package is introduced in the EU.

We would be happy to speak further about the detail if you have questions.