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

Following the implementation of the Windsor Agreement, a new framework is coming into effect in the new year affecting the UK licensing regime for medicinal products, giving the Medicines and Healthcare products Regulatory Agency (MHRA) the exclusive authority to licence medicines across the whole of the UK.  The changes to the UK licensing regime will have knock-on effects on the Supplementary Protection Certificate (SPC) framework. To accommodate for this, The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (the Windsor Framework SPC Regulations) were laid before Parliament on 31 October 2024 to come into force on 1 January 2025. This will amend the existing assimilated Regulation (EC) No 469/2009 as it applies in the UK.

Although the UK SPC application process will eventually be simplified, the Windsor Framework SPC Regulations insert new definitions and additional provisions, as well as an Annex setting out transitional arrangements to address issues relating to territorial scope, validity, duration, expiry and paediatric extensions.Continue Reading Windsor Agreement changes to UK Assimilated SPC Regulation

On 5 April 2024, the MHRA updated various guidance documents on the impact of the Windsor Agreement (the Agreement) on parallel imports into and within the UK. Since the end of the Brexit transition period, EMA-issued parallel distribution notices (PDNs) ceased to be valid in Great Britain (GB). A PDN must be obtained by a parallel distributor prior to engaging in parallel distribution in the EU. In GB, PDNs were replaced by Parallel Import Licences (PLPIs), which allowed distribution of products in GB only; while PDNs continued to be valid in Northern Ireland (NI).

As of 1 January 2025, when the Agreement is due to take effect, PDNs will no longer be valid in NI. All parallel imports into GB and NI will require a PLPI from the MHRA that will apply across the whole UK, and any PLPIs that were previously limited to GB will automatically convert into UK-wide PLPIs from this date.Continue Reading Brexit update: Changes to parallel imports in the UK