At the start of Brexit guidelines were unclear and prompted regulatory changes for the industry, marking a step in its history.

Now with the new Windsor Framework the industry is starting to see the start of UK guidelines coming through, with much more to come.

 This is our brief overview of the new two category system which we hope will make it clear just how these groups will impact your pharmacovigilance activities and requirements.

 The Windsor Framework, effective from 1 January 2025, introduces significant changes to pharmacovigilance responsibilities in the UK.

 All medicines will now be licensed UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA), eliminating the need for separate authorisations for Northern Ireland.

 Medicines are categorised in to two groups:

• Category 1: Medicines previously under the EU Centralised Procedure, now authorised UK-wide by the MHRA under UK law. Pharmacovigilance for these products will follow Part 11 of the Human Medicines Regulations (HMRs) and Schedule 12A, aligning with current UK requirements. Marketing Authorisation Holders (MAHs) must submit Periodic Safety Update Reports (PSURs) to the MHRA, adhering to EU submission timelines in the absence of UK-specific requirements. While EU PSUR outcomes don't legally apply, MAHs are expected to keep UK licences current with scientific developments.

• Category 2: Medicines outside the scope of the EU Centralised Procedure, continuing to follow existing pharmacovigilance requirements under Part 11 of the HMRs and the Commission Implementing Regulation (EU) No 520/2012. MAHs for these products must comply with EU regulations, including PSUR submissions and other safety obligations.

All medicines must display a 'UK Only' label, indicating they are exclusively for the UK market.

The EU Falsified Medicines Directive (FMD) safety features will no longer apply in Northern Ireland; thus, UK medicines will not include FMD-specific features.

The Windsor framework brings no changes to the requirements for a PSMF, UK QPPV andNational Contact Person for Pharmacovigilance. The need for a for a UK PSMF stays, for all UK MA’s. The UK QPPV can reside in the EU but must appoint a UKNCP. For Category 1 products the PSMF and QPPV notifications are to the MHRA.For Category 2 products the notifications should be via the Article 57database. 

In short: The new Windsor Framework does not alter the underlying principles of pharmacovigilance in the UK.Nevertheless MAHs should review and understand the category system and adjust their pharmacovigilance systems to comply with these new requirements, ensuring seamless operations across the UK.

Rosina Zahoor

Senior Pharmacovigilance Consultant