As part of the Windsor Framework agreement, important changes to pharmacovigilance for medicines authorized in the UK will take effect on 1 January 2025. These changes are designed to streamline and enhance the regulation of medicines across the UK.

Key Changes Effective from 1 January 2025:

1. UK-Wide Licensing by MHRA:

   – Starting from 2025, all medicines approved in the UK will be licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) and governed by the Human Medicines Regulation 2012 (HMRs), as amended.

   – Products previously eligible for authorization by the European Commission in Northern Ireland under the EU’s Centralised Procedure will now be authorized across the entire UK by the MHRA. These will be classified as **Category 1 products** and must adhere to specific pharmacovigilance requirements outlined in Part 11 and Schedule 12A of the HMRs.

2. Pharmacovigilance Requirements:

   – While the overall pharmacovigilance requirements will remain largely consistent with current standards, certain aspects will differ depending on whether a product is classified as Category 1 or Category 2.

For further details and guidance, please refer to the official publication here.