# Supplementary information for pharmaceutical wholesalers on the Windsor Framework

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a2299194-b657-423a-905b-c33ddcf22e7f
Type: Guidance
Published: January 9, 2025

> Starting January 1, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) has implemented a new UK-wide licensing regime for medicinal products under the Windsor Framework. This regulatory shift establishes a uniform system where the MHRA authorizes all medicines across the entire United Kingdom, including Northern Ireland. Previously, under the original Northern Ireland Protocol, novel medicines for Northern Ireland required authorization from the European Commission. The new framework eliminates this requirement, ensuring that identical products with the same packaging are available in both Great Britain and Northern Ireland simultaneously. While the provided text does not list specific violations or inspection dates, it highlights the transition from a dual-jurisdiction model to a centralized UK process. For wholesalers and industry stakeholders, the required actions involve adapting supply chain logistics and packaging standards to align with this single-market approach. This change is designed to simplify the distribution of pharmaceuticals and ensure consistent access to treatments across all regions of the UK by removing previous regulatory barriers between Northern Ireland and the rest of the country.

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## Content

The Windsor Framework introduces a UK-wide licensing regime, meaning that the same medicinal products, in the same packs with the same packaging will be available across the whole UK. The Medicines and Healthcare products Regulatory Agency (MHRA) will license all medicines across the UK, including novel medicines, which under the original Protocol had to be authorised for Northern Ireland by the European Commission. This information is designed to help wholesalers understand the main changes that have been introduced by the Windsor Framework’s medicines arrangements which came into effect on 1 January 2025.

## Attachments

- [Supplementary information for pharmaceutical wholesalers on the Windsor Framework](https://assets.publishing.service.gov.uk/media/677fc97822a085c5ff5c0529/Windsor_Framework_Pharmaceutical_Wholesaler_Guide__Jan_2025_.pdf)