# Supplementary information for pharmacists and medicines procurers on the Windsor Framework

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/89d67dba-9a7e-461c-9cc6-58fd4a66a7d7
Type: Guidance
Published: January 9, 2025

> The Windsor Framework marks a significant shift in the regulation and distribution of medicinal products within the United Kingdom. Effective January 1, 2025, a UK-wide licensing regime has been established, ensuring that medicinal products are available in identical packs and packaging across all regions. Under this updated regulatory framework, the Medicines and Healthcare products Regulatory Agency (MHRA) is now the sole authority for licensing all medicines throughout the UK. This change includes the authorization of novel medicines, which were previously governed by the European Commission for the Northern Ireland market under the original Northern Ireland Protocol. This guidance is specifically tailored for pharmacists, pharmacy technicians, and healthcare procurement professionals. It serves to clarify the operational changes necessary to comply with the unified licensing system. The transition eliminates the need for separate regulatory processes for Northern Ireland, thereby streamlining the supply chain and ensuring parity in medicine access. While the document does not highlight specific company violations or inspection findings as it is a general guidance, it emphasizes the mandatory shift to MHRA-led oversight. Professionals in the field are required to familiarize themselves with these arrangements to ensure seamless procurement and dispensing practices. The new system simplifies the logistical requirements for pharmaceutical companies and distributors, as they no longer need to manage distinct inventory or labeling requirements for different parts of the UK market.

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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 Northern Ireland Protocol had to be authorised for Northern Ireland by the European Commission. This information is designed to help pharmacists, pharmacy technicians and those with responsibility for procuring medicines understand the main changes that have be introduced by the Windsor Framework’s medicines arrangements which came into effect on 1 January 2025.

## Attachments

- [Supplementary information for pharmacists and medicines procurers on the Windsor Framework](https://assets.publishing.service.gov.uk/media/677fc96e6f01ae28ab5c0562/Windsor_Framework_Pharmacists___Medicines_Procurers_Guide__Jan_2025_.pdf)