MHRA Windsor Framework Hub
A hub for information on the main changes introduced by the Windsor Framework
This information is designed to help you understand the main changes that implementing the Windsor Framework will introduce for medicines and what you need to do to prepare. It includes a collection of documents that provide guidance on the Windsor Framework agreement on supply of medicines in Northern Ireland.
From 1 January 20251, the Windsor Framework introduces new rules in the UK for product licensing, labelling, and the EU Falsified Medicines Directive (FMD). It will ensure that medicines can be approved and licensed on a UK-wide basis by the Medicines and Healthcare products Regulatory Agency (MHRA) and medicines can be supplied in the same packs across the UK. It also provides for the disapplication of FMD safety features for medicines marketed and supplied in Northern Ireland.
1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14.
Further information is available in the guidance listed below.
Guidance
Windsor Framework explainer
An explainer document for the pharmaceutical industry which brings together in a simpler format, the information published in our Windsor Framework guidance collection. The guidance below explains the main changes that implementing the Windsor Framework will introduce on 1 January 2025 and what you need to do to prepare.
Video explainer series
Watch our series of 6 short videos explaining what you need to do ensure you are ready for the implementation of the Windsor Framework.
Webinar Recordings
A 2-part series of recordings from our Windsor Framework industry webinars. Watch our experts explain the information in our published guidance and how you can prepare for implementation.
Updates to this page
Last updated 20 November 2024 + show all updates
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• Added Windsor Framework explainer document • Added video explainer series • Added October 2024 webinar recording
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Added 'Advertising and Promotion following agreement of the Windsor Framework' to the guidance section.
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Added September Webinar recording
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Added new guidance to collection for wholesalers & manufacturers guidance following agreement of the Windsor Framework
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First published.