Guidance

Wholesalers & manufacturers guidance following agreement of the Windsor Framework

Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework

• From: Medicines and Healthcare products Regulatory Agency
• Published: 12 September 2024
• Last updated: 11 March 2025
  Show all updates

  1. 11 March 2025

     Updated to remove footnote: “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" from Wholesalers & manufacturers guidance following agreement of the Windsor Framework attachment.

  2. 20 February 2025

     Updated the document Wholesalers & manufacturers guidance following agreement of the Windsor Framework to add Windsor Framework Wholesaler and Manufacturers Q&A and FMD Q&A

  3. 12 September 2024

     First published.

Documents

Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework

HTML

Windsor Framework disapplication of EU falsified medicines directive Q&A

PDF, 276 KB, 6 pages

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Windsor Framework wholesaler and manufacturer Q&A

PDF, 323 KB, 9 pages

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Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

Guidance to support manufacturers and wholesale dealers authorised by the MHRA and the associated qualified persons (QPs), responsible persons (RPs) and responsible persons for import (RPis), in order to implement the arrangements of the Windsor Framework for human medicines.