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 — See all updates

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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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.

Updates to this page

Published 12 September 2024
Last updated 11 March 2025 show all updates

  1. 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. 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. First published.

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