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ARTICLE · 28 NOVEMBER 2024

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Implementation Of The Windsor Framework

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The Windsor Framework ("WF") as implemented by Regulation (EU) 2023/1182 removes the option for jointly labelled medicines to be marked as NI/GB/UK.

GlobalAntitrust/Competition Law
Kate McKenna
Kate McKenna
Kate Lenihan
Kate Lenihan
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The Windsor Framework ("WF") as implemented by Regulation (EU) 2023/1182 removes the option for jointly labelled medicines to be marked as NI/GB/UK. The Framework will be directly applicable for medicines for human use from 1st January 2025 and UK medicines will be required to be labelled as "UK only". The HPRA published a helpful updates from an Irish regulatory perspective, including a first post on 25 May 2023 regarding implications for Marketing Authorisation Holders ("MAHs") supplying medicines to the Irish market and the expiry of the existing exemptions. This was followed by guidance in the form of Questions and Answers for Stakeholders, which were updated most recently on 25 October 2024.

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