UK-wide licensing for human medicines
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
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This guidance is designed to provide information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Updates to this page
Published 29 September 2023Last updated 30 August 2024 + show all updates
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• Added section numbers throughout guidance • Section 1 – Added reference to Human Medicines Regulations • Section 2 – Amended glossary of terms • Section 3 – Amended to include further clarity on how licensing will change for EU centrally authorised products • Section 4 – Added new section on Category 1 and 2 products, the new product classification for all medicinal products that are licensed on a UK-wide basis • Section 5 – Amended to provide further clarity on changes to territorial application • Section 6 – Amended to provide further clarity on existing UK-wide MAs granted through the MRP/DCP • Section 7 – Amended to provide further clarity on existing MA numbers before 1 January 2025 • Section 8 – Amended to provide further clarity on Reference Medical Products before and after 1 January 2025 and Data and Marketing Exclusivity periods • Section 9 – Divided previous summary table into table 3 and table 4. Both tables include new references to Category 1 and Category 2 products.
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First published.