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.
Documents
Details
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
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Updated to amend sentence in section 1 and add link to UK-wide licensing for human medicines: supplementary guidance
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Updated 'contact us' information.
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Changed to update contact info and footnotes
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Added link to Windsor Framework Category 1 and 2 lists of individual products.
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Added Windsor Framework - category 1 and 2 flow chart for initial applications
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바카라 사이트� Added section numbers throughout guidance 바카라 사이트� Section 1 바카라 사이트� Added reference to Human Medicines Regulations 바카라 사이트� Section 2 바카라 사이트� Amended glossary of terms 바카라 사이트� Section 3 바카라 사이트� Amended to include further clarity on how licensing will change for EU centrally authorised products 바카라 사이트� Section 4 바카라 사이트� 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 바카라 사이트� Section 5 바카라 사이트� Amended to provide further clarity on changes to territorial application 바카라 사이트� Section 6 바카라 사이트� Amended to provide further clarity on existing UK-wide MAs granted through the MRP/DCP 바카라 사이트� Section 7 바카라 사이트� Amended to provide further clarity on existing MA numbers before 1 January 2025 바카라 사이트� Section 8 바카라 사이트� Amended to provide further clarity on Reference Medical Products before and after 1 January 2025 and Data and Marketing Exclusivity periods 바카라 사이트� Section 9 바카라 사이트� 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.