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.
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.
First published.