by In2Pharma | Oct 13, 2025 | News
Europe Following the revision of the Variation Regulation effective as of 1 January 2025, the European Commission (EC) has adopted and published the final version of the guidelines concerning the classification of variations and the operation of the relevant...
by In2Pharma | Oct 13, 2025 | News
Luxembourg A new version (V5 – September 2025) of the document ‘Fees in relation to marketing authorizations Luxembourg’ has been published. This updated version clarifies that for applications for variation type IA/IB, no fees are required for notifications (e.g.,...
by In2Pharma | Feb 14, 2025 | News
Luxembourg Since January 2025, the payment system for variation fees in Luxembourg has changed. In the past, variation fees were paid bi-annual and based on the number of products and variations included in the submission. As from January 2025, variations need to be...
by In2Pharma | Dec 27, 2024 | News
Europe An update to Delegated Regulation (EU) 2024/1701, which amends Regulation (EC) No 1234/2008, has been published and will come into effect on 1 January 2025. This regulation addresses the examination of variations to the terms of marketing authorisations for...
