Update Variation Regulation

Update Variation Regulation

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...
Updates Farmastatus platform

Updates Farmastatus platform

Belgium As of 11 December 2024, the platform FarmaStatus (application that collects information about the availability of medicines in Belgium) will undergo multiple changes: Change in lay-out FarmaStatus: The application will get a similar lay-out as other...
Safety threshold for saccharin is increased

Safety threshold for saccharin is increased

Europe Based on all available data, it was concluded that the human consumption of saccharin does not withhold health risks and acceptable daily intake could be increased. Therefore, EFSA concluded that saccharin acceptable daily intake could be increased from 5 to 9...
Release of the European Shortages Monitoring Platform

Release of the European Shortages Monitoring Platform

Europe As part of Regulation (EU) 2022/123, an EU platform has been realised to prevent, monitor, and manage any medicine shortages across the EU of centrally authorised medicines. The European Shortages Monitoring Platform (ESMP) has the purpose to facilitate...
Import medicines special needs

Import medicines special needs

Belgium The new article 105/1 of the Royal Decree of 14 December 2006 on medicinal products for human use entered into force on 1 November 2024. This provision allows wholesalers in possession of an authorisation to purchase medicinal products (WDA) to place...