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...
by In2Pharma | Dec 20, 2024 | News
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...
by In2Pharma | Dec 9, 2024 | News
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...
by In2Pharma | Dec 2, 2024 | News
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...
by In2Pharma | Nov 14, 2024 | News
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...
by In2Pharma | Nov 5, 2024 | News
Belgium The Royal Decree published on 30 September 2024, amending the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use, adds two elements concerning the search for substitutes, in the event of unavailability. In the first place, a...