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...
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...
New regulation Ecodesign for Sustainable Products

New regulation Ecodesign for Sustainable Products

Europe We would like to inform you of a significant new EU regulation—the Ecodesign for Sustainable Products Regulation (ESPR)—which came into force on July 18th, 2024, replacing the previous 2009 legislation. This regulation is designed to make products more...
New legislation on packaging for veterinary medicines

New legislation on packaging for veterinary medicines

Europe On 9/04/2024 CBG published three new implementing acts regarding the new legislation on packaging for veterinary medicines in Europe. The following implementing acts (IAs) have been published: Implementing regulation (EU) 2024/875: This regulation establishes a...