by In2Pharma | Aug 14, 2025 | News
Europe The European Commission has published draft guidelines detailing the revised framework for variations to marketing authorisations of human medicines. These guidelines follow the updated Variation Regulation (EU) 2024/1701, which became applicable on 1 January...
by In2Pharma | Jul 31, 2025 | News
Belgium A new web-based eAF (electronic Application Form) from the Product Lifecycle Management Portal (PLM Portal) has been established for variation applications for non-centrally authorised products. The use of this new web-based eAF is recommended, yet, the...
