EMA Mandates Web-Based Electronic Application Forms for Centrally Authorised Products Starting September 1, 2026

The European Medicines Agency (EMA) has made the use of its PLM web-based electronic Application Form (eAF) mandatory for all Centrally Authorised Products (CAPs) as of September 1, 2026. This regulatory change aims to enhance the efficiency, accuracy, and consistency of regulatory submissions by enabling automated data processing and seamless integration with other EMA systems. Companies are encouraged to verify their Product Management Service (PMS) data, ensure correct user access rights, and familiarize themselves with the web-based eAF functionalities to ensure a smooth transition. Submissions for human CAP variations using the older interactive PDF eAF will be rejected from this date forward, unless a valid technical reason prevents the use of the web-based version.