Belgium: Reminder End of Transition Period & Important Year-End Deadlines for Submitting Dossiers to the FAMHP

End of Transition Period for Clinical Trials

FAHMP reminds all stakeholders, that starting from 31 January 2025, all clinical trials are required to be converted into Clinical Trials Information System (CTIS) and comply with Regulation 536/2014.

Clinical trials that are still under Directive 2001/20/EC and expected to be continued beyond 31 January 2025 are advised to submit a transition application in CTIS by mid-November to complete the transition process in time. Otherwise, it is recommended to submit them after the transition period under CTR 536/2014.

Important Year-End Deadlines to Submit Dossiers

As the year comes to a close, the Belgian Agency for Medicines and Health Products (FAMHP) has announced key deadlines for dossier submissions across various departments. These deadlines ensure timely processing during the holiday season, helping applicants and regulatory teams manage workloads efficiently and maintain high standards in healthcare regulation.

1. Dossiers for Marketing Authorization Division (human use), Marketing Authorization Division (variations and renewals), Medical Devices & IVD Devices

   • Deadline: 12 December 2024

2. Dossiers for the Research and Development Division (human use)

   • Clock Stop: 23 December 2024 until 7 January 2025 (16-day delay)

     
     

To avoid delays, applicants are urged to submit all necessary documents and ensure they are complete by this date. Any new applications, modifications, or requests involving medical devices or IVD devices should also be finalized by the deadline.

Any dossiers submitted for Point 1 will be validated start on 2 January 2025 and dossiers submitted for Point 2 will be processed start on 8 January 2025.

Source: Federal Agency for Medicines and Health Products (FAMHP)