During the end-of-year period, the FAMHP will be closed from Wednesday 25 December 2024 to Wednesday 1 January 2025. Deadlines have been set for the submission of different types of dossiers.
- Dossiers for the Research and Development Division (human use)
A clock stop will be applied from 23 December 2024 to 7 January 2025: a 16-day delay will be added for all procedures. All dossiers submitted during this clock stop will be processed from 8 January 2025 onwards.
It concerns the following dossiers:
• all dossiers submitted according to the Clinical Trials Regulation (CTR);
• substantial amendments/modifications under the Clinical Trials Directive (Directive 2001/20/EC) and CTR pilot;
• answers to Grounds for Non-Acceptance (GNA)/Requests For Information (RFI) for substantial modifications under the Clinical Trials Directive and CTR pilot (the updated response time will be indicated in the GNA/RFI letter);
• unmet medical need (UMN) dossiers;
• medical device dossiers (clinical investigations under the Medical Devices Regulation, MDR);
• medical device dossiers for in vitro diagnostics (performance studies under In-Vitro Diagnostics Regulation, IVDR).
This principle is in line with CTR and the general annual clock stop that applies to the submission of CTR files in all European countries during the end-of-year period. This principle is also extended in Belgium to all MDR, IVDR and UMN dossiers.
Important: reminder end of transition period
From 31 January 2025, all clinical trials must be converted to the Clinical Trials Information System (CTIS) and must follow the rules of Regulation 536/2014.
We recommend that for clinical trials which are still ongoing under Directive 2001/20/EC and that are expected to continue beyond 31 January 2025, a transition application should be submitted in CTIS by mid-November at the latest in order to complete the transition process in time. Therefore, we also recommend not to submit substantial amendments anymore under Directive 2001/20/EC, but to submit them after transition under CTR 536/2014.
- Dossiers for other divisions at the FAMHP
Thursday 12 December 2024 is the deadline to submit dossiers to the following divisions:
• the Marketing Authorisation Division (human use);
• the Medicines for Veterinary Use Division;
• the National Innovation Office and Scientific Technical Advice Unit (national scientific-technical advice requests and requests for simultaneous national scientific advice);
• the Proper Use Division;
• the Marketing Authorisation Division (variations and renewals).
The validation procedure for dossiers submitted after 12 December 2024 will start on 2 January 2025.