During the end-of-year period, the FAMHP will be closed from Friday 25 December 2026 to Friday 1 January 2027. 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 2026 to 7 January 2027: a 16-day delay will be added for all procedures. All dossiers submitted during this clock stop will be processed from 8 January 2027 onwards.
It concerns the following dossiers:
- all dossiers submitted according to the Clinical Trials Regulation (CTR);
- 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 the 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.
- Dossiers for other divisions at the FAMHP
Thursday 10 December 2026 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, Notified body consultation procedures);
- the Marketing Authorisation Division (variations and renewals).
The validation procedure for dossiers submitted after Thursday 10 December 2026 will start on 4 January 2027.
- Thursday 24 December 2026 is the deadline to submit dossiers for the Proper Use division.
For dossiers submitted after Thursday 24 December 2026, administrative processing will start on 4 January 2027.
This does not affect the applicable legal deadlines, which are calculated from the date of submission.
Excerpt from the official page. The original is authoritative.