Deadlines for the submission of dossiers during the end-of-year period

date: 19/10/2023

During the end-of-year period, the FAMHP will be closed from Monday 25 December 2023 to Monday 1 January 2024. 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 2023 to 7 January 2024: a 16-day delay will be added for all procedures. All dossiers submitted during this clock stop will be processed from 8 January 2024 onwards.

It concerns the following dossiers: 
•    all CTR dossiers;
•    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);
•    temporary discontinuations;
•    unmet medical need (UMN) dossiers;
•    medical device (meddev)/clinical investigation (CI) dossiers.

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.

-    Dossiers for other divisions at the FAMHP
Tuesday 12 December 2023 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 2023 will start on 2 January 2024.

Last updated on 19/10/2023