During the end-of-year period, the FAMHP will be closed from Monday 26 December 2022 through Friday 30 December 2022. Deadlines have been set for the submission of different types of dossiers.
Dossiers for the Research and Development Division (human use)
Tuesday 13 December 2022 is the final date to submit the following dossiers:
- initial applications for phase I monocentric Directive CTA dossiers;
- substantial amendments for phase I monocentric Directive CTA dossiers;
- substantial modifications for phase I monocentric CTR pilot dossiers.
Tuesday 20 December 2022 is the final date to submit the following dossiers:
- initial applications and substantial amendments for phase I multicentric/phase II/phase III/phase IV Directive CTA dossiers;
- answers to Grounds for Non-Acceptance (GNAs) for initial Directive CTA dossiers and substantial modifications (all phases, including phase I monocentric);
- substantial modifications for phase I multicentric/phase II/phase III/phase IV CTR pilot dossiers;
- answers to Requests For Information (RFIs) for substantial modifications in CTR pilot (all phases, including phase I monocentric);
- temporary halts;
- Unmet Medical Need (UMN) dossiers;
- Medical Device (Meddev)/Clinical Investigation (CI) dossiers.
The validation procedure for phase I monocentric dossiers submitted after 13 December 2022, and the validation procedure for dossiers or assessment of responses to GNAs/RFIs submitted after 20 December 2022, will start on 9 January 2023.
In addition, the applicants will receive a delay to provide their responses to GNAs/RFIs if the deadline to provide their responses would fall after 20 December 2022. This will be indicated in the GNA/RFI letter.
The following dossiers can be submitted until Friday 23 December 2022:
- initial Directive COVID-19 CTA dossiers;
- substantial amendments to Directive COVID-19 CTA dossiers;
- CTR pilot COVID-19 substantial modifications.
A nine-day clock-stop will apply during the end-of-year period, until Sunday 1 January 2022 included.
Please inform us in advance, before 20 December 2022, if you intend to submit a COVID-19 dossier before 23 December 2022.
EU regulation on clinical trials with medicines
A general annual clock stop applies in all European countries during the year-end period, from 23 December 2022 to 7 January 2023.
This means that a delay of 16 days is provided for all proceedings running during this clock stop.
Dossiers for other divisions at the FAMHP
Tuesday 13 December 2022 is the final date 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);
- the Proper Use Division;
- the Marketing Authorisation Division (variations and renewals).
The validation procedure of dossiers submitted after 13 December 2022 will start on 2 January 2023.