During the end-of-year period, the FAMHP will be closed from Monday 27 December 2021 through Friday 31 December 2021. Deadlines have been set for the submission of different types of dossiers.
Dossiers for the Research and Development Division (human use)
Tuesday 14 December 2021 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 21 December 2021 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 (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 initial CTR pilot dossiers and substantial modifications (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 14 December 2021, and the validation procedure for dossiers or assessment of responses to GNAs/RFIs submitted after 21 December 2021, will start on 10 January 2022.
In addition, the applicants will receive a delay to provide their responses to GNAs/RFIs until 10 January 2022 if the deadline to provide their responses would fall after 21 December 2021. This will be indicated in the GNA/RFI letter.
COVID-19 dossiers
The following dossiers can be submitted until Friday 24 December 2021:
- 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 2 January 2022 included.
Please inform us in advance, before 21 December 2021, if you intend to submit a COVID-19 dossier before 24 December 2021.
Note that 14 December 2021 is the last possible time slot for the submission of an initial CTR pilot dossier, including COVID-19 dossiers.
Dossiers for other divisions at the FAMHP
Tuesday 14 December 2021 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 14 December 2021 will start on 3 January 2022.