Submission of dossiers during end-of-year period: final date is 15 December, except for COVID-19 dossiers

During the end-of-year period the FAMHP will be closed from Friday 25 December 2020 up to and including Sunday 3 January 2021. Deadlines have been set for the submission of different types of files.

Final date: Tuesday 15 December 2020
Tuesday 15 December 2020 is the final date for submitting dossiers or answers to GNAs (Grounds for Non-Acceptance) or RFIs (Requests For Information) to the Research and Development Division (human use). This arrangement concerns:

  • initial Directive CTA dossiers or substantial amendments or temporary halts of these dossiers;
  • initial CTR pilot dossiers or substantial modifications or temporary halts of these dossiers;
  • UMN dossiers;
  • Meddev/CI dossiers.

The validation procedure of dossiers or assessment of responses to GNAs/RFIs submitted after 15 December 2020 will only start on 4 January 2021. In addition, the applicants will receive a delay as well to provide their responses to GNAs/RFIs until 4 January 2021 if the deadline to provide the responses would fall after 15 December 2020. This will be indicated in the GNA/RFI letter.

Tuesday 15 December 2020 is also the final date for submitting dossiers to:

  • 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 15 December 2020 will only start on 4 January 2021.

Exception for COVID-19 dossiers
Initial Directive COVID-19 CTA dossiers or substantial amendments, and initial CTR pilot COVID-19 dossiers or substantial modifications can be submitted until 24 December 2020. However, a ten days clock-stop will apply while the FAMHP is closed (from Friday 25 December 2020 until Sunday 3 January 2021 included). Please inform the FAMHP in advance (before 15 December 2020) if you intend to submit a COVID-19 dossier between 15 and 24 December 2020.

Last updated on
28/10/2020