11 and 17 December 2019: final date for submitting dossiers during Christmas holidays

During the Christmas holidays, the FAMHP will be closed from Wednesday 25 December 2019 until Wednesday 1 January 2020 included.

Wednesday 11 December 2019 is the final date for submitting initial applications and applications for substantial amendments for phase I monocentric clinical trials to the Research and Development Division (human use).

The validation procedure of dossiers submitted after 11 December 2019 will only start on 2 January 2020.

Tuesday 17 December 2019 is the final date for submitting dossiers to the Research and Development Division (human use), 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 and the Marketing Authorisation Division (variations and renewals).

The validation procedure of dossiers submitted after 17 December 2019 will only start on 2 January 2020.

Remark: there is no final date for submitting UMN dossiers, initial CTR pilot dossiers or substantial modifications of CTR pilot dossiers. For these types of dossiers an eight days clock stop will apply while the FAMHP is closed (from Wednesday 25 December, 2019 until Wednesday 1 January, 2020 included).

Last updated on
06/11/2019