Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP
August 17, 2021
A new version of the guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP is available.
Source: FAMHP
The submission of dossiers and documents via the Common European Submission Portal (CESP) to the Research and Development division (human use) of the FAMHP is compulsory. As from now, dossiers for genetically modified organisms (GMOs) for deliberate release also must be submitted via CESP. This no longer needs to be done on CD-ROM.