Electronic submissions for marketing authorisations for medicinal products for human use : novelties

The new version (v2.11) of the national esubmission guideline is available.  This guideline is applicable from 2nd December 2011 for all dossiers submitted at the FAMHP for human use with the exception for dossiers for homeopathic medicines and the psurs. The checker which is used for the technical validation of the dossiers and the CTD tree structure has also been adapted.

More information: page eSubmission




























Last updated on 02/12/2011