Hotfix for BfArM eValidator (Software for technical validation of e-submissions)

The folder name check for EU m1-3-1-spc-label-pl reported false negatives due to an error in the configuration (the language folder is missing in the software configuration). The hotfix corrects this error. For NeeS, the Module TOC check reported false negatives for absent modules. The hotfix corrects this error. The style sheet reference check did not handle all valid syntax options properly. Hence, false negatives might have been reported. The hotfix corrects this error. The new rule for EU submissions "Sequence number not already used" did not work properly and reported false negatives. In M4, the new EU criteria do not allow additional subfolders at the study report level. The ICH specification however recommends using such folders for submissions with multiple files per study. Due to the new strict folder name check applied to most of the profiles, the 3.1 SP1 release reported all such subfolders in M4 as invalid. The hotfix corrects this error, i.e. the additional subfolders are now considered as valid, except for the new EU profile (which will be mandatory as of 1 September 2011).

For more information and download the validator please click: BfArM e-Validator