The Belgian Federal Agency for Medicines and Health Products (FAGG) has released an updated version 2.11 of the national eSubmission Guideline applicable for electronic submissions for human medicinal products in Belgium. The update dated 02 December 2011 has been issued to "reflect EU requirements and in order to reflect validation reports to be saved in the workingdocuments folder".
eCTD validation reports are required in electronic form for all eCTD sequences and must now been provided in a "<sequence>-workingdocuments" folder accompanying each eCTD sequence submitted. eCTD validation reports can be provided using the EURS validator (Extedo) or the eValidator (Lorenz).
In addition, the Belgian "NeeS-Checker" validation tool that must be used in case of NeeS submissions has been updated to version 2.9.c. The new version fixes some bugs regarding variable filenames within the 3.2.S.4.2 and 3.2.S.4.3 sections and some performance problems.
To find more information please click here: Exalon: BE: Update of the national eSubmission Guideline and corresponding NeeS checker
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