The Belgian Federal Agency for Medicines and Health Products (FAHMP) has released a new version of their national "eSubmission Guidelines" document, version 2.10 which will be in force from today, 01. September 2011.
The new version of the "eSubmission Guidelines" takes into account the new EU eCTD validation criteria 3.1 and NeeS validation criteria 2.1 that are in force since 01. September 2011. Consequently, significant changes have been introduced in the new version:
The previously used Belgian "FAGGeCTDChecker" has been updated. It is now called "NeeS" checker and will no longer be used for eCTD submissions. According to the new eCTD validation criteria 3.1, non-conformity to the recommended file/folder naming convention constitutes a violation against "Best Practice" guidance but will not result in a "Fail" of the corresponding criteria 15.BP2 and 15.BP3. Consequently, such deviations will not automatically lead to a rejection by the FAHMP and should be justified in the cover letter or rewiewer's guide. (Note: This is a change to previous procedures, where electronic submissions in eCTD and NeeS format that did not reach the pre-defined score according to the FAHMP roadmap were rejected)
For More information please click here: Exalon: BE: New version of eSubmission Guideline released by FAHMP
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