01.09.2011

BE: New version of eSubmission Guideline released by FAHMP

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 eCTD submissions, corresponding eCTD validation report results created either by Extedo`s EURS validator or Lorenz`eValidator must be provided together with each eCTD sequence on hard media in a separate location outside the eCTD structure. An example screenshot is given in the updated "eSubmission Guidelines". (Exalon Note: Unfortunately this couldl lead to increased workload for the creation and QC of electronic media in MRP/DCP procedures where Belgium is included as RMS or CMS. In this case the CD/DVD for Belgium is most likely to be prepared separately.)

Interestingly, the FAHMP request the EURS validation report / eValidator report also for NeeS sumbissions where Belgium act as the RMS in MRP/DCP.

Further minor updates include additional instructions on the handling of MS Word files in "<sequence>-workingdocuments" folders, national translations of SPC, Labeling and Package Leaflet in variation procedures and the usage of the Module 1 "Additional Data" section.

The new version 2.10 of the "eSubmission Guidelines" and the new "NeeS checker" version 2.9a are available for download from the FAHMP website (see link at the bottom of this article)

[Source: FAHMP website]

Links:

www.fagg-afmps.be/en/human_use/medicines/Medicines/MA_procedures/esubmission/

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