07.12.2010

DE: BfArM releases new version 3.1 of the "eValidator"

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The German Federal Institute for Drugs and Medical Devices (BfArM) has released a new version of the "eValidator" used to validate incoming applications in eCTD and NeeS format. The new version of the "eValidator" is available for download from the BfArM website.

Main changes introduced with release 3.1 of the "eValidator" (developed by Lorenz Life Science, www.lorenz.cc):

  • eCTD:Reused files will be handled properly within all contexts and scopes, i.e. inside an index file, between index files in the same sequence, between sequences and between different applications.
  • NeeS: A rule has been added, which checks the validity of the links in the TOC files only. This rule has the severity "Error" while the remaining PDF link rules are now set to "Warning" or "Information", meaning that the agency is willing to tolerate invalid links as long as the links in the TOC files are ok.

More changes have been introduced in the new version of the "eValidator". Details can be obtained from the Release notes included in the download package. 

[Source: BfArM website]







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