DE: New version of the eValidator available from BfArM

The German Federal Institute of Drugs and Medical Devices (BfArM) has released a new version of the eSubmission validation software "eValidator" (by Lorenz, www.lorenz.cc ) used by BfArM to validate incoming eCTDs and NeeS .

The new version of the eValidator contains the following changes:

• Mutability of rule severity levels has been switched off to avoid changes by mistake and prevent confusion for customers
• Backbone links to multiple referenced files will no longer be considered as error as long as they are referencing to files in the same index file, i.e. which are located in the same sequence
• The revised version of the NeeS Guidance Document, dated March 2010,  has been taken into account
• The presence of node extensions (which are allowed in the EU) will be displayed for information, without issuing an error

The BfArM advises applicants strongly to re-download the eValidator (file size: 7 MB) and to update their local installation.

[Source: BfArM website]

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