- Before submitting or uploading your dossier you have to perform a validation to check whether your dossier really complies with the requirements mentioned above (ICH M2 eCTD v.3.2.2, EU M1 v.2.0, v 3.0.1 as of July 1, 2016); file and folder naming convention for eCTD and NeeS, PDF configurations) or whether you have to eliminate errors.
- The BfArM offers an updated version of a tool which checks your dossier against validation criteria for the eCTD format as well as for NeeS compilations and PDF files which can be downloaded and used free of cost. The current changes improve the correct function in case of checking PDF files, where an unstable functioing could have occurred. Therefore, the update is highly recommended. A correct technical validation of sequences may not be possible using previous versions of the eValidator.
eValidator v5.9.1 (FileTypex-zip-compressed, 15MB, File does not fully comply with accessibility standards)
After download and extraction the tool can be installed on a PC and can be activated without sending user details back. The tool offers basic functionalities in accordance with the current specifications of eCTD EU M1 v3.0.1 and ICH M2 – M5 v. 3.2.2 (Validation criteria v6.1) as well as of NeeS (Validation criteria v4.1); the default settings are in accordance with European requirements.
Further technical support for using the BfArM eValidator is not available.
Use of the BfArM eValidator is based on a general license for which the user does not have to pay or register. The end-user license agreement can be downloaded and reviewed separately before installing the software.
- The BfArM offers additionally a specific
Validation profile for parallelimport applications (FileTypex-zip-compressed, 24KB, File does not fully comply with accessibility standards)
in NeeS format. Here you can find (only in German) instructions for installation
- In any case, BfArM will perform its own technical validation. Applicants will be informed if errors occur. Therefore, statement of a return e-mail address to which the validation report can be sent is highly recommended.
- Errors will make it impossible to check-in your dossier, you will be requested to correct the submission and finally to re-submit the new version of that same sequence.
Any deadlines will not start counting until the technical validation has been successful.