Technical Validation
Technical Validation
- Before submitting or uploading your dossier you have to perform a validation in order to check whether your dossier does in fact comply with the requirements stated above (ICH M2 eCTD v.3.2.2, EU M1, v 3.0.3; and with the file and folder naming convention for eCTD and NeeS, PDF configurations) or whether you have to eliminate errors.
- The BfArM will no longer offer 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. Instead, you can refer to the websites of Lorenz Life Science (which ist the BfArM's service provider in this context for updates of the eValidator. The current changes concern the implementation of the validation criteria for eCTD v7.1 and for NeeS v4.3. Therefore, the update is highly recommended. A correct technical validation of sequences may not be possible using previous versions of the eValidator.
- 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 v3.0.3 and ICH M2 – M5 v. 3.2.2 (Validation criteria v7.1) as well as of NeeS (Validation criteria v4.3); the default settings are in accordance with European requirements.
Further technical support for using the eValidator is not available.
Use of the 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.
Parallel Import
The BfArM additionally offers a specific
in NeeS format. Here you can find (only in German) instructions for installation
The previous version of the eValidator can still be used for parallel imports. Therefore, the download option is still offered but is only reliable for parallel import submissions:
- 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.
- Warnings will be ignored for check-in, but if applicable you will be informed in order to help you to avoid such "inaccuracies" in the future.