eSubmission
created: 2010.03.26
updated: 2010.05.03
In regard of submissions in electronic format details and additional conditions for paperless submissions will be explained concerning the following topics:
- Participation of BfArM at the Common EU Submission Platform (CESP) Project
- General rules for acceptance of so-called electronic-only submissions
- Electronic Common Technical Document (eCTD)
- Non-eCTD electronic Submission (NeeS)
- Technical Validation
- Step-by-Step guide
- e-Submission Ordinance in accordance with the German Medicines Act (AMG-EV)
- Frequently Asked Questions
In case of uncertenties or questions do not hesitate to send an e-mail to info-esubmission@bfarm.de . Please, state your address and the way we can phone you a swell as a detailed description of the problem.