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Information from BfArM regarding paper submission after 5 August 2013

Based on changes to the administrative practise of 5 August 2013, BfArM no longer requires paper-based submissions for all application procedures, specifically in cases where the PharmNet.Bund portal, CESP or electronic storage media (CD/DVD) have been used for transmission.
Due to recent experiences, BfArM would strongly advise applicants not to submit additional paper copies when following the above-mentioned processes. Paper-based submissions are only necessary if the information required can only be represented by paper documents submitted by mail.
Paper-based submissions are only considered if an explicit reference is made that these submissions contain additional documents.
Apart from this rule, BfArM may also request paper documents by way of exception in cases where there may be doubts about authenticity or correctness.

In case of uncertainties or questions please do not hesitate to send an e-mail to info-esubmission@bfarm.de . Please state your address and how we can reach you by telephone as well as a detailed description of the problem.

Date 2016.02.09