Section 7 (1) of the Ordinance on GCP lays down that applications for the authorisation of a clinical trial must be submitted in a paper version and the application form as well as the documents to be attached mustin addition, also be submitted to the federal competent authority on an electronic data carrier.

Since both competent authorities are changing over to purely electronic processing of the documents step by step, the format of the electronic data carrier is becoming increasingly more important. For this purpose, the BfArM and the PEI have prepared a submission structure for electronic data carriers (CD-ROM/DVD) designed to harmonise and standardise the submission of applications including the appropriate documentation attached. This structure shows a major similarity to the submission formats of other European authorities. BfArM and PEI are trying their best to push through a uniform European submission format.

Sample folder for the electronic submission (size: 2 KB)

The ZIP archive contains the following folder structure:

In those cases where applicants adhere completely to the specifications of the electronic submission format, the BfArM / PEI renounces the submission of additional paper copies for the application. For this purpose, the cover letter for the application must contain a note confirming that the application contained in the electronic data carrier and the documents pertaining to it have been submitted in compliance with the currently applicable specifications published on the homepage of the BfArM / PEI and that the electronic version is identical with the original version on paper. If this is the case, the submission of the original of the application bearing the applicant's signature and one electronic data carrier will suffice.