Many companies have already started to submit their authorisation applications electronically. With regard to a centralised marketing authorisation, this has been the only way for some time. For a Certificate of Suitability (CEP) application both ways can still be used, though: sending in paper form or electronic transmission.
The EDQM recently published an updated guidance entitled "Guidance for electronic and paper submissions for certificates of suitability (CEPs) applications". This document describes in detail the use of different formats for the submission and the respective procedure. The following formats are accepted:
To better structure the extensive information additional sections can be introduced in all three formats (extension of granularity). When submitting these documents in paper form, they are initially scanned by the EDQM and then destroyed. Due to this process there can be a delay depending on the volume of the documentation, because the clock-start for the dossier begins only after this process is complete.
Basically, switching from paper to electronic submission is possible and recommended by the EDQM. However, once a company opted for the electronic way, going back to paper dossier is impossible.
The guideline contains 6 Annexes, describing the directory and folder structure of the formats and the granularity levels in more details. Annex 6 is particularly useful as it lists the most common mistakes that may lead to a blocking of the application process.