How do I Apply for a CEP? An Updated Guideline of the EDQM Provides Information

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:

 
•eCTD — This is the format that is used for the electronic submission of authorisation applications. However, the guideline points out that from a technical perspective it remains a 'standalone' dossier, which is distinct from any marketing authorisation eCTD dossier and life cycle. Furthermore, it is recommended to validate the eCTD technically prior to submission to the EDQM (using validation checker tools). If error messages appear during the validation by the EDQM, the submission is blocked or rejected, which delays the whole process of submission. The EDQM recommends the use of this format. 

•NeeS — The "non eCTD electronic submission" (NeeS) uses a format different from the CTD. Structure and specification of the format must meet the requirements described in the guidance document of the "EU telematics implementation group for electronic submissions" (TIGes) with the title "TIGes harmonised guidance for non eCTD electronic submissions (NeeS) for human medicinal products in the EU".

 
•PDF — In this format, the modules 1–3 have to be listed separately. The use of bookmarks is recommended.

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.

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