According to the eSubmission Roadmap, from July 1st 2019, the use of the Common European Submission Portal (CESP) has become mandatory also for AIFA.
This system is applicable only to mutual recognition and decentralized procedure (MRP/DCP) submissions, for the moment, while for the national procedures, companies should follow the same rules.
However, in order to ensure an appropriate implementation of the CESP program, despite the submission via CESP, AIFA recommends maintaining the same submission modalities (following the dispositions of 20th December 2018): for new MAA/line extension submitted through national, mutual recognition, repeat use and decentralized procedures, the eCTD sequence should still be provided to AIFA in a CD-ROM by courier with the relevant cover letter and eAF (original signed paper copy or digital signed electronic copy).
For variation applications and renewals, the upload on the AIFA Front END system is still required, together with the cover letter and eAF (original signed paper copy or digital signed electronic copy). In this case, the submission of the CD-ROM is required only when the size of the documentation does not allow the upload on the system.
As for the Active Substance Master File (ASMF), the dossier should be submitted in eCTD format in a CD-ROM by courier, together with a submission letter and signed letter of access (original signed paper copy or digital signed electronic copy).
RPN has created its own CESP account and is able to support companies with the submission through the portal.