IMB Guide to Electronic Submissions – RIO to be replaced by CESP

From early February 2013, the IMB online portal, RIO, will no longer be available.

RIO will be replaced by the CESP (Common European Submission Portal) here.

The IMB Guide to Electronic Submissions  has been updated to reflect this change and can be found via the following link:

Guide to electronic submissions – human medicines

The IMB strongly recommends electronic submissions, either in eCTD format, non-eCTD (NeeS) format without paper copies or through CESP. This applies to new applications; responses to validation queries and review of assessment questions, supplementary information, variations, renewals, periodic safety update reports (PSURs), active substance master files (ASMFs) / drug master files (DMFs).

To view the full article about the closure of RIO and change to electronic submissions, please visit the HPRA website: http://www.hpra.ie/