Guidance on Submissions to the MHRA from 1st January 2013 – Details announced!

The MHRA has confirmed the new arrangements for making submissions.  The changes go further than expected.

From 1st January 2013, new marketing authorisation applications, variations, renewals, PSURs and BROMI applications must be submitted in validated NeeS or eCTD format.   Applications submitted in Special Mail 5 format will no longer be accepted.

All submissions received by the MHRA will be technically validated using the Extedo Eurs is Yours (EiY) validation tool before being passed to the Scientific Validation and Assessment teams for content validation.

Regulis has experience of making submissions in both formats and offer a full NeeS and eCTD publishing service.  If your company needs further information or advice on implementing the published best practice guides or the EiY validation tool, please contact Regulis via our Contacts page or by emailing enquires@regulis.com.