Phasing out of non-eCTD electronic submissions in the UK

From 1st July 2015, the MHRA will no longer accept new marketing authorisation (MA) applications for decentralised procedure (DCP) in non-eCTD (NeeS) format

All new MA applications in DCP must be submitted in electronic common technical document (eCTD) format.

For the time being, new MA applications in mutual recognition procedure (MRP) can still be submitted in either NeeS or eCTD.  NeeS is planned to phased out completely by 1 January 2017.

Regulis can publish both formats of electronic dossier for clients.