Mandatory use of eCTD for Decentralised Procedures in UK

Marketing authorisation () applications submitted to in non-electronic submissions () will be rejected. Around 90% of new applications for decentralised procedures () received by are already submitted in format.

Along with other national competent authorities () we intend to make this change mandatory in line with the EU roadmap, which has been progressed in consultation with industry, trade bodies and other

New applications in mutually recognised procedures will still be accepted in both and formats, however applicants are encouraged to use format wherever possible as the use of the format for these applications is planned to be phased out by 1 January 2017.