From 01 July 2015, new marketing authorisation applications for decentralised procedures must be submitted in electronic common technical document (eCTD) format. Marketing authorisation applications submitted to the MHRA in non-eCTD format will be rejected. Around 90% of new applications for decentralised procedures received by MHRA are already submitted in eCTD format. New marketing authorisation applications in mutually recognised procedures will still be accepted in both non-eCTD and eCTD formats, however applicants are encouraged to use eCTD format wherever possible as the use of the non-eCTD submission formats for these applications is planned to be phased out by 1 Jan 2017.
The decentralised and mutual recognition procedures are European marketing authorisation procedures which are based on the principle of recognition of the assessment by a Reference Member State. The decentralised procedure is used to obtain a marketing authorisation in several EU Member States when the applicant does not yet have a marketing authorisation in any country. The applicant requests one country to be the Reference Member State (RMS). The RMS circulates its draft assessment report to the other concerned Member States and the applicant for comment. In the mutual recognition procedure, a marketing authorisation has already been issued by the RMS and the RMS’s assessment report forms the basis for requesting other Member States’ mutual recognition of the marketing authorisation, unless they have objections on the grounds of a potentially serious risk to public health, in which case further discussions would be held in the Coordination group for Mutual recognition and Decentralised procedures (CMDh).