Update of eCTD and eDok specification documents


Various specification documents are being updated.



Documents are valid with immediate effect. 

Submissions by post or via the Portal will be accepted from 1 December 2018, yet will not be processed before 1 January 2019. Please use the relevant cover sheets or templates for submissions in line with the existing or new requirements. 

Please note the procedure for submissions according to HMV4 before 1 January 2019 (during the transitional period). For further details, please refer to the information dated 30 September 2018: